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Introduction Spinal manipulation therapy (SMT) is used throughout the world by chiropractors, osteopaths, physiotherapists and other manual therapists, yet there are no systematic data collection mechanisms in place to monitor and evaluate adverse events (AE) that occur after SMT. We established a reporting and learning system (“SafetyNet”) to fill this void and to address several aims, one of which is a prospective population-based active surveillance study to (a) document AE after SMT, (b) identify potential risk factors, and (c) develop potential strategies to mitigate risk. The purpose of this paper is to describe the development and validation of provider and patient measurement instruments to identify potential SMT AE in provider offices. Methods Instrument development and validation occurred in a step-wise fashion: (1) definition of terms (e.g. adverse event, seriousness); (2) identification and development of key domains, items, and sub-items; and (3) assessment of relevant measurement properties. Results Two provider short instruments, a provider long instrument, and a pre and post treatment patient comment instruments were developed, refined, and pilot tested with 12 providers and 300 patients. Conclusions The development and validation of instruments to evaluate SMT AEs may benefit the SMT research community as well as clinicians and their patients by providing rigorous prospective assessment of potential SMT-related AEs and their risk factors, thus enhancing patient safety and the promotion of a safety culture. Placing the instruments in providers’ offices for use on consecutive patients is next on the SafetyNet research agenda.

Summary Objectives The objectives of this study were (i) to identify levels of awareness and understanding of a patient safety incident (PSI) reporting system by members of the British Chiropractic Association (BCA); (ii) to identify BCA members’ attitudes to the reporting of PSIs; (iii) to identify possible barriers to incident reporting and the use of the Chiropractic Reporting and Learning System (CRLS) by BCA members. Design Qualitative, semi-structured interviews. Setting Chiropractic practices in Dorset, Hampshire and Wiltshire, and the Anglo-European College of Chiropractic (AECC) outpatient clinic. Subjects Seven chiropractors (four female, three male) with between 6 months’ and 27 years’ practice experience. Methods Interviews were recorded and subsequently transcribed verbatim. Data were analysed using thematic analysis. Results All participants were aware of the CRLS prior to being contacted and were positive in their attitudes towards it. The interviewees considered the CRLS as a tool that could help the profession to achieve accountability and openness, and improve patient safety. Reasons identified for under-reporting included fear of retribution, being too busy and insufficient clarity on what to report. Conclusions The CRLS was considered to be of benefit to the profession. However, until there is greater clarity of the purpose and role of the CRLS, the system will probably remain under-utilised. Strategies should be implemented to improve the reporting of PSIs to the CRLS, including extensive education of the profession. In particular, chiropractors need to understand that without personal initiative on a local as well as national level, improving patient safety by learning from reporting may be difficult to achieve.

Objective Patients with nonspecific musculoskeletal disorders may vary in their response to treatment. This study set out to identify the predictors for either improvement or worsening in symptoms for which cervical spine manipulation is indicated. Method A large prospective study recorded details on patients, their presenting symptoms, and type of treatment. At the end of the consultation, any immediate improvement or worsening in presenting symptoms was noted. At the follow-up visit, information was collected on the patients' self-reported improvement. Results Data were collected from 28 807 treatment consultations (in 19 722 patients) and 13 873 follow-up treatments. The presenting symptoms of “neck pain,” “shoulder, arm pain,” “reduced neck, shoulder, arm movement, stiffness,” “headache,” “upper, mid back pain,” and “none or one presenting symptom” emerged in the final model as significant predictors for an immediate improvement. The presence of any 4 of these predictors raised the probability for an immediate improvement in presenting symptoms after treatment from 70% to ~95%. With regard to immediate worsening, “neck pain,” “shoulder, arm pain, “headache,” “numbness, tingling upper limbs,” “upper, mid back pain,” and “fainting, dizziness, light-headedness” emerged as predictors; and the presence of any 4 of these raised the probability for immediate worsening from 4.4% to ~12%. For global improvement, only 2 predictors were identified; but these did not enhance the postprediction probability. Conclusions This study is the first attempt to identify variables that can predict immediate outcomes in terms of improvement and worsening of presenting symptoms, and global improvement, after cervical spine manipulation. The predictor variables were strongest for immediate improvement.

Study Design - Prospective national survey. Objective - To estimate the risk of serious and relatively minor adverse events following chiropractic manipulation of the cervical spine by a sample of U.K. chiropractors.Summary of Background Data. The risk of a serious adverse event following chiropractic manipulation of the cervical spine is largely unknown. Estimates range from 1 in 200,000 to 1 in several million cervical spine manipulations. Methods - We studied treatment outcomes obtained from 19,722 patients. Manipulation was defined as the application of a high-velocity/low-amplitude or mechanically assisted thrust to the cervical spine. Serious adverse events, defined as “referred to hospital A&E and/or severe onset/worsening of symptoms immediately after treatment and/or resulted in persistent or significant disability/incapacity,” and minor adverse events reported by patients as a worsening of presenting symptoms or onset of new symptoms, were recorded immediately, and up to 7 days, after treatment. Results - Data were obtained from 28,807 treatment consultations and 50,276 cervical spine manipulations. There were no reports of serious adverse events. This translates to an estimated risk of a serious adverse event of, at worse ≈1 per 10,000 treatment consultations immediately after cervical spine manipulation, ≈2 per 10,000 treatment consultations up to 7 days after treatment and ≈6 per 100,000 cervical spine manipulations. Minor side effects with a possible neurologic involvement were more common. The highest risk immediately after treatment was fainting/dizziness/light-headedness in, at worse ≈16 per 1000 treatment consultations. Up to 7 days after treatment, these risks were headache in, at worse ≈4 per 100, numbness/tingling in upper limbs in, at worse ≈15 per 1000 and fainting/dizziness/light-headedness in, at worse ≈13 per 1000 treatment consultations. Conclusion - Although minor side effects following cervical spine manipulation were relatively common, the risk of a serious adverse event, immediately or up to 7 days after treatment, was low to very low.

Summary Objective To design and test a reporting format for patient safety incidents (PSIs) related to chiropractic practice. Design A pilot study of adverse event monitoring. Setting Field chiropractic practice and the teaching clinic of the Anglo-European College of Chiropractic. Subjects Members of the British Chiropractic Association and final year clinical students. Methods Following design of a reporting format, chiropractors and/or final year clinical students responded by completing a form and submitting this to a central collection point for analysis. Results Forms were received from seven field practitioners and from 63 students providing information on a number of PSIs. The low number of field practitioners responding prevented any summative analysis and the results are therefore presented individually. With reference to the final year clinical students, the majority of PSIs were associated with misuse of therapeutic equipment (32%) and the treatment intervention itself (31%). Conclusions Gathering information on PSIs using this format was shown to be both feasible and fit for purpose. Further work is planned to widen access and to facilitate and promote the attributes for an informed safety culture for the chiropractic profession.

The combined extended and rotated cervical spine position has been postulated to affect vertebral artery blood flow by primarily causing a narrowing of the vessel lumen, usually within the artery contralateral to the side of head rotation. The production of brainstem symptoms during the manoeuvre has generally been considered to be a positive test result. As a consequence, functional pre-manipulation testing of the cervical spine has been part of clinical screening undertaken by chiropractors and other manual practitioners to rule out the risk of possible injury to the vertebral artery. To date, these testing procedures are taught to students and carried out in daily clinical practice, despite the considerable controversy that exists about their validity. This paper considers and discusses the usefulness of functional pre-manipulation testing for clinical scenarios, involving dissection, spasm or stenosis of the vertebral artery, and makes the following recommendations: (1) Practitioners must assess the patient thoroughly, through careful history taking and physical examination, for the possibility of vertebral artery dissection. It is important to note that vertebral artery dissection (VAD) may present as pain only, and may not be associated with symptoms and signs of brainstem ischaemia. (2) If there is a strong likelihood of VAD, provocative pre-manipulation tests should not be performed, and the patient must be referred appropriately. (3) In the patient presenting with symptoms of brainstem ischaemia due to non-dissection stenotic vertebral artery pathologies, provocative testing is very unlikely to provide any useful additional diagnostic information. (4) In the patient with unapparent vertebral artery pathology, where spinal manipulative therapy (SMT) is considered as the treatment of choice, provocative testing is very unlikely to provide any useful information in assessing the probability of manipulation induced vertebral artery injury.

Background context: Neck pain is a leading cause of morbidity and health care utilisation worldwide, and spinal manipulative therapy (SMT) has become an increasingly popular therapeutic approach for the treatment of mechanical neck disorders and headache. Within the UK, the chiropractic profession is one of the main providers for SMT, however, the frequency with which neck manipulations are carried out is unknown. Purpose: To establish the number of annual patient visits at which at least one cervical manipulation treatment had been performed by practising members of the British (BCA) and Scottish (SCA) chiropractic associations. Methods: A self-administered questionnaire was sent to 399 registered chiropractors chosen from the membership databases of the BCA and SCA. The chiropractors were asked to enter the total number of patient visits in which at least one cervical manipulation had been administered during a predetermined study week. Results: A total of 291 questionnaires were returned (response rate 72.9%). Based on 281 usable data files, one BCA or SCA chiropractor performs on average a minimum of 40 cervical spine manipulations each week. Assuming that the average BCA/SCA chiropractor works for 49 weeks per year, this equates to 1975 treatment visits per year at which at least one cervical spine manipulation is administered. At the time the sample was taken for this study, a combined total of 1139 chiropractors were registered on the BCA and SCA databases. By extrapolation, the combined membership of the BCA and SCA, would therefore perform a minimum of 2,250,664 cervical spine manipulations or adjustments in 1 year. Conclusions: This study, for the first time, established that, for 2003, the average BCA and SCA chiropractor administered a weekly minimum of 40 cervical spine manipulations and that, on an annual basis, a conservative estimate of 2.25 million cervical spine manipulations are carried out.

Recent changes in the National Health Service (NHS) in the UK have included a major push towards improving the quality of patient care and the safety of the offered services under the mantle of clinical governance. The various elements that constitute clinical governance are, in the main, just as relevant to the chiropractic profession as they are to the NHS. Some of these elements, such as “clinical risk management” and “openness and accountability” may perhaps be more challenging to adopt by organisations and their members, as changes in organisational culture are required. These issues are discussed and an opinion on how they may relate to the chiropractic profession is offered.

Background It is not uncommon for chiropractors to be associated with sports teams for injury prevention, treatment, or performance enhancement. There is increasing acceptance of the importance of sports psychology in the overall management of athletes. Recent findings indicate mental hardiness can be determined reliably using specific self-assessment questionnaires. This study set out to investigate the hardiness scores of professional footballers and examine the correlation between two questionnaires. It also included a mental hardiness rating of players by two coaches, and examined differences in hardiness and mental toughness between national and international players. Methods Two self-assessment questionnaires (modified Sports Mental Toughness Questionnaire [SMTQ-M] and Psychological Performance Inventory [PPI-A]) were completed by 20 male professional footballers. Two coaches, independently rated each player. A percentage score from each questionnaire was awarded each player and an average score was calculated ({SMTQ-M % + PPI-A %} ÷ 2). The PPI-A and SMTQ-M scores obtained for each player were analysed for correlation with Pearson’s correlation coefficient. Cohen’s kappa inter-reliability coefficient was used to determine agreement between coaches, and between the players’ hardiness scores and coaches’ ratings. The independent t-test was used to examine differences between national and international players. Results The players’ scores obtained from PPI-A and SMTQ-M correlated well (r = 0.709, p < 0.001). The coaches ratings showed significant, weak to moderate agreement (Cohen's kappa = 0.33). No significant agreement was found between player self-assessments and coaches’ ratings. The average ({SMTQ-M % + PPI-A %} ÷ 2) mean score was 77% (SD = 7.98) with international players scoring 7.4% (p = 0.04) higher than non-international players. Conclusions The questionnaires (SMTQ-M and PPI-A) correlated well in their outcome scores. These findings suggest that coaches moderately agree when assessing the level of mental hardiness of football players. There was no agreement between player self-assessment and ratings by coaches. Footballers who play or had played for national teams achieved slightly higher mental hardiness scores. Either questionnaire can offer the clinician a cost-effective, valuable measure of an individual’s psychological attributes, which could be relevant within the wider context of bio-psycho-social model of care.

Spinal manipulative therapy to the cervical, and especially the upper cervical, spinehas been linked to stroke of the posterior circulation affecting the cerebellum and brain stem. Two cases are presented in which chiropractors manipulated patients who presented with neck pain and headaches, resulting in post-manipulative stroke in both cases. Analysis of the cases and review of the relevant literature demonstrate that these scenarios remain both extremely rare and unpredictable. Appropriate post-indicent management is a key factor in the patient's prognosis.

Background The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. Methods An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent’s practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann–Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite ‘% positive agreement’ score calculated for each dimension. Results Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. Gender differences were observed with female chiropractors appearing to be more risk averse. Conclusions Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by re-evaluating the case. The unlikeliness of safety incident reporting is probably due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.

Background In 2009, the heads of the Executive Council of the European Chiropractors' Union (ECU) and the European Academy of Chiropractic (EAC) involved in the European Committee for Standardization (CEN) process for the chiropractic profession, set out to establish European guidelines for the reporting of adverse reactions to chiropractic treatment. There were a number of reasons for this: first, to improve the overall quality of patient care by aiming to reduce the application of potentially harmful interventions and to facilitate the treatment of patients within the context of achieving maximum benefit with a minimum risk of harm; second, to inform the training objectives for the Graduate Education and Continuing Professional Development programmes of all 19 ECU member nations, regarding knowledge and skills to be acquired for maximising patient safety; and third, to develop a guideline on patient safety incident reporting as it is likely to be part of future CEN standards for ECU member nations. Objective To introduce patient safety incident reporting within the context of chiropractic practice in Europe and to help individual countries and their national professional associations to develop or improve reporting and learning systems. Discussion Providing health care of any kind, including the provision of chiropractic treatment, can be a complex and, at times, a risky activity. Safety in healthcare cannot be guaranteed, it can only be improved. One of the most important aspects of any learning and reporting system lies in the appropriate use of the data and information it gathers. Reporting should not just be seen as a vehicle for obtaining information on patient safety issues, but also be utilised as a tool to facilitate learning, advance quality improvement and to ultimately minimise the rate of the occurrence of errors linked to patient care. Conclusions Before a reporting and learning system can be established it has to be clear what the objectives of the system are, what resources will be required and whether the implementing organisation has the capacity to operate the system to its full advantage. Responding to adverse event reports requires the availability of experts to analyse the incidents and to provide feedback in a timely fashion. A comprehensive strategy for national implementation must be in place including, but not limited to, presentations at national meetings, the provision of written information to all practitioners and the running of workshops, so that all stakeholders fully understand the purposes of adverse event reporting. Unless this is achieved, any system runs the risk of failure, or at the very least, limited usefulness.

Background Augmenting validated paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages (cost, rapidity and reliability). However, equivalence of online and paper questionnaires cannot be assumed, nor can acceptability to respondents. The aim was to test whether online and written versions of the Roland Morris Disability Questionnaire (RMDQ), a standard measure of functional disability in back pain, are equivalent at both group and individual levels to establish whether they can be used interchangeably. Methods This is a within-participants equivalence study. 167 participants with back pain fully completed both the paper and online versions of the RMDQ in random order. Participants were recruited from a chiropractic clinic and patient support groups in Southern England. Limits of equivalence were pre-defined as 0.5 RMDQ points, the Bland-Altman range was calculated, and participants' comments were examined using content analysis. Results The mean score difference was 0.03 (SD = 1.43), with the 95% Confidence Interval falling entirely within our limits of equivalence (-0.19 to 0.25). The Bland-Altman range was -2.77 to 2.83 RMDQ points. Participants identified unique advantages and disadvantages associated with each version of the RMDQ. Conclusions The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably. The Bland-Altman range appears to reflect the known measurement properties of the RMDQ. Furthermore, participants' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper.

This case report details diagnosis of an apparent compression fracture of the lateral mass of the atlas vertebra with an associated avulsion fracture of the medial portion of the lateral mass. Congenital abnormalities of the posterior arches of both atlas and axis were also noted. The patient, a 59-year-old Caucasian male had two previous incidents of severe cervico-cranial trauma but was asymptomatic on presentation though demonstrating reduced cervical ranges of motion. Fractures of the atlas are considered rare, and isolated fractures of the lateral mass have only been reported on seven previous occasions, seldom being visualised on plain film radiographs. None of these cases involve a compression fracture of the lateral mass which may therefore be regarded as an unique radiological finding.

Professor Ernst has published a so-called ‘systematic’ review1 of adverse events following spinal manipulation based on low quality evidence including, for the most part, case reports (JRSM 2007;100:330-338). The whole point of systematic reviews is to get away from an author's often strong prior beliefs and opinions, and instead present an impartial and even-handed review of the evidence. Essential ingredients are that the evidence is critically appraised and the recommendations based firmly on the quality of the evidence presented. In this case, all of the evidence was included indiscriminately and the findings of a causal link between spinal manipulation and adverse events based on unsupportive low-level evidence. Moreover, Professor Ernst makes a judgement on this apparent causation as either ‘certain’, ‘likely’ or ‘possible’. There are no criteria presented in this paper for how such judgements were made. Of course, the absence of high-quality evidence is not to say there is no risk associated with spinal manipulation: there are safety issues with all interventions. What we need to know is the nature and the size of those risks. In the UK, there are estimated to be well over two million cervical spine manipulations by chiropractors each year.2 Given the number of cervical spine manipulations done worldwide it is likely, even if under-reporting is as high as Professor Ernst suggests, that the level of risk of a serious adverse event is extremely low. To turn Professor Ernst's point on under-reporting and publication bias around, could it be that journals of medicine are unlikely to publish findings which might be considered ‘positive’? Good evidence on safety is of paramount importance; what we have here is poor quality evidence and unsubstantiated claims masquerading as a systematic review.