A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery.

The benefits of pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) are restricted by poor uptake and completion. Lay health workers (LHWs) have been effective in improving access to treatment and services for other health conditions. We have successfully shown the feasibility of this approach in a PR setting and its acceptability to the LHWs and COPD patients. We present here the feasibility of assessment, and the fidelity of delivery of LHW support achieved for COPD patients referred for PR. LHWs, volunteer COPD patients experienced in PR, received training in the intervention including communication skills, confidentiality and behaviour change techniques (BCTs). Interactions between LHWs and patients were recorded, transcribed and coded for delivery style and BCTs. Inter-rater agreement on the coding of delivery style and BCTs was high at >84%. LHWs built rapport and communicated attentively in over 80% of interactions. LHWs most consistently delivered BCTs concerning information provision about the consequences of PR often making those consequences salient by referring to their own positive experience of PR. Social support BCTs were also used by the majority of LHWs. The use of BCTs varied between LHWs. The assessment of intervention delivery fidelity by LHWs was feasible. LHW training in the setting of PR should add emphasis to the acquisition of BCT skills relating to goal setting and action planning.

The National COPD Audit - what you need to know.

The secondary care work stream of the National COPD Audit Programme aims to improve care and outcomes for patients with exacerbation of chronic obstructive pulmonary disease (COPD) wherever and whenever they are admitted to hospital. To achieve this, prospective audit is combined with real-time feedback of data to individual units, together with support for quality improvement and high-level change levers. COPD exacerbations comprise a large proportion of the acute take. Only by working collaboratively across emergency, acute and general medicine, respiratory, geriatric and other teams can individual trusts deliver optimal care. This review provides background to the national COPD audit programme, relevant to all those caring for people with COPD exacerbations in secondary care.

Time to NIV and mortality in AECOPD hospital admissions: an observational study into real world insights from National COPD Audits.

Background: Randomised control trial (RCT)-derived survival figures for acute exacerbation of chronic obstructive pulmonary disease admissions managed with non-invasive ventilation (NIV) have not been replicated in UK clinical audits. Subsequent guidelines have emphasised the need for timely NIV application. Methods: Data from the 2008 and 2014 national chronic obstructive pulmonary disease audits was used to analyse the association between time to NIV and mortality. Results: 1032 patients received NIV in 2008, and 1612 in 2014. Overall mortality rates reduced between the audits from 24.9% in 2008 to 16.8% in 2014 but time to NIV lengthened. In 2014, 20.9% of patients received NIV within 60 min versus 24.9% in 2008 (p=0.001). The proportion of patients receiving NIV between 3 and 24 hours increased from 31.3% in 2008 to 39% in 2014 (p=0.001). Patients admitted with hypercapnic acidotic respiratory failure who received NIV within 3 hours had lower in-patient mortality than those who received NIV between 3 and 24 hours, 15.9% versus 18.4%, but this did not reach statistical significance (p=0.425), but acidotic patients receiving NIV >24 hours after admission had significantly higher mortality (28.9%, p=0.002). A second cohort admitted with hypercapnia but normal range pH, who developed later acidosis, had higher mortality (24.6%), compared with those acidotic on admission (18% p≤0.001) and an extremely high mortality when NIV was given >24 hours after admission (42.6%). Conclusion: Survival rates for those treated with NIV has improved between the two audits but remains lower than reported in RCTs. Patients who developed acidosis after admission and received NIV later in the hospital stay have even higher mortality and deserve further study and clinical attention.

Inaccurate diagnosis of COPD: the Welsh National COPD Audit.

BACKGROUND: The diagnosis of chronic obstructive pulmonary disease (COPD) is confirmed with spirometry demonstrating persistent airflow obstruction. AIM: To evaluate the clinical characteristics and management of patients in primary care on COPD registers with spirometry incompatible with COPD. DESIGN AND SETTING: A primary care audit of Welsh COPD Read-Coded patient data from the Quality and Outcomes Framework (QOF) COPD register in Wales. METHOD: Patients on the QOF COPD register with incompatible spirometry (post-bronchodilator forced expiratory lung volume in 1 second/forced vital capacity [FEV1/FVC] ratio ≥0.70) were compared with those with compatible spirometry (FEV1/FVC <0.70). RESULTS: This audit included 63% of Welsh practices contributing 48 105 patients. Only 19% (n = 8957) of patients were post-bronchodilator FEV1/FVC Read-Coded and were included in this study. Of these, 75% (n = 6702) had compatible spirometry and 25% (n = 2255) did not. Patients with incompatible spirometry were more likely female (P = 0.009), never-smokers (P<0.001), had higher body mass index (P<0.001), and better mean FEV1 (P<0.001). Medical Research Council (MRC) breathlessness scores, exacerbation frequency, and asthma co-diagnosis were similar between groups. Patients in both groups were just as likely to receive inhaled corticosteroid (ICS) and long-acting beta-agonists (LABAs), but patients with incompatible spirometry were less likely to receive long-acting muscarinic antagonists (LAMAs) (P<0.001) or LABA/ICS (P = 0.002) combinations. CONCLUSION: Patients on the COPD QOF register with spirometry incompatible with COPD are symptomatic and managed using significant resources. If quality of care and effective resource use are to be improved, focus must be given to correct diagnosis in this group.

Comparing the Diagnostic Accuracy of Simple Tests to Screen for Diabetic Peripheral Neuropathy: Protocol for a Cross-Sectional Study.

BACKGROUND: Various tests are used to detect diabetic peripheral neuropathy by assessing sense perception in the feet. Tests vary in terms of time and resources required. Simple tests are those that can be conducted quickly and easily in primary care without laboratory equipment. There are some limitations to these simple tests, an example being the variable amplitude of the 128 Hz tuning fork. A new test, VibraTip (McCallan Medical, UK), might be a valuable alternative as it emits a consistent amplitude and may offer improved diagnostic accuracy. OBJECTIVE: The aims of this study are to estimate the diagnostic accuracy of the VibraTip device for diabetic peripheral neuropathy against the reference standard of sural nerve conduction velocity measurement, and to assess whether the VibraTip offers superior diagnostic accuracy to other routine tests based on vibration or touch. METHODS: The study will prospectively recruit adults with type 2 diabetes who are due to attend a routine follow-up clinic. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be sural nerve conduction velocity measurement. RESULTS: Funding is being sought to conduct this research. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against sural nerve conduction velocity measurement, including sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio. Receiver operating characteristic curves will be constructed and compared for each test. CONCLUSIONS: This study will be the first within-study comparison of 5 simple tests for screening diabetic peripheral neuropathy and will address uncertainties in the potential benefits of using VibraTip in comparison with the other tests.

Virtual Touch™ Quantification to Diagnose and Monitor Liver Fibrosis in Hepatitis B and Hepatitis C: A NICE Medical Technology Guidance.

Virtual Touch™ Quantification (VTq) is a software application used with Siemens Acuson ultrasound scanners to assess the stiffness of liver tissue. The National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee (MTAC) selected VTq for evaluation and invited the company to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by NICE, independently assessed the evidence submitted. The EAC conducted its own systematic review, meta-analysis and economic analysis to supplement the company's submitted evidence. The meta-analyses comparing VTq and transient elastography (TE) with liver biopsy (LB) provided pooled estimates of liver stiffness and stage of fibrosis for the study populations (hepatitis B, hepatitis C or combined populations). When comparing significant fibrosis (Metavir score F ≥ 2) for both hepatitis B and C, VTq had slightly higher values for both sensitivity and specificity (77 and 81 %) than TE (76 and 71 %). The overall prevalence of cirrhosis (F4, combined populations) was similar with VTq and TE (23 vs. 23 %), and significant fibrosis (F ≥ 2) was lower for VTq than for TE (55 vs. 62 %). The EAC revised the company's de novo cost model, which resulted in a cost saving of £53 (against TE) and £434 (against LB). Following public consultation, taking into account submitted comments, NICE Medical Technology Guidance MTG27 was published in September 2015. This recommended the adoption of the VTq software to diagnose and monitor liver fibrosis in patients with hepatitis B or hepatitis C.

Multicentre prospective survey of SeHCAT provision and practice in the UK.

OBJECTIVE: A clinical diagnosis of bile acid malabsorption (BAM) can be confirmed using SeHCAT (tauroselcholic ((75)selenium) acid), a radiolabelled synthetic bile acid. However, while BAM can be the cause of chronic diarrhoea, it is often overlooked as a potential diagnosis. Therefore, we investigated the use of SeHCAT for diagnosis of BAM in UK hospitals. DESIGN: A multicentre survey was conducted capturing centre and patient-level information detailing patient care-pathways, clinical history, SeHCAT results, treatment with bile acid sequestrants (BAS), and follow-up in clinics. Eligible data from 38 centres and 1036 patients were entered into a validated management system. RESULTS: SeHCAT protocol varied between centres, with no standardised patient positioning, and differing referral systems. Surveyed patients had a mean age of 50 years and predominantly women (65%). The mean SeHCAT retention score for all patients was 19% (95% CI 17.8% to 20.3%). However, this differed with suspected BAM type: type 1: 9% (95% CI 6.3% to 11.4%), type 2: 21% (95% CI 19.2% to 23.0%) and type 3: 22% (95% CI 19.6% to 24.2%). Centre-defined 'abnormal' and 'borderline' results represented over 50% of the survey population. BAS treatment was prescribed to only 73% of patients with abnormal results. CONCLUSIONS: The study identified a lack of consistent cut-off/threshold values, with differing centre criteria for defining an 'abnormal' SeHCAT result. BAS prescription was not related in a simple way to the SeHCAT result, nor to the centre-defined result, highlighting a lack of clear patient care-pathways. There is a clear need for a future diagnostic accuracy study and a better understanding of optimal management pathways.

A Multicenter Prospective Study to Investigate the Diagnostic Accuracy of the SeHCAT Test in Measuring Bile Acid Malabsorption: Research Protocol.

BACKGROUND: Bile acid malabsorption (BAM) is one possible explanation for chronic diarrhea. BAM may be idiopathic, or result from ileal resection or inflammation including Crohn's disease, or may be secondary to other conditions, including cholecystectomy, peptic ulcer surgery, and chronic pancreatitis. No "gold standard" exists for clinical diagnosis of BAM, but response to treatment with a bile acid sequestrant (BAS) is often accepted as confirmation. The SeHCAT (tauroselcholic [selenium-75] acid) test uses a radiolabeled synthetic bile acid and provides a diagnostic test for BAM, but its performance against "trial of treatment" is unknown. Fibroblast growth factor 19 (FGF-19) and 7-alpha-hydroxy-4-cholesten-3-one (C4) also offer potential new biomarkers of BAM. OBJECTIVE: This protocol describes a multicenter prospective study to evaluate the diagnostic accuracy of SeHCAT and 2 biomarkers in predicting BAM as assessed by trial of treatment. METHODS: Participating gastroenterology centers should have a minimum workload of 30 SeHCAT patients per annum. Patients should not be pregnant, on medication that could confound follow-up, or have any severe comorbidity. All eligible patients attending a gastrointestinal appointment will be invited to participate. On attending the SeHCAT test, blood and fecal samples will be collected for analysis of FGF-19 by enzyme-linked immunosorbent assay and for C4 and fractionated bile acids by liquid chromatography-mass spectrometry. A capsule containing radiolabeled SeHCAT will be administered orally and a scan performed to measure SeHCAT activity. Patients will return on day 7 to undergo a second scan to measure percentage SeHCAT retention. The test result will be concealed from clinicians and patients. BAS will be dispensed to all patients, with a follow-up gastroenterologist appointment at 2 weeks for clinical assessment of treatment response and adherence. Patients responding positively will continue treatment for a further 2 weeks and all patients will have a final follow-up at 8 weeks. The diagnostic accuracy of the SeHCAT test and biomarkers will be analyzed at different thresholds using sensitivity, specificity, positive and negative predictive value, likelihood ratios, and area under the curve in a sample of 600 patients. Multivariable logistic regression models will be used to assess the association between presence of BAM and continuous SeHCAT retention levels after adjustment for confounders. RESULTS: Funding is being sought to conduct this research. CONCLUSIONS: The SeHCAT test for diagnosis of BAM has been in common use in the United Kingdom for more than 30 years and an evidence-based assessment of its accuracy is overdue. The proposed study has some challenges. Some forms of BAS treatment are unpleasant due to the texture and taste of the resin powder, which may negatively affect recruitment and treatment adherence. Trial of treatment is not as "golden" a standard as would be ideal, and itself warrants further study.

The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.

The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.