Laura Cocking

PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial

Objective To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries. Design Pragmatic, multicentre, parallel group, randomised controlled trial. Setting Five English hospitals. Participants 200 adults (71% (n=142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours. Interventions PCA (n=99) or nurse titrated analgesia (treatment as usual; n=101). Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. Results 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval −2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant. Conclusions PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.

PAin SoluTions In the Emergency Setting (PASTIES)—patient controlled analgesia versus routine care in emergency department patients with non-traumatic abdominal pain: randomised trial

Objective To determine whether patient controlled analgesia (PCA) is better than routine care in providing effective analgesia for patients presenting to emergency departments with moderate to severe non-traumatic abdominal pain. Design Pragmatic, multicentre, parallel group, randomised controlled trial Setting Five English hospitals. Participants 200 adults (66% (n=130) female), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe non-traumatic abdominal pain and were expected to be admitted to hospital for at least 12 hours. Interventions Patient controlled analgesia or nurse titrated analgesia (treatment as usual). Main outcome measures The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant’s hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate or severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. Results 196 participants were included in the primary analyses (99 allocated to PCA and 97 to treatment as usual). Mean total pain experienced was 35.3 (SD 25.8) in the PCA group compared with 47.3 (24.7) in the treatment as usual group. The adjusted between group difference was 6.3 (95% confidence interval 0.7 to 11.9). Participants in the PCA group received significantly more morphine (mean 36.1 (SD 22.4) v 23.6 (13.1) mg; mean difference 12.3 (95% confidence interval 7.2 to 17.4) mg), spent less of the study period in moderate or severe pain (32.6% v 46.9%; mean difference 14.5% (5.6% to 23.5%)), and were more likely to be perfectly or very satisfied with the management of their pain (83% (73/88) v 66% (57/87); adjusted odds ratio 2.56 (1.25 to 5.23)) in comparison with participants in the treatment as usual group. Conclusions Significant reductions in pain can be achieved by PCA compared with treatment as usual in patients presenting to the emergency department with non-traumatic abdominal pain. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280.

A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes

BACKGROUND Identification of permanent hearing impairment at the earliest possible age is crucial to maximise the development of speech and language. Universal newborn hearing screening identifies the majority of the 1 in 1000 children born with a hearing impairment, but later onset can occur at any time and there is no optimum time for further screening. A universal but non-standardised school entry screening (SES) programme is in place in many parts of the UK but its value is questioned. OBJECTIVES To evaluate the diagnostic accuracy of hearing screening tests and the cost-effectiveness of the SES programme in the UK. DESIGN Systematic review, case-control diagnostic accuracy study, comparison of routinely collected data for services with and without a SES programme, parental questionnaires, observation of practical implementation and cost-effectiveness modelling. SETTING Second- and third-tier audiology services; community. PARTICIPANTS Children aged 4-6 years and their parents. MAIN OUTCOME MEASURES Diagnostic accuracy of two hearing screening devices, referral rate and source, yield, age at referral and cost per quality-adjusted life-year. RESULTS The review of diagnostic accuracy studies concluded that research to date demonstrates marked variability in the design, methodological quality and results. The pure-tone screen (PTS) (Amplivox, Eynsham, UK) and HearCheck (HC) screener (Siemens, Frimley, UK) devices had high sensitivity (PTS ≥ 89%, HC ≥ 83%) and specificity (PTS ≥ 78%, HC ≥ 83%) for identifying hearing impairment. The rate of referral for hearing problems was 36% lower with SES (Nottingham) relative to no SES (Cambridge) [rate ratio 0.64, 95% confidence interval (CI) 0.59 to 0.69; p < 0.001]. The yield of confirmed cases did not differ between areas with and without SES (rate ratio 0.82, 95% CI 0.63 to 1.06; p = 0.12). The mean age of referral did not differ between areas with and without SES for all referrals but children with confirmed hearing impairment were older at referral in the site with SES (mean age difference 0.47 years, 95% CI 0.24 to 0.70 years; p < 0.001). Parental responses revealed that the consequences to the family of the referral process are minor. A SES programme is unlikely to be cost-effective and, using base-case assumptions, is dominated by a no screening strategy. A SES programme could be cost-effective if there are fewer referrals associated with SES programmes or if referrals occur more quickly with SES programmes. CONCLUSIONS A SES programme using the PTS or HC screener is unlikely to be effective in increasing the identified number of cases with hearing impairment and lowering the average age at identification and is therefore unlikely to represent good value for money. This finding is, however, critically dependent on the results of the observational study comparing Nottingham and Cambridge, which has limitations. The following are suggested: systematic reviews of the accuracy of devices used to measure hearing at school entry; characterisation and measurement of the cost-effectiveness of different approaches to the ad-hoc referral system; examination of programme specificity as opposed to test specificity; further observational comparative studies of different programmes; and opportunistic trials of withdrawal of SES programmes. TRIAL REGISTRATION Current Controlled Trials ISRCTN61668996. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 36. See the NIHR Journals Library website for further project information.

The cost-effectiveness of patient-controlled analgesia vs. standard care in patients presenting to the Emergency Department in pain, who are subsequently admitted to hospital

The clinical effectiveness of patient‐controlled analgesia has been demonstrated in a variety of settings. However, patient‐controlled analgesia is rarely utilised in the Emergency Department. The aim of this study was to compare the cost‐effectiveness of patient‐controlled analgesia vs. standard care in participants admitted to hospital from the Emergency Department with pain due to traumatic injury or non‐traumatic abdominal pain. Pain scores were measured hourly for 12 h using a visual analogue scale. Cost‐effectiveness was measured as the additional cost per hour in moderate to severe pain avoided by using patient‐controlled analgesia rather than standard care (the incremental cost‐effectiveness ratio). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. The cost per hour in moderate or severe pain averted was estimated as £24.77 (€29.05, US

A directly comparative two-gate case–control diagnostic accuracy study of the pure tone screen and HearCheck screener tests for identifying hearing impairment in school children

30.80) (bootstrap estimated 95%CI £8.72 to £89.17) for participants suffering pain from traumatic injuries and £15.17 (€17.79, US

THE COST-EFFECTIVENESS OF PATIENT CONTROLLED ANALGESIA VERSUS ROUTINE CARE IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT IN PAIN, WHO ARE SUBSEQUENTLY ADMITTED TO HOSPITAL

18.86) (bootstrap estimate 95%CI £9.03 to £46.00) for participants with non‐traumatic abdominal pain. Overall costs were higher with patient‐controlled analgesia than standard care in both groups: pain from traumatic injuries incurred an additional £18.58 (€21.79 US

Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

23.10) (95%CI £15.81 to £21.35) per 12 h; and non‐traumatic abdominal pain an additional £20.18 (€23.67 US

Executive summary from 2007 report

25.09) (95%CI £19.45 to £20.84) per 12 h.

Update of the diagnostic accuracy systematic review

Objectives This study directly compared the accuracy of two audiometry-based tests for screening school children for hearing impairment: the currently used test, pure tone screen and a device newly applied to children, HearCheck Screener. Design Two-gate case–control diagnostic test accuracy study. Setting and participants Hearing impaired children (‘intended cases’) aged 4–6 years were recruited between February 2013 and August 2014 from collaborating audiology services. Children with no previously identified impairment (‘intended controls’) were recruited from Foundation and Year 1 of schools between February 2013 and June 2014 in central England. The reference standard was pure tone audiometry. Tests were administered at Nottingham Hearing Biomedical Research Unit or, for some intended cases only, in the participant’s home. Main outcome measures Sensitivity and specificity of the pure tone screen and HearCheck tests based on pure tone audiometry result as reference standard. Results 315 children (630 ears) were recruited; 75 from audiology services and 240 from schools. Full test and reference standard data were obtained for 600 ears; 155 ears were classified as truly impaired and 445 as truly hearing based on the pure tone audiometry assessment. Sensitivity was estimated to be 94.2% (95% CI 89.0% to 97.0%) for pure tone screen and 89.0% (95% CI 82.9% to 93.1%) for HearCheck (difference=5.2% favouring pure tone screen; 95% CI 0.2% to 10.1%; p=0.02). Estimates for specificity were 82.2% (95% CI 77.7% to 86.0%) for pure tone screen and 86.5% (95% CI 82.5% to 89.8%) for HearCheck (difference=4.3% favouring HearCheck; 95% CI0.4% to 8.2%; p=0.02). Conclusion Pure tone screen was better than HearCheck with respect to sensitivity but inferior with respect to specificity. As avoiding missed cases is arguably of greater importance for school entry screening, pure tone screen is probably preferable in this context. Study registration number Current controlled trials: ISRCTN61668996.

False-negative results from screening tests

Objectives & Background The clinical effectiveness of patient controlled analgesia (PCA) has been demonstrated in a variety of settings. However, PCA is rarely utilized in the emergency department (ED). The aim of this study was to compare the cost effectiveness of PCA versus treatment as usual (TAU) in patients admitted to the ward from the ED with pain due to traumatic injury or non-traumatic abdominal pain. This is the cost-effectiveness analysis of the previously reported PAin SoluTions In the Emergency Setting (PASTIES) study. Methods Pain scores were measured hourly for 12 hours using a visual analogue scale from 0–100 mm. Scores of 45 mm or above reflected moderate or severe pain. Cost-effectiveness is reported as the additional cost per hour in moderate to severe pain avoided by using PCA rather than TAU, the incremental cost-effectiveness ratio (ICER). Sampling variation was estimated using bootstrap methods and the effects of parameter uncertainty explored in a sensitivity analysis. Results For patients suffering pain from traumatic injuries, the cost per hour in moderate or severe pain averted (ICER) was estimated as £24.77 (bootstrap estimate 95% CI=£8.72 to £89.17). The ICER for patients with abdominal pain was estimated as £15.17 (bootstrap estimate 95% CI=£9.03 to £46.00). Overall costs were higher with PCA than TAU in both groups: for pain from traumatic injuries an additional £18.58 (95% CI 15.81 to 21.35) per 12 hours; for abdominal pain £20.18 (95% CI 19.45 to 20.84). Conclusion The cost of PCA use in ED varies with the clinical scenario, but is in the region of £15–£25 per hour of moderate or severe pain averted. Overall additional costs are around £20 per 12-hour patient episode. Figure 1 Sampling variation for traumatic pain trial: ICER estimates from 1,000 bootstrap samples shown on the cost-effectiveness plane Figure 2 Sampling variation for abdominal pain trial: ICER estimates from 1,000 bootstrap samples shown on the cost-effectiveness plane