Article Text

Original research
Patient-reported harm following cancellation of planned surgery at a Danish university hospital: a cross-sectional study
  1. Anette Viftrup1,
  2. Sussie Laustsen2,3,
  3. Maria Levin Pahle1,
  4. Pia Dreyer1,3,
  5. Lone Nikolajsen1,4
  1. 1Department of Anaesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark
  2. 2Department of cardiology, Aarhus University Hospital, Aarhus, Denmark
  3. 3Department of Public Health, Aarhus University, Aarhus, Denmark
  4. 4Department of Clinical Medicine, Aarhus University, Aarhus, Midtjylland, Denmark
  1. Correspondence to Anette Viftrup; anetvift{at}rm.dk

Abstract

Objectives To estimate the prevalence and severity of patient-reported physical and non-physical harm following surgery cancellation.

Design Cross-sectional study.

Setting A large Danish university hospital.

Participants Patients (≥18 years) from various surgical specialities, such as orthopaedic, spinal, abdominal, gynaecological, thoracic, vascular and urological surgery whose surgery was cancelled <2 weeks prior to the scheduled date due to hospital-related causes.

Outcome

Patient-reported physical and non-physical harm, defined as physical worsening, emotional strain and other consequences, measured using a patient-reported survey.

Results We identified 785 patients whose surgery was cancelled from 1 December 2021 to 1 June 2022, of whom 436 (55.5%) responded to the electronic survey. Physical worsening was reported by 42% and emotional strain by 48% of patients. One-third of patients reported an inability to continue daily activities, and 28% reported a need for an increased dose of analgesics. Emotional strain included various negative feelings such as being disappointed (59%) and lonely (31%). Furthermore, 44% of the respondents feared deterioration of their disease and 9% experienced anxiety of dying. The relative risk of emotional strain was higher in females than in males (54% vs 41%, adjusted relative risk (RR)=1.32 (1.08; 1.63)). A waiting period >30 days compared with ≤30 days was associated with a higher risk of physical worsening (25.3% vs 48.9%, adjusted RR=1.93 (1.42; 2.63)).

Conclusions Harm, measured as physical worsening and emotional strain, is reported with severity by nearly half of respondents following cancellation.

  • Cross-Sectional Studies
  • Health Services Accessibility
  • Safety
  • Stress, Psychological

Data availability statement

No data are available.

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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • This study provides important new insights into the prevalence, characteristics and severity of patient-reported harm following surgery cancellations, highlighting the need for preventive measures to reduce both physical and non-physical harm unintentionally caused by the healthcare system.

  • As no validated patient-reported questionnaire was found to measure all important aspects of the construct, a thorough conceptualisation and pilot-testing were done to ensure content validity of the questionnaire. Still, further validation and refinement of the instrument are recommended.

  • Although a sensitivity analysis using imputed data to account for the high number of non-responders produced similar results, non-response bias may still influence the findings.

  • Participants in this study were drawn from a single university hospital, and the generalisability of results could be improved by including multiple study sites across Denmark.

BACKGROUND

Surgery cancellation poses an ongoing challenge for patients, healthcare professionals and healthcare systems. The global prevalence of cancellations on the scheduled day of surgery was reported to be 18% between 2010 and 2020.1 The COVID-19 pandemic and shortage of nursing staff further exacerbated the problem of surgery cancellations and thereby contributed to an increase in the number of patients who experienced extended waiting periods.2–4 The main reasons for surgery cancellation can be described in three overall categories comprising hospital-related causes (ie, staff shortage, lack of intensive care unit or postanaesthesia care unit bed capacity or lack of surgical equipment), patient-related causes (ie, non-attendance or medical reasons) and surgeon- or anaesthesia-related causes (ie, lack of available surgeons or anaesthesiology staff).5 Surgery cancellations due to hospital-related causes have been associated with significantly more negative reactions and feelings among patients than cancellations from other causes.6 Waiting for surgery has also been found to negatively impact patients’ mental health, including diminished quality of life, uncertainty, fear of deterioration, as well as increased levels of anxiety and depression.7 Furthermore, results from a qualitative study of adult patients with delayed surgeries due to the COVID-19 pandemic showed varying impacts on physical health, ongoing pain and prolonged use of pain medication.8 However, knowledge on how and to what extent patients are affected or harmed by surgery cancellation is limited.

According to Sokol-Hessner et al (2015), harm is defined as ‘any outcome that negatively affects the patient’s health and/or quality of life’.9 Thereby, the concept of harm has evolved beyond its primary focus on physical harm to encompass non-physical harm.10 Non-physical harm is described to include emotional, psychological and sociobehavioural negative impacts.10 ‘Delay in care’ or being turned away from a scheduled appointment is an example of harm that may negatively impact patients, cause negative emotions and feelings, erode trust, adversely impact the patient-provider relationship and reduce the perceived quality of care.10 11 While healthcare professionals do not intend to behave disrespectfully during surgery cancellation, the event may nevertheless be experienced as disrespectful at the system level by patients and/or families.

Previous studies have described an increased risk of negative physical impact following surgery cancellation including a higher prevalence of postoperative complications, increased pain and problems with activities of daily living.12 13 Additionally, a recent study reviewing patients’ experiences of surgery cancellation found that patients may react with non-physical symptoms such as anxiety and depression in the extended waiting period following cancellation.14 These consequences may be construed as harmful and may have an impact on patients’ clinical conditions. Thus, exploration and increased knowledge about any harm related to surgery cancellation are essential in preventing and limiting negative physical and non-physical impacts on patients. To our knowledge, there are no studies that estimate the prevalence and severity of patient-reported physical and non-physical harm following surgery cancellation. Therefore, this study examined the physical and non-physical consequences of surgery cancellation from the patients’ perspective.

Objectives

To estimate the prevalence and severity of patient-reported physical and non-physical harm following surgery cancellation.

Methods

Study design and setting

This cross-sectional study was conducted at a Danish university hospital among patients from various surgery specialities, including orthopaedic, spinal, abdominal, gynaecological, thoracic, vascular and urological surgery. The hospital is one of the largest university hospitals in the Nordic countries, with approximately 85 000 surgeries performed annually.

Participants

Adult patients ≥18 years of age who had experienced cancellation of planned surgery during the 6-month period from 1 December 2021 to 1 June 2022 were identified from the Business Intelligence portal, a database holding information from the electronic medical record of patients admitted to the hospital. Patients were invited to participate in the study if their planned surgery included hospitalisation and if the cancellation was a result of hospital-related causes, occurring <2 weeks ahead of the scheduled date with a postponement >24 hours. For this study, no distinction was made between cancellation and postponement. Cancellations caused by patient-related, surgeon- or anaesthesia-related causes were not included in the study. An invitation and a link to the software programme Research Electronic Data Capture, which included the survey, was emailed to all identified patients in June 2022 by a secure electronic mail system used primarily for communications with public authorities in Denmark. Patients failing to respond received a reminder 2 weeks after the first invitation.

Physical and non-physical harm

Physical harm was defined as ‘physical worsening’ in the survey. Subtypes of physical harm dealt, among others, with the prevalence and severity of newly experienced rapid heartbeat, stomach problems and ability to continue daily activities. Non-physical harm was defined as ‘emotional strain’ and ‘other harmful consequences’. Subtypes of non-physical harm included different negative feelings following cancellation such as disappointment, sadness, stress and anxiety of dying. Subtypes of ‘other harmful consequences’ included inability to work, financial loss and the need for therapeutic healthcare contact. An ordinal scale was used to measure the severity of harm with the following responses: ‘not at all’, ‘a little’, ‘somewhat’, ‘quite a bit’ and ‘very much’. In addition, patients could elaborate on their replies by answering three open-ended questions.

Development of the survey to measure physical and non-physical harm

We found no instrument designed to measure patient-reported harm in relation to surgery cancellation. Hence, a self-administered survey with 30 items was developed (for an English translation of the questionnaire, see online supplemental appendix). The survey was qualified for use in a clinical context by aligning it with the first five steps of the six-step procedure described by de Vet HCW et al.15 The first step included the determination and definition of the concept to be measured. The conceptualisation took inspiration from a previously published review and literature on patient safety.9–11 14 In anticipation of capturing the multidimensional nature of physical and non-physical harm following surgery cancellation, the survey was divided into three main themes: ‘physical worsening’, ‘emotional strain’ and ‘other harmful consequences’. Selection and phrasing of the items and the response options were accomplished by reviewing existing instruments. The contents of the items were preliminary pilot-tested, consulting experts (n=5) and non-healthcare professionals (n=5).

Patient and public involvement

Patients were first involved in the research by pilot-testing of the survey. Patients (n=7) on the surgical ward who had experienced surgery cancellation were asked to complete the survey and participate in the interviews initiated by the primary investigator (AV). Patients were asked to respond to the following questions related to the survey: ‘Is the phrasing of items correct/understandable?’ ‘Do items cover relevant topics and are they acceptable?’ ‘Are the chosen response options exclusive (ie, that they did not overlap one another) and exhaustive (ie, the response included all possible response options)?’ and ‘Are there any missing items?’ Additionally, the time taken to complete the survey was recorded, and patients’ views on the length and burden of the survey were assessed.

Patient interviews resulted in adaptations of the survey, specifically, redundancies were removed, questions were reformulated and items related to insomnia, sadness, anxiety about disease exacerbation and dying, mistrust and physical consequences were added.

No patients were involved in the design, recruitment or conduct of the study. No patients were involved in the dissemination of the study results to participants and relevant wider patient communities.

Statistical analyses

We calculated the prevalence of physical and non-physical harm including subtypes. To visualise and clarify the reporting of the severity of physical and non-physical harm, we dichotomised answers into two categories. The answers ‘not at all’ and ‘a little’ were combined into one category, and ‘somewhat’, ‘quite a bit’ and ‘very much’ were combined into another category. The relative risk (RR) for associations between patients’ characteristics (age and gender) and physical worsening and emotional strain was calculated using binary regression models. The association between the length of the waiting period and physical worsening and emotional strain was analysed using a generalised linear model with a log-link function adjusting for gender and sex, and relative risk were estimated. Estimates were given with 95% CIs and the significance level was set at <0.05.

Due to missing data from non-respondents, a sensitivity test was performed with multiple imputation using chained equations (MICE). We tabulated the characteristics of respondents and non-respondents with respect to age and gender. Variables for gender and age were used for the imputation.

Data containing written patient notes from open-ended questionnaire items were systematically processed using the qualitative data analysis tool NVivo since the data material was extensive. However, a few quotes were selected to underpin the results from the quantitative analysis, but an extensive analysis is not reported in the present study.

The checklist ‘Strengthening the Reporting of Observational Studies in Epidemiology’ was used. The content of this paper follows the REporting of studies Conducted using Observational Routinely-collected Data guidelines. All statistical analysis was performed using a statistical software for data sciene (STATA) (18.0 MP-Parallel Edition).

Ethics approvals and registration

The study was approved by the Central Denmark Region Committees on Health Research (ID 1-16-02-70-22), and patient identification was approved by the hospital management. Patients were given written information about the project, the nature of voluntary participation, confidentiality and the right to withdraw their approval, and gave informed consent to participate in the study via the secure electronic mail system.

Results

In total, 785 patients were eligible for the study, 436 (55.5%) of whom responded to the survey. The respondents’ mean age was 59 years (19–89 years), and 54% were female (table 1). Qualitative data contained written patient notes from open-ended items of physical worsening (n=210 notes), emotional strain (n=193 notes) and other consequences (n=170 notes), respectively.

Table 1

Characteristics of 436 patients experiencing surgery cancellation and details about their cancellation

Respondent patients were notified about their cancellation by email (37%), phone call (40%) or at the hospital 23% (table 1). A total of 25% of respondent patients reported they were informed about the cancellation by a physician, 19% by a nurse, 42% by a secretary and 14% did not know who had notified them. The median waiting period from cancellation to completed surgery was 39 days (IQR 8–98) (table 1). The survey did not contain data on the number of cancellations experienced by the individual patients, but patient notes suggested that patients were negatively affected if they experienced repeated cancellations. For example, one patient wrote:

“I had the surgery cancelled tree times. The last two were especially hard as I attended at the hospital and waited for 5 and 13 hours respectively – and then I was sent home”.

Physical harm (physical worsening)

During the extended waiting period, 42% of patients reported a worsening in their physical health (figure 1). A total of 36% of respondents reported either complete inability or only a little capacity to continue their daily activities. Approximately one-third (28%) of patients replied that they needed a stronger or higher dose of analgesics in their extended waiting period. Among these, patients who underwent spinal surgery represented the highest percentage (56%) and patients in need of other orthopaedic surgery, the second highest (38%). Additionally, patients reported symptoms such as newly experienced rapid heartbeat (10%) and stomach problems (10%) in the extended waiting period (figure 2). New-onset insomnia was reported by 29% of patients, and 13% reported they had started using sleeping pills or sedatives. The results showed no significant difference in patient-reported physical worsening between the females and males (41.3% vs 40.5%, adjusted relative risk (RR)=1.02 (0.82; 1.29)) or between the groups aged 19–65 versus aged >65 (39% vs 44%, adjusted RR=1.13 (0.90; 1.42)).

Figure 1

Patient-reported physical worsening and emotional strain following surgery cancellation.

Figure 2

Patients’ responses following surgery cancellation. Items: Did the cancellation cause you to –

When evaluating the difference in physical worsening between patients who waited for a new scheduled surgery ≤30 days versus >30 days, the risk of reporting physical worsening in the group waiting >30 days was 93% higher than in the group waiting for≤30 days, adjusted for gender and sex (25.3% vs 48.9%, adjusted RR=1.93 (1.42; 2.63), p<0.001). Results did not differ significantly in the imputed data (adjusted RR=1.88 (1.39; 2.54), p<0.001).

Non-physical harm (emotional strain)

Overall, 48% of patients reported emotional strain in their extended waiting period (figure 1). Data from the notes revealed that patients were mentally burdened when they experienced cancellation close to their planned surgery. “It is a mental strain to get a message about cancellation the day before surgery without any explanation”. “It was a harsh experience to be sent home after 4 hours of waiting, wearing hospital clothing in a cold waiting room”. Other negative feelings were observed, among which the feeling of being disappointed was the most dominant feeling which was reported by 59% of patients. Moreover, frustration and anger were reported by 58% and 36% of patients, respectively (figure 2). We observed no significant difference in patient-reported levels of anger or fear of deterioration when categorising the hospital staff (doctors vs secretaries/nurses) into two groups responsible for managing cancellation information.

Patient-reported feelings also included feelings of being lonely (31%), sad (48%) and stressed (38%) in the extended waiting period (figure 2). This was underlined by a written note stating, “I am mentally distressed and depressed by the waiting time”. Several patients feared deterioration of their disease (44%) and 9% reported anxiety of dying from their disease. One patient noted, “My relatives are anxious that I may die (while waiting). Both me and my relatives are mentally affected by that”.

A total of 68% of all patients replied they feared another cancellation, and 34% of patients stated the experience eroded their trust in the healthcare system. This was emphasised in the following note: “You become distrustful and ask: Will it also happen next time, even though they promised me that they did not cancel a surgery twice?”

The risk of experiencing emotional strain following cancellation was significantly higher in females than in males (54% vs 41%, adjusted RR=1.32 (1.08; 1.63)). The same pattern was found for feelings of stress (adjusted RR=1.35 (1.05; 1.73)) and feelings of sadness in the extended waiting period (adjusted RR=1.44 (1.17; 1.77)). The results showed no significant difference in patient-reported emotional strain between the groups aged 19–65 versus aged >65 (52% vs 43%, adjusted RR=0.84 (0.69; 1.03)). No difference in the risk of emotional strain was found between those patients who waited for a new scheduled surgery for ≤30 days versus >30 days (42.6% vs 47.6%, adjusted RR=1.15 (0.91; 1.43)). A similar result was found after analysing the imputed data.

Non-physical harm (other harmful consequences)

The survey also highlighted the impact of surgery cancellation on patients’ need for healthcare contact. During the extended waiting period for surgery, 22% (n=96) of patients reported having been in contact with their general practitioner (GP) about their medical condition. Among the 96 patients, the number of interactions with their GP was ≥186. Hence, some patients had more than one contact. The same pattern was seen for patients who contacted the hospital ward, resulting in a total of ≥310 phone calls to the ward from 171 patients.

Notes regarding other consequences included difficulties planning everyday life, such as when to return to the workplace or educational institution, and concerns about an extended illness period. Patients also expressed uncertainty about their job situation, and six patients noted that they lost their jobs due to the extended waiting period. Furthermore, a total of 15% (n=63) responded that they had experienced negative financial consequences.

Discussion

In this explorative cross-sectional study, we found that the overall prevalence of patient-reported physical worsening was 42% and that 48% of patients expressed emotional strain in the extended waiting period. Hence, surgery cancellation and a subsequent new waiting period inflict both physical and non-physical harm on patients.

Information about surgery cancellation was given in person on the day of scheduled surgery to 23% of the respondents. Additionally, the study did not describe how long before scheduled surgery patients had their surgery cancelled. It is therefore not evident if the burden of harm is associated with the time point at which patients are notified. Even so, notes from the survey revealed that patients were mentally burdened when they experienced cancellation close to their planned surgery. This is in line with former studies showing that the closer to the scheduled operation date patients received information about cancellation, the more negative feelings and dissatisfaction were expressed.16–18 Hence, the timing of information about cancellation relative to the scheduled date of surgery may be of importance. Previous studies have also shown that patients prefer to be informed by a doctor and that an angry reaction was sustained when patients were informed by a nurse or a non-health professional.17 19 Another study found that the need to talk with a doctor applied particularly to elderly patients.6 Our study did not establish a difference in patient-reported anger or fear of deterioration between dichotomised groups of hospital staff (doctors vs secretaries/nurses), conveying the information about cancellation. Thus, further elaboration on what matters to patients during the notification of cancellation is needed.

On average, patients waited >1 month for rescheduled surgery. It was affirmed that a longer waiting period (>30 days) produced a higher risk of reporting physical worsening than a shorter waiting period (≤30 days). Studies have explored the impact of waiting for elective surgery mostly without taking the harmful event of cancellation into account.20–24 These studies reported adverse physical consequences due to waiting, and improved condition over time was only reported before shoulder and elbow orthopaedic surgery.21 In our search for studies investigating physical harm following surgery cancellation, four studies were identified.12 13 25 26 A retrospective survey of patients following joint replacement surgery (hip or knee) showed significantly more complications (n=50) such as myocardial infarction, wound infection and pneumonia in a group of 60 patients having their surgery cancelled than in a matched group of 60 patients having the same type of surgery (n=30) (p<0.03).25 Similarly, in a retrospective cohort study on cancer patients, Eskander et al13 found that patients in the cancelled cohort had a higher complication rate during hospitalisation than patients in the control cohort (7.3% vs 4.9%; p<0.01).13 Myocardial infarction was the only complication showing a significant difference between groups when making individual analysis. No association was found between prolonged waiting time and poorer survival.13 Moreover, another study found that the most prevalent negative physical effects reported by patients, when cancellations occurred on the day of the scheduled surgery, included hunger, thirst and headaches.26 We uncovered instances of physical worsening in the prolonged waiting period. Notably, one-third of patients reported a heightened need for analgesics, and 36% reported some degree of difficulty in continuing their daily activities. Protracted acute pain in patients may convert to chronic pain,27 and patients may be at risk of increasing their intake of opioids after surgery if they reported preoperative opioid use.28 Hence, guidance and close follow-up during tapering are important when patients have a heightened need for pain medication during an extended waiting period. New-onset insomnia was also found among 29% of patients in the present study, creating a need for sleeping pills or sedatives for 13% of patients. This was also reported to be common among patients in a waiting position before a scheduled date of surgery.29 As in our study, a few studies have mentioned other symptoms, such as rapid heartbeat, stomach problems, chest pain and nausea in relation to the cancellation of open-heart surgery and orthopaedic surgery.16 30 The severity of the underlying disease and type of surgery may influence the association between waiting time and patient-reported physical worsening. Investigation of physical harm following cancellation of elective surgery is accordingly essential in every surgical area.

There is also evidence suggesting surgery cancellation affects patients’ mental health. Two studies found a correlation between surgery cancellation and subsequent anxiety and depression.6 30 Overall, 48% of patients reported emotional strain in the extended waiting period. Strain manifested as various negative feelings, such as being disappointed (59%), lonely (31%) and feeling sad (48%). This strain was further supported by several quotes describing how the uncertainty caused mental distress and depressive thoughts. Furthermore, a significantly higher risk of emotional strain and feelings of stress and sadness following cancellation were found among females than among males. However, these findings have not been consistent in the literature.6 30 Hence, it is imperative to focus attention on identifying which individual patients suffer most from emotional strain in the prolonged waiting period. In a qualitative study, patients stated their worries about the deterioration of their condition while waiting for surgery - particularly patients with cancer diagnoses.18 Our study did not measure anxiety level, but 44% of the patients reported they were worried about deterioration, and 9% of patients reported they were anxious that they might die from their disease while waiting for surgery. Hence, mental distress and anxiety in patients experiencing surgery cancellation are issues of concern in the healthcare system. Accordingly, the call to implement systematic screening of patients’ physical and mental health while waiting for surgery is relevant.25 29 Finally, surgery cancellation may reduce trust in the healthcare system as a total of 68% of respondents reported fear of another cancellation. Lack of confidence was corroborated 14 times in the written notes in the present study. In an earlier study, 50% of patients feared another cancellation.30 Comparatively, comparing outcomes from our study to those of the previous study (68% vs 50%), a noteworthy increase in concern was evident. Thus, endeavours to avoid cancellations and thereby prevent any physical and non-physical harm in patients experiencing surgery cancellation are warranted.

Limitations

A new survey was developed to measure harm in relation to surgery cancellation. Despite our diligent effort to attain preliminary pilot testing for the tool, we recommend that the instrument undergo further validation and refinement before considering its reuse in other contexts.

We sought to minimise selection problems by including all patients in the consecutive 6 month study period. However, the study response rate was 55.5%. The high number of non-respondents may be explained by the patients’ vulnerable situation, as evidenced in frustrated emails sent by patients to the primary investigator (data not reported). Due to the high number of non-respondents, a sensitivity analysis was performed with MICE. Results were almost similar after analysis with imputed data. Furthermore, a higher response rate and inclusion of multiple study sites in Denmark may have increased the generalisability of results. Finally, we calculated mean follow-up days from the scheduled date to receipt of survey submission between respondents and non-respondents to examine if a different follow-up time could influence the response rate. A minor variation in mean follow-up days between groups was found (151 days vs 145 days).

Conclusion

To our knowledge, this is one of the first studies to estimate the prevalence and severity of patient-reported physical and non-physical harm following surgery cancellation. Harm, measured as physical worsening and emotional strain, was reported with severity by nearly half of respondents. Approximately one-third of patients reported an inability to continue daily activities, and 28% reported a need for an increased dose of analgesics in the prolonged waiting period. Respondents also reported emotional strain including different negative feelings. A total of 44% of the respondents feared deterioration of their disease and 9% experienced anxiety of dying. We also affirmed that the RR of experiencing emotional strain was significantly higher among females than among males and that a longer waiting period (>30 days) produced a higher risk of reporting physical worsening than a shorter waiting period (≤30 days) did.

Data availability statement

No data are available.

Ethics statements

Patient consent for publication

Ethics approval

This study involves human participants and was approved by the Central Denmark Region Committees on Health Research (ID 1-16-02-70-22). Participants gave informed consent to participate in the study before taking part.

References

Supplementary materials

  • Supplementary Data

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Footnotes

  • Contributors Contributors: study design: AV, SL, PD and LN. Conceptualisation and development of questionnaire: AV, SL, PD and LN. Data collection: AV and MLP. Analysis of data: AV. Interpretation of data: AV, SL, MLP, PD and LN. Drafting the work: AV. Reviewing the work critically: AV, SL, MLP, PD and LN. Final approval: AV, SL, MLP, PD and LN. AV is the guarantor.

  • Funding This work was supported by the Novo Nordisk Foundation (grant number: NNF21OC0072570).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

  • 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.