Radiography (2004) 10, 139e144

REVIEW ARTICLE

A critical analysis of a locally agreed protocolfor clinical practice

A. Owena,), P. Hoggb, J. Nightingaleb

aWythenshawe Hospital, Manchester, UKbUniversity of Salford, Salford, Greater Manchester, UK

Received 30 December 2003; revised 13 January 2004; accepted 4 February 2004

Abstract Within the traditional scope of radiographic practice (including ad-vanced practice) there is a need to demonstrate effective patient care and man-agement. Such practice should be set within a context of appropriate evidenceand should also reflect peer practice. In order to achieve such practice the useof protocols is encouraged. Effective protocols can maximise care and managementby minimising inter- and intra-professional variation; they can also allow for de-tailed procedural records to be kept in case of legal claims. However, whilst liter-ature exists to encourage the use of protocols there is little published materialavailable to indicate how to create, manage and archive them.

This article uses an analytical approach to propose a suitable method for proto-col creation and archival, it also offers suggestions on the scope and content of aprotocol. To achieve this an existing clinical protocol for radiographer reporting ba-rium enemas is analysed to draw out the general issues. Proposals for protocol cre-ation, management, and archival were identified.

The clinical practice described or inferred in the protocol should be drawn fromevidence, such evidence could include peer-reviewed material, national standardsand peer practice. The protocol should include an explanation of how to proceedwhen the radiographers reach the limit of their ability. It should refer to the initialtraining required to undertake the clinical duties as well as the on-going continualprofessional updating required to maintain competence. Audit of practice shouldbe indicated, including the preferred audit methodology, and associated with thisshould be a clear statement about standards and what to do if standards are notadequately met. Protocols should be archived, in a paper-based form, for lengthyperiods in case of legal claims. On the archived protocol the date it was in clinicaluse should be included.ª 2004 Published by Elsevier Ltd on behalf of The College of Radiographers.

KEYWORDSProtocol based care;Advanced practice;Legal;Radiography

) Corresponding author.E-mail address: anowen@smtr.nhs.uk (A. Owen).

1078-8174/$ - see front matter ª 2004 Published by Elsevier Ltd on behalf of The College of Radiographers.doi:10.1016/j.radi.2004.02.007

140 A. Owen et al.

Introduction

This article analyses an ‘existing’ clinical protocolfor radiographer reporting barium enemas, to drawout general issues related to the creation, man-agement and archival of protocols on which thepractice is based; this ‘existing’ protocol had beenused to guide routine radiographic practice in alarge teaching hospital. The purpose of this ar-ticle, using the barium enema reporting protocolas a vehicle, is to suggest practical advice on thedevelopment, use and on-going appraisal of clini-cal protocols. This article has value to radiographicpractice at consultant, advanced practitioner, as-sistant practitioner and practitioner levels. Sincestandards should be set for the responsibilities,rather than for any one professional group, theprotocol would have universal value to professionsother than radiographers. Notwithstanding this,‘radiographers’ will be referred to throughoutthe text because this article is focused to radio-graphic practice.

A protocol may be described as an official for-mality of etiquettedput more simply, an agreed[documented] system under which ‘something’ isconducted.1 For clinical purposes, a protocolshould describe a detailed framework withinwhich a patient is managed. Furthermore, giventhe research-based climate in which we operate,the framework should be based upon good qualityevidence.2 Typically, in imaging and therapy, theprotocol is likely to apply to a ‘category’ of pa-tientsdfor barium enema reporting this is clearlythe case. Thus, in the context of imaging andtherapy, the primary purpose of the protocol isto provide a clear indication of how, certain cate-gories of, patients will be managed and by whom.Consequently, if the protocol is based upon goodresearch evidence, and the radiographer adheresto it, then one should be assured of the best avail-able management and care. If all professionalswork to the same protocol then all patients shouldbe assured of the same quality of service, reducinginter- and intra-operator variability.

In the context of clinical negligence claims, it isessential that practice is based upon best evidenceand peer practice.3,4 Some argue that such prac-tice need not be documented (ie presented in awritten form), and it is known that in a numberof clinical centres this is the case. However, giventhat clinical negligence claims may arise some 21years after the patient’s examination has beenconducted (ie for children) it becomes difficult,even impossible, to construct a legal defencewhen what was actually done, and also why it

was done, was not remembered.3 In this contextalone the argument for not having written proto-cols is refuted. The value of evidence-based writ-ten protocols is therefore established.

The main body of this article is presented inthree sections. First, in the section ‘Descriptionof the ‘existing’ barium enema reporting proto-col’, there is an explanation of how the ‘existing’clinical protocol for radiographer reporting bariumenemas was created; the protocol will then be pre-sented. Second, in the section ‘Analysis of the pro-tocol’, there is a critique of the protocol and theapproach taken to its creation and review/man-agement. Finally, in the section ‘Developmentand ingredients of a clinical protocolda sugges-tion’, a proposal is made to indicate how a proto-col might be created and managed effectively. Atthe end of the process, suggestions are made asto what YOU need to think about when developingyour own protocols.

Description of the ‘existing’ bariumenema reporting protocol

The protocol to be discussed can be seen in Fig. 1.The protocol for radiographer reporting of

barium enema examinations was developed froman existing protocol for Radiology Registrarreporting of the same examination. (The consul-tant GI radiologist developed the original proto-col.) This was augmented by a new protocol onreport content following the RcR audit of 2003recommendations.5

The Gastrointestinal (GI) Radiographer wrotethe protocol, who then passed it to the consultantradiologist and Radiology Business Manager forcomment. It is marked with a creation date, andreview date, however no names or signaturesappear on the protocol document itself.

The protocol sets out to say how and when ex-aminations are to be reported. How significantfindings should be communicated to the referrerand wider GI team. What to do in the case of in-patient reports, and how to deal with examina-tions where there is doubt as to the presence ofpathology.

At the time the protocol was developed, severalother hospitals in the region were contacted in anattempt to acquire copies of their protocols, tolook at peer practice, however none were avail-able. This may have been due to the fact thatradiographer reporting of barium enemas was inits infancy at that time, with the first cohort ofstudents on the GI reporting course having just

Clinical practice protocol analysis 141

qualified. A similar exercise carried out nowwould undoubtedly yield more information.

Analysis of the protocol

As already suggested, there is limited literaturereadily available to guide how protocols are devel-oped and managed. Given this it becomes difficultto perform a fully evidence-based analysis of theabove protocol. Nonetheless, the approach takenhere will be to use the limited available evidence,from the professional bodies, special interestgroups, peer-reviewed papers on best practiceand the website national electronic library forhealth, combined with some examples of existing

Figure 1 The protocol.

clinical practice. For the purpose of analysis, theitems from the above protocol will, where possi-ble, be taken sequentially to assist with informa-tion assimilation.

Authorship

Two professional groups (a radiographer and theradiologists) developed the protocol. Literaturesuggests that all stakeholders should be in-volved.6,7 The Special Interest Group in Radio-graphic Reporting (SIGRR)8 supports the view thata team should be set up to develop reporting pro-tocols. Ideally, in addition to the radiographer andthe radiologists, the stakeholder group might havebeen broader. Thus the development team mayhave included professionals such as the GI nursespecialist, secretaries, receptionists, radiographeraids, assistant practitioners and the surgical andmedical teams.7 The difficulty in this approach isthat widening the development team would almostcertainly lead to difficulty in reaching a consensusof opinion. NICE7 suggest that a team of 6e10 is theoptimal number for such a group. This documentalso suggests ways of selecting team members.

A quite important point not explicitly stated onthe protocol is the authorisation of its use. AgainSIGRR8 provides valuable information. At 4.5 thisdocument indicates that

The scope of reporting is defined in theprotocol and must be agreed by reportingradiographers, the professional head of ra-diography within the trust, and the clinicaldirector of the clinical radiology department.It must also be authorised at trust boardlevel.

The National Electronic Library for Health givesan example of an X-ray protocol where there is pro-vision for all of the above to authorise its usage.

Dates

The date the protocol was implemented was indi-cated on the protocol, which complies withAlderson and Hogg’s suggestion,3 this is also sup-ported by SIGRR.8 However, on the protocol itselfthere was no indication of what should happenwhen it is updated; similarly there was no indica-tion of what should happen to the ‘old’ protocolwhen the original protocol has been updatedand it is no longer used. As suggested earlier,particularly for clinical negligence claims, Alder-son and Hogg3 suggest that once a protocol is

142 A. Owen et al.

updated the ‘old’ protocol should be archived in asuitable place, marked to indicate when it was inforcedie ‘start date’ and ‘end date’. Ideally,archived protocols should be paper-based, ratherthan stored on digital media. This minimises sig-nificantly any possibility of the prosecution sug-gesting tampering with the protocol after it hadbeen archived. Perhaps in the future read onlyCD-Roms may have a part to play.

Double reporting

Within the trust double reporting is the norm forall barium examinations, and this is taken to meanthat the person who undertakes the examinationreviews the images and hand writes a report. Thisreport, along with the images, is then taken to aset session with either a consultant GI radiologistor the GI advanced practice radiographer for re-view. This is specifically written into the protocol.However, it would be useful here to state howother hospitals in the area were reporting their ba-rium enemas, so that the protocol was in line withlocal peer practice.

Literature supporting double reporting and thedifferent methods of double reporting could bemade reference to within the protocol. When aprotocol is updated the literature should be ‘re-searched’ in case more up-to-date reference ma-terial has become available. This would ensurethat current best practice was being followed.

Time scales

The protocol indicates that the report must beready within 48 h, with In-patients having a provi-sional report placed in the medical notes at thetime of the examination. The National Audit of Ra-diographic Reporting Services,5 the Royal Collegeof Radiologists, standard for turnaround of reportson GP, and In-patients was set at 24 h, however theaudit showed this to be unachievable, particularlyin large acute hospitals. Thus the setting of a lowerturnaround time, particularly for an examinationwhere two individual reports are produced is notunreasonable. However, the protocol does notsay if this target is to be audited. Within section3 of the same audit report, it is suggested that:

[4.3.7] It is good practice to write a reportdirectly into the patients records (though thisadvice indicates it applies when a radiologistcarries out the examination)

Thus the protocol complies with the principle ofthis report.

The Cancer Plan9 also sets time scales for treat-ment of cancer patients from initial diagnosis. Toensure that these are adhered to, the protocolmakes a suggestion as to how this category ofpatients’ reports should be communicated backto the referrer.

Training for radiographer reporting

The protocol states that only radiographers whohave undertaken and passed a recognised trainingprogram will be allowed to double report. Thiscomplies with statements made by the College ofRadiographers.12 Similarly SIGRR8 reflects theneed for adequate training and education. TheRoyal College of Radiologists states that reportingshould be carried out by an accredited radiologistor properly delegated. In stating that radiogra-phers should have attended a recognised trainingcourse the protocol is reflecting the views ofboth professional bodies.

Within the protocol a procedure is highlightedas to the path to follow when the [radiographic]reporter is unsuredin this case they are advisedto approach a specialist/senior member of staff.Alderson and Hogg,3 exploring case law,10 makeclear the legal value of including this within a pro-tocol. Similarly the Society and College of Radiog-raphers also recognise that radiographers, asprofessionals, must acknowledge their own limita-tions and scope of practice, as reflected in state-ment 5 in the Statements for ProfessionalConduct.11 The SIGRR emphasis this point too.9

Being encouraged to acknowledge ones own limita-tions, and thus seek help and advice as required,may also engender a culture of learning andteam working which in turn may improve servicequality even further.

Audit

Although the protocol states that audit will be car-ried out on a regular basis, there is no definition in-dicated within the protocol as to what audit is, orindeed what should be audited and why. However,within the protocol reference is made to ‘IRMER2000’13 and within this Statutory Instrument is adefinition of [clinical] audit:

A systematic approach or review of medicalradiological procedures, which seeks to im-prove the quality and outcome of patient

Clinical practice protocol analysis 143

care through structured review. Wherebyradiological practices, procedures and resultsare examined against agreed standards forgood medical radiological procedures, in-tended to lead to modification of practiceswhere indicated and the application of newstandards if necessary.

The aim of the audit therefore becomes clearer,however precisely what should be audited is notobvious. One might consider that accuracy of the‘reporters’ should be examined, and this wouldbe quite appropriate. However, the [double] re-porting process sits within a broader context, suchas patient satisfaction, financial and human re-source implications, national targets, patient out-comes (including survival rates and quality of life),waiting times and report turnaround time. Thesemight be audited too. Returning to audit of thereporting process itselfdexact details of what isto be audited should be indicated.

In 2003,14 a national audit was conducted toassess the sensitivity of double contrast bariumenemas (DCBE) in the diagnosis of colo-rectal car-cinoma. This sort of report might prove a valuableresource for [reporting] standard setting againstwhich performance can be measured. Similarly,work by Murphy and Loughran15 give some insightabout the standards of radiographers’ per-formance on lesion detection in barium enemastudies. Similarly, Halligan et al.16 have conductedwork to assess observer variation and suggest amethodology to assess this.

When developing a method for audit/analysis ofperformance, care should be exercised regardingthe limitations of the approach. For example,Shrovon17 notes deficiencies in Halligan et al.’s16

work. In academic circles this is common not leastbecause nothing is perfect and intellectual debateis encouraged regarding information in the publicdomain. Variation in the quality of published mate-rial highlights the importance of discriminating, ina scientific fashion, between good and bad evi-dence. Another important [audit] information notincluded within the protocol is a definition ofwhat an acceptable level of performance is. Thisis particularly important here because there is cur-rently no nationally agreed standard. The SIGRR9

notes that there is an absence of national stand-ards or performance measures, consequently sug-gesting that local standards may need to beagreed and implemented. The SIGRR9 goes on tosuggest that audit may assess reports for accuracy,structure and effectiveness of communications toreferring healthcare practitioners. SIGRR9 indi-cates that the outcome of such an exercise ‘should

be fed back into the process’. Also, and quiteimportantly, should performance fall below thelocally (or nationally) agreed standard of per-formance then there should be a clear statementincluded on what action(s) should be taken toremedy the situation. It might be worth notingthat some X-ray departments operate within rec-ognised quality frameworks (eg ISO 9000) and thequality assurance of department protocols fallswithin this kind of overarching quality framework.

It is evident that the protocol met many of thepublished suggestions regarding the general ap-proach to developing a protocol and its contents.However, there were several points on which itfailed. Nonetheless, the process of analysis doessuggest areas in which the protocol could be im-proved. That said, it is worth noting that if a pro-tocol is too detailed it may significantly restrictpracticedthis may be particularly restrictive for‘experienced’ staff. Conversely, if the protocol isnot adequately detailed then it may not be suffi-ciently supportive for ‘less experienced’ staff.

Development and ingredientsof a clinical protocolda suggestion

Reflecting on the protocol for radiographer report-ing barium enemas and through examination of theliterature whilst taking into account known clinicalpractice, the following might be seen as a goodstarting point for the development and manage-ment of a clinical protocol and also what couldbe addressed within it.

Protocol development and management andpoints that should be addressed within a protocol:

� Precise details of what should be done andwhen during the [clinical] procedures shouldbe indicated.

� An indication that the protocol has been‘approved’ for clinical use with ‘appropriate’authorities.

� Stakeholders should be included in the devel-opment (and review) process.

� National standards, where available, should beincluded.

� Good quality relevant literature (ideally peer-reviewed) should be used, and cited.

� The people responsible for creating it, includ-ing names as well as designations (ie jobtitles), should be included on the protocol.

� The date it was implemented, and also thedate by which it should be reviewed/revised,should be indicated.

144 A. Owen et al.

� The date it ceased to be used in clinicalpractice should be written onto ‘old’ proto-cols. Old protocols, in a paper version, shouldbe suitably archived.

� The audit process for the clinical activity,paying ‘adequate’ detail to methodology andalso how data are processed and reported,should be included.

� If the protocol sits within other guidance, rulesor protocols they should be clearly stated onthe protocol.

� The required level of training and educationincluding continual professional developmentfor staff should be stated.

� Definitions of ‘new’ words and terms or/anddefinitions of words and terms used in a newcontext should be included.

� What to do/who to seek help from, when anunsure situation is reached, should be outlined.

Finally, considering the need to evidence peerpractice and also meet the need to share good/best practice we would suggest that you considerplacing your protocols into forums for use by otherprofessionals. Additionally or alternatively, wewelcome written comments about your protocolin relation to this article. Such comments shouldbe directed to the Editor in Chief of this journal.

References

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