Paper Pro Forma Research Articles

Evaluating the challenges in implementation of the royal college of ophthalmologists (RCOphth) 2020 guidelines on hydroxychloroquine retinopathy screening at Rochdale eye unit, United Kingdom

AbstractPurpose: The Royal College of Ophthalmologists (RCOphth) updated their hydroxychloroquine (HCQ) retinopathy screening guidelines in 2020. The aim of our study was to analyse the implementation of these guidelines at Rochdale Eye Unit, UK, along with identification of any challenges/areas for development.Methods: A retrospective study of patients visiting the hydroxychloroquine screening clinic at Rochdale Eye Unit between 1st January – 1st of March 2022 was performed. Utilizing the 2020 RCOphth guidelines as a “gold standard” screening clinic checklist, data were collected determining if patients fulfilled screening criteria, if the department's data collection proforma identified patients with risk factors for developing retinopathy, the investigations undertaken, documentation and communication of the diagnosis, and selection of an appropriate outcome.Results: 54 patients were identified, 14 males and 40 females, 100% of whom were on HCQ therapy. 37% did not meet the screening criteria. A paper proforma comprising of drug, dose, duration, renal disease, tamoxifen use, and macular co‐morbidity was completed for 100% of patients, however, did not include patient's ethnicity, weight (cumulative dose calculation), or last renal function. 51 patients (94%) had SD‐OCT and FAF as first line investigation. 10 patients (19%) also had Visual Field‐10‐2. Currently, there is no standardized process for interpretation of investigations and documentation of findings. Although, 100% of diagnoses were communicated to the GP, there no was evidence of written information about HCQ retinopathy or results of investigations being sent to patients at present. 19 patients (35%) had the incorrect outcome selected, including re‐invitation for annual monitoring despite treatment cessation or prior to >5 years of HCQ treatment.Conclusions: To address the encountered challenges, we recommend review of all bookings unfulfilling screening criteria, devising a more comprehensive proforma (including ethnicity, weight, last renal function) and a six‐point clinician's checklist comprising of proforma review, investigation interpretation/documentation aid, prompt for communicating with patient/referrer, considering driving eligibility, and guidance for selecting appropriate outcome.

Usability of novel major TraumaApp for digital data collection

BackgroundDelivery of major trauma care is complex and often fast paced. Clear and comprehensive documentation is paramount to support effective communication during complex clinical care episodes, and to allow collection of data for audit, research and continuous improvement. Clinical events are typically recorded on paper-based records that are developed for individual centres or systems. As one of the priorities laid out by the Scottish Trauma Network project was to develop an electronic data collection system, the TraumaApp was created as a data collection tool for major trauma that could be adopted worldwide.MethodsThe study was performed as a service evaluation based at the Queen Elizabeth University Hospital Emergency Department. Fifty staff members were recruited in pairs and listened to five paired major trauma standby and handover recordings. Participants were randomised to input data to the TraumaApp and one into the existing paper proforma. The time taken to input data add into was measured, along with time for clarifications and any errors made. Those using the app completed a System Usability Score.ResultsNo statistically significant difference was demonstrated between times taken for data entry for the digital and paper documentation, apart from the Case 5 Handover (p < 0.05). Case 1 showed a significantly higher time for clarifications and number of errors with digital data collection (p = 0.01 and p = 1.79E-05 respectively). There were no other differences between data for the app and the proforma. The mean System Usability score for this cohort was 75 out of 100, with a standard deviation of 17 (rounded to nearest integer).ConclusionDigital real-time recording of clinical events using a tool such as the TraumaApp is comparable to completion of paper proforma. The System Usability Score for the TraumaApp was above the internationally validated standard of acceptable usability. There was no evidence of improvement in use over time or familiarity, most likely due to the brevity of the assessments and the refined user interface. This would benefit from further research, exploring data completeness and a potential mixed methods approach to explore training requirements for use of the TraumaApp.

A retrospective audit of the introduction of a facial trauma admission Proforma

<b>Introduction</b>: Comprehensive documentation has particular pertinence when recording information for facial trauma patients. Patient records have a medico legal value, as a common aetiology of facial trauma is as a result of a criminal event. In addition notes ensure continuity of care whilst being reviewed by multiple members of the team and aid effective surgical decision. Commonly, documentation at presentation is incomplete and varied in format. This retrospective two-cycle audit analysed information captured at initial presentation of surgically managed mandibular fractures at the Queen's Medical Centre, Nottingham, to identify if an improvement in record keeping occurred using a dedicated trauma proforma. <b>Materials and Methods</b>: Ten clerking records before and after proforma introduction were accessed through Medway or DHR computer systems, and analysed against the minimum dataset for documentation stipulated by Royal College of Surgeons of England guidelines. These included dates of injury/assessment; referral source; mechanism of injury; medical history; occlusion; tenderness; dental trauma; imaging; diagnosis and management plan recording. The standard was that 100% of records were complete. <b>Results/Statistics</b>: Prior to the proforma, some data points were consistently not recorded; presence of pain (50%); dental trauma (30%); diagnosis (50%) and analgesia (30%). Overall, the proforma improved record keeping by 26% in data captured, particularly in domains that were poorly recorded. However it should be noted that one third of patients records examined in the second cycle, included completed proformas. <b>Conclusions/Clinical Relevance</b>: This audit demonstrated an increase in data quantity and quality, with the use of a dedicated proforma. With multiple handovers during shifts and frequent staff turnover, a structured proforma prevents information from being omitted and provides a way of obtaining the information needed, in a standardised, reproducible way. A structured proforma aids future audits and assessment of service performance. Furthermore, proformas provided a high education value to junior members of the team, who commonly admit trauma patients, and act as an aid-memoir to guide clinical examination. Consequently, digitalisation of this proforma on Medway, is planned to increase access to the proforma, which is particularly apt for this cohort of patients examined in this study, as access to a paper proforma has its limitations.

Botulinum toxin type A versus anticholinergics for cervical dystonia.

This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. Before BtA, anticholinergics were the most widely accepted treatment. To compare the efficacy, safety, and tolerability of BtA versus anticholinergic drugs in adults with cervical dystonia. We searched the Cochrane Movement Disorders' Trials Register to June 2003, screened reference lists of articles and conference proceedings to September 2018, and searched CENTRAL, MEDLINE, and Embase, with no language restrictions, to July 2020. Double-blind, parallel, randomised trials (RCTs) of BtA versus anticholinergic drugs in adults with cervical dystonia. Two review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias and quality of the evidence. We resolved disagreements by consensus or by consulting a third review author. If enough data had been available, we were to perform meta-analyses using a random-effects model for the comparison of BtA versus anticholinergic drugs to estimate pooled effects and corresponding 95% confidence intervals (95% CI). The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event. We included one RCT of moderate overall risk of bias (as multiple domains were at unclear risk of bias), which included 66 BtA-naive participants with cervical dystonia. Two doses of BtA (Dysport; week 0 and 8; mean dose 262 to 292 U) were compared with daily trihexyphenidyl (up to 24 mg daily). The trial was sponsored by the BtA producer. BtA reduced cervical dystonia severity by an average of 2.5 points (95% CI 0.68 to 4.32) on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale 12 weeks after injection, compared to trihexyphenidyl. More participants reported adverse events in the trihexyphenidyl treatment group (76 events), compared with the BtA group (31 events); however, the difference in dropouts due to adverse events was inconclusive between groups. There was a decreased risk of dry mouth, and memory problems with BtA, but the differences were inconclusive between groups for the other reported side effects (blurred vision, dizziness, depression, fatigue, pain at injection site, dysphagia, and neck weakness). We found very low-certainty evidence that BtA is more effective, better tolerated, and safer than trihexyphenidyl. We found no information on a dose-response relationship with BtA, differences between BtA formulations or different anticholinergics, the utility of electromyography-guided injections, or the duration of treatment effect.

Factors associated with admission to bed-based care: observational prospective cohort study in a multidisciplinary same day emergency care unit (SDEC)

BackgroundThe development of ambulatory emergency care services, now called ‘Same Day Emergency Care’ (SDEC) has been advocated to provide sustainable high quality healthcare in an ageing population. However, there are few data on SDEC and the factors associated with successful ambulatory care in frail older people. We therefore undertook a prospective observational study to determine i) the clinical characteristics and frailty burden of a cohort in an SDEC designed around the needs of older patients and ii) the factors associated with hospital admission within 30-days after initial assessment.MethodsThe study setting was the multidisciplinary Abingdon Emergency Medical Unit (EMU) located in a community hospital and led by a senior interface physician (geriatrician or general practitioner). Consecutive patients from August–December 2015 were assessed using a structured paper proforma including cognitive/delirium screen, comorbidities, functional, social, and nutritional status. Physiologic parameters were recorded. Illness severity was quantified using the Systemic Inflammatory Response Syndrome (SIRS> 1). Factors associated with hospitalization within 30-days were determined using multivariable logistic regression.ResultsAmong 533 patients (median (IQR) age = 81 (68–87), 315 (59%) female), 453 (86%) were living at home but 283 (54%) required some form of care and 299 (56%) had Barthel< 20. Falls, urinary incontinence and dementia affected 81/189 (43%), 50 (26%) and 40 (21%) of those aged > 85 years.” Severe illness was present in 148 (28%) with broadly similar rates across age groups. Overall, 210 (39%) patients had a hospital admission within 30-days with higher rates in older patients: 96 (87%) of < 65 years remained on an ambulatory pathway versus only 91 (48%) of ≥ 85 years (p < 0.0001). Factors independently associated with hospital admission were severe illness (SIRS/point, OR = 1.46,95% CI = 1.15–1.87, p = 0.002) and markers of frailty: delirium (OR = 11.28,3.07–41.44, p < 0.0001), increased care needs (OR = 3.08,1.55–6.12, p = 0.001), transport requirement (OR = 1.92,1.13–3.27), and poor nutrition (OR = 1.13–3.79, p = 0.02).ConclusionsEven in an SDEC with a multidisciplinary approach, rates of hospital admission in those with severe illness and frailty were high. Further studies are required to understand the key components of hospital bed-based care that need to be replicated by models delivering acute frailty care closer to home, and the feasibility, cost-effectiveness and patient/carer acceptability of such models.

Botulinum toxin type A therapy for hemifacial spasm.

This is an update of a Cochrane Review, first published in 2005. Hemifacial spasm (HFS) is characterised by unilateral, involuntary contractions of the muscles innervated by the facial nerve. It is a chronic disorder, and spontaneous recovery is very rare. The two treatments routinely available are microvascular decompression and intramuscular injections with botulinum toxin type A (BtA). To compare the efficacy, safety, and tolerability of BtA versus placebo in people with HFS. We searched CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. We ran the electronic database search, with no language restrictions, in July 2020. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with HFS. Two review authors independently assessed records. We planned to select included studies, extract data using a paper pro forma, and evaluate the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We planned to perform meta-analyses. The primary efficacy outcome was HFS-specific improvement. The primary safety outcome was the proportion of participants with any adverse event. We found no parallel-group randomised controlled trials comparing BtA and placebo in HFS. We did not find any randomised trials that evaluated the efficacy and safety of botulinum toxin type A in people with hemifacial spasm, so we are unable to draw any conclusions. Observational data show a strong association between BtA treatment and symptom improvement, and a favourable safety profile. While it is unlikely that future placebo-controlled RCTs will evaluate absolute efficacy and safety, they should address relevant questions for both people with HFS (such as long-term effects, quality of life, and other patient-reported outcomes), and clinicians (such as relative effectiveness of different BtA formulations and schemes of treatment) to better guide clinical practice.).

Botulinum toxin type A therapy for blepharospasm.

This is an update of a Cochrane Review first published in 2005. Blepharospasm is the second most common form of focal dystonia. It is a disabling disorder, characterised by chronic, intermittent or persistent, involuntary eyelid closure, due to spasmodic contractions of the orbicularis oculi muscles. Currently, botulinum toxin type A (BtA) is considered the first line of therapy for this condition. To compare the efficacy, safety, and tolerability of BtA versus placebo in people with blepharospasm. We searched Cochrane Movement Disorders' Trials Register, CENTRAL, MEDLINE, Embase, reference lists of included articles, and conference proceedings. We ran all elements of the search, with no language restrictions, in July 2020. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with blepharospasm. Two review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus, or by consulting a third review author. We performed meta-analyses using a random-effects model, for the comparison of BtA versus placebo, to estimate pooled effects and corresponding 95% confidence intervals (95% CI). We did not carry out any prespecified subgroup analyses. The primary efficacy outcome was improvement on any validated symptomatic rating scale. The primary safety outcome was the proportion of participants with any adverse event. We included three RCTs, assessed at low to moderate overall risk of bias, which randomised 313 participants with blepharospasm. Two studies excluded participants with poorer prior responses to BtA treatment, therefore, they included an enriched population with a higher probability of benefiting from this therapy. All trials were industry-funded. All RCTs evaluated the effect of a single BtA treatment session. BtA resulted in a moderate to large improvement in blepharospasm-specific severity, with a reduction of 0.93 points on the Jankovic Rating Scale (JRS) severity subscale at four to six weeks after injection (95% confidence interval (CI) 0.61 to 1.25; I² = 9%) compared to placebo. BtA was also resulted in a moderate to large improvement in blepharospasm-specific disability and blepharospasm-specific involuntary movements at four to six weeks after injection (disability: 0.69 JRS disability subscale points, 95% CI 0.18 to 1.19; I² = 74%; blepharospasm-specific involuntary movements: standardised mean difference (SMD) 0.79, 0.31 to 1.27; I² = 58%) compared to placebo. BtA did not show a risk of adverse events (risk ratio (RR) 1.18, 95% CI 0.87 to 1.60; I² = 0%). However, BtA increased the risk of vision complaints and eyelid ptosis (vision complaints: RR 5.73, 95% CI 1.79 to 18.36; I² = 51%; eyelid ptosis: RR 4.02, 95% CI 1.61 to 10.00; I² = 39%). There was no distinction between BtA and placebo in the number of participants who dropped out of the trial. A single trial estimated the duration of effects to be 10.6 weeks (range 6.1 to 19.1). We found no evidence supporting the existence of a clear dose-response relationship with BtA. We found no data reporting the impact of BtA on health-related quality of life, or the development of secondary non-responsiveness. We are moderately certain that a single BtA treatment resulted in a clinically relevant reduction of blepharospasm-specific severity and disability, and have low certainty that it is well tolerated, when compared with placebo. There is low-certainty evidence that people treated with BtA are not at an increased risk of developing adverse events, though BtA treatment likely increases the risk of visual complaints and eyelid ptosis. There are no data from RCTs evaluating the effectiveness and safety of repeated BtA injection cycles. There is no evidence from RCTs to allow us to draw definitive conclusions on the optimal treatment intervals and doses, or the impact on quality of life.

Botulinum toxin type A therapy for cervical dystonia.

This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia, and is a highly disabling movement disorder, characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. To compare the efficacy, safety, and tolerability of BtA versus placebo, in people with cervical dystonia. We searched Cochrane Movement Disorders' Trials Register, CENTRAL, MEDLINE, Embase, reference lists of articles, and conference proceedings in July 2020. All elements of the search, with no language restrictions, were last run in July 2020. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with cervical dystonia. Two review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third review author. We performed meta-analyses using a random-effects model, for the comparison of BtA versus placebo, to estimate pooled effects and corresponding 95% confidence intervals (95% CI). We performed preplanned subgroup analyses according to BtA dose used, the BtA formulation used, and the use (or not) of guidance for BtA injections. The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event. We included nine RCTs, with moderate, overall risk of bias, that included 1144 participants with cervical dystonia. Seven studies excluded participants with poorer responses to BtA treatment, therefore, including an enriched population with a higher probability of benefiting from this therapy. Only one trial was independently funded. All RCTs evaluated the effect of a single BtA treatment session, using doses from 150 U to 500 U of onabotulinumtoxinA (Botox), 120 U to 240 U of incobotulinumtoxinA (Xeomin), and 250 U to 1000 U of abobotulinumtoxinA (Dysport). BtA resulted in a moderate to large improvement from the participant's baseline clinical status, assessed by the investigators, with a mean reduction of 8.09 points in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS total score) at week four after injection (95% CI 6.22 to 9.96; I² = 0%) compared to placebo. This corresponded, on average, to a 18.4% improvement from baseline. The mean difference (MD) in TWSTRS pain subscore at week four was 2.11 (95% CI 1.38 to 2.83; I² = 0%) compared to placebo. Overall, both participants and clinicians reported an improvement of subjective clinical status. It was unclear if dropouts due to adverse events differed (risk ratio (RR) 2.51; 95% CI 0.42 to 14.94; I² = 0%) However, BtA treatment increased the risk of experiencing an adverse event (R) 1.23; 95% CI 1.05 to 1.43; I² = 28%). Neck weakness (14%; RR 3.40; 95% CI 1.19 to 9.71; I² = 15%), dysphagia (11%; RR 3.19; 95% CI 1.79 to 5.70; I² = 0%), and diffuse weakness or tiredness (8%; RR 1.80; 95% CI 1.10 to 2.95; I² = 0%) were the most common treatment-related adverse events. Treatment with BtA resulted in a decreased risk of dropouts. We have moderate certainty in the evidence across all of the aforementioned outcomes, with the exception of subjective assessment and tolerability, in which we have high confidence in the evidence. We found no evidence supporting the existence of a clear dose-response relationship between BtA and improvement in cervical dystonia-specific impairment, a destinction between BtA formulations, or a variation with use of EMG-guided injection for efficacy outcomes. Due to clinical heterogeneity, we did not pool health-related quality of life data, duration of clinical effect, or the development of secondary non-responsiveness. We are moderately certain in the evidence that a single BtA treatment session resulted in a clinically relevant reduction of cervical dystonia-specific impairment, and pain, and highly certain that it is well tolerated, compared with placebo. There is moderate-certainty evidence that people treated with BtA are at an increased risk of developing adverse events, most notably, dysphagia, neckweakness and diffuse weakness or tiredness. There are no data from RCTs evaluating the effectiveness and safety of repeated BtA injection cycles. There is no evidence from RCTs to allow us to draw definitive conclusions on the optimal treatment intervals and doses, the usefulness of guidance techniques for injection, the impact on quality of life, or the duration of treatment effect.

Improvement of the Efficiency and Completeness of Neuro-Oncology Patient Referrals to a Tertiary Center Through the Implementation of an Electronic Referral System: Retrospective Cohort Study.

BackgroundQuality referrals to specialist care are key for prompt, optimal decisions about the management of patients with brain tumors.ObjectiveThis study aimed to determine the impact of introducing a Web-based, electronic referral (eReferral) system to a specialized neuro-oncology center, using a service-developed proforma, in terms of waiting times and information completeness.MethodsWe carried out a retrospective cohort study based on the review of medical records of referred adult patients, excluding follow-ups. Primary outcome measures were durations of three key phases within the referral pathway and completion rates of six referral fields.ResultsA total of 248 patients were referred to the specialist center during the study period. Median (IQR) diagnostic imaging to referral intervals were 3 (1-5) days with eReferrals, and 9 (4-19), 19 (14-49), and 8 (4-23) days with paper proforma, paper letter, and internal referrals, respectively (P<.001). Median (IQR) referral to multidisciplinary team decision intervals were 3 (2-7), 2 (1-3), 8 (2-24), and 3 (2-6) days respectively (P=.01). For patients having surgery, median (IQR) diagnostic imaging to surgery intervals were 28 (21-41), 34 (27-51), 104 (69-143), and 32 (15-89) days, respectively (P<.001). Proportions of complete fields differed significantly by referral type in all study fields (all with Ps <.001) except for details of presentation, which were present in all referrals. All study fields were always present in eReferrals, as these are compulsory for referral submission. Depending on the data field, level of completeness in the remaining referral types ranged within 69% (65/94) to 87% (82/94), 15% (3/20) to 65% (13/20), and 22% (8/41) to 63% (26/41) in paper proforma, paper letter, and internal referrals, respectively.ConclusionsAn electronic, Web-based, service-developed specific proforma for neuro-oncology referrals performs significantly better, with shorter waiting times and greater completeness of information than other referral types. A wider application of eReferrals is an important first step to streamlining specialist care pathways and providing excellent care.International Registered Report Identifier (IRRID)RR2-10.2196/10.2196/15002

Botulinum toxin type A therapy for cervical dystonia.

This is an update of a Cochrane Review first published in 2005. Cervical dystonia is the most common form of focal dystonia and is a highly disabling movement disorder characterised by involuntary, usually painful, head posturing. Currently, botulinum toxin type A (BtA) is considered the first line therapy for this condition. To compare the efficacy, safety, and tolerability of botulinum toxin type A (BtA) versus placebo in people with cervical dystonia. To identify studies for this review we searched Cochrane Movement Disorders' Trials Register, CENTRAL, MEDLINE, Embase, reference lists of articles and conference proceedings. All elements of the search, with no language restrictions, were run in October 2016. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtA versus placebo in adults with cervical dystonia. Two review authors independently assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third review author. We performed meta-analyses using a random-effects model for the comparison of BtA versus placebo to estimate pooled effects and corresponding 95% confidence intervals (95% CI). In addition, we performed preplanned subgroup analyses according to BtA dose used, the BtA formulation used, and the use or not of guidance for BtA injection. The primary efficacy outcome was improvement in cervical dystonia-specific impairment. The primary safety outcome was the proportion of participants with any adverse event. We included eight RCTs of moderate overall risk of bias, including 1010 participants with cervical dystonia. Six studies excluded participants with poorer responses to BtA treatment, therefore including an enriched population with a higher probability of benefiting from this therapy. Only one trial was independently funded. All RCTs evaluated the effect of a single BtA treatment session, using doses from 150 U to 236 U of onabotulinumtoxinA (Botox), 120 U to 240 U of incobotulinumtoxinA (Xeomin), and 250 U to 1000 U of abobotulinumtoxinA (Dysport).BtA was associated with a moderate-to-large improvement in the participant's baseline clinical status as assessed by investigators, with reduction of 8.06 points in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS total score) at week 4 after injection (95% CI 6.08 to 10.05; I2 = 0%) compared to placebo, corresponding on average to a 18.7% improvement from baseline. The mean difference (MD) in TWSTRS pain subscore at week 4 was 2.11 (95% CI 1.38 to 2.83; I2 = 0%). Overall, both participants and clinicians reported an improvement of subjective clinical status. There were no differences between groups regarding withdrawals due to adverse events. However, BtA treatment was associated with an increased risk of experiencing an adverse event (risk ratio (RR) 1.19; 95% CI 1.03 to 1.36; I2 = 16%). Dysphagia (9%) and diffuse weakness/tiredness (10%) were the most common treatment-related adverse events (dysphagia: RR 3.04; 95% CI 1.68 to 5.50; I2 = 0%; diffuse weakness/tiredness: RR 1.78; 95% CI 1.08 to 2.94; I2 = 0%). Treatment with BtA was associated with a decreased risk of participants withdrawing from trials. We have moderate certainty in the evidence across all of the aforementioned outcomes.We found no evidence supporting the existence of a clear dose-response relationship with BtA, nor a difference between BtA formulations, nor a difference with use of EMG-guided injection.Due to clinical heterogeneity, we did not pool data regarding health-related quality of life, duration of clinical effect, or the development of secondary non-responsiveness. We have moderate certainty in the evidence that a single BtA treatment session is associated with a significant and clinically relevant reduction of cervical dystonia-specific impairment, including severity, disability, and pain, and that it is well tolerated, when compared with placebo. There is also moderate certainty in the evidence that people treated with BtA are at an increased risk of developing adverse events, most notably dysphagia and diffuse weakness. There are no data from RCTs evaluating the effectiveness and safety of repeated BtA injection cycles. There is no evidence from RCTs to allow us to draw definitive conclusions on the optimal treatment intervals and doses, usefulness of guidance techniques for injection, the impact on quality of life, or the duration of treatment effect.

Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.

This is an update of a Cochrane review first published in 2003. Cervical dystonia is the most common form of focal dystonia and is a disabling disorder characterised by painful involuntary head posturing. There are two available formulations of botulinum toxin, with botulinum toxin type A (BtA) usually considered the first line therapy for this condition. Botulinum toxin type B (BtB) is an alternative option, with no compelling theoretical reason why it might not be as- or even more effective - than BtA. To compare the efficacy, safety and tolerability of botulinum toxin type A (BtA) versus botulinum toxin type B (BtB) in people with cervical dystonia. To identify studies for this review we searched the Cochrane Movement Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, reference lists of articles and conference proceedings. All elements of the search, with no language restrictions, were last run in October 2016. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) comparing BtA versus BtB in adults with cervical dystonia. Two independent authors assessed records, selected included studies, extracted data using a paper pro forma, and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third author. We performed meta-analyses using the random-effects model, for the comparison BtA versus BtB to estimate pooled effects and corresponding 95% confidence intervals (95% CI). No prespecified subgroup analyses were carried out. The primary efficacy outcome was improvement on any validated symptomatic rating scale, and the primary safety outcome was the proportion of participants with adverse events. We included three RCTs, all new to this update, of very low to low methodological quality, with a total of 270 participants.Two studies exclusively enrolled participants with a known positive response to BtA treatment. This raises concerns of population enrichment, with a higher probability of benefit from BtA treatment. None of the trials were free of for-profit bias, nor did they provide information regarding registered study protocols. All trials evaluated the effect of a single Bt treatment session, and not repeated treatment sessions, using doses from 100 U to 250 U of BtA (all onabotulinumtoxinA, or Botox, formulations) and 5000 U to 10,000 U of BtB (rimabotulinumtoxinB, or Myobloc/Neurobloc).We found no difference between the two types of botulinum toxin in terms of overall efficacy, with a mean difference of -1.44 (95% CI -3.58 to 0.70) points lower on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) for BtB-treated participants, measured at two to four weeks after injection. The proportion of participants with adverse events was also not different between BtA and BtB (BtB versus BtA risk ratio (RR) 1.40; 95% CI 1.00 to 1.96). However, when compared to BtA, treatment with BtB was associated with an increased risk of one adverse events of special interest, namely treatment-related sore throat/dry mouth (BtB versus BtA RR of 4.39; 95% CI 2.43 to 7.91). Treatment-related dysphagia (swallowing difficulties) was not different between BtA and BtB (RR 2.89; 95% CI 0.80 to 10.41). The two types of botulinum toxin were otherwise clinically non-distinguishable in all the remaining outcomes. The previous version of this review did not include any trials, since these were still ongoing at the time. Therefore, with this update we are able to change the conclusions of this review. There is low quality evidence that a single treatment session of BtA (specifically onabotulinumtoxinA) and a single treatment session of BtB (rimabotulinumtoxinB) are equally effective and safe in the treatment of adults with certain types of cervical dystonia. Treatment with BtB appears to present an increased risk of sore throat/dry mouth, compared to BtA. Overall, there is no clinical evidence from these single-treatment trials to support or contest the preferential use of one form of botulinum toxin over the other.

Botulinum toxin type B for cervical dystonia.

This is an update of a Cochrane review first published in 2004, and previously updated in 2009 (no change in conclusions). Cervical dystonia is a frequent and disabling disorder characterised by painful involuntary head posturing. Botulinum toxin type A (BtA) is usually considered the first line therapy for this condition, although botulinum toxin type B (BtB) is an alternative option. To compare the efficacy, safety and tolerability of botulinum toxin type B (BtB) versus placebo in people with cervical dystonia. We identified studies for inclusion in the review using the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, reference lists of articles and conference proceedings, last run in October 2015. We ran the search from 1977 to 2015. The search was unrestricted by language. Double-blind, parallel, randomised, placebo-controlled trials (RCTs) of BtB versus placebo in adults with cervical dystonia. Two independent authors assessed records, selected included studies, extracted data using a paper pro forma and evaluated the risk of bias. We resolved disagreements by consensus or by consulting a third author. We performed one meta-analysis for the comparison BtB versus placebo. We used random-effects models when there was heterogeneity and fixed-effect models when there was no heterogeneity. In addition, we performed pre-specified subgroup analyses according to BtB doses and BtA previous clinical responsiveness. The primary efficacy outcome was overall improvement on any validated symptomatic rating scale. The primary safety outcome was the number of participants with any adverse event. We included four RCTs of moderate overall methodological quality, including 441 participants with cervical dystonia. Three studies excluded participants known to have poorer response to Bt treatment, therefore including an enriched population with a higher probability of benefiting from Bt treatment. None of the trials were independently funded. All RCTs evaluated the effect of a single Bt treatment session using doses between 2500 U and 10,000 U. BtB was associated with an improvement of 14.7% (95% CI 9.8% to 19.5) in the patients' baseline clinical status as assessed by investigators, with reduction of 6.8 points in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS-total score) at week 4 after injection (95% CI 4.54 to 9.01). Mean difference (MD) in TWSTRS-pain score at week 4 was 2.20 (95% CI 1.25 to 3.15). Overall, both participants and clinicians reported an improvement of subjective clinical status. There were no differences between groups in the withdrawals rate due to adverse events or in the proportion of participants with adverse events. However, BtB-treated patients had a 7.65 (95% CI 2.75 to 21.32) and a 6.78 (95% CI 2.42 to 19.05) increased risk of treatment-related dry mouth and dysphagia, respectively. Statistical heterogeneity between studies was low to moderate for most outcomes. All tested dosages were efficacious against placebo without clear-cut evidence of a dose-response gradient. However, duration of effect (time until return to baseline TWSTRS-total score) and risk of dry mouth and dysphagia were greater in the subgroup of participants treated with higher BtB doses. Subgroup analysis showed a higher improvement with BtB among BtA-non-responsive participants, although there were no differences in the effect size between the BtA-responsive and non-responsive subgroups. A single BtB-treatment session is associated with a significant and clinically relevant reduction of cervical dystonia impairment including severity, disability and pain, and is well tolerated, when compared with placebo. However, BtB-treated patients are at an increased risk of dry mouth and dysphagia. There are no data from RCTs evaluating the effectiveness and safety of repeated BtB injection cycles. There are no RCT data to allow us to draw definitive conclusions on the optimal treatment intervals and doses, usefulness of guidance techniques for injection, and impact on quality of life.

PWE-309 Intravenous lidocaine infusions for abdominal surgery

<h3>Introduction</h3> The Western General Hospital in Edinburgh currently performs several hundred major abdominal surgeries per year. We have adopted perioperative intravenous lidocaine infusions (PILI) as a routine analgesic adjunct for its ease of use and safety profile and have experienced improved analgesic requirements and return of gut function. Lidocaine is a sodium channel blocking amide local anaesthetic but also has secondary analgesic effects and anti-inflammatory effects. For these reasons peri-operative intravenous lidocaine infusions have been investigated for their potential to improve outcomes for patients undergoing major surgery. A recent meta-analysis of 1,754 patients found benefit from the use of PILI especially for patients undergoing abdominal surgery.¹We report the introduction of PILI according to a local protocol. The primary objective was to compare our safety data with that expected from the meta-analysis. Our secondary objective was to compare return of bowel function data to that reported by the Early Recovery after Surgery (ERAS) database, which collected data for all patients undergoing major colonic surgery independently of our audit. <h3>Method</h3> The trust scientific officer waived the requirement for ethical approval as this was considered a change in clinical practice. A local protocol for the administration of PILI was suggested to local clinicians based on the available evidence. Training was delivered to recovery and high dependency unit staff who would be caring for patients receiving PILI. Data were collected prospectively using a standard anonymised paper pro forma. <h3>Results</h3> Over a period of 24 months data on 127 uses of PILI were collected prospectively, which included 73 patients undergoing colonic resection. Lidocaine infusion was stopped early on nine (7%) occasions; three (2.4%) due to tracking up the vein and three (2.4%) patients reported parasthesiae. Three (2.4%) stoppages were for reasons later deemed to be unrelated. No other adverse events or reactions were reported. Data were available for the assessment of bowel function in 53 patients and patients in the PILI cohort who underwent colonic resection experienced a more rapid return of bowel function (return of flatus, mean days (SD): 2.84 (1.2) v 3.55 (1.7), p &lt; 0.0001; return of bowel opening: 4.17 (2.0) v 4.81 (2.3), p = 0.014). <h3>Conclusion</h3> PILI is a safe and easily administered peri-operative adjunct which may promote return of gut function after colorectal resection. A multicentre RCT is suggested; powered to address gut function, length of stay, opiate use and perioperative dysrhythmia following colonic resection. The forthcoming Delphi Games may be an opportunity to address this since perioperative ileus is an identified objective. <h3>Disclosure of interest</h3> None Declared. <h3>Reference</h3> Vigneault L, <i>et al</i>. Can. J. Anaesth. 2011;58:22–37

Converting a paper proforma template to a user friendly electronic database to collect traumatic brain injury data

Abstract A structured reporting system which is based on a uniform template will permit uniform data collection and future statistics and will facilitate and validate independent or comparative audit of performance and quality of care. The successful establishment of a multi-center registry depends on the development of a concise data entry form, data entry system and data analysis to continuously maintain the registry. In the first phase we introduced the paper data collection form, in second phase this data form was converted to an electronic interface. In this second phase of the study the paper proforma which was developed in the first phase was converted into an electronic database by using the FileMaker Pro 13 Advanced®. The FileMaker Pro 13 Advanced® is capable to store the data, provides user friendly interface to enter data and can be converted the standalone runtime program to install in any other computer system. The next step is to explore the possibility whether it would be feasible to use this as a multicenter traumatic brain injury registry.

Care of Burns in Scotland: 3-year data from the Managed Clinical Network National Registry

Introduction The Managed Clinical Network for Care of Burns in Scotland (COBIS) was launched in April 2007. Primary aims included establishing and maintaining a registry of complex burn injury in Scotland and setting mechanisms to regularly audit outcome of burn treatment against nationally agreed standards of care. On behalf of COBIS, we present 3-year incidence and mortality data of Scottish patients admitted with a complex burn injury in this abstract. Methods From January 2010 onwards, data were prospectively collected for all patients in Scotland with complex burn injury admitted to Scottish burns units. Data collection was initially on a paper pro forma, but subsequently evolved into a web-based audit data capture system to securely link hospital sites involved in the delivery of care of complex burns. Data collected included extent and mechanism of burn, presence of airway burn or smoke inhalational injury, comorbidities, complications, length of stay, interventions and mortality. Quality, completeness and consistency of data collection are audited with feedback to the individual units. Results In a population of approximately 5.3 million, the annual incidence of complex burn injury is 499 to 537 (9 to 10 per 100,000). The incidence of a major burn is 5% of burn admissions. The hospital mortality from a burn is 1 to 2.2%. See Table 1. Table 1. Numbers of complex burns in Scotland 2010 to 2012 Conclusion From these data, Scotland now has comprehensive national figures for complex burn injury. This allows for benchmarking against other international indices, few of which provide comprehensive data. COBIS data can now also be correlated with other mortality data sources. As data quality improves, detailed analysis of mortality data will allow COBIS to identify contributing issues affecting burns patients. Some issues identified already are that patients with burns often die soon after their discharge from hospital of other related and unrelated causes. Subsequent analysis of this will allow COBIS to identify and address issues that may be contributing to these statistics.

P58 Nuclei acid amplification tests (NAAT) for Trichomonas vaginalis: should they change who we screen for infection

BackgroundUK national guidelines recommend screening for Trichomonas vaginalis (TV) in symptomatic women and men with persistent urethritis using culture +/− wet mount microscopy. Screening of asymptomatic patients is not recommended...

Botulinum toxin type A versus anticholinergics for cervical dystonia

Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases are idiopathic and generally cervical dystonia is a life-long disorder. Botulinum toxin Type A (BtA) is now the first line therapy. Before BtA, anticholinergics were the most widely accepted treatment, so it is important to understand how these two treatments compare. To compare the clinical efficacy and safety of BtA versus anticholinergic drugs in the treatment of cervical dystonia. We searched the Cochrane Movement Disorders Group trials register (June 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2003), MEDLINE 1977 to June 2003), EMBASE (1977 to June 2003) and reference lists of articles. We also contacted manufacturers and researchers in the field. Randomised studies comparing BtA versus any anticholinergic drug for the treatment of cervical dystonia. Two reviewers independently assessed trial quality and extracted data. Study authors were contacted for additional information. Adverse effects information was collected from the trials. We found only one trial suitable for inclusion and accordingly no meta-analysis was performed. It compared BtA versus trihexyphenidyl in 66 patients with cervical dystonia. Although this was a relatively small trial with short duration, the results can probably be generalized for the population, since the trial appears to be unbiased and produced clear clinically significant results. The results favoured BtA, and the difference was similar in size to that obtained in a systematic review comparing BtA with placebo. BtA was better tolerated. The available evidence suggests that BtA injections provide more objective and subjective benefit than trihexyphenidyl to patients with cervical dystonia. We could not draw any conclusions about other anticholinergic drugs. Future trials should explore the role of anticholinergic drugs in patients that do not get benefit with BtA.

Accelerating the audit cycle: data gathering, analysis and dissemination of results by electronic methods. The third Yorkshire audit of genital chlamydial management

An electronic database was used as an audit tool by a peripatetic audit or to collect data on the management of genital chlamydial infection from genitourinary medicine clinics. A paper proforma was used to obtain data on clinic facilities. The database generated pre-specified quantitative reports for comparison to national standards and guidelines, as well as comparison of performance between clinics and to a previous regional audit. Feedback and discussion took place to identify interventions intended to improve practice. This methodology allowed for rapid dissemination of the audit findings to clinics.

Botulinum toxin type A therapy for blepharospasm

Blepharospasm is a focal dystonia characterized by chronic intermittent or persistent involuntary eyelid closure due to spasmodic contractions of the orbicularis oculi muscles. Other facial and neck muscles are also frequently involved. Most cases are idiopathic and blepharospasm is generally a life-long disorder. Its severity can range from repeated frequent blinking to persistent forceful closure of the eyelids with functional blindness. Botulinum toxin type A (BtA) is the current first line therapy. To determine whether botulinum toxin (BtA) is an effective and safe treatment for blepharospasm. We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, handsearches of the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, communication with other researchers in the field, reference lists of papers found using above search strategies, and contact with authors and drug manufacturers. Studies were eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of blepharospasm. They must have been randomised and placebo-controlled. We used a paper pro-forma to collect data from the included studies using double extraction by two independent reviewers. The two reviewers separately assessed each trial for internal validity and they settled differences between them by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, and changes in quality of life assessments. We found few controlled trials. They were of short duration and enrolled small numbers of patients. Because of their poor internal validity, the characteristics of the populations studied, and the types of interventions and outcomes, none of the trials fitted our criteria for inclusion. However, all these trials found BtA to be superior to placebo as did large case-control and cohort studies, which reported that around 90% of patients benefited. There are no high quality, randomised, controlled efficacy data to support the use of Bt for blepharospasm. Despite this, other studies suggest that BtA is highly effective and safe for treating blepharospasm and support its use. The effect size (90% of patients benefit) seen in open studies makes it very difficult and probably unethical to perform new placebo-controlled trials of efficacy of BtA for blepharospasm. Future trials should explore technical factors such as the optimum treatment intervals, different injection techniques, doses, Bt types and formulations. Other issues include service delivery, quality of life, long-term efficacy, safety, and immunogenicity.

Botulinum toxin type A in the treatment of lower limb spasticity in cerebral palsy.

To determine whether botulinum toxin (BtA) is an effective and safe treatment for lower limb spasticity in children with cerebral palsy. Functional outcomes are of particular interest. Studies for inclusion in the review were identified using the Movement Disorders Review Group trials register, the Cochrane Controlled Trials Register, MEDLINE, pharmaceutical company databases, communication with other researchers in the field and reference lists of papers found using above search strategies. Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of leg spasticity in children with cerebral palsy. They must have been randomised and include a concurrent control group receiving another intervention. A paper pro forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Meta-analysis was not possible because results were presented in an incompatable form. A Peto odds ratio was calculated where this was appropriate, otherwise a descriptive summary of the results of the individual studies was compiled. Three eligible studies were found each with small numbers of subjects. They were short term, used single injection sessions with follow-up of between 4 and 26 weeks. One study (Koman), of twelve ambulant children, compared BtA with injection of a placebo and found non-significant improvements in gait in the BtA group compared to the placebo group. Two studies (Corry, Flett) compared BtA with the use of casts. Each included 20 ambulant children and found improvements in gait, range of ankle movement and muscle tone in both the BtA and cast groups. However there were no significant differences between the groups in either trial. One of these trials (Flett) also assessed motor function using the gross motor function measure (GMFM) (Russell, 1989) and found significant improvements in each group compared to baseline but no significant differences between the groups. The other trial (Corry) performed 3D gait analysis on those children able to co-operate. Maximal plantar flexion and maximal dorsiflexion during walking were both found to be significantly greater in the BtA group compared to the cast group. In all other dimensions there were no significant differences between the groups. This systematic review has not revealed strong controlled evidence to support or refute the use of BtA for the treatment of leg spasticity in cerebral palsy. Ongoing randomised controlled trials are likely to provide useful data on the short term effects of BtA for leg spasticity. Future research should also assess the longer term use of BtA. Ideally studies should be pragmatic in their approach to dose and distribution of toxin to reflect practise. Outcome measures assessing function and disability would give the most useful information.