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Abstract
Background Pain is very common in childhood emergency department (ED) attendances, but is under-recognised and undertreated. Sequential national paediatric analgesia audits demonstrate suboptimal outcomes in several domains. The Donabedian framework examines the structures, processes and outcomes to evaluate quality of care. To date there has been no network-level exploration of structures supporting analgesic practices or attempts to address failure to attain national standards.
Objective To benchmark current variation in assessment and management of childhood pain at network level.
Methods Online survey distributed between December 2016 and January 2017 exploring health system structures including pain score tools, pain assessment/protocols, training, practice guidelines and analgesic agent usage. We explored structures, processes and outcomes to identify interventions, and their potential effectiveness and feasibility.
Results In total 95% (38/40 sites) responded, including 25 tertiary (66%) and 13 secondary hospitals (34%), with a total annual paediatric ED census of 1 225 000 (range 11 500–65 000). Availability of analgesics varied included topical wound anaesthesia in 29/38 sites (76%), oral diclofenac sodium in 22/38 sites (58%) and tramadol in 16/38 sites (42%). Pain assessment was mandatory in initial assessment in 34/38 sites (89%), and 18/38 sites had a policy on frequency of pain assessment (47%). Local guidance aligned with national guidance in 21/38 sites (55%). There was no staff training at induction/orientation in 14/38 sites (37%) and no mandatory competencies in pain management in 23/38 sites (61%). Play specialist services were available in 21/38 sites (55%).
Conclusion Despite national guidance and recommendations from multiple audits, there are substantial variations in structures relating to pain assessment and management across sites. The lack of uniformity is a likely root cause for the persistent suboptimal practices identified by serial national audits. A whole system and person-centred approach to improving pain outcomes by utilising effective interventions seeks to improve paediatric pain outcomes.
- pain
- analgesia
- pharmacology
- therapeutics
- qualitative research
Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information. All data relevant to the study are included in the article.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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What is known about the subject?
Multiple prior UK audits of pain assessment and management in children demonstrated deficiencies in optimal analgesia practices most notably in adequate timely analgesia administration and the reassessment after intervention.
Minimal progress to address the deficiencies highlighted in the audits has been demonstrated to date.
What this study adds?
Uniform health system structures and guidance to support optimal analgesic practices were lacking in the frequency of pain assessment, training and competencies in pain management and paediatric sedation.
A uniform system for paediatric pain management is needed. Potential opportunities for network-wide improvement include mandated early pain assessment with timely analgesia administration and mandated reassessment.
Introduction
Pain is present in most childhood trauma presentations,1 and in over 60% of all patients presenting to emergency departments (EDs).2 The extensive short and long-term consequences of inadequately treated acute pain have led to universal acceptance that pain management should begin at the earliest opportunity.3 Current standards, therefore, recommend simple, timely, sequential processes of recognition, assessment, intervention, reassessment and maintenance of pain relief.4
The Royal College of Emergency Medicine (RCEM) identified pain management as a key indicator of quality of care in EDs;5 it has subsequently published and revised guidelines on pain management in children4 and developed clinical standards for EDs,6 also incorporated into ‘Facing the future: Standards for children in emergency care settings’ by the Intercollegiate Committee.7 This approach to standardising and improving care is reflected in other national and international guidelines.3 Seven successive national audits of ED childhood pain management since 2003 have demonstrated some improvement in prehospital analgesia (29% in 2017/2018 audit), and in recording of pain score on arrival (national median of 12% in 2003 to 55% in 2017/2018).8 However, continued deficiencies persist in timely management of pain in patients with moderate and severe pain,8 and most notably a near complete absence of pain re-evaluation after administering analgesia. The three components approach (structures, processes and outcomes) for evaluating quality of care9 underpins measurement for improvement. Structures (physical and organisational characteristics where healthcare occurs) affect process measures, which affects outcome measures.10 Understanding structures is fundamental in driving improvement. To date there has been no network-level exploration of structures supporting analgesic practices, or attempts to address failure to attain national standards.
Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) identified acute pain as a research priority.11 The vision of this collaboration is knowledge creation and implementation to improve emergency care of children through robust multicentre research, and knowledge translation in the emergency care system. Any such research or translation in the quality of paediatric pain management can only be delivered once existing structures, processes and outcomes are well described.
The aim of this study was to describe system structures relating to management of acute pain in children presenting to EDs.
Methods
Study setting
This study was completed between 16 December 2016 and 16 January 2017 across PERUKI, a research collaborative representing a mix of tertiary and district general hospitals in urban and rural settings. Site lead investigators completed an online survey which explored service structures for acute childhood pain management in their ED, with content also pertaining to local guidelines and pathways for pain management. Survey content was developed iteratively based on existing recommendations and published literature, with consensus derived in the study team where necessary.
The survey consisted of 27 questions including contact details, institution characteristics, pain assessment and scoring tools, analgesic pathways, medications available, information given to patients and carers, education, audit and quality improvement performed and other aspects of pain management. The survey included single and multiple-answer questions to establish the presence or absence of relevant elements within each ED. Likert 5-point scales on frequency, as well as open questions to solicit further comments, were used. The full survey is available in the online supplemental appendix 1, and results are reported in line with the CHERRIES statement (online supplemental appendix 2).12
Supplemental material
Supplemental material
Data collection and statistical analysis
The survey was distributed using Online Surveys (JISC, https://www.onlinesurveys.ac.uk/) and was open for 1 month; reminders were sent 2 weeks and 1 week before the survey closed. Data were analysed using Excel (Microsoft Office 365) and responses are presented using descriptive statistics, including number and proportion, or median as appropriate to the underlying distribution. Free-text answers were themed and then described volumes in each theme are presented.
Patient and public involvement
Patients were not involved in the design, recruitment and conduct of the study.
Results
Study responses
Thirty-eight sites responded to the survey from forty surveyed (95% response rate). The total annual paediatric attendance across all participating sites was 1 225 000, ranging from 11 500 to 65 000 (median 30 000); site characteristics are described in table 1.
Respondent characteristics, n=38
ED pain assessment and management
Pain assessment and scoring during initial assessment were mandatory in 34 sites (89%). Pain assessment tools used are detailed in figure 1. A median of 3 tools were used in each site (range 1–4); the ‘other scale’ category comprised assessment tools that were unique and used in single sites.
Pain assessment tools used across different sites.14
Additional processes or pathways to promote/obligate analgesia administration and/or pain score reassessment were integrated within 18 sites (47%). They included mandatory pain scoring as a routine observation in seven sites (18%), prompts on patient charts to score and manage pain in three sites (8%), patient group direction (PGD) administration of medication in three sites (8%), regular analgesia audits in two sites (5%), mandatory pain assessment in triage in two sites (5%) and specific guidelines or pathways in two sites (5%).
Guidelines
Twenty-nine sites (76%) had a guideline, 21 (72%) of these were in line with RCEM guidance as reported by the site lead. Aspects of pain management covered by the guidelines are summarised in tables 2 and 3. Eight sites (21%) had no current (local) pain management guideline; two sites with an annual paediatric census over 50 000, six sites were tertiary centres, two were district general hospital and five were paediatric trauma centres. In sites with local guidance, the number of relevant documents at each site varied from 1 to 6, and the length of document ranged from 1 to 134 pages (median length 8.5 pages).
Aspects covered in local guidelines in sites where guidelines were in line with RCEM,4 n=21
Aspects covered in local guidelines/policies for each site, n=38
Pharmacology availability is detailed in table 4. Variation existed in the availability of medications such as oral diclofenac sodium, tramadol and topical wound anaesthesia. There was access to ED point-of care ultrasound to aid with procedures (eg, nerve blocks) in 34 sites (89%). Digital nerve blocks were performed in 37 sites (97%) and femoral nerve blocks in 34 sites (89%). Paediatric procedural sedation was available in 14 sites (37%).
Pharmacology availability
Patient group directions
PGDs existed in 35 sites (92%). The number of PGDs for analgesia at each site varied between 2 and 6 with a median of 3. PGDs for paracetamol and ibuprofen existed in over 90% of sites, topical anaesthesia in 75%, and nitrous oxide/Entonox in 34%. The frequency of PGDs for topical wound anaesthesia gel, codeine, oral morphine and lidocaine were 11%, 5%, 3% and 3%, respectively.
Patient and carer empowerment
At 19 sites (50%), strategies were used to empower patients/parents to request analgesia. Parents were encouraged either verbally or through visual prompts to seek additional analgesia in 18 sites (47%) when required. Three sites (8%) gave written information on pain/analgesia to paediatric patients and five sites (13%) gave information to parents/carers for use while in the ED. In 15 sites (39%) written information on pain/analgesia was given to parents/carers on discharge.
Audit, governance and education for pain management
Nine sites (24%) audited pain management in children during the preceding year, and 24 sites (63%) within the last 5 years. Seventeen sites (45%) made changes based on audit results; these focused on reassessment and documentation in 11 sites (29%), improving access to assessment tools in two sites (5%), new guidance in two sites (5%), new patient leaflets in one site (3%), increased PGD administration of medication at triage in one site (3%) and mandated pain assessment after triage in one site (3%).
Training was included in induction/orientation in 24 sites (63%), professional development in 16 sites (42%) and pain/analgesia competencies were mandatory in 15 sites (39%). Quality improvement processes relating to pain assessment or management were in operation in 18 sites (47%). These included regular audits of pain scoring and analgesia administered, the development of new guidelines/policies/protocol to improve areas of practice and increased training of staff.
Non-pharmacological management
There was restricted access to a play specialist in 21 sites (55%); the remaining sites had no access. The median number of items for distraction or entertainment was 3.5 (range 1–8, figure 2). Other items reported included different modalities for light and/or sensory distraction in nine sites (24%).
Amenities and equipment available to assist with non-pharmacological analgesia. DVD, digital video disc; TV, television.
Immobilisation strategies employed for traumatic injuries prior to clinician assessment varied. Arm slings were applied very frequently/frequently in most sites (29 sites, 76%), though Futura splints were not applied/infrequently applied in most sites (32 sites, 84%).
Discussion
We have described the structures relating to paediatric pain management across an international paediatric emergency network, and identified significant variations contributing to processes and outcomes in paediatric pain management.10 Variations included guideline availability and content, staff education, pain reassessment, pain scale usage, pharmacological accessibility, PGD usage and procedural sedation availability. Variation existed in non-pharmacological approaches, including distraction amenities, parental empowerment and access to play services.
The aim of timely, efficient and adequate pain management is not being achieved in EDs despite multiple sequential audits, with deterioration in timeliness of treatment being demonstrated in the most recent national audit of patients with moderate and severe pain.8 A recent UK study identified that other ED tasks were prioritised over pain management if this was not aligned with department core priorities, and not perceived as a key organisational priority for which staff were held accountable.13 When recommending interventions one must consider a hierarchy of effectiveness, and each solution’s level of feasibility. A systematic review and narrative synthesis of ED interventions to improve pain management revealed it was impossible to estimate effectiveness of interventions, or identify which had the greatest impact.14 A hierarchy of intervention effectiveness in EDs has been described, with forcing functions having highest effectiveness, and education or personal initiative/vigilance having the lowest.15 Medication safety literature demonstrates system based interventions are the most effective, with highest leverage, but are the least feasible; conversely, person-based interventions are least-effective, with lowest leverage, but are most feasible.16
Results demonstrated that 1/4 of paediatric hospitals and trauma centres, and 1/3 of hospitals with an annual paediatric ED attendance over 50 000, did not have local guidance to support best practice in paediatric pain management. In previous studies, introducing pain protocols and education in EDs have improved analgesia provision, including usage of intravenous analgesia.17 National guidance4 and standards6 which promote optimised pain assessment and management need to be implemented uniformly, as failure to do so commonly leads to oligoanalgesia.18 In EDs, this should be interdisciplinary, with clear lines of responsibility for achieving and measuring pain control. Multimodal pain management strategies are needed to minimise pain and discomfort that incorporate a combination of pain control strategies, such as opioids, non-steroidal anti-inflammatory drugs and non-pharmacological interventions.19 The uniform implementation of a single national guideline is a potentially moderately effective intervention, through simplification and standardisation of pain management across the health system.
Education varied in content, availability and strategy across sites. Under half delivered formal professional training in pain management, or mandated pain/analgesia competencies, implying that pain education is a low priority for over 50% of responding sites. Education and training are essential in enabling effective pain management,18 and knowledge acquisition through mandated training could be targeted at a national or network level. This intervention is likely moderately effective, and highly feasible, especially if delivered from post-graduate training institutions. To optimise the feasibility of such a strategy, it is essential to simplify practices and content. For example, ten different pain scales were in use, a factor which is a potential threat to any national training package given the lack of translation between institutions. Simplifying by reducing the volume, and standardising pain tool usage, is a medium leverage and moderately effective intervention. Coupling these strategies align well with existing literature, as previous evidence-based knowledge translation interventions demonstrates sustained improvement in paediatric pain practices.20
Assessment and reassessment of pain are central to optimising pain management, but given current constraints on healthcare systems, reassessment of any condition or symptom in stable patients, including pain, is often the most challenging element of care. Pain is reassessed in only 15% of ED patients nationally.8 There is significant positive association between documentation of a pain score and subsequent use of any analgesic,21 and the converse is also true.18 One moderate to highly effective system-based intervention is alerts using the electronic triggers in ED information systems for pain reassessment. Using technology to engage parents in acute pain care, including reassessment, may improve the child’s experience, increase parental satisfaction and reduce anxiety.22
A large difference in the quantities of non-pharmacological analgesia resources across sites existed. Level 1 evidence from systematic reviews/meta-analysis of relevant randomised trials demonstrated that non-pharmacological analgesia reduces pain,3 and Intercollegiate guidelines therefore state all EDs that treat children should employ a play specialist.7 This method of pain control is often overlooked, and sites should prioritise incorporating this as a priority. The forcing function of mandating such an intervention is most effective in achieving a successful change and may not be a huge burden when one considers the cost and availability of smart devices.
Local accessibility to medications, practices, and attitudes effect optimal practice.18 There was widespread access to intranasal opioids and nitrous oxide/Entonox. Intranasal opioids have gained increased popularity over intravenous opioids due to their fast onset, safety and ease of administration.23 RCEM guidelines advocate diclofenac sodium, codeine or oral morphine for moderate pain.4 Since 2013, this has become more limited as codeine is contraindicated in children under 12 years due to the risk of toxicity.24 Morphine can require incremental dosing with frequent pain reassessment to achieve optimal analgesia due to the risk of respiratory depression. Barriers to the routine use of morphine include opiophobia and monitoring requirements.24 Intranasal fentanyl is equivalent to intravenous/intramuscular morphine in reducing pain associated with acute paediatric fracture in the ED and internal evidence where it was incorporated into a triage protocol demonstrated earlier onset analgesia compared with intravenous opioids.3 We suggest bodies producing national guidance include drugs suitable for intranasal administration for moderate to severe pain. Other alternatives including inhaled methoxyflurane3 may become future additions following completion of randomised controlled trials.
Modifying organisational infrastructure to remove barriers is crucial. The universal implementation of PGDs could yield a moderately effective solution. These enable administration of specified prescription-only medicines to groups of patients under an overarching prescription, removing the need for individual-level prescription every time, with consequent reductions in time to analgesia.25 Single-checked PGDs are used successfully in many paediatric EDs without increasing rates of medication errors.25 Broadening their use and incorporating nurse-led protocols are likely to reduce time to analgesia and improve pain assessment.21
We have described current pain management structures in paediatric emergency care at a network level, and provided an insight into acute paediatric pain management. Variation is high, which likely contributes to poor pain outcomes identified in national audits. We, therefore, recommend person-centred and whole system interventions, of varying effectiveness, addressing these structural variations, to improve pain outcomes for children attending EDs which are summarised in box 1.
Suggested Solutions (with effectiveness and feasibility) to improve paediatric pain management in emergency department (ED)
Reprioritise paediatric pain management as a core principle in each ED aiming to reduce patient distress through pharmacological and non-pharmacological interventions (least effective, most feasible).
Integration of mandated pain assessment and reassessments using electronic triggers in an ED information system (moderately to highly effective, moderately to highly feasible).
Simplification and standardisation of pain management to support best practice including a concise number of pain scales (moderately effective, highly feasible).
Choice of medications available, route of administration and consideration of the intranasal route for moderate pain (moderately effective, moderately feasible).
Incorporate training on acute pain management at induction and developing pain management competencies (least effective, highly feasible).
Expand the number of medications available through patient group directions (PGDs) and single check PGDs (moderately effective, highly feasible).
Expand access to play specialist services and non-pharmacological interventions (uncertain effectiveness and feasibility).
Empower patients/parents to request analgesia (least effective, most feasible).
Expand access to paediatric procedural sedation for all sites (moderately effective, least feasible).
Regular local audits of pain management to monitor practices and highlight areas for improvement with frontline staff. (least effective, most feasible).
Limitations
This survey relied on accurate reporting by one clinician at each site based on our designed survey. These reports are unverified and are a single person’s views of each department which may over-report or under-report certain aspects. The results of compliance of guidelines to RCEM standards are reported based on the site leads interpretation and the guidelines sent to the study team were not analysed to verify this. Our approach allowed us to gain insight into many sites across the network, and our response rate means we are confident we identified key variations. We identified variation in practice, but we cannot determine best practice. We did not seek information on the prehospital management of pain, the qualifications of staff who assess and administer analgesia, staff motivations regarding pain assessment and management or documentation in medical records in our survey. This limits the ability to fully evaluate the structures of healthcare in the sites.
Conclusions
Controlling pain is a cornerstone of compassionate care. There has been serial and widespread documentation of the substandard pain outcomes currently provided in the management of acute pain in children. A revised and effective approach is needed. This survey has identified an opportunity for structural improvements to support the current national guidance for the management of pain in children.4 Potential opportunities for network-wide improvement include uniform guidance to mandate early pain assessment with timely effective analgesia administration and mandated reassessment. Other key areas for improvement include staff training and competencies, non-pharmacological analgesia and increasing the number of PGD medications and single-checked PGDs.
Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information. All data relevant to the study are included in the article.
Ethics statements
Ethics approval
This study was reviewed in line with the Healthcare Regulatory Authority framework by the Research and Development department at the lead site (Birmingham Children’s Hospital NHS Foundation Trust) and was deemed to be service evaluation.
Acknowledgments
The following acted as site leads for this study and were responsible for survey completion and sharing guidelines: M Anderson, Great North Children's Hospital, Newcastle; A Appelboam, Royal Devon and Exeter Hospital, Exeter; M Barrett, Children’s Health Ireland at Crumlin, Dublin; T Bolger, Children’s Health Ireland at Tallaght, Dublin; A Boyle, Addenbrooke's Hospital, Cambridge; J Browning, Royal Hospital for Sick Children, Edinburgh; M Clark, Royal London Hospital, Bart’s Health NHS Trust; F Cleugh, St Mary’s Hospital, London; D Cook, North Manchester General Hospital, Manchester; A Cowton, County Durham and Darlington NHS Foundation Trust; C Deasy, Cork University Hospital, Cork; J Evans, Sheffield Children’s NHS Foundation Trust, Sheffield; S Foster, Royal Hospital for Sick Children, Glasgow; S Gardner, Ormskirk and District General Hospital, Ormskirk; C Gough, Nottingham Children’s Hospital, Nottingham; D Hall, Evelina Hospital, London; S Hall, Queen Elizabeth Hospital, Woolwich; S Hartshorn, Birmingham Children’s Hospital, Birmingham; M Jacobs, West Hertfordshire Hospitals NHS Trust, Watford; H Jarman, St George's Hospital, London; G Johnson, Royal Derby Hospital, Derby; S Knight, University Hospital Southampton NHS Foundation Trust, Southampton; J Maney, Royal Belfast Hospital for Sick Children, Belfast; K Manning, Western Sussex Hospitals NHS Trust, West Sussex; S Messahel, Alder Hey Hospital, Liverpool; S Prudhoe, City Hospitals Sunderland Foundation Trust, Sunderland; M Nyirenda, Lewisham and Greenwich NHS Trust, London; G Patton, Royal Aberdeen Children’s Hospital, Aberdeen; K Potier, Royal Manchester Children’s Hospital, Manchester; Z Roberts, Children’s Hospital for Wales, Cardiff; D Roland, University Hospitals Leicester NHS Trust, Leicester; F Sa'adedin, King's College Hospital, London; A Scott, James Cook University Hospital, Middlesbrough; A Smith, Bristol Royal Hospital for Children, Bristol; J Smith, Derriford Hospital, Plymouth; E Walton, Royal Alexandra Children’s Hospital, Brighton; A Wedgewood, Royal United Hospital, Bath; S Wong, Royal Free London NHS Foundation Trust, London;
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @stuarthartshorn
Collaborators PERUKI site leads: Mark Anderson, Great North Children's Hospital, Newcastle; Andrew Appelboam, Royal Devon and Exeter Hospital, Exeter; Michael J Barrett, Children’s Health Ireland at Crumlin, Dublin; Turlough Bolger, Children’s Health Ireland at Tallaght, Dublin; Adrian Boyle, Addenbrooke's Hospital, Cambridge; Jen Browning, Royal Hospital for Sick Children, Edinburgh; Matthew Clark, Royal London Hospital, Bart’s Health NHS Trust; Francesca Cleugh, St Mary’s Hospital, London; Dianne Cook, North Manchester General Hospital, Manchester; Amanda Cowton, County Durham and Darlington NHS Foundation Trust; Conor Deasy, Cork University Hospital, Cork; Jayne Evans, Sheffield Children’s NHS Foundation Trust, Sheffield; Steven Foster, Royal Hospital for Sick Children, Glasgow; Sharryn Gardner, Ormskirk and District General Hospital, Ormskirk; Chris Gough, Nottingham Children’s Hospital, Nottingham; Dani Hall, Evelina Hospital, London; Sharon Hall, Queen Elizabeth Hospital, Woolwich; Stuart Hartshorn, Birmingham Children’s Hospital, Birmingham; Michelle Jacobs, West Hertfordshire Hospitals NHS Trust, Watford; Heather Jarman, St George's Hospital, London; Graham Johnson, Royal Derby Hospital, Derby; Suzanne Knight, University Hospital Southampton NHS Foundation Trust, Southampton; Julie-Ann Maney, Royal Belfast Hospital for Sick Children, Belfast; Katie Manning, Western Sussex Hospitals NHS Trust, West Sussex; Shrouk Messahel, Alder Hey Hospital, Liverpool; Sarah Prudhoe, City Hospitals Sunderland Foundation Trust, Sunderland; Maggie Nyirenda, Lewisham and Greenwich NHS Trust, London; Gareth Patton, Royal Aberdeen Children’s Hospital, Aberdeen; Katherine Potier, Royal Manchester Children’s Hospital, Manchester; Zoe Roberts, Children’s Hospital for Wales, Cardiff; Damian Roland, University Hospitals Leicester NHS Trust, Leicester; Firas Sa'adedin, King's College Hospital, London; Alex Scott, James Cook University Hospital, Middlesbrough; Alice Smith, Bristol Royal Hospital for Children, Bristol; Jason Smith, Derriford Hospital, Plymouth; Emily Walton, Royal Alexandra Children’s Hospital, Brighton; Anna Wedgewood, Royal United Hospital, Bath; Shye-Wei Wong, Royal Free London NHS Foundation Trust, London;
Contributors SD, MB, ML and SH contributed to the study design. SD was involved in the data analysis. All authors contributed to the study implementation/data acquisition, manuscript preparation and revisions.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.