Exploring glass as a novel method for hands-free data entry in flexible cystoscopy

We present a way to annotate cystoscopy finding on Google Glass in a reproducible and hands free manner for use by surgeons during operations in the sterile environment inspired by the current practice of hand-drawn sketches. We developed three data entry variants based on speech and head movements. We assessed the feasibility, benefits and drawbacks of the system with 8 surgeons and Foundation Doctors having up to 30 years' cystoscopy experience at a UK hospital in laboratory trials. We report data entry speed and error rate of input modalities and contrast it with the participants' feedback on their perception of usability, acceptance, and suitability for deployment. The results are supportive of new data entry technologies and point out directions for future improvement of eyewear computers. The findings can be generalised to other endoscopic procedures (e.g. OGD/laryngoscopy) and could be included within hospital IT in the future

Preconception care for women with type 1 or type 2 diabetes mellitus: a mixed-methods study exploring uptake of preconception care

Background: Diabetes mellitus is a global health problem and one of the most common medical conditions in pregnancy. A wide range of modifiable risk factors are associated with diabetes mellitus in pregnancy, and it is widely acknowledged that preconception care (PCC) is beneficial for women with pre-existing diabetes mellitus. However, uptake of PCC services is low. Objectives: To systematically review qualitative research on PCC for women with pre-existing diabetes mellitus of childbearing age, identify facilitators of and barriers to uptake of PCC and establish themes and gaps in knowledge. Through qualitative interviews explore views on the provision of, and facilitators of and barriers to the uptake of, PCC. Design: Mixed methods encompassing a systematic review and qualitative interviews. Setting: Two secondary care sites and 11 primary care sites. Participants: Women of childbearing age with pre-existing type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) of white British or Pakistani origin. Interventions: None. Analysis: A narrative synthesis of the literature using thematic analysis and a thematic analysis of the qualitative interview data using the method of constant comparison. Results: Eighteen qualitative studies were included in the systematic review and a quality appraisal was carried out using relevant criteria for qualitative research appraisal, including a narrative summary of study quality. Twelve interviews with women with pre-existing T1DM or T2DM were carried out. This fell short of the original aim of interviewing 48 women owing to challenges in recruitment, especially in primary care. A synthesis of these data shows that uptake of PCC is influenced by a range of factors, including the complexity of pregnancy planning, the skill and expertise of health professionals who provide care to women with diabetes mellitus, the role of health professionals in the delivery of PCC, and the quality of relationships between women and health professionals. Limitations: Owing to significant challenges with recruitment of participants, particularly in primary care, 12 interviews with women with pre-existing T1DM or T2DM were carried out, which fell short of the a priori sample size. Conclusions: Reconceptualising PCC to place greater emphasis on pregnancy planning, fertility and contraception would lower some of the existing barriers to uptake of care. It is important to clarify who is responsible for the delivery of PCC to women with pre-existing diabetes mellitus and to ensure that the correct expertise is available so that opportunities for advice giving are maximised. Relationships between women and health professionals should be based on a partnership approach that encourages mutual trust and respect, focusing on positive change rather than negative outcomes. Future work: Further research is needed to investigate the views and experiences of stakeholders that commission, design and deliver PCC services for women with pre-existing diabetes mellitus; to explore experiences of women from minority or ethnically diverse backgrounds; to investigate the role of family support in contraception, pregnancy planning and PCC; and to investigate the management of diabetes mellitus in neonatal care and its role in breastfeeding. Study registration: This study is registered as PROSPERO CRD42014015592 and ISRCTN12983949. Funding: The National Institute for Health Research Health Technology Assessment programme

The management of type 2 diabetes with fixed‐ratio combination insulin degludec/liraglutide (IDegLira) versus basal‐bolus therapy (insulin glargine U100 plus insulin aspart): a short‐term cost‐effectiveness analysis in the UK setting

Aim: To evaluate the cost‐effectiveness of IDegLira versus basal‐bolus therapy (BBT) with insulin glargine U100 plus up to 4 times daily insulin aspart for the management of type 2 diabetes in the UK. Methods: A Microsoft Excel model was used to evaluate the cost‐utility of IDegLira versus BBT over a 1‐year time horizon. Clinical input data were taken from the treat‐to‐target DUAL VII trial, conducted in patients unable to achieve adequate glycaemic control (HbA1c <7.0%) with basal insulin, with IDegLira associated with lower rates of hypoglycaemia and reduced body mass index (BMI) in comparison with BBT, with similar HbA1c reductions. Costs (expressed in GBP) and event‐related disutilities were taken from published sources. Extensive sensitivity analyses were performed. Results: IDegLira was associated with an improvement of 0.05 quality‐adjusted life years (QALYs) versus BBT, due to reductions in non‐severe hypoglycaemic episodes and BMI with IDegLira. Costs were higher with IDegLira by GBP 303 per patient, leading to an incremental cost‐effectiveness ratio (ICER) of GBP 5924 per QALY gained for IDegLira versus BBT. ICERs remained below GBP 20 000 per QALY gained across a range of sensitivity analyses. Conclusions: IDegLira is a cost‐effective alternative to BBT with insulin glargine U100 plus insulin aspart, providing equivalent glycaemic control with a simpler treatment regimen for patients with type 2 diabetes inadequately controlled on basal insulin in the UK

The impact of Type 2 diabetes prevention programmes based on risk-identification and lifestyle intervention intensity strategies: a cost-effectiveness analysis.

AIMS: To develop a cost-effectiveness model to compare Type 2 diabetes prevention programmes targeting different at-risk population subgroups with a lifestyle intervention of varying intensity. METHODS: An individual patient simulation model was constructed to simulate the development of diabetes in a representative sample of adults without diabetes from the UK population. The model incorporates trajectories for HbA1c , 2-h glucose, fasting plasma glucose, BMI, systolic blood pressure, total cholesterol and HDL cholesterol. Patients can be diagnosed with diabetes, cardiovascular disease, microvascular complications of diabetes, cancer, osteoarthritis and depression, or can die. The model collects costs and utilities over a lifetime horizon. The perspective is the UK National Health Service and personal social services. We used the model to evaluate the population-wide impact of targeting a lifestyle intervention of varying intensity to six population subgroups defined as high risk for diabetes. RESULTS: The intervention produces 0.0003 to 0.0009 incremental quality-adjusted life years and saves up to £1.04 per person in the general population, depending upon the subgroup targeted. Cost-effectiveness increases with intervention intensity. The most cost-effective options are to target individuals with HbA1c > 42 mmol/mol (6%) or with a high Finnish Diabetes Risk (FINDRISC) probability score (> 0.1). CONCLUSION: The model indicates that diabetes prevention interventions are likely to be cost-effective and may be cost-saving over a lifetime. In the model, the criteria for selecting at-risk individuals differentially impact upon diabetes and cardiovascular disease outcomes, and on the timing of benefits. These findings have implications for deciding who should be targeted for diabetes prevention interventions

Exploring the provision of diabetes nutrition education by practice nurses in primary care settings

Background High‐quality nutrition education is recommended as an essential component of diabetes care. In the UK, there has been a gradual shift of inter‐professional boundaries with respect to providing nutritional care for people with type 2 diabetes. Only a minority now regularly receive advice from a dietitian. Instead, increased demands for nutrition education are being absorbed by practice nurses. The present study seeks to explore this situation through the views of practice nurses on the services that they provide and the issues they face. Methods A qualitative approach using semi‐structured interviews was employed. Practice nurses were recruited using purposive sampling, and nine were interviewed. Data were analysed using the Framework Method. The Theoretical Domains Framework from the COM‐B (‘capability’, ‘opportunity’, ‘motivation’ and ‘behaviour’) model of behaviour change, as increasingly employed to explore the behaviour of healthcare professionals, was used to further frame the findings. Results Practice nurses reported that ongoing diabetes nutrition education only took place at annual review appointments and was limited to 5–10 min. They described how they are expected to take on a more advanced role in diabetes nutrition education than they can provide and are becoming increasingly isolated in this role as a result of a lack of time, practical and informational support, and training standards and provision. Conclusions A range of service improvements led by dietitians, which focus on strengthening the working environment and enhancing professional support available for practice nurses who provide diabetes nutrition education, could improve quality of care and health outcomes in people with diabetes within current time restraints

Association between age and access to immediate breast reconstruction in women undergoing mastectomy for breast cancer.

BACKGROUND: National guidelines state that patients with breast cancer undergoing mastectomy in England should be offered immediate breast reconstruction (IR), unless precluded by their fitness for surgery or the need for adjuvant therapies. METHODS: A national study investigated factors that influenced clinicians' decision to offer IR, and collected data on case mix, operative procedures and reconstructive decision-making among women with breast cancer having a mastectomy with or without IR in the English National Health Service between 1 January 2008 and 31 March 2009. Multivariable logistic regression was used to examine the relationship between whether or not women were offered IR and their characteristics (tumour burden, functional status, planned radiotherapy, planned chemotherapy, perioperative fitness, obesity, smoking status and age). RESULTS: Of 13 225 women, 6458 (48·8 per cent) were offered IR. Among factors the guidelines highlighted as relevant to decision-making, the three most strongly associated with the likelihood of an offer were tumour burden, planned radiotherapy and performance status. Depending on the combination of their values, the probability of an IR offer ranged from 7·4 to 85·1 per cent. A regression model that included all available factors discriminated well between whether or not women were offered IR (c-statistic 0·773), but revealed that increasing age was associated with a fall in the probability of an IR offer beyond that expected from older patients' tumour and co-morbidity characteristics. CONCLUSION: Clinicians are broadly following guidance on the offer of IR, except with respect to patients' age

Clinical effectiveness and cost-effectiveness results from the randomised, Phase IIB trial in previously untreated patients with chronic lymphocytic leukaemia to compare fludarabine, cyclophosphamide and rituximab with fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab: the Attenuated dose Rituximab with ChemoTherapy In Chronic lymphocytic leukaemia (ARCTIC) trial

Background: The conventional frontline therapy for fit patients with chronic lymphocytic leukaemia (CLL) is fludarabine, cyclophosphamide and rituximab (FCR). Rituximab (Mabthera®, Roche Products Ltd) targets the CD20 antigen, which is expressed at low levels in CLL. The standard dose of rituximab in CLL (375 mg/m2 in cycle 1 and 500 mg/m2 in cycles 2–6) was selected based on toxicity data only. Small doses of rituximab (as low as 20 mg) have biological activity in CLL, with an immediate reduction in circulating CLL cells and down-regulation of CD20. Phase II trials had suggested improved efficacy with the addition of mitoxantrone to FCR. The key assumption for the Attenuated dose Rituximab with ChemoTherapy In CLL (ARCTIC) trial was that the addition of mitoxantrone to fludarabine, cyclophosphamide and low-dose rituximab would be more effective than conventional FCR. Objectives: To assess whether fludarabine, cyclophosphamide, mitoxantrone and low-dose rituximab (FCM-miniR) (100 mg of rituximab per cycle) was non-inferior to FCR in frontline CLL. Complete response (CR) rate was the primary end point, with the secondary end points being progression-free survival (PFS), overall survival (OS), overall response rate, eradication of minimal residual disease (MRD), safety and cost-effectiveness. Design: ARCTIC was a UK multicentre, randomised, controlled, open, Phase IIB non-inferiority trial in previously untreated CLL. A total of 206 patients with previously untreated CLL who required treatment, according to the International Workshop on Chronic Lymphocytic Leukaemia criteria, were to be randomised to FCR or FCM-miniR. There was an independent Data Monitoring and Ethics Committee (DMEC) with a pre-planned interim efficacy assessment on 103 participants. Results: The DMEC’s interim analysis led to early trial closure. Although the response rates in both arms were higher than anticipated, FCM-miniR had a lower CR rate than FCR. This was partly attributable to the higher toxicity associated with mitoxantrone. A total of 100 participants completed FCR, 79 completed FCM-miniR and 21 commenced FCM-miniR but switched to FCR following DMEC recommendations. The CR rate for participants receiving FCR was 76%, compared with 55% for FCM-miniR (adjusted odds ratio 0.37; 95% confidence interval 0.19 to 0.73). Key secondary end points also showed that FCR was superior, with more participants achieving MRD negativity (57% for FCR vs. 46% for FCM-miniR). More participants experienced a serious adverse reaction with FCM-miniR compared with FCR (50% vs. 41%). At a median of 37.3 months’ follow-up, the PFS and OS rates are good compared with previous studies, with no significant difference between the treatment arms. The economic analysis indicates that because FCM-miniR is less effective than FCR, FCM-miniR is not expected to be cost-effective over a lifetime horizon, producing a mean cost-saving of –£7723, a quality-adjusted life-year loss of –0.73 and a resulting incremental net monetary loss of –£6780. Conclusions: FCM-miniR is less well tolerated, with poorer response rates, than FCR, partly owing to the additional toxicity associated with mitoxantrone. In view of this, FCM-miniR will not be taken forward into a larger definitive Phase III trial. The trial demonstrated that oral FCR yields extremely high response rates compared with historical series with intravenous chemotherapy. Future work: We shall compare the results of ARCTIC with those of the ADMIRE (Does the ADdition of Mitoxantrone Improve Response to FCR chemotherapy in patients with CLL?) trial, which compared FCR with FCM-R to assess the efficacy of low- versus standard-dose rituximab, allowing for the toxicity associated with mitoxantrone. Trial registration: Current Controlled Trials ISRCTN16544962. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 28. See the NIHR Journals Library website for further project information

A genome-wide association study provides evidence of sex-specific involvement of Chr1p35.1 (<i>ZSCAN20-TLR12P</i>) and Chr8p23.1 (<i>HMGB1P46</i>) with diabetic neuropathic pain

AbstractNeuropathic pain is defined as pain arising as a direct consequence of a lesion or a disease affecting the somatosensory system and it affects around 1 in 4 diabetic patients in the UK. The purpose of this genome-wide association study (GWAS) was to identify genetic contributors to this disorder. Cases of neuropathic pain were defined as diabetic patients with a multiple prescription history of at least one of five drugs specifically indicated for the treatment of neuropathic pain. Controls were diabetic individuals who were not prescribed any of these drugs, nor amitriptyline, carbamazepine, or nortriptyline. Overall, 961 diabetic neuropathic pain cases and 3260 diabetic controls in the Genetics of Diabetes Audit and Research Tayside (GoDARTS) cohort were identified. We found a cluster in the Chr1p35.1 (ZSCAN20-TLR12P) with a lowest P value of 2.74×10−7 at rs71647933 in females and a cluster in the Chr8p23.1, next to HMGB1P46 with a lowest P value of 8.02×10−7 at rs6986153 in males. Sex-specific narrow sense heritability was higher in males (30.0%) than in females (14.7%). This GWAS on diabetic neuropathic pain provides evidence for the sex-specific involvement of Chr1p35.1 (ZSCAN20-TLR12P) and Chr8p23.1 (HMGB1P46) with the disorder, indicating the need for further research

The need to improve fertility awareness

Women and men globally are delaying the birth of their first child. In the UK, the average age of first conception in women is 29 years. Women experience age-related fertility decline so it is important that men and women are well-informed about this, and other aspects of fertility. A group of UK stakeholders have established the Fertility Education Initiative to develop tools and information for children, adults, teachers, parents and healthcare professionals dedicated to improving knowledge of fertility and reproductive health

Reasonable adjustments to provide equitable and inclusive assessment, screening and treatment of osteoporosis for adults with intellectual disabilities: a feasibility study

Background: People with intellectual disabilities are a high risk population for developing osteoporosis and fragility fractures, yet they experience barriers to accessing dual‐energy x‐ray absorptiometry (DXA) bone mineral density (BMD) screening and fracture assessment. Reasonable adjustments are a statutory requirement in the UK, but there is a paucity of evidence‐based examples to assist their identification, implementation and evaluation. Method: Thirty adults with intellectual disabilities underwent DXA BMD screening and fracture risk assessment. Reasonable adjustments were identified and implemented. Results: The presence of osteopenia or osteoporosis was detected in 23 out of 29 (79%) participants. Osteoporosis professionals report that 17 of 18 reasonable adjustments identified and implemented are both important and easy to implement. Conclusion: Adults across all levels of intellectual disabilities can complete DXA BMD screening with reasonable adjustments. Widely implementing these reasonable adjustments would contribute to reducing inequalities in health care for adults with intellectual disabilities