Pain assessment in the critically ill adult- Recent evidence and new trends.pdf

8/16/2019 Pain assessment in the critically ill adult- Recent evidence and new trends.pdf

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Intensive and Critical Care Nursing (2016) 34, 1—11

Available online at www.sciencedirect.com

ScienceDirect

j ournal homepage : www.elsevier .com/ iccn

REVIEW

Pain assessment in the critically ill adult:

Recent evidence and new trends

Céline Gélinas ∗

Ingram School of Nursing, McGill University, Montreal, QC H3A 2A7, Canada

Accepted 3 March 2016

KEYWORDS

Pain;Pain assessment;Behaviours;Vital signs;Pupillometry;Critically ill;Intensive care

Summary Pain assessment in the critically ill adult remains a daily clinical challenge. Posi-

tion statements and practice guidelines exist to guide the ICU care team in the pain assessment

process. The patient’s self-report of pain remains the gold standard measure for pain and

should be obtained as often as possible. When self-report is impossible to obtain, observational

pain scales including the Behavioural Pain Scale (BPS) and the Critical-Care Pain Observation

Tool (CPOT) have been recommended for clinical use in the critically ill adult. However, their

adaptation and validation in brain-injured and burn ICU patients is required. Family caregivers

may help in the identification of pain-related behaviours and should be more involved in the

ICU pain assessment process. Fluctuations in vital signs should only be considered as cues for

further assessment of pain with appropriate tools, and may better represent adverse events of severe pain. Other physiologicmeasures of pain should be explored in the ICU, and pupillometry

appears as a promising technique to further study. Implementation of systematic pain assess-

ment approaches using tools adapted to the patient’s ability to communicate and condition

has shown positive effects on ICU pain practices and patient outcomes, but randomised control

trials are needed to confirm these conclusions.

© 2016 Elsevier Ltd. All rights reserved.

Implications for Clinical Practice

• Pain measures must be selected according to the patient’s ability to communicate.• Behavioural pain scales remain alternative measures in the ICU patient unable to self-report.• Fluctuations in vital signs could be considered as adverse events of severe pain rather than indicators for painassessment.

• Pain management initiatives must involve the ICU inter-professional team for better practices and patient outcomes.

∗ Tel.: +514 398 6157; fax: +514 398 8455.E-mail address: [email protected]

http://dx.doi.org/10.1016/j.iccn.2016.03.0010964-3397/© 2016 Elsevier Ltd. All rights reserved.

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2 C. Gélinas

Introduction

Pain is an enduring concern and a common symptom incritically ill adults. Indeed, pain has been shown to be expe-rienced at rest by more than 30% of patients (Chanqueset al., 2007), and this percentage exceeds 50% duringcommon care procedures in the intensive care unit (ICU)(Gélinas, 2007a; Puntillo et al., 2001, 2014). Turning, endo-

tracheal suctioning, tube or drain removal, wound careand arterial line insertion are procedures described as themost painful by ICU patients in large international studies(Puntillo et al., 2001, 2014). Nurses are facing numerouschallenges with pain assessment in the ICU as many patientsare unable to self-report because of various factors such asaltered level of consciousness (LOC), sedation and mechan-ical ventilation. Under-assessment of pain represents oneof the primary barriers to the adequate treatment of painin critically ill patients (Pasero et al., 2009). The evidencedemonstrating absent or incomplete assessment of pain isassociated with negative patient outcomes such as longerduration of mechanical ventilation and ICU length of stay,

and increased mortality (Kastrup et al., 2009; Payen et al.,2009), is a particular concern for nurses. This paper mighthelp nurses in reversing this situation through the review of steps for proper pain assessment, recent evidence and newtrends in measures and indicators for the assessment of painin the critically ill adult.

Definition of pain and its gold standardmeasure

As per the universal definition by the International Associa-tion for the Study on Pain (IASP, 1979), pain is described asan unpleasant sensory and emotional experience associated

with actual or potential tissue damage or described in termsof such damage. This definition has remained unchanged inthe Kyoto protocol of IASP Basic Pain Terminology (Loeserand Treede, 2008). In other words, pain is recognised as amultidimensional subjective experience which implies thatpain has to be reported by the person who is experiencingit. Such a definition of pain highlights that the patient’s self-report is the gold standard measure of pain and should beobtained as often as possible. However, the IASP Task Forceon Taxonomy (1994) has acknowledged that ‘‘The inabil-ity to self-report does not negate the possibility that anindividual is experiencing pain and is in need of appropri-ate pain-relieving treatment’’. Therefore, pain assessmentmethods must be adapted to the patient’s cognitive capacityand condition (Herr et al., 2011).

A stepwise approach for pain assessment andthe Communication Model of Pain

Pain should be monitored routinely in all adult ICU patients(Barr et al., 2013). In their position statement, the AmericanSociety for Pain Management Nursing (ASPMN) has proposeda 4-step approach for the assessment of pain which can besummarised as follows: (1) always attempt to obtain thepatient’s self-report of pain; (2) use a validated behaviouralpain scale or look for behavioural changes; (3) ask the

family or caregiver about the patient’s pain behaviours; and(4) attempt an analgesic trial when pain is suspected, andreassess for pain (Herr et al., 2011).

The 0—10 Numeric Rating Scale (NRS) is commonly usedin clinical practice, and an enlarged visual format of theNRS was found to be the most feasible and discriminativeself-report scale in comparison to other scales (i.e., visualanalogue scale, verbal descriptor scale) and formats (i.e.,

oral versus visual) for measuring pain intensity in criticallyill adult patients (Chanques et al., 2010). The vertical ther-mometer format has also been found to be easier to use bycritically ill adults and older adults (Gélinas, 2007b; Herr,2011). When a self-report of pain intensity is not possible,a simple ‘‘yes or no’’ indicating the presence versus theabsence of pain should be considered as a valid self-report(Herr et al., 2011). When self-report of pain is impossibleto obtain, validated behavioural pain scales should be usedas alternative measures for pain assessment. The family canalso provide the care team with relevant information on thepatient’s pain behaviours to enhance the detection of pain.However, not much is known about the family members’perception of patients’ pain-related behaviours in the ICUcontext. To our knowledge, only one qualitative study hasbeen conducted with seven family members of ICU patientswith a traumatic brain injury (TBI) (Vanderbyl and Gélinas,2014). Interestingly, family members identified behavioursindicative of pain similar to those included in most scalesrecommended for clinical use such as facial expressions,body movements and muscle rigidity. More specifically, theydescribed movements of the eyes and the mouth, tears oreye weeping, touching or trying to touch the pain site andvisible muscle tension. They also provided meaningful expla-nations of their perception in relation to their knowledgeof the patient. Another study examined the interrater reli-ability of proxy reporters of pain (Puntillo et al., 2012).

Family proxy reporters were found to be closer to ICUpatients’ self-reports when compared to nurses and physi-cians. Specifically in regards to pain, moderate intraclasscorrelation coefficient (ICC) of 0.43 and 0.45 were foundbetween patient-family member reports of pain intensityand pain distress, respectively. Lower ICCs of 0.19—0.40were obtained between patient-nurse and patient-physicianpain reports (Puntillo et al., 2012). Unfortunately, little evi-dence exists about proxy reporters’ reliability in the painassessment process and further research is necessary.

The Communication Model of Pain (Hadjistavropoulos andCraig, 2002; Hadjistavropoulos et al., 2011) also offers aninteresting conceptual foundation for the assessment of pain(Fig. 1). This A B C model conceptualises pain as an inter-

nal state (A) that may be encoded in particular features of expressive behaviours (B), allowing observers or raters todraw inferences (C) about the nature of the patient’s expe-rience. More specifically, the processing of the pain stimulusis modulated by intrapersonal and/or contextual factors (A)influencing the way pain is experienced in each individual.Gender, age, ethnicity, health condition and the context inwhich this individual is evolving are examples of these fac-tors. The use of mechanical ventilation and the administra-tion of analgesic and sedative agents are more specific to thecritical care context and add challenges to pain assessment.The pain stimulus is encoded in self-report (for patients ableto communicate) and behaviours (B) which are decoded by


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Pain assessment in the critically ill adult 3

Figure 1 Adapted from the Communication Model of Pain (Hadjistavropoulos and Craig, 2002).

observers (C). Self-report depends on higher mental process-ing while behaviours are less subject to voluntary controland are more automatic. Behaviours may be more difficultto decode by observers, and educational training is of greatimportance to support them in developing the competenceof adequately assessing pain behaviours using observationalmeasures. For example, standardised training for the useof BPS and CPOT has led to appropriate tool utilisation intopractice and consistent scoring among ICU nurses and physi-cians (Chanques et al., 2006; Gélinas et al., 2011a,b).

Such a conceptual framework may guide nurses in consid-ering different aspects of the patient’s situation and thecontext in which he/she is evolving in the pain assessmentprocess. It also provides a strong scientific basis for the

most appropriatemethods to assess pain i.e., self-report andbehavioural observation to be interpreted by decoders (e.g.,nurses and family caregivers). Furthermore, it fits nicelywith the current recommendations and guidelines for painassessment (Barr et al., 2013; Herr et al., 2011).

Challenges with the use of behavioural painscales

As previously mentioned, when the patient’s self-report isimpossible to obtain, behavioural pain scales should be used.To date, a total of eight behavioural pain scales have beendeveloped and/or validated for use with nonverbal critically

ill ICU adults (Gélinas et al., 2013). From this recent criti-cal review and a previous one (Pudas-Tähkä et al., 2009),both the 5—12 Behavioural Pain Scale (BPS: Payen et al.,2001) and the 0—8 Critical-Care Pain Observation Tool (CPOT:Gélinas et al., 2006) were identified as the scales with themost robust psychometric properties (i.e., validity and reli-ability) for detecting pain in medical, surgical and traumaICU patients. Briefly, the content of these two scales issimilar to three items related to facial expression, bodymovements, and compliance with the ventilator. The CPOThas a fourth item assessing muscle rigidity, and compliancewith the ventilator can be replaced with vocalisation in non-mechanically ventilated patients. An adaptation of the BPS,

called BPS-NI for non-intubated patients (Chanques et al.,2009) includes an item related to vocalisation in place of compliance with the ventilator for non-mechanically ven-tilated patients. Both the BPS and CPOT were shown todiscriminate between nociceptive procedures known to bepainful and non-nociceptive procedures (i.e. discriminantvalidation), to be related to the patient’s self-report of pain(i.e. criterion validation) and to lead to consistent scoreswhen used independently by different raters (i.e. interraterreliability). In the Society of Critical Care Medicine (SCCM)practice guidelines (Barr et al., 2013), the BPS and the CPOTare the two suggested scales for clinical use in ICU patientsunable to self-report and whose motor function is intact andbehaviours are observable. Therefore, these scales are of

limited use in patients with a Glasgow Coma Scale (GCS)(Teasdale and Jennett, 1974) score of three or a RichmondAgitation Sedation Scale (RASS) score of −5 (Sessler et al.,2002) as such scores indicate that the patient is unrespon-sive or unarousable. Some questions pertaining to their useare discussed.

How should we interpret behavioural pain scores?

Cut-off scores for the presence of pain have been estab-lished for the BPS (>5) (Payen et al., 2007) and CPOT (>2)(Gélinas et al., 2009) which both represent more than twopoints from their respective minimal score. Behavioural pain

scores based on the nurse’s observation of the patient shouldbe interpreted differently from the patient’s self-report painintensity scores. In fact, although they both represent painscores, they are not measuring the same dimension of pain.More specifically, the patient’s self-report of pain intensityrelates to the sensory dimension of pain which refers tothe perception of pain by the person who is experiencingit (Melzack and Casey, 1968). On the other hand, the nurse’sobservational scores are associated with the behaviouralcomponent of pain i.e., behavioural responses exhibited bypatients to express their pain (McGuire, 1992) and decodedby an external observer (as illustrated in the C component of Fig. 1). Self-reported pain intensity scores and behavioural


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Figure 2 Pain Intervention Algorithm© Gélinas C (2016). NRS, Numeric Rating Scale; CPOT, Critical-Care Pain Observation Tool.

pain scores move in the same direction (i.e., when one scoreincreases, the other score increases as well) (Herr et al.,2011; Gélinas et al., 2013), but are not equal scores. More-over, while it is useful to classify the intensity of pain asmild,moderate and severe for the development of pain manage-ment protocols, it is important to know that behaviouralpain scales only allow the detection of the presence versus

absence of pain. Indeed, in most studies, this criterion of presence versus absence of pain was used to establish BPS(Chen et al., 2014) and CPOT (Echegaray-Benites et al.,2014; Gélinas and Johnston, 2007; Li et al., 2014) cut-off scores. However, in a previous study with postoperativeICU patients, it was found that the CPOT cut-off score >2could better classify patients who self-reported moderateto severe pain (Gélinas et al., 2009). Knowing this, opi-oid and/or non-opioid analgesic agents could be trialledwhen cut-off scores of behavioural pain scales are reached.An intervention algorithm with the CPOT was created tohelp guide the ICU care team in their decision for painmanagement (Fig. 2), and its implementation still needs tobe trialled in clinical practice. Nevertheless, pain manage-

ment protocols must be adapted to take into account thatbehavioural pain scores cannot discriminate between mild,moderate and severe levels of pain.

Can behavioural pain scales be used in any

critically ill adult patient population?

Although behavioural pain scales have been developed foruse in critically ill adults, some challenges remain in spe-cific patient groups. These include ICU patients with a braininjury, burns, delirium and a cognitive deficit. Evidence andchallenges with the use of behavioural pain scales in thesegroups are discussed.

The study of pain in ICU patients with a brain injuryfrom a traumatic and a non-traumatic source has receivedsome attention from research teams around the world.In a first Canadian study by Gélinas and Arbour (2009),unconscious ICU patients with a TBI (n= 43) exhibited dif-ferent behaviours such as a relaxed face (70%), eye weeping(14%), eye opening (16%) and relaxed muscles (72%) dur-

ing turning. Not surprisingly, their CPOT score was lower(mean= 2.05) in comparison with surgical ICU patients(mean= 3.30) ( p < 0.001). Similar findings were found ina study by a research team from Iran (Dehghani et al.,2014) who found higher BPS scores during endotrachealsuctioning (mean= 7.75) compared with a non-nociceptiveprocedure (i.e., eye care) (mean =3.28) in 50 critically illTBI patients ( p < 0.001). Unfortunately, the authors did notprovide details regarding item scores so it is difficult todraw conclusions on their specific behavioural responsesto the nociceptive procedure. Description of behaviouralresponses in critically ill TBI patients (n= 45) was furtherexplored by the same Canadian research group (Arbouret al., 2014a). During turning, a high proportion of TBI

patients showed neutral behaviours (i.e., relaxed face48.9%, absence of body movements 44.4%, and relaxed mus-cles 88.9%) and this was influenced by their LOC. In fact,87.5% of unconscious TBI patients (n = 8) were more likelyto exhibit a relaxed face and to remain immobile. How-ever, significant proportions of altered LOC and consciousTBI patients exhibited pain-related behaviours or autonomicresponses including moaning (>50%), brow lowering (>38%),face flushing (>33%), eye opening (>25%), eye weeping(>25%) and limb flexion (>23%). A positive high correlation(r s = 0.82; p < 0.001) was found between the number of pain-related behaviours/autonomic responses and the patient’sself-reported 0—10 pain intensity. Only four conscious TBI


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patients (n = 16; 25%) exhibited a full grimace and triedto reach their pain site during turning. Interestingly, inthose able to self-report their pain (n = 13/16), nine of themreported pain during turning but only one exhibited a grim-ace and muscle rigidity; such findings are opposite to theThunder Project in which these two behaviours were themost frequent in ICU patients who reported pain (Puntilloet al., 2004).

To our knowledge, only three studies addressed pain-related behaviours in ICU patients with a non-traumaticbrain injury. In a first study by a research team fromKorea (Lee et al., 2013), pain was assessed at rest andduring endotracheal suctioning using the CPOT on five spe-cific days (i.e., 1, 3, 6, 9 and 14) after ICU admissionin 31 brain-injured patients most of them with a cere-bral haemorrhage and two with a brain tumour. None hada GCS of 13—15 and patients were unable to self-report.Mean CPOT scores decreased over time, and were higherin ICU patients who did not undergo brain surgery (n= 9)after including analgesic use as a covariate which wascommon in the surgery group (n = 22). Consistent with pre-vious validation studies, mean CPOT scores were higherranging from 2.58 to 3.26 during endotracheal suctioning.Therefore, the CPOT cut-off score of >2 for the presenceof pain was reached during a painful procedure in thispatient group. In another study by a research team fromSwitzerland (Roulin and Ramelet, 2014), pain behaviourswere described in 116 ICU patients with a non-traumaticbrain injury (i.e., 66% with intracranial haemorrhage, 30.2%with anoxic or ischaemic origin and others). Patients wereclustered into three groups according to their LOC: (a)stereotyped responses i.e., limb flexion/extension or noresponse to a nociceptive stimulus (n =37); (b) localisedresponses to a nociceptive stimulus (n =33); and (c) thoseable to self-report and to follow commands (n = 46). Some

differences in pain behaviours were observed during turningacross the three groups. For instance, brow lowering, eyeclosure and touching the pain site were observed more oftenin the self-report group (63%, 73% and 29% respectively) thanin the localised group (29%, 65% and 7%) and the stereo-typed group (51%, 35% and 4%) ( p < 0.05). Interestingly, faceflushing was more frequently identified in the stereotypedgroup (43%) than in the localised (19%) and the self-reportgroups (21%) ( p < 0.05). Opposite to what was found in TBIpatients (Arbour et al., 2014a; Gélinas and Arbour, 2009),muscle rigidity was observed in similar proportions (32—48%)in all three groups. Overall, median number of behaviourswas higher during turning than at rest ( p < 0.01). In addition,a moderate positive correlation was found between number

of behaviours and the patient’s self-report of pain inten-sity using the 0—10 NRS (r s = 0.53) in the self-report group(n = 30/46) during turning. However, the grimace which is akey facial expression of pain was not described.

The last study conducted in non-traumatic brain injuryICU patients was led by a Canadian team (Echegaray-Beniteset al., 2014) with elective brain surgery ICU patients (n = 43)who underwent either a craniotomy (79%) or a craniec-tomy (21%). Pain was assessed with the CPOT before, duringand after two procedures: (a) non-nociceptive: non-invasiveblood pressure (NIBP) and (b) nociceptive: turning. CPOTscores were higher during turning (median = 2; range 0—6)in comparison with rest (median = 0; range 0—3) and NIBP

(median = 0; range 0—6) ( p


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6 C. Gélinas

delirium; however, further testing by other research teamsis required to support such conclusions.

Assessment tools can only be shown to be valid for a spe-cific purpose, in a determined group of respondents and in agiven context (Streiner et al., 2014). As specified in the rec-ommendation related to BPS and CPOT in the PAD guidelines(Barr et al., 2013), their use should be considered with cau-tion in brain-injured ICU patients. Indeed, recent evidence

has shown that ICU patients with a brain injury affectingtheir LOC appear to have different behavioural reactions topain, such as the absence of grimace and muscle rigidity inmost of them. Therefore, existing behavioural pain scalesmay not be applicable to those patients and further adapta-tion of these scales may be necessary. Insufficient evidenceis available in burn patients (Wibbenmeyer et al., 2011).However,wemay anticipate that burns on the face and limbsmay affect facial expressions and limb movements whichwould necessitate adaptation of existing pain scales. TheBPS-NI and CPOT appear to be valid for use in ICU patientswith delirium but this has to be replicated by other researchteams to support external validity. Yet no evidence on thevalidity of the use of behavioural pain scales in ICU patientswith cognitive deficit is available and research is definitelyneeded.

Impact of the implementation of painassessment tools on ICU practices and patientoutcomes

A recent systematic review described the impact of painassessment on critically ill patients’ outcomes (Georgiouet al., 2015). A total of 10 eligible studies were identified.Overall, there was evidence of positive effects on the detec-tion and management of pain, and on patient outcomes

including duration of mechanical ventilation, ICU length of stay, adverse events and mortality. However, an observa-tional pre-experimental design was used in all studies, and ahigher level of evidence research (i.e., experimental design)is necessary to draw firm conclusions. Some key studies forwhich methodological quality was evaluated as moderateto strong in the systematic review were selected for fur-ther discussion of implementation strategies and outcomes.These studies targeted the implementation of systematicpain assessment approaches using the BPS, CPOT and NRS.Although its methodology quality was considered weak byGeorgiou et al. (2015), the implementation study of theNVPS by Topolovec-Vranic et al. (2010) is also discussed asit described patient satisfaction which was rarely addressed

previously.The first study to evaluate the impact of a system-

atic pain and sedation assessment approach was conductedby a research team from France led by Chanques et al.(2006) who implemented the NRS and BPS (Payen et al.,2001) along with RASS (Sessler et al., 2002) in a medico-surgical ICU. Using a pre/post prospective controlleddesign (n =100 in control group and n= 130 in interven-tion group), they documented decreased incidence of pain(63% versus 42%, p = 0.002) and agitation events (29% versus12%, p = 0.002), and increased therapeutic changes (esca-lation and de-escalation) of analgesics and psychoactivedrugs post-implementation. Verbal information and written

support tools on the evaluation of pain were provided toICU nurses, physicians and residents; pocket cards weredistributed to nurses, and posters were placed in everypatient’s room. After patients were assessed for pain withthe NRS or the BPS by ICU nurses, physicians were noti-fied of a pain event (NRS> 3 or BPS >5) or an agitationevent (RASS > 2) and could intervene accordingly. Decreasesin mechanical ventilation duration and nosocomial infection

rate were demonstrated in the intervention group ( p < 0.05)but no differences in ICU length of stay and mortalitywere found. Another research team from Australia imple-mented the BPS along with RASS in a general ICU (Williamset al., 2008) using a pre/post-test study design. Educa-tion on the tool use was provided to all staff. Outcomeswere documented in 369 and 400 mechanically ventilatedpatients before and after the tool implementation, respec-tively. The proportion of ICU patients who received sedativeswith or without analgesics was greater after tool implemen-tation (88%) than before (57%) ( p < 0.001). No differencein duration of mechanical ventilation was found betweenthe two groups (Williams et al., 2008). In a pre/postprospective study from a German research team (Radtkeet al., 2012), the NRS and BPS were also implementedalong with a sedation (RASS: Sessler et al., 2002) anddelirium (Delirium Detection Score: Otter et al., 2005)scales in three ICUs. A total of 619 ICU patients wereincluded i.e., 241 in the pre-training period, 228 in thepost-training period and 150 in the follow-up period. Thislatter period representing the extended training (with threeconsecutive educational sessions, and an ICU support teamavailable during the implementation phase) was comparedwith standard training (one educational session of 45-minuteduration) in the post-training period and was found tolead to more significant changes in ICU practices (i.e.,more frequent documentations of pain assessments) and

to their sustainability at 1-year follow-up ( p < 0.01). Toolimplementation had no impact on mechanical ventilationduration and ICU length of stay. Pain monitoring was asso-ciated with a decrease in mortality (OR = 0.35 with 95% CI:0.14—0.86).

More recently, in a quality improvement project led byChanques’ team, systematic pain assessments with NRS orBPS were completed by ICU nurses during the first turning of the day (De Jong et al., 2013), and appropriate pain man-agement interventions were provided in collaboration withphysicians. Similar educational strategies (i.e., training insmall group sessions, posters) from the first study (Chanqueset al., 2006) were used, and the clinical information systemsoftware was updated. A total of 630 care procedures were

analysed in 193 ICU patients i.e., 53 at baseline (n= 184 pro-cedures), 90 during implementation (n= 299 procedures) and50 post-implementation (n = 149 procedures). The incidenceof severe pain as defined by NRS > 6 or BPS> 5 decreasedsignificantly from 16% at baseline to 6% during the imple-mentation phase, and 2% post-implementation ( p < 0.05).Incidence of at least one severe adverse event (i.e., cardiacarrest, arrhythmias, tachycardia, bradycardia, hyperten-sion, hypotension, desaturation, bradypnoea or ventilatordistress) also significantly decreased from 37% at baseline to17% during implementation, and 21% post-implementation( p < 0.05). Patients who had severe pain were more likely toexperience a severe adverse event (OR= 2.74 (1.54; 4.89),


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pain measures (i.e., self-report scores versus behaviouralscores) so they adequately represent score interpretationof pain levels or presence versus absence of pain. Fam-ily caregivers should be systematically consulted to betterunderstand the patient’s behavioural responses to pain (Herret al., 2011). A change in nursing ICU practice in relation tothe use of vital signs in the ICU pain assessment processmust happen. Fluctuations in vital signs should be consid-

ered as adverse events to severe pain (De Jong et al., 2013)rather than indicators for pain assessment as they are notvalid for this purpose (Barr et al., 2013; Herr et al., 2011).Finally, pain assessment and management is a collaborativeeffort and pain management initiatives must involve the ICUinter-professional team for better outcomes.

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