Amanda Young

Use of an Automated Bolus Calculator Reduces Fear of Hypoglycemia and Improves Confidence in Dosage Accuracy in Patients with Type 1 Diabetes Mellitus Treated with Multiple Daily Insulin Injections

Background: Many patients do not intensify their insulin regimens. It is believed that lack of adherence may be largely due to fear of hypoglycemia. We hypothesized that utilization of an automated bolus calculator (bolus advisor) might reduce fear of hypoglycemia and encourage patients to achieve improved glycemic control. Method: We surveyed 1,412 type 1 diabetes mellitus (T1DM) patients treated with multiple daily insulin injection therapy at 270 hospitals in the United Kingdom and Republic of Ireland to assess their attitudes and behaviors regarding insulin therapy after use of a bolus advisor (Accu-Chek® Aviva Expert blood glucose meter and bolus advisor system, Roche Diagnostics). The device automatically calculates bolus dosages based on current blood glucose values, anticipated meal intake, and other parameters. Results: Five hundred eighty-eight T1DM patients responded to the survey. Respondents were predominantly female, age <1 to 70 years, with diabetes duration of <1 to >15 years. Respondents had 4–12 weeks prior experience using the bolus advisor. 76.7% of respondents indicated current bolus advisor use to calculate insulin boluses for meals/snacks always or quite often. 52.0% of respondents indicated that fear of hypoglycemia was reduced (39.0%) or significantly reduced (13.0%). 78.8% indicated that confidence in the insulin dose calculation improved (50.8%) or significantly improved (28.0%). 89.3% indicated that the bolus advisor made bolus calculation easy or very easy compared with manual calculation. Conclusions: Most patients felt that using the bolus advisor was easier than manual bolus calculation, improved their confidence in the accuracy of their bolus dosage, and reduced their fear of hypoglycemia. Randomized trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes.

Psychosocial Aspects of Closed and Open Loop Insulin Delivery: Closing the Loop In Adults with Type 1 Diabetes in the Home Setting

To explore the psychosocial experiences of closed‐loop technology and to compare ratings of closed‐ and open‐loop technology for adults with Type 1 diabetes taking part in a randomized crossover study.

Evaluating the clinical appropriateness of nurses’ prescribing practice: method development and findings from an expert panel analysis

Background: The number of nurses independently prescribing medicines in England is rising steadily. There had been no attempt systematically to evaluate the clinical appropriateness of nurses’ prescribing decisions. Aims: (i) To establish a method of assessing the clinical appropriateness of nurses’ prescribing decisions; (ii) to evaluate the prescribing decisions of a sample of nurses, using this method. Method: A modified version of the Medication Appropriateness Index (MAI) was developed, piloted and subsequently used by seven medical prescribing experts to rate transcripts of 12 nurse prescriber consultations selected from a larger database of 118 audio-recorded consultations collected as part of a national evaluation. Experts were also able to give written qualitative comments on each of the MAI dimensions applied to each of the consultations. Analysis: Experts’ ratings were analysed using descriptive statistics. Qualitative comments were subjected to a process of content analysis to identify themes within and across both MAI items and consultations. Results: Experts’ application of the modified MAI to transcripts of nurse prescriber consultations demonstrated validity and feasibility as a method of assessing the clinical appropriateness of nurses’ prescribing decisions. In the majority of assessments made by the expert panel, nurses’ prescribing decisions were rated as clinically appropriate on all nine items in the MAI. Conclusion: A valid and feasible method of assessing the clinical appropriateness of nurses’ prescribing practice has been developed using a modified MAI and transcripts of audio-recorded consultations sent to a panel of prescribing experts. Prescribing nurses in this study were generally considered to be making clinically appropriate prescribing decisions. This approach to measuring prescribing appropriateness could be used as part of quality assurance in routine practice, as a method of identifying continuing professional development needs, or in future research as the expansion of non-medical prescribing continues.

Evaluating prescribing competencies and standards used in nurse independent prescribers’ prescribing consultations An observation study of practice in England

Background Independent prescribing of medicines by nurses is widely considered to be part of advanced nursing practice, and occurs within an episode of patient care that can be completed independently by a nurse. Nurse prescribers therefore require the competencies necessary to manage a consultation—such as history taking and diagnostic skills—and subsequently need to decide on any appropriate medicine to be prescribed. Safe prescribing should also involve an accurate, legible and comprehensive written prescription and documentation of the consultation in the patient’s records. However, the extent to which nurse independent prescribers use prescribing competencies and standards in practice had not been researched prior to this study. Aim To describe the frequency with which nurses use a range of prescribing competencies in their prescribing consultations, in order to provide a measure of the quality and safety of nurses’ independent prescribing practices. Design and methods Across 10 case study sites, 118 nurse independent prescribers’ prescribing consultations were analysed using non-participant observation and a structured checklist of prescribing competencies. Documentary analysis was also undertaken of a) prescriptions written (n =132) by nurses and b) the record of the prescribing episode in patient records (n =118). Sample and setting 118 prescribing consultations of 14 purposively selected nurse independent prescribers working in primary and secondary care trust case study sites in England. Findings Nurse independent prescribers were issuing a prescription every 2.82 consultations; nurses used a range of assessment and diagnosis competencies in prescribing consultations, but some were employed more consistently than others; nurses almost universally wrote full and accurate prescription scripts for their patients; nurses recorded each of their prescribing consultations, but some details of the consultation and the prescription issued were not always consistently recorded in the patient records. Conclusion The findings from this observation study provide evidence about the quality and safety of nurses’ prescribing consultations in England.

Alcohol-associated risks for young adults with Type 1 diabetes: a narrative review.

Diabet. Med. 29, 434–440 (2012)

Time to publication for NIHR HTA programme-funded research: a cohort study.

Objective To assess the time to publication of primary research and evidence syntheses funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme published as a monograph in Health Technology Assessment and as a journal article in the wider biomedical literature. Study design Retrospective cohort study. Setting Primary research and evidence synthesis projects funded by the HTA Programme were included in the cohort if they were registered in the NIHR research programmes database and was planned to submit the draft final report for publication in Health Technology Assessment on or before 9 December 2011. Main outcome measures The median time to publication and publication at 30 months in Health Technology Assessment and in an external journal were determined by searching the NIHR research programmes database and HTA Programme website. Results Of 458 included projects, 184 (40.2%) were primary research projects and 274 (59.8%) were evidence syntheses. A total of 155 primary research projects had a completion date; the median time to publication was 23 months (26.5 and 35.5 months to publish a monograph and to publish in an external journal, respectively) and 69% were published within 30 months. The median time to publication of HTA-funded trials (n=126) was 24 months and 67.5% were published within 30 months. Among the evidence syntheses with a protocol online date (n=223), the median time to publication was 25.5 months (28 months to publication as a monograph), but only 44.4% of evidence synthesis projects were published in an external journal. 65% of evidence synthesis studies had been published within 30.0 months. Conclusions Research funded by the HTA Programme publishes promptly. The importance of Health Technology Assessment was highlighted as the median time to publication was 9 months shorter for a monograph than an external journal article.

Holistic Impact of Closed-Loop Technology on People With Type 1 Diabetes.

The artificial pancreas (closed-loop insulin delivery) is a potentially exciting technological advance in diabetes. Using a continuous glucose monitor (CGM) and a control algorithm to modulate insulin delivery by a subcutaneous insulin infusion (CSII) pump, preliminary results from non-hospital settings look promising.1-5 Understanding the biomedical and psychological impact of these systems is crucial if it is to be a viable therapy choice for people with type 1 diabetes (T1DM). Recent research has explored the holistic impact of closed-loop technology overnight in the home setting.4,5 Here we report 3 case studies from new research1 demonstrating the impact, benefits and challenges experienced by adults in a closed-loop trial used overnight at home for 1 month. For a 33-year-old male, T1DM diagnosis aged 8 (CSII-5 years), HbA1c 8.6% (71 mmol/mol), BMI 30.6 kg/m2, time spent overnight during closed-loop with normal glucose (3.9 - 8.0 mmol/l) increased by 34% compared to control (real-time CGM combined with CSII) (average glucose level overnight 2.3 mmol/l lower). The experience was “life-changing.” The closed-loop system provided a novel sense of security and confidence, and feeling like “a better version of myself.” Night-time hypoglycemia, which had been a major concern, was reportedly eliminated. Feeling safe at night on closed-loop, this participant reported a “sense of loss” when it ended. Similar experiences were reported by other participants: cessation of night-time hypoglycemia and improved sleep, leading to improved daytime diabetes control and greater peace of mind. For a 32-year-old female, T1DM diagnosis aged 15 (CSII-10 years), HbA1c 8.5% (69 mmol/mol), BMI 26.9 kg/m2, time spent with normal glucose levels overnight increased from 48% to 56% during closed-loop (average glucose level 0.5 mmol/l lower), without increasing time spent hypoglycemic. The participant explained that closed-loop enabled her to better perform at work, provided greater flexibility, and had a positive impact waking up on a “good” number. She described her experience as “the best control I’ve had for several years,” although getting used to the equipment took some time. For a 30-year-old male, T1DM diagnosis aged 10 (CSII-8 years), HbA1c 7.2% (55 mmol/mol), BMI 27.2 kg/m2, during closed-loop, time spent euglycemic overnight increased by 12% (average glucose 8.0 vs 9.2 mmol/l). This participant experienced a number of technological difficulties at the beginning, which were described as “intensely irritating,” especially the design of the pump. Although once on closed-loop he explained how it “kind of takes some weight off your mind.” All participants reported technological challenges such as system portability, frequent alarms, and poor device connectivity. These data provide unique insight into the experience of participants using closed-loop technology. Closed-loop was associated with improved blood glucose control and psychosocial functioning. Greater control over diabetes was commonly reported, more broadly than blood glucose control. Benefits included “time off” from thinking about diabetes constantly, feelings of “normality,” and increased flexibility. The participants had trust in the algorithm during overnight infusion of insulin. However, downsides were commonly reported with hardware (pump and sensor). Next-generation technology may improve participants’ experiences and acceptability further.

The clinical relevance and newsworthiness of NIHR HTA-funded research: a cohort study

Objective To assess the clinical relevance and newsworthiness of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme funded reports. Study design Retrospective cohort study. Setting The cohort included 311 NIHR HTA Programme funded reports publishing in HTA in the period 1 January 2007–31 December 2012. The McMaster Online Rating of Evidence (MORE) system independently identified the clinical relevance and newsworthiness of NIHR HTA publications and non-NIHR HTA publications. The MORE system involves over 4000 physicians rating publications on a scale of relevance (the extent to which articles are relevant to practice) and a scale of newsworthiness (the extent to which articles contain news or something clinicians are unlikely to know). Main outcome measures The proportion of reports published in HTA meeting MORE inclusion criteria and mean average relevance and newsworthiness ratings were calculated and compared with publications from the same studies publishing outside HTA and non-NIHR HTA funded publications. Results 286/311 (92.0%) of NIHR HTA reports were assessed by MORE, of which 192 (67.1%) passed MORE criteria. The average clinical relevance rating for NIHR HTA reports was 5.48, statistically higher than the 5.32 rating for non-NIHR HTA publications (mean difference=0.16, 95% CI 0.04 to 0.29, p=0.01). Average newsworthiness ratings were similar between NIHR HTA reports and non-NIHR HTA publications (4.75 and 4.70, respectively; mean difference=0.05, 95% CI −0.18 to 0.07, p=0.402). NIHR HTA-funded original research reports were statistically higher for newsworthiness than reviews (5.05 compared with 4.64) (mean difference=0.41, 95% CI 0.18 to 0.64, p=0.001). Conclusions Funding research of clinical relevance is important in maximising the value of research investment. The NIHR HTA Programme is successful in funding projects that generate outputs of clinical relevance.

The completeness of intervention descriptions in published NIHR HTA funded trials: a cross sectional study

Methods A checklist for assessing intervention descriptions was applied to NIHR HTA funded RCTs published in Health Technology Assessment. The checklist was piloted twice on a sample of 10 reports. Kappa scores were generated to assess agreement in the checklist application. The checklist was modified and applied to all 98 NIHR HTA funded single trial RCTs published in the journal from January 1999 March 2011. Three assessors independently applied the checklist. Disagreements in scoring were discussed in the team; differences were then explored and resolved.

How to reduce the risk of failing to reach recruitment targets: lessons learnt from a pump pilot trial

Diabet. Med. 29, 1600–1601 (2012)