Evidence Based Clinical Guidelines For The Physiotherapy .

Figure 1: Key stages of the Guideline Development Process(14)Guideline Development Group formedand key question developed/modifiedGroups/Practitioners attempt toimplement the guidelines more activelyData from research and relevantpractice patterns identifiedthrough literature searchesGuidelines disseminated tomembers/relevant population /published in recognised journalsData reviewed and strength of evidenceweighed up through critical appraisal.Specific recommendations made whichform the basis of the GuidelinePeer review undertaken/other organisationinvited to endorse the GuidelineIntroductionThe need to drive up clinical standards and the quality ofclinical services so that meaningful improvements for thepatient are seen, whilst maintaining cost effectiveness, is acentral theme found in all recent government publicationspertaining to the NHS(8,9). Therapists need to prove that theyare providing clinically effective interventions and demonstratetheir ongoing commitment to Continuing ProfessionalDevelopment (CPD) in order to maintain state registration.(10)Clinicians working within amputee rehabilitation havereported using the first edition in many different ways(11): as a reference tool to guide best recognised clinical practice. to aid in the identification of personal and team learningneeds specific to physiotherapy treatment of adults withlower limb prostheses. to benchmark local services against national, evidencebased recommendations and use the findings as driversin the development of local service provision and localprotocols.BACPAR have therefore decided to instigate the updating ofthis guideline to support and facilitate the ongoing hard workCSP SKIPP Clinical Guideline 03 (2012) Amputee Rehabilitationof it’s membership striving to achieve best clinical outcomesand secure the optimal local service provisions for patients whohave undergone lower limb amputation.Evidence Based Clinical Guidelinesn Definition of Clinical Guidelines:Evidence Based Guidelines (EBGs) are ‘Systematicallydeveloped statements to assist practitioner and patientdecisions about appropriate health care for specificcircumstances’(12).A clinical guideline is not a mandate for practice – it can onlyassist the clinician with the decision making process abouta particular intervention. Regardless of the strength of theevidence on which the guideline recommendations are made,it is the responsibility of the individual clinician to interprettheir application for each particular patient encounter. This willinclude taking account of patient preferences as well as localcircumstances; patient consent should always be gained priorto any treatment.(2)The practice of evidence based medicine means integrating5

Methods Used to Update the Guideline & Scope of the Guidelineindividual clinical expertise with the best available externalevidence from systematic research(12). Figure 1 highlights thekey stages undertaken by the authors of the first edition of thisguideline. The filtering and refining of research informationto create a ‘knowledge product’ with clear, concise and explicitrecommendations and aims, follows the knowledge translationmodel proposed by Graham et al(13). The previous and updatedguidelines seek to guide the clinician/stakeholder throughsteps of knowledge acquisition and transfer and facilitateinstrumental use of this new knowledge by actioning changesin clinical behaviour.n Clinical Governance & Professional Responsibility:Clinical Governance has been a central theme promotedwithin the NHS since the publication of ‘The New NHSModern, Dependable’(15). This government white paper notonly emphasised the concept of ‘Evidence Based Practice’ butplaced a statutory duty on health organisations to examine thequality of healthcare provided(16).Although many political and policy changes have beenundertaken since this time the elements of clinical governancecontinue to drive many changes within the Physiotherapyprofession. Successive Governments have recognised theneed for health care professionals to be informed of changeand improvements within clinical practice and to remainin touch with current research findings that affect clinicaldecision-making (17). The Health Professions Council havenow made continuing professional development a regulatoryrequirement for physiotherapists and, through commitmentto lifelong learning, physiotherapists are required to bereflective practitioners and base clinical judgements on themost appropriate information available(10).n Resource ImplicationsIn the year ending 31st March 2007 there were 4957 newreferrals to NHS (non-military) prosthetic service centres inthe United Kingdom(18). Military veterans are treated withinthe NHS once they are discharged from the forces. The AuditCommission identified the provision of equipment services,including prostheses, as an area for investigation, resulting inthe report ‘Fully Equipped’ (19). The report examined economy,efficiency and effectiveness of service provision. The costof the prosthetic service to the NHS requires an enormouscommitment in terms of finances, equipment and resourcesand warrants maximum clinical effectiveness to ensure a costefficient service.significant resources. Using a prosthesis to minimise thedisability caused by the loss of a limb demands highly skilled,specialised therapeutic input as well as the use of costlyprosthetic componentry.n Identifying the need for guidelines specific tophysiotherapy treatment of adults with lower limbprostheses:In the field of amputee rehabilitation strategic thinkingis needed to address the long-term needs of the patient.This involves teamwork and consultation, which shouldinclude the patient and their carers. There is a wide variationnationally in the quality, type of service and care offered byphysiotherapists to adults with lower limb amputation(19, 27).‘Senior colleagues’ are the most relied upon source to informand develop many clinicians practice within specific areasof amputee rehabilitation(28). It is however recognised that ahigh number of these senior staff specialising in amputee andprosthetic rehabilitation are lone practitioners(29) and thatspecific CPD opportunities for more experienced cliniciansmay be limited. It is therefore important to ensure thatprofessional expertise is integrated with scientific evidence topromote truly ‘Evidence Based Practice’(30). In these instancesguidelines may be helpful in assisting the clinician access theresearch base, eliminate unacceptable local/national practicevariations and improve the quality of clinical decisions bypromoting reflection upon therapeutic strategies currentlyutilised.There is resistance amongst some practitioners towardsadoption of EBGs as there is a fear that diminished personalautonomy, restriction of clinical freedom and resourcelimitations may lead to ‘average’ clinical practice beingwidely promoted rather than clinical excellence(12,31,32).These guidelines are not mandatory and BACPAR recognisethat local resources, clinician prioritisation, as well asthe rehabilitation environment in which the practitionerworks, will influence their implementation. It is howeverencouraging that senior clinicians currently practicing in thefield of amputee/ prosthetic rehabilitation do report using thefirst edition of this guideline in a number of ways as identifiedin the introduction (11).Methods Used to Update the GuidelineMajor lower limb amputation has a profound effect onquality of life with high levels of morbidity and mortality(20-26).The number of people undergoing amputation is small interms of overall national health need, affecting 51,000 of thepopulation (19).“.Any decision to update a guideline must balance the need toreflect changes in the evidence against the need for stability.” (p.14)Multidisciplinary rehabilitation of this client group consumesThe first edition was published with the expectation that6The NICE Guideline manual(33) suggests thatCSP SKIPP Clinical Guidline 03 (2012) Amputee Rehabilitation

Figure 2: Summary of the six basic steps identified inthe updating of a Guideline (33)Define the SCOPEUpdate the CLINICAL QUESTIONDevelop criteria for LITERATURE SEARCH and conduct searchdeveloped by NICE(33) (Figure 2). The CSP were keptinformed at regular intervals of the progress of the update.n Professional AdvisersDuring the update of these guidelines the views ofprofessional advisers recognised as being stakeholders/interested parties, were sought – see Appendix 2a. Theircomments and suggestions informed the guidelines. Althoughusers views were not taken at this time the first edition hadsought user involvement during the development of theguideline – see Appendix 2b.n FundingThe guidelines were developed without external funding. Theproject was funded by BACPAR and supported by the CSP.Adopt valid protocols for LITERATURE REVIEWand apply to evidenceScope of the GuidelineSynthesise and analyse data and produce EVIDENCE SUMMARIESDecide if there is sufficient, high quality evidence toCHANGE RECOMMENDATIONS or developNEW RECOMMENDATIONS where indicatedit would be reviewed and updated as required. In 2009the BACPAR Executive Committee decided to review andupdate the guidelines. This was perceived as necessary due topotential changes in physiotherapy management over timeand the possible new evidence available. Priority was given tothis update to ensure the work remained relevant and valid.n The Guideline Update GroupA working party of BACPAR members was formed reflectingthe necessary experience and skills needed to compile clinicalguidelines (Appendix 1a). All members had an understandingof the use of guidelines in assisting and informing clinicalpractice, with some members having post graduate experienceof guideline development. The BACPAR Guideline Coordinators led the working party. No member declared aconflict of interest.Details of the 2003 working party involved in thedevelopment and writing of the first edition are detailed inAppendix 1b.No physiotherapy specific literature/information regardingthe update of clinical guidelines was identified. The methodsutilised during the updating process have therefore beendrawn from those outlined within ‘The Guideline Manual’CSP SKIPP Clinical Guideline 03 (2012) Amputee RehabilitationThe scope of this guideline remains purposefully broad. Itis not BACPAR’s intention to include prescriptive details ofspecific physiotherapy management as these would detractfrom the broader overview that these guidelines present.They are intended to be a framework for best practice thatall physiotherapists should aspire to achieve as part of theirprofessional responsibilities.These guidelines are applicable to all major levels ofamputation, including bilateral amputation, regardless of theunderlying aetiology or age.These guidelines commence when the patient receives theirfirst lower limb prosthesis (for that particular residual limb)and conclude when the patient is discharged from activetreatment to a maintenance/review programme.The levels of amputation covered by the guidelines are: transpelvic hip disarticulation transfemoral knee disarticulation transtibial ankle disarticulationThese guidelines do not cover: pre-operative and pre-prosthetic management of the lowerlimb amputee the prescription of specific types of equipment such aswalking aids, wheelchairs and prosthetic componentry.7

The Literature Search, The Appraisal Process & The Consensus ProcessThe Clinical QuestionThe clinical question is unchanged from the firstedition of these guidelines:What is best practice in the physiotherapymanagement of adults with lower limb prostheses?The Guideline Update Group sought to assesswhether new evidence and/or clinical/prostheticdevelopments have changed what is considered tobe best physiotherapy practice.The Literature Searchn Aims of the SearchTo identify literature relating to physiotherapy management ofadults with lower limb prostheses from July 2002 to September2010.n Inclusion CriteriaArticles were included if they were: published from July 2002 relevant to lower limb amputees/subjects with limb loss relevant to adults, 18 years of age and older relevant to all pathologies/causes of amputation relevant to all major levels of amputation i.e. Transpelvic,hip disarticulation, transfemoral, knee disarticulation,transtibial and ankle disarticulations (excluding partialfeet).n Exclusion CriteriaArticles were excluded if they were related to: pre operative care of the amputee surgical management of the amputee immediate post operative care of the amputee upper limb amputees paediatric amputees minor levels of amputation e.g. partial foot specific prosthetic productsn MethodLiterature searches were conducted in February 2009 and againin September 2010 under the supervision of a librarian usingthe search protocol and key words detailed in the first editionof the guidelines. The following databases were searched:AMED, BioMed Central, British Nursing Index, Cinahl,Cochrane, DARE, Embase, King’s Fund, Medline, OT Seeker,PEDRO, RECAL and REHABDATA.8n Selection of relevant articlesThe results from each database search were assessed for allpotentially relevant articles by reading the titles. All potentialarticles were copied onto clipboard and duplicates removed.The abstracts were then studied to ensure the article met theinclusion criteria. All articles that were relevant were obtainedin full to be critically analysed.Three extra articles were sourced from suggestions by externalreviewers. This increased the number of articles analysed to 28.Moher et al(34) state that poor reporting diminishes the valueof systematic reviews and subsequent guidelines developedfrom such evidence. The PRISMA statement has beendeveloped and distributed internationally and suggests manypoints to improve reporting quality and transparency. Figure3 details a completed PRISMA flow diagram illustrating theflow of information through the different phases of literatureidentification and review.Table 1: Number of articles found from each database searchDatabaseNumberofresultsArticles identified aspotentially relevantfrom reading titleNumber ofarticles analysedafter 16 (6 duplicate)1Cochrane8411OT Seeker131 (duplicate of aboveresult)0RECAL27048 (11 duplicates)7Embase1696 (4 duplicates)1King’s Fund0--Medline199518DARE50-PEDRO133 (2 duplicates)0REHABDATA80-Total1123151 (no duplicates)25CSP SKIPP Clinical Guidline 03 (2012) Amputee Rehabilitation

Records identified throughdatabase searching (n ure 3: PRISMA (2009) Flow Diagram illustrating the flow of information through the different phasesof the literature identification and review processAdditional records identifiedthrough other sources (n 3)Records after duplicates removed (n 1102)Records screened (n 154)Records excluded (n 126)Full-text articles excluded (n 12)Full-text articles assesedfor eligibility (n 28) poor methodology 2 conclusions do not inform PT intevention 3 No significant conclusions drawn 2 Not appropriate to the scope of the guideline 5Studies included in qualitativesynthesis (n 16)Reference: Moher et al (34). Template accessed via www.prisma-statement.orgThe Appraisal ProcessThe CASP (Critical Appraisal Skills Programme) tools (35),specifically developed to help evidence-based analysis in healthand social care settings, were selected to guide article appraisal.There are seven separate tools devised to help appraisedifferent types of research methodology (see Appendix 4 foran example); each has simple applicability and all appraiserswere familiar with their use. Appendix 5 details the literaturereviewers who took part in the appraisal process.28 articles were critically appraised between three appraisalgroups; each group consisted of two appraisers.Articles were excluded if both of the appraisers felt the studywas not relevant to the guidelines, contained inconclusive evidence purely descriptive.n Classification of included articles:The individuals in each appraisal group carried out separatereviews on full text articles prior to discussing it in orderto minimise potential bias. For each article the appraisercompleted an ‘evidence table’ detailing the study design,characteristics, subject of study, comments, potential use inguidelines and level of evidence. The quality of each article wasclassified using the SIGN grading tool(36) (Appendix 7). Anydifferences of opinion were resolved by consensus agreement ofthe Guideline Update Group detailed in Appendix 1a.16 articles were identified as providing new evidence.Completed evidence tables were reviewed by the GuidelineUpdate Group and, where ambiguous or contradictorycomments were found, the full text article was revisited andfurther detail added. The evidence tables for all articles utilisedin the previous and current edition of this guideline are foundin Appendix 8.Details of the articles excluded after full review are displayed inAppendix 6.CSP SKIPP Clinical Guideline 03 (2012) Amputee Rehabilitation9

The Consensus Process, Drafting the Updated Guideline, Guideline Audit ToolsThe Consensus ProcessIt was recognised in the first edition(1) that, in some clinicalareas, the literature did not provide sufficient evidence todevelop recommendations; the authors therefore chose theDelphi Technique to obtain consensus opinion where theliterature was lacking.Given the length of time that had elapsed since publicationit was felt by the Guideline Update Group important that theexpert opinion (from which ‘D’ graded recommendations hadbeen developed) be scrutinised to ensure they continue to be atrue reflection of current ideas and clinical practice.n The Delphi TechniqueThe Delphi Technique involves a series of questions to ‘obtainthe most reliable consensus of opinion of a group of experts by a series of intensive questionnaires interspersed withcontrolled opinion feedback’(38).It is a widely utilised methodology within healthcare forgathering expert opinion and turning it into group consensus(39)and, although more time consuming and labour intensivethan a conference, the Delphi Technique ensures: all contributors have an equal voice. that geographical barriers do not prevent participation. consideration of all possible options for treatment. practicing clinicians have the opportunity to contribute toand develop the guidelines.n The Delphi ProcessIn the original process two rounds of postal questionnaireswere sent out before recommendations were written. It wasdecided that these recommendations would be the startingpoint for the Delphi questionnaire for the second edition(Appendix 9).No literature could identify a universally acceptable percentageat which it could be determined that consensus agreementhad been reached. Previously, it was decided that if 75% ormore of the respondents scored more than 75% agreementwith a statement, consensus would be reached. If consensuswas below 75% the statement would not have the agreementof the panel and the question would be refined for a secondround. If consensus could not be reached after all the rounds ofquestionnaires then no recommendation would be written.n The Consensus PanelNo specific panel size has been identified as being optimalfor the Delphi process; representation should be assessed by‘qualities of the expert panel rather than it’s numbers’ (39).The consensus panel utilised in the updating process consistedentirely of physiotherapists because the Delphi questions were10directly r

Evidence Based Clinical Guidelines 5 Methods used to update the guideline 6 Scope of the guideline 7 The Clinical Question 8 The Literature Search 8 The Appraisal Process 9 The Consensus Process 10 Good Practice Points (GPPs) 10 Drafting the updated guideline 11 Guideline Audit Tools 11