Ten years of online incident reporting and learning using CPiRLS: implications for improved patient safety.

doi:10.21203/rs.3.rs-2109508/v1

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Ten years of online incident reporting and learning using CPiRLS: implications for improved patient safety.

https://doi.org/10.21203/rs.3.rs-2109508/v1

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Journal Publication

published 15 Feb, 2023

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Background

Safety Incident (SI) reporting and learning via incident reporting systems (IRS) is used to identify areas for patient safety improvement. The Chiropractic Patient Incident Reporting and Learning System (CPiRLS) was launched in 2009 and is currently available to all UK chiropractors and members of the European Chiropractors Union (ECU). The primary aim was to analyse the SIs submitted to CPiRLS over a 10-year period to identify key areas for patient safety improvement.

Method

All SIs on CPiRLS were extracted and analysed over a 10-year period (April 2009 to March 2019). Frequency statistics were used to describe 1) the level of SI reporting and learning by the chiropractic profession 2) the nature of the reported SIs including levels of patient harm. Key areas for patient safety improvement were identified following review of the database and consideration by an expert panel.

Results

A total of 268 SIs were recorded on the database over the 10-year period, of those, 85% originated from the UK. Evidence of learning was documented in 143 (53.4%) SIs. The largest subcategory of SIs related to post-treatment distress or pain, n = 71 (26.5%). Twenty-nine (10.8%) of all SIs involved a (potential) trip or fall with an additional eight SIs relating to syncope. A total of 26 (9.7%) SIs represented some type of rib distress or pain with 14 suggesting a rib fracture was likely to have occurred. Twenty-two (8.2%) SIs related to (potentially) missing a potential serious underlying pathology. Fourteen (5.2%) SIs involved disruption in the continuity of care. Six key areas of patient safety improvement were identified following review of the data and consideration of the expert panel.

Conclusion

Under-reporting of SIs is apparent on CPiRLS, however, an upward trend was identified over the 10-year period. Several key areas for patient safety improvement have been identified that need to be disseminated to the chiropractic profession including through the development of safer practice notices. Improved reporting practice needs to be facilitated to improve the value and validity of reporting data. CPiRLS is important in identifying key areas for patient safety improvement and should be reviewed periodically.

Chiropractic

Manual therapy

Incident reporting

Patient safety

Risks

Adverse events

Improvement of patient safety has long been a priority [1, 2]. One means of addressing this is the reporting of and learning from safety incidents that have arisen. A safety incident (SI) is any type of deviation from normal clinical care that may occur and that has the potential to cause patient harm [3]. SIs include patient accidents and documentation errors as well as adverse events (AEs). Within the manual therapy context, an AE refers to negative outcomes associated with but not necessarily caused by treatment [4].

Incident reporting systems (IRSs), are used to record and review SIs to facilitate improvement in patient safety and can vary in their aim, design and scale [3]. IRSs have been shown to identify safety needs, enabling improved clinical settings and processes [5], however improved patient safety outcomes have not yet been established [6, 7]. Despite limited evidence of the effectiveness of IRSs, healthcare organisations have been utilising them to direct priorities for patient safety.

The amount of learning drawn from IRSs is variable, with the focus too often being on reporting [8]. The concept of learning from IRSs is ill-defined and there is a lack of literature on learning from such systems. The common practice of reviewing SIs and issuing patient safety reports may not be enough as learning is a complex, social process [8]. In England, a new national syllabus for enhancing patient safety in healthcare includes learning from patient safety incidents as a key domain [9], emphasising the importance of reacting to reported SIs.

The majority of chiropractors do not work in large organisations with established clinical governance structures in place [10]. Furthermore, there is no systemic oversight of safety performance and limited opportunities for the profession to identify or learn from SIs. Thus, engagement with IRSs has a role to play in the development of a robust safety and governance culture within the chiropractic profession.

While benign AEs e.g. soreness or dizziness following manual therapy are a common occurrence, observed in approximately 30–50% of treatments for spinal pain [11], the risks of significant harm associated with manual therapy are low [12]. Serious AEs are extremely rare and a causal relationship with manual therapy has not been established [11, 13]. The detection of severe AEs associated with manual therapy, is a limitation of most research designs, due to their rarity. However, IRSs can play a role in their investigation [4], potentially identifying serious incidents and any contributing factor and enabling learning and subsequent behaviour or system change to occur. Within manual therapy, patient safety is often focused on AEs and there is little understanding about the other types of SIs that can occur in chiropractic practice. To date, only case reports exist within the manual therapy literature in relation to SIs that do not result in harm but have the potential to do so i.e. ‘near misses’ [14, 15]. IRSs focused on learning can encourage the reporting of near misses as well as the identification of SIs that have the potential to occur in the future.

Within the UK and Europe, the Chiropractic Patient Incident Reporting and Learning System (CPiRLS) is an IRS that enables chiropractors to report and learn from SIs (16). Chiropractors are encouraged to report any SIs resulting in harm or potential harm, prompting reflection and/or discussion with others. Once a SI has been reported, all other users of the CPiRLS database can view and comment on the SI to facilitate shared learning. CPiRLS was developed and launched in 2009 [16] and is currently accessible to all chiropractors in the United Kingdom (UK) and, since 2013, all members of the European Chiropractors Union (ECU). CPiRLS is a secure and anonymous online system designed to replace and unify two previous UK paper-based versions [16, 17].

Following the launch of the CPiRLS, internal SI monitoring and analysis resulted in the issue of two safety notices detailing the risks of rib fracture and falls respectively [18]. A recent analysis of 10 years of accumulated serious SIs reported in medical emergency units enabled the identification of key areas of risk and actions that may be taken to mitigate these and prevent future SI occurrence [5]. As the number of reported SIs grows, CPiRLS provides an increasingly valuable dataset for in-depth analysis of levels of SI reporting, nature and severity of SIs, including patient harm, and potential learning and improvement from these.

The aim of this study was to analyse the SIs submitted to CPiRLS over a 10-year period (2009 to 2019) in order to enhance patient safety.

Objectives

1) Review the level of SI reporting and learning by the chiropractic profession.

2) Characterise the nature of the reported SIs.

3) Identify key areas for patient safety improvement.

CPiRLS Database

CPiRLS (accessible at https://cpirls.org/) is owned and maintained by the Royal College of Chiropractors (RCC). Access to CPiRLS content is password protected but open to all UK chiropractors and European chiropractors who are members of the ECU. CPiRLS automatically records the country of origin of the reporting clinician. However, all SIs are reported anonymously by chiropractors, who cannot be identified within the system.

SIs are initially recorded as red (actually occurred), amber (near miss) or green (potential to occur). Data captured for each SI includes 1) Patient demographics i.e. patient age and gender 2) SI classification and description 3) Actions following the SI 4) Details of (potential) patient harm and 5) possible contributing factors. A combination of selection from drop-down categories and free text entry is used. An example of the data entry for the reporting of a red incident is demonstrated in additional file 1.

Analysis

The CPiRLS database was accessed, and data extracted into Microsoft Excel relating to all SIs submitted between April 2009 and March 2019. Frequency statistics were used to describe reporting levels and to characterise the data captured for SIs. Documented indicators of learning from SIs were identified by one researcher (MT) by reviewing the “Describe the actions taken immediately and in the longer term” free text section.

Key areas for patient safety improvement were initially identified by one researcher (MT) following review of SIs within the database. Key areas for patient safety comprised of:

1) Frequently recorded subcategories (> 5% total SIs) inclusive of any additional SIs following cleansing of the data i.e. SIs not subcategorised or subcategorised incorrectly.

2) Additional key areas identified following review of the CPiRLS database.

Key areas identified were subsequently considered for agreement by the RCC CPiRLs Development Group.

Levels of incident reporting and learning by the chiropractic profession

A total of 268 SIs were reported over the ten year period, with an average 30.5% increase over whole years (2010–2018), demonstrating an upward trend over time (additional file 2). Fifty-nine comments were made in response to 38 SIs. Table 1 provides the distribution of country of origin of the SIs reported, indicating that the majority (85%) were from the UK. The SIs involved 148 (58.2%) female and 86 (32.1%) male patients and a further 34 (12.7%) with no gender specified. SIs were recorded representing patients in all age groups (additional file 2) with a modal patient age group of 55–64 years old with 54 (20.1%) SIs recorded. Six SIs were recorded for patients under the age of 16.

Table 1

Country of origin of reported incidents.
Country	Number of Reported Incidents
Australasia	2 (0.7%)
Belgium	19 (7.1%)
Netherlands	2 (0.7%)
Norway	1 (0.4%)
SafetyNET (Canada)	3 (1.1%)
Sweden	13 (4.9%)
UK	228 (85.1%)
Total	268

SIs were assigned to all pre-defined categories, but only 26 of the 36 pre-defined subcategories on CPiRLS. One fifth of SI’s were not assigned to a category or subcategory. A clear and documented indicator of learning from the reporting chiropractor was present in 143 (53.4%) SIs. Documented indicators of learning included personal reflection, discussion of change of practice or policy, additional training, discussion with others as well as completion of a clinical audit cycle.

Characterisation of safety incidents reported

Table 2 provides the categorisation and numbers of SIs reported. ‘Treatment/ Management’ was the largest category, accounting for over half of all SIs. The largest subcategory involved patients experiencing post-treatment distress/pain.

Table 2

Frequency of Safety Incident Categories
SI Category	SI Subcategory	Number of SIs
Accidents/ Equipment/ Infrastructure	Patient trip/ fall	23 (8.6%)
	Equipment malfunction	7 (2.7%)
	Failure to use equipment appropriately	7 (2.7%)
	Health and Safety measures inadequate	5 (1.9%)
	Failure to dispose of sharps and clinical waste appropriately	1 (0.4%)
	Exposure to blood	2 (0.7%)
	Exposure to harmful substances	1 (0.4%)
	Other	3 (1.1%)
	Unspecified	1 (0.4%)
	Subtotal	50 (18.6%)
Documentation	Patient record inadequate	3 (1.1%)
	Failure to document diagnosis/prognosis	1 (0.4%)
	Patient record misplaced	3 (1.1%)
	Records confused, treated wrong patient	5 (1.9%)
	Failure to gain consent	1 (0.4%)
	Other	5 (1.9%)
	Subtotal	18 (6.7%)
Examination/ Assessment	Incorrect diagnosis	8 (3%)
	Investigation undertaken to detriment of patient	5 (1.9%)
	Significant pathology missed	6 (2.2%)
	Case history inadequate, missed secondary condition	4 (1.5%)
	Over-exposure of film	1 (0.4%)
	Failure to request X-ray report	1 (0.4%)
	Failure in referral process	1 (0.4%)
	Other	11 (4.1%)
	Unspecified	2 (0.7%)
	Subtotal	39 (14.6%)
Treatment/ Management	Patient experienced post-treatment distress/pain	76 (28.4%)
	Wrong positioning of patient during treatment	5 (1.9%)
	Patient experienced significant post-treatment effects e.g. neurological problem, disc prolapsed	14 (5.2%)
	Patient experienced negative effects during treatment e.g. fracture rib or clavicle	22 (8.2%)
	Suggested drugs to patient which had adverse effect	1 (0.4%)
	Did not modify treatment plan to take account of patient preferences or health needs	8 (3%)
	Slow to refer after patient did not respond to treatment	2 (0.7%)
	Other	13 (4.9%)
	Unspecified	6 (2.2%)
	Subtotal	147 (54.9%)
Other	Unspecified	14 (5.2%)
	Subtotal	14 (5.2%)
Total SIs		268

The distribution of SI types and harm reported to have occurred is shown in Fig. 1. Of the 81 SIs in which patient harm was reported to have occurred (red incidents), 42 SIs were reported as avoidable, and 51 SIs reported that the chiropractors actions or inactions were likely to be responsible for the patient harm that occurred.

Identification of key areas for patient safety improvement

Following review of data (provided in Table 2) and consideration by the RCC CPiRLs Development Group, six areas for patient safety improvement were identified.

Trips and Falls

Approximately one fifth of all SIs were categorised under ‘Accidents/ Equipment/ Infrastructure’, with almost half of these involving a patient trip or fall. An additional six incorrectly subcategorised SI’s relating to a trip or fall were identified through searching the database. The majority of SIs involved the patient (potentially) falling off the chiropractic bench whilst rolling or transferring from the bench. A common situation involved the chiropractor not supervising the patient during this time. Where SIs reported patients ages, approximately half involved patients over the age of 65. Seven trips and falls actually occurred (Red SIs) and resulted in patient harm. In all seven of these SIs, the chiropractor reported that the incident was avoidable.

An additional eight distinct SIs were identified involving a patient fainting or feeling faint but not associated with treatment. The majority of SIs involving fainting or feeling faint occurred during the examination phase, with two of these occurring during a blood pressure reading.

Failure to recognise serious underlying pathologies

The category of examination/ assessment accounted for somewhat fewer SIs. On review significant overlap was present between the following subcategories: ‘Failure in referral process’, ‘failure to request X-ray report’, ‘incorrect diagnosis’, ‘significant pathology missed’ around the theme of (potentially) missing a serious underlying pathology. Across these subcategories and following a review of the database, a total of 22 SIs involving (potentially) missing a serious underlying pathology were identified. Most chiropractors demonstrated some form of personal reflection when recording the SI. However, seven reported SIs did not include any evidence of learning or action taken to mitigate further risk of (potential) patient harm. A commonly recorded contributing factor was absent, delayed or inappropriate referral to another healthcare professional or directly for imaging. Other factors included inadequate history taking or examination as well as a positive response to care masking underlying pathology.

Adverse Events associated with chiropractic patient management

i) Post-treatment distress/pain

The largest single subcategory overall related to post-treatment distress or pain, which accounted for over one quarter of all SIs. Of these, Twenty one were associated with the cervical spine, of which 11 described neurological symptoms e.g. dizziness, following some form of treatment. Spinal manipulation was reportedly used in the majority of cases (n = 14); however, it is unclear as to whether the patient also received additional treatment modalities. Twenty-one SIs were reported following treatment of the lumbopelvic region, pain was the most common reaction described. Almost half of these (n = 10) clearly described soft tissue techniques as the modality associated with the post treatment experience. This was most commonly described as trigger point therapy to the gluteal region resulting in a combination of pain as well as localised bruising. The majority of patients experiencing pain following soft tissue treatment were female (n = 8) and all patients were over 45 years old. A further nine SIs reported post-treatment distress or pain following the use of acupuncture or dry needling.

ii) Suspected rib fractures

A total of 26 SIs involving some type of rib injury associated with treatment were identified. Fourteen of these indicated that a rib fracture was likely to have occurred. Available patient and treatment characteristics are summarised in Table 3.

Table 3

Incidents involving a suspected rib fracture
Patients Gender	Patients Age	Treatment Technique	Onset Following Treatment
Female	55–64	Lumbar manipulation – side posture	Immediate
Female	45–54	Thoracic manipulation - prone	Immediate
Female	75+	Thoracic manipulation – prone	Within 1 hour
Male	75+	Thoracic manipulation – prone	Immediate
Male	65–74	Thoracic manipulation	Undisclosed
Male	55–64	Thoracic manipulation - supine	Immediate
Female	65–74	Thoracic manipulation	Immediate
Female	45–54	Thoracic manipulation – prone	Immediate
Female	55–64	Thoracic manipulation-prone	Immediate
Female	45–54	Thoracic manipulation-prone	Immediate
Female	55–64	Thoracic manipulation – with drop	Within 24 hours
Female	45–54	Thoracic manipulation - prone	Immediate
Female	55–64	Sacral drop - prone	Undisclosed
Female	55–64	Lumbar manipulation – side posture	Undisclosed

Consideration of the data on rib injuries reveal some apparent trends. Most of the suspected rib fractures occurred in female patients. All patients affected were over the age of 45 years with the modal age group being 55–64 years. Most suspected rib fractures involved manipulation directly to the thoracic spine (n = 11). Eight SIs stated the patient positioning during thoracic spine manipulation, with seven of these describing involved the patient in the prone position. Two SIs involved a lumbar side posture manipulation resulting in a suspected rib fracture. The majority of SIs involving a suspected rib fracture did not disclose a consideration of the patient’s risk of osteoporosis.

iii) Significant post-treatment effects

In total 18 SIs were identified that reported significant post-treatment effects, although two of these actually occurred during assessment rather than treatment. Several clinicians described actions taken following the incident to learn from the event and reduce the risk of recurrence. However, 11 did not document any learning or action taken from the SI. A commonly recorded contributing factor was inadequate history taking (in relation to relevant medical/ family history). One case suggested that the fact the patient saw a different clinician may have contributed to the incident due to a lack of awareness of the patient’s prior case history.

Continuity of Care

A theme identified on analysis across the database was a break in continuity of care i.e. a patient’s care involving more than one practitioner. A total of 14 (5.2%) SIs across subcategories reported on this theme. These SIs mostly involved some form of locum cover (n = 12), meaning a different chiropractor within the clinic or an external locum. Most commonly (n = 5) the patient experienced some form of post-treatment distress/ pain. It was reported that lack of familiarity with the patient’s case was a contributing factor e.g. delivering care in a different way. On reflection, chiropractors mentioned that there were signs the patient was uncomfortable with having care from another chiropractor, which should have triggered ceasing or modifying care.

This analysis of 10 years of safety incident reporting through CPiRLS, identified 268 SIs. There were some indicators of learning by chiropractors in their reporting of incidents, but low levels of subsequent commentary or engagement, among other CPiRLS users. Characterisation of the nature of incidents reported indicated that the majority were ‘red’, indicating that the SI had occurred. The harm levels reported varied, with 9 red SIs being reported as ‘serious’ harm, 41 SIs being reported as ‘avoidable’ and 52 reported as being caused by the chiropractor’s action/inaction, suggesting targets for safety improvements. The final objective of the study was to identify key areas for safety improvement, and this analysis indicated that trips/ falls (including fainting), recognising serious underlying pathologies, reducing the risk of AEs (including suspected rib fractures) as well as continuity of care are potential targets to consider for safety improvement. The risk of trips/falls in a chiropractic clinic and suspected rib fractures following manual therapy are established risks with patient safety notices published by the CPiRLS team in 2009 [18]. The new knowledge from this study should now be disseminated to the profession, including issuing updated and new safer practice notices related to the key areas identified.

Fluctuations in yearly reporting rates on CPiRLS were demonstrated, although on average the reporting rate is increasing, suggesting more chiropractors are engaging with the system over time. Expected reporting rates are difficult to benchmark, however, given the known high incidence of benign post treatment AEs associated with manual therapy [11], under-reporting is likely to be present. Under-reporting is a significant limitation of IRSs in general, with a low sensitivity of incident reporting being observed [19]. CPiRLS relies on chiropractors to proactively report patient SIs rather than actively screen for them. A recent RCT comparing two IRSs identifying AEs associated with chiropractic management found a significant difference in the reporting rate of AEs. In that study, CPiRLS was used as a control and produced significantly lower reporting rates (0.1%) compared to active surveillance involving questionnaires completed by the chiropractor and patient following each appointment (8.8%) [20].

Whilst a positive attitude towards patient safety has been observed within the chiropractic profession, SI reporting is an unlikely course of action [21]. A lack of engagement with SI reporting is common across healthcare [22, 23]. Barriers to SI reporting within the chiropractic profession have previously been reported, including time requirements and lack of clarity on reporting [24, 25]. Chiropractors, like other private practitioners, are reimbursed based predominantly on patient contact time. Clinical governance activities such as SI reporting require time that is not directly reimbursed. This is a difficult barrier to overcome without direct incentives in place to encourage behavior change. Other barriers to SI reporting may be modifiable, such as clinician understanding of incident reporting. Education may have an important role in addressing misconceptions and uncertainties about SI reporting within the chiropractic profession. Some chiropractors may not be aware that CPiRLS is completely anonymous with appropriate online encryption in place.

In this study, we found that most cases documented some aspect of learning, however, the emphasis of SIs in the database was often on reporting rather than learning. Whilst SI reporting is important, learning must also occur to improve patient care for an IRS to be deemed effective [8]. In a recent registrant survey within the UK, the majority of chiropractors (58%) stated their workplace used an IRS, ranging from the CPiRLS to local clinic systems. These registrants stated that regular discussions about SIs are carried out to improve patient safety. Some participants mentioned checking the CPiRLS database directly to learn from SIs to improve patient safety [10]. The lack of documented learning may reflect the CPiRLS current format rather than chiropractors’ attitudes and behaviours towards incident reporting and learning. Setting parameters and expectations around data entry may improve the quality of data available for future analysis and subsequent learning.

Patient safety improvement

The risk of patient falls is well known within healthcare, with the potential for severe harm. Within the UK National Health Service (NHS), as recorded on the National Reporting and Learning System (NRLS), falls are the most common SI reported [26]. This data is based predominately on hospital settings for which it has been demonstrated that 20–30% of falls can be prevented through appropriate risk management [27]. It is important for chiropractors to be aware of the risk of patient falls and undertake appropriate risk assessments with mitigating measures in place to reduce the risk of occurrence. In particular, it is important to ensure appropriate patient positioning and supervision of the patient during transitions involving the treatment table.

Fainting (syncope) had not been previously identified as a risk and is not currently a reporting subcategory with CPiRLS. Fainting (or feeling faint) has been identified as a common, benign AE associated with cervical manipulation [28] and acupuncture treatment [29], but should also be considered at other points in the clinical encounter. Fainting is very common within the population and may occur due to a variety of reasons [30]. An important consideration would be adequate first aid training to develop the competence and confidence to manage patients who have fainted or feel faint.

Due to the frequency of benign AEs associated with manual therapy, it is not surprising that the largest category on the database was treatment/ management. It is difficult to establish a causal relationship between manual therapy and AEs due to a number of confounding variables including: Presence of underlying pathology [31], patient treatment beliefs [32], contextual and the natural history of musculoskeletal pain [33]. In addition, clinicians and patients appear to have different perceptions of what defines an AE [32, 34]. It is notable that some chiropractors reported AEs resulting from treatment, and categorised and described them as such. Other chiropractors reported that an underlying pathology was present, and the natural history of the pathology resulted in a temporal association between treatment and an AE.

The design of CPiRLS does not enable us to establish causality in the relationship between manual therapy and AEs, however analysis of the database has identified key points for reflection and learning to reduce the risk of occurrence of AEs. AEs were reported at all stages of patient management, including assessment, and were associated with all forms of manual therapy. In particular, benign AEs in the lumbopelvic region where often reported to be related to soft tissue treatment. A study that reviewed the risk of care in the UK osteopathy profession concluded that particular types of treatment including manipulation were not related to outcomes, including AEs [35]. There may be a limited awareness among practitioners and the public about the risks of non-manipulative techniques associated with AEs. Patients should be adequately informed about the currently established risks associated with manual therapy to ensure informed consent is gained and shared decision making can occur.

In our study, AEs associated with the thoracic spine related to harm to the ribs. Rib fracture following spinal manipulation is a well-established AE, however, there is limited literature available on this topic. A recent qualitative case series described three incidents of rib fracture following manipulation [36]. Based on clinician recall, only one of the three cases described a prone technique being performed. However, our analysis of CPiRLS data has identified prone thoracic spine manipulation as a potential risk factor for rib fracture. This requires further investigation since, to our knowledge, this has not been previously proposed or evaluated as an independent risk factor. Our analysis of the CPiRLS database also highlighted that a suspected rib fracture is a potential outcome following a range of manual therapy techniques and is not limited to manipulation of the thoracic spine. Caution should be applied as not all SIs involving suspected rib fractures stated the type of manipulation performed. This study has added new knowledge to our understanding of rib fractures associated with manipulation of the spine, but more research is required to understand the risks involved.

Before considering manual therapy, patients should be adequately and periodically screened for osteoporosis and the risk of fragility fractures. Osteoporosis is regarded as a relative contra-indication to manipulation [37]. Chiropractors should be familiar with the numerous risk factors involved, including but not limited to gender, age, alcohol intake, lack of physical activity, long term corticosteroid use, smoking and previous fragility fracture [38]. Osteoporosis is commonly associated with older age i.e. postmenopausal patients, however a number of incidents involved patients in a lower age group i.e. 45–54. The RCC has recently published a Chiropractic Quality Standard on the management of osteoporosis within a chiropractic care setting [39]. This standard recommends all patients over 40 should be periodically assessed for the possibility of osteoporosis. In addition, manual therapy forces should be modified to reduce the risk of harm to patients at risk of osteoporotic fractures. Previous CPiRLS data analysis did not identify the risk for patients in this lower age range. A benefit of periodically analysing CPiRLS data is it allows safer practice notices and other resources to be developed to enhance patient safety.

In relation to the cervical spine, this study found that benign AEs involving neurological symptoms were experienced by patients in additions to pain. A secondary analysis of a cross-sectional survey of patients receiving manual therapy found treatment to the neck has the greatest number of symptoms perceived as an AE [32]. This finding is theorised to be due to patient treatment beliefs around manual therapy to the neck, influenced by increased awareness of serious complications i.e. frequent media coverage of neurovascular events [32]. Cervical manipulation was described in the majority of cases associated with benign AEs on the CPiRLS database, however, details of reported treatments were limited. Cervical manipulation may present an increased risk for benign AEs, however the literature is not clear [11]. It is advisable for chiropractors to always consider the appropriateness of different treatment modalities in shared decision making with patients. For example, consideration of cervical manipulation in light of the potential association with increased risk but lack of superior efficacy compared to other approaches [40].

A controversial association between cervical manipulation and serious AEs, such as neurovascular events, continues to exist [41]. In the case of neurovascular events, a temporal association may be more likely i.e. a patient with underlying vascular pathology of the neck presenting with neck pain and/or headaches [31]. Two SIs identified in the CPiRLS database that reported potential neurovascular events were associated with assessment, and stated that treatment did not occur. This highlights the possibility of patients presenting with underlying vascular pathologies and experiencing a neurovascular event in the absence of cervical manipulation.

Chiropractors reporting SIs often reflected on the importance of case history taking when, in retrospect, the patient was shown to be presenting with serious underlying pathology. To enhance patient safety, patients should always be screened for masqueraders of musculoskeletal pain (including vascular pathologies of the neck) through appropriate case history taking and physical examination [42]. Consideration should also be given to continuity of care during the management of patients. Analysis of the CPiRLS database has highlighted that lack of an established relationship between the practitioner and patients may present a risk for SIs, including missing a serious underlying pathology.

Study Limitations

We found that the accuracy of reporting in terms of correct categorisation of SIs was variable. SIs that had not been assigned a category or subcategory accounted for a about one fifth of total cases. In addition, a number of SIs were incorrectly assigned a category or subcategory. Some subcategories were redundant, and some contained significant overlap. Missing data limited the ability to analyse the CPiRLS database. This was apparent in discrete data fields as well as open text fields. The data entry in open text fields was variable, with key information often omitted. A review of the categorisation and reliability of categorisation of incidents is proposed to improve the quality of future reporting.

As only one researcher independently analysed the data, there is further potential for inaccuracies in the analysis. In addition, extraction of details within the SIs could have been unreliable e.g. patient positioning during treatment. However, this was mitigated by only extracting details that were unambiguous.

The severity of harm described in the CPiRLS system has to be interpreted with caution; currently, CPiRLS provides no definition of low, moderate or severe harm. AEs have been defined in relation to manual therapy based on level of severity [4, 43] and it will be important to adapt such a set of definitions into the CPiRLS.

Only chiropractors can report a patient safety incident on CPiRLS which is done on a voluntary basis. Chiropractors will report an incident if they believe an AE or other type of SI has occurred. This is therefore dependent on direct observation of an SI by a chiropractor or patient disclosure. Patients and clinicians may attribute AEs to chiropractic care using different criteria based on their beliefs about manual therapy. Patients may not report symptoms that they do not feel are associated with chiropractic care. Conversely, some rare symptoms experienced by patients following manual therapy e.g. depression have been strongly perceived by patients to be an AE [32]. Symptoms of this nature may not be perceived as AEs by chiropractors and therefore unlikely to be reported onto CPiRLS.

Future direction of the CPiRLS

Wangler et al, developed nine recommended features for the successful establishment of a chiropractic reporting and learning system [44], and these are partly met by the CPiRLS. The aim of CPiRLS should be reviewed to prioritise the type of incident reporting and learning that will drive patient safety within chiropractic. An expert panel (The CPiRLS development group) has been appointed by the RCC to further develop CPiRLS and promote its use within the profession. To encourage the profession to engage with CPiRLS, and to increase the reporting levels and learning from that data, a number of measures are required. These include publishing clearer guidelines and definitions for reporting on CPiRLS, including definitions of severity of harm. The classification of SIs on CPiRLS should be refined to exclude redundant categories and subcategories to make the system more intuitive to use. The observed variability of reporting of some SI types may be a reflection of the usability of the current system.

While two trends in the type of incidents reported have been previously identified and evidence-based guidance produced, these safety notices should be updated based on the findings of this study and recommendations of current guidelines. New safer practice notices should be developed and published to educate the profession on the potential risks identified and recommended mitigation strategies. Interaction in the form of comments with reported SIs appears to have ceased; however, the learning value of this approach is uncertain. As recommended, a more appropriate strategy may be a mechanism of timely feedback to the individual reporter by the expert panel [44]. The CPiRLS database should continue to be reviewed on a timely and periodic basis, with the results shared with the profession. CPiRLS must also receive continued support from the professional associations and educational institutions to improve the culture of reporting and to drive awareness among students and clinicians.

This detailed review of patient SI reporting by the (mainly) UK and European chiropractic profession demonstrates that, while there is significant under-reporting, there has been an upward trend in SI reporting to CPiRLS during the period 2009–2019. Characterisation of the nature of reported SIs has enabled identification of key areas for patient safety improvement representing a potential increased risk to patient safety during chiropractic management. This information needs to be disseminated to practicing clinicians to optimise learning from SIs and facilitate appropriate risk management strategies. To continue to drive the culture of incident reporting and learning forward, several important measures have been identified that need to be actioned by the profession. This evaluation demonstrates that CPiRLS has an important role in improving patient safety in the chiropractic profession.

AE: Adverse event

CPiRLS: Chiropractic patient incident reporting and learning system

ECU: European Chiropractors Union

NRLS: National Reporting and Learning System

NHS: National Health Service

RCC: Royal College of Chiropractors

SI: Safety incident

UK: United Kingdom

Ethics approval and consent to participate

Ethics approval was granted from the Health and Social Care Ethics Panel, London South Bank University (ETH1920-0138).

Consent for publication:

Not applicable

Availability of data and materials:

Due to ethical concerns, supporting data cannot be made openly available. Further information about the data and conditions for access are available through the Royal College of Chiropractors

Competing interests:

MT is chair and GS and RF are members of the CPiRLS Development Group. GS is a chiropractor and a trustee of the Royal College of Chiropractors. RF is the Chief Executive of the Royal College of Chiropractors. The Royal College of Chiropractors was involved in the development of the Chiropractic Patient Incident Reporting and Learning System (CPiRLS) and is a licensor of its use. The Royal College of Chiropractors is a co-funder of Chiropractic and Manual Therapies.

Funding:

The study was not commissioned and no funding was received.

Authors' contributions:

MT and RF conceived the original study. MT and GS developed the research aims. MT analysed the data and undertook the first draft of the manuscript. All authors reviewed and revised the manuscript. All authors approved the final version.

Acknowledgements:

The authors are extremely grateful to all members of the CPiRLS Development Group for reviewing the key areas of patient safety.

Author Information:

MT is a chiropractor and senior lecturer at London South Bank University with an interest in patient safety as well as patient beliefs towards manual therapy. GS is a chiropractor and is the Director of Research and a Trustee of the Royal College of Chiropractors. She has an interest in promoting evidenced informed patient safety information to clinicians to improve clinical practice. RF is Chief Executive of The Royal College of Chiropractors, a biologist and an educationalist with interests in professional development and the safety and quality of patient care. He was involved in the development of the CPIRLS.

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published 15 Feb, 2023

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10 Oct, 2022
Reviewers invited by journal
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You are reading this latest preprint version

Ten years of online incident reporting and learning using CPiRLS: implications for improved patient safety.

Status:

Journal Publication

Version 1

Abstract

Background

Method

Results

Conclusion

Figures

Background

Study Aim

Method

CPiRLS Database

Analysis

Results

Levels of incident reporting and learning by the chiropractic profession

Characterisation of safety incidents reported

Identification of key areas for patient safety improvement

Trips and Falls

Failure to recognise serious underlying pathologies

i) Post-treatment distress/pain

ii) Suspected rib fractures

iii) Significant post-treatment effects

Continuity of Care

Discussion

Patient safety improvement

Study Limitations

Future direction of the CPiRLS

Conclusion

Abbreviations

Declarations

References

Supplementary Files

Status:

Journal Publication

Version 1