National Institute for Health and Care Excellence Low Back Pain (update) Scope Consultation Table 21 st October 18 th November 2013

Transcription

1 National Institut for Halth and Car Excllnc Low Back Pain (updat) Scop Consultation Tabl 21 st Octobr 18 th vmbr 2013 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. 1. SH AbbVi Thr is low awarnss of axial spondyloarthropathy/ankylosing spondylitis amongst non- rhumatologists and patints with inflammatory back pain ar undr rcognisd as thy rprsnt a small group (15%)1, of all patints prsnting with chronic back pain. Thrfor thr is a diagnostic dlay of btwn 8-11 yars for patints with ankylosing spondylitis 2,3. Although inflammatory causs of back pain ar outsid th scop of this guidlin, in th sction (4.3.1) which dals with systmatic assssmnt of nonspcific low back pain, it would b usful to highlight th nd to idntify and xclud inflammatory back pain, in ordr to rais awarnss amongst primary car practionrs and rduc th dlay facd by ths patints. Dvlopr s Rspons Plas rspond to ach commnt Thank you for your commnt and usful information. NICE will b dvloping a guidlin on srongativ arthropathis which will bgin dvlopmnt shortly. 2. SH Acupunctur Association of Chartrd Physiothrapists 3. SH Acupunctur Association of Chartrd Physiothrapists 4. SH Acupunctur Association of Chartrd 1 Undrwood MR t al. Br J Rhumatol v; 34 (11): Fldtkllr E t al. Rhumatol Int 2003; 23: Khan MA t al. Ann Rhum Dis 2002; 61 (suppl 3): iii Th trm prsistnt was challngd by th attnds at th scoping group as it was flt that th scop would b too broad and not patint- frindly in trms of intrprtation a Insrtion of th word chronic - chronic nds to b dfind as how is this diffrnt to prsistnt? Th documnt should us similar trminology throughout d Timings ar crucial from a halth and conomic prspctiv. Thrfor timings for intrvntions nd to b considrd in ithr a pathway or stppd approach.g. surgry is xpnsiv but thn Thank you for your commnt. This has now bn rmovd from th titl, which is now rwordd as: Low back pain and sciatica: managmnt of non-spcific low back pain and sciatica. Thank you for your commnt. This has bn amndd to low back pain. Any trms usd in th dvlopmnt of th guidlin will b spcifically dfind. Thank you for your commnt. Timings will b considrd whn th vidnc is rviwd, including timlinss of PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 1 of 116

2 Stakholdr Physiothrapists 5. SH Acupunctur Association of Chartrd Physiothrapists 6. SH Acupunctur Association of Chartrd Physiothrapists 7. SH Acupunctur Association of Chartrd Physiothrapists Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. to rfr vryon at 2 wks to spcialist assssmnt (Physio tc) would also b xpnsiv. Considration of stppd approachs to input would b usful in trms of complianc for implmntation d Complmntary/altrnativ- Acupunctur is considrd as adjunct to othr thraputic and managmnt stratgis within physiothrapy scop of practic as pain rlif is primarily th main part of th patint s focus as many outcom masurs acknowldg. Thrfor acupunctur nds to b considrd as both a singl tratmnt stratgy AND as part of multimodal stratgis. In physiothrapy practic, CG88 has bn wllimplmntd and thrfor it could b argud that a nw rviw of acupunctur is unwarrantd if it is as a rsult of a prcivd lack of complianc Lwis t al (2011) considrd conomic valuation/clinical ffctivnss for acupunctur and sciatica. Car should b takn whn conducting sarchs as dfining th trms sciatica/radicular/ nrv root symptoms as limiting sarchs to spcific trminology may rsult in bias c Th inclusion of th Puls articl rsarch has rvald a potntial bias against acupunctur and it is mislading and incorrct rgarding currnt practic in th NHS. Thr ar many rasons why implmntation of CG88 has bn poor and any argumnt should not b basd just on th prcivd lack of uptak of acupunctur. Thr ar many biass against acupunctur within this documnt suggsting that th qustions wr not spcific nough or dirctd at practitionrs. For xampl, many commissionrs ar unawar that acupunctur is within Physiothrapy scop of practic and is usd widly for pain rlif within th NHS. Many NHS Physiothrapy dpartmnts hav Dvlopr s Rspons Plas rspond to ach commnt assssmnt. Thank you for your commnt. Th intntion is that tratmnts will b considrd on thir own, and in combinations if vidnc is idntifid. This will b dtrmind by th GDG whn th protocols for th rviw qustions ar draftd, and spcifid in th appropriat rviw protocols. Thank you for your commnt. Systmatic litratur sarchs will b undrtakn during guidlin dvlopmnt. Sarchs will utilis databas indxing and natural languag trms in ordr to rtriv all rlvant matrial whil balancing snsitivity and prcision. Plas s th NICE Guidlins Manual for furthr information on dvlopmnt mthods: Thank you for your commnt. Th Puls survy, basd on a Frdom of Information rqust of 127 Primary Car Organisations (PCOs) showd that only 15% of ths PCOs had any rcord of funding acupunctur for low back pain. Whilst acupunctur may b dlivrd by physiothrapists as part of thir scop of practic, th survy shows that this work is not commissiond. This implis a failur of commissionrs to adquatly PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 2 of 116

3 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. takn stps to nsur that thy do comply with th guidanc (for CQC purposs and to nsur bst practic) and hav auditd complianc. In addition, many GP practics still snd thir patints to othr vnus for tratmnt so it is hardly surprising that only 15% offrd acupunctur in thir practics. In th documnt on vn statd that thy would not accpt acupunctur unlss it showd clinical xcptionality which is unralistic for any tratmnt stratgy for such a varid clint group. Dvlopr s Rspons Plas rspond to ach commnt fund a NICE rcommndation and dos not imply a bias against acupunctur. W hav also now includd a rfrnc to a rcnt abstract which also highlights that th guidanc has not bn implmntd in primary car, which is not spcific to acupunctur. 8. SH Acupunctur Association of Chartrd Physiothrapists 9. SH Acupunctur Association of Chartrd Physiothrapists 10. SH Acupunctur Association of Chartrd Physiothrapists 11. SH Acupunctur Association of Chartrd d Issu with th word chronic. As this is a common thm throughout th documnt, it suggsts that th GDG alrady has difficultis with consistnt trminology c S abov- as acut also nds dfining if it is to b usd within th documnt. Hnc prhaps th standard dfinitions (as dfind in th rsarch litratur) do not fit with th practicalitis (as statd in th scoping group fdback) of implmntation and may b a furthr barrir to good complianc in th nxt guidlins d It is imprativ that all non-pharmacological intrvntions hav th sam statistical tsts applid to thm and b consistnt in th rsarch qustions and th typ of vidnc considrd. Rcommndations should not b mad just on th basis of chapr but lss ffctiv tratmnts (for xampl hot baths/orthotics in th OA kn guidlins) unlss th car is givn in a stppd approach or as part of a car pathway d Advrs vnts should b considrd ovr quivalnt tim frams. For xampl, whn th litratur is accssd for advrs vnts in acupunctur (Ernst) th tim fram considrd is 40 Thank you for your commnt. This wording has now bn amndd. Thank you for your commnt. Th full guidlin will contain a glossary in which ths trms will b clarly dfind. Thank you for your commnt. Th mthodology of systmatic rviws will b consistnt according to th NICE mthods manual Whil th typ of vidnc considrd for rviws may diffr, this will b rflctd in th quality rating of this vidnc. Th GDG will always considr th quality of th vidnc in dvloping rcommndations. Th GDG must considr cost ffctivnss for ach intrvntion rviwd. Thank you for your commnt. Th GDG will considr th nd to spcify timpoints for masurmnt of outcoms PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 3 of 116

4 Stakholdr Physiothrapists 12. SH Acupunctur Association of Chartrd Physiothrapists 13. SH Arthritis and Musculoskltal Allianc 14. SH Arthritis and Musculoskltal Allianc 15. SH Arthritis and Musculoskltal Allianc Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. yars. Any pharmacological or pharmacological intrvntion Dvlopr s Rspons Plas rspond to ach commnt pr rviw. should b considrd ovr comparabl tim spans for parity Patint choic should also b takn into considration. Thank you for your commnt. W agr this is an important factor. Th lay mmbrs of ach GDG ar vital in rprsnting th patint prspctiv. Th guidlin will also cross rfr to th NICE guidlin CG138 Patint xprinc in adult NHS srvics, in which patint choic is a ky focus of th rcommndations. 1 Gnral Commnt 2 Gnral Commnt ARMA wlcom th widning of th scop of th rviw. Back pain can b tratd and managd in primary and scondary sttings; ARMA dos not fl that this is sufficintly dmonstratd nor xplaind in th Draft Scop, and is a ky aspct which should b xpandd upon (a) W suggst that this statmnt also acknowldgs th availability of othr primary halth car practitionrs, not just GPs, and that patints hav th accss to ths car providrs. (b) ARMA suggst th inclusion of xrcis to improv outcoms. Physical activity has bn gratly rcognisd to rduc lowr back pain symptoms, and so should b accordingly incntivisd. Thank you for your commnt. Thank you for your commnt. Th scop stats that th guidlin will apply to all sttings in which NHS fundd car is providd. Thank you for your commnt. Th intntion of this sction is just to provid background information and w do not agr that it nds to b rwordd. Exrcis is includd within th list of possibl intrvntions in 3.2b. 16. SH Arthritis and Musculoskltal Allianc (a) commnt. (b) commnt (c) ARMA advis th considration of subgroups popl with back pain gnrally suffr from comorbiditis too, and so ths nds must also b considrd. In addition it would also b usful to includ subgroups for mrgncy rfrrals, and for thos who hav xhaustd all rcommndd tratmnt intrvntions. Thank you for our commnts c stats subgroups that will apply for th whol of th guidlin. Additional subgroups may b idntifid for spcific rviw qustions, dtrmind by th GDG and dtaild in th rviw protocol. 17. SH Arthritis Car 1 Gnral, & Arthritis Car wlcoms th proposd updat of th NICE Thank you for your commnts. Any PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 4 of 116

5 Stakholdr Ordr Sction para Commnts Plas insrt ach nw commnt in a nw row. guidlin on low back pain (LBP). W not both that this is a rviw of th whol prvious guidlin and th poor complianc with prvious guidlin. W bliv that a coordinatd programm of activity is ndd to addrss th burdn of musculoskltal disas, of which low back pain is an important componnt. Dvlopr s Rspons Plas rspond to ach commnt intrvntions that fall within th rviw protocols will b considrd if vidnc is idntifid. Th protocols will b draftd by th GDG basd on th aras spcifid in th scop onc dvlopmnt bgins. 18. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 19. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 20. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity For xampl, w wlcom th inclusion of xrcis in th list of issus covrd for th managmnt of LBP. Popl with ostoarthritis can xprinc improvmnts in thir condition, including pain lvls, through undrtaking gnral xrcis, muscl strngthning, and wight loss, as pr NICE clinical guidanc (GC59). W submit that all of ths intrvntions should b includd in th rmit of th updat. 1 Gnral W wlcom th widning of th scop of th rviw, as this will man th guidlins ar mor clinically rlvant (particularly including lg pain/sciatica), howvr w not th substantial incras in workload associatd with this rviw for th GDG. In particular it will b difficulty to provid clinically usful guidanc for this larg population will guidanc b brokn down to ithr i) duration of condition or ii) othr. W would wlcom th guidanc rcommnding a holistic assssmnt of th patint s condition including risk stratification Population w rcognis th rduction of duration of symptoms to wks but qury th rational bhind 2 wks is thr a clinical rational for this? W ar unawar of any diffrnc in patint s prognosis if thir pain has lastd 10 days vrsus 15 days for xampl W ar dlightd to not that suspctd radicular pain/sciatica is includd in this rviw. Thank you for your commnt. W acknowldg th bradth of this scop and larg workload involvd. Th work plans and timlins for this guidlin will b plannd accordingly. Th GDG will considr how bst to sub-divid th aras for rviw and for prsntation of th final guidanc during dvlopmnt, with th intntion of producing usr frindly guidanc. Thank you for your commnt. Th cut-off point for prsntation has now bn rmovd from th scop. Thank you for your commnt. 21. SH Arthritis Rsarch d W not that th cut-off point of 12 months has bn rmovd and Thank you for your commnt. PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 5 of 116

6 Stakholdr UK Primary Car Cntr, Kl Univrsity 22. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 23. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 24. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 25. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 26. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. wlcom this, howvr this will man that a nw body of litratur will now bcom rlvant for rviw by th GDG rlating to th managmnt of chronic pain syndrom Could this b rwordd to all sttings in which NHS fundd car is rcivd. Collagus who attndd th scoping workshop blivd this had bn agrd. It is important this includs NHS fundd car to tak into account th implications of commissioning of any qualifid providr from NHS commissionrs who will potntially b commissioning car from privat providrs for NHS patints W ar dlightd to s that prognostic factors ar includd as w bliv that th catgorisation of acut/subacut/chronic is now lss valid with strong vidnc for stratification of patints according to thir risk of ongoing disability. Thr nds to b guidanc for th assssmnt of patints in primary car (including vidnc for imaging/scrning for prognostic factors tc) Th rviw of pharmacological intrvntion should includ antiinflammatoris opioids, muscl rlaxants (including bnzodiazpins), antidprssants, anticonvulsant nuromodulators and antibiotics in crtain subgroups of LBP (collagus attnding th scoping workshop bliv this was agrd). In addition w would highlight th nd for th rviw to includ th rol of anti-tnf thrapis in th managmnt of sciatica Will non-pharmacological intrvntions includ modalitis such as Ti-chi and yoga? W ar plasd to s th rviw including multi-modal thrapis as this rflcts dirct clinical car (with clinicians oftn utilising packags of car) but can w clarify that th rviw group will allow th combination of packags of car (.g. combining svral typs of non-pharmacological and pharmacological thrapis in combination) Dvlopr s Rspons Plas rspond to ach commnt Thank you for your commnt. This has bn amndd in th scop to bttr rflct whr thr guidanc will apply, Thank you for your commnt. Thank you for your commnt, ths pharmacological tratmnts ar includd within th ovrarching hadings statd in th scop. Anti-TNF thrapis for sciatica will b considrd undr th hading of injction thrapis. Thank you for your commnt. If vidnc is idntifid for ths modalitis, thy will b considrd within xrcis thrapis, but rviwd as sparat tratmnt options. Thank you for your commnt. Th scop has bn r-wordd as Combind thrapis to mor dirctly rflct what is intndd. Any combinations that ar idntifid in th litratur will b considrd, including combinations of PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 6 of 116

7 Stakholdr 27. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 28. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 29. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 30. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity 31. SH Arthritis Rsarch UK Primary Car Cntr, Kl Univrsity Ordr Sction Commnts Plas insrt ach nw commnt in a nw row Psychological intrvntions again w s this as on of th combination thrapis and wondr why this is considrd sparatly (s point abov). Clinicians us physical and psychological intrvntions in combination and for th guidlins to b rlvant for clinicians (and hnc incras uptak/adoption of th guidanc in practic) th guidlins nd to rflct this Injction thrapis will this includd all typs (i.. imaging guidd and non-guidd injction thrapis)? W would qury why thr is a spcific hading for surgry whilst thr is no spcific sction highlighting th nd for rfrral for spcialist (not ncssarily surgical) opinion. Collagus attnding th scoping workshop flt that this was a ky ara that ndd addrssing. W would rcommnd that th GDG considrd a hading: Indication for onward spcialist rfrral which allows for rfrral for othr intrvntions such as spcialist spinal physiothrapy; imaging/mir; pain managmnt spcialists; as wll as spcialist surgical opinion Work loss and arly rtirmnt du to LBP should b considrd as an outcom? Sction 3.1b highlightd th issu of work but this is not includd as an outcom. W would rcommnd that rduction in work loss and arly rtirmnt du to LBP should b sn as an outcom bcaus of LBP s contribution to ths two aras Tim to rcovry again this should b considrd as an outcom. Evidnc from trials for sciatica hav shown that patints can improv quickr with som tratmnts tim to rcovry thrfor sms to b an important outcom and thr is dangr that rlvant vidnc will b missd if this is not includd. Dvlopr s Rspons Plas rspond to ach commnt packags of car. Thank you for your commnt. W acknowldg that psychological intrvntions may b givn in combination with othr thrapis. Th intntion is that psychological thrapis givn alon, or in combination with othr thrapis includd in th guidlin scop, will b includd if vidnc is idntifid in th litratur. Thank you for your commnt. Ths will b covrd within th scop of th guidlin. Thank you for your commnt. Th guidlin will covr rfrral for spcialist assssmnt. W ar unabl to covr all options for rfrral, but will look at typs of surgry spcifically, and thrfor rfrral for surgry is th only option spcifically dtaild in th scop. Thank you for your commnt, outcoms for ach condition will b dtrmind pr rviw qustion in th protocols. Th outcoms listd in th scop ar th ky ons that will b considrd across th guidlin and ar not all-inclusiv. Thank you for your commnt, outcoms for ach condition will b dtrmind pr rviw qustion in th protocols. Th outcoms listd in th scop ar th ky ons that will b considrd across th PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 7 of 116

8 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. 32. SH BackCar 1 Svral studis show that back pain and physical factors ar not associatd onc you account for psychosocial factors. Furthrmor, th attribution of physical causs is a risk factor for nonspcific symptoms. This suggsts that w ar unwittingly driving th incras of back pain through public halth and primary car mssaging. 33. SH BackCar 2 Psychosocial factors ar consistnt prdictors of back pain, and low back pain is common to svral validatd assssmnts of somatisation. Th vidnc suggsts that nonspcific back pain is fundamntally psychosomatic. 34. SH BackCar 3 In commnts on th scop, group #4 said, psychological intrvntions do not nd to b ld by a psychologist. It is quit alarming to think that psychological intrvntions ar bing dispnsd lik mchanical rcips. Should surgons lad surgry? 35. SH BackCar 4 Th r-mphasis of th Alxandr Tchniqu in th guidlins is to b commndd as it has bn improprly rprsntd to dat. Th AT modl intgrats cognitiv and affctiv dimnsions. AT is not mrly postural ducation. This is a vital distinction to mak. 36. SH BackCar 5 Th Danish antibiotics trial did not us an activ placbo control. Bioclavid has vry obvious sid ffcts. Without an activ placbo control th rsults cannot b distinguishd from a placbo ffct in patints who ralisd thy wr in th right group. 37. SH BackCar 6 Th stanc of smoking cssation should b strngthnd by actually stating spcific vidncs, namly that (a) surgical and non-surgical back pain tratmnts statistically fail in smokrs, (b) havy occupational lifting only prdicts back pain in smokrs, (c) smoking dpndncy is strongly associatd with dysfunction on svral psychological assssmnts. 38. SH BackCar 7 Evn th magic bullt will not work on a non-compliant patint. Similarly, if guidlin implmntation rmains poor, thn vn th bst guidlins in th world ar uslss. This procss is subjct to Dvlopr s Rspons Plas rspond to ach commnt guidlin and ar not all-inclusiv. Thank you for your commnt. Th assssmnt of psychosocial factors and rol of psychological thrapis ar includd within th scop of this guidlin. Thank you for your commnt. Th guidlin intnds to rviw psychosocial factors as prognostic indicators for nonspcific low back pain and psychological thrapis in th managmnt of nonspcific low back pain. Thank you for your commnt. Th guidlin will indicat th skills rquird by th clinician to dlivr intrvntions, rathr than thir profssion. Thank you for your commnt. Thank you for your commnt. Th GDG will considr th quality of availabl vidnc for ach sparat rviw in forming thir rcommndations. Thank you for your commnt. Smoking cssation will b considrd within th hading of lifstyl intrvntions if thought appropriat by th GDG. Thank you for your commnt. Th adhrnc of various clinicians to NICE guidanc dos not fall within th rmit of PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 8 of 116

9 Stakholdr 39. SH British Acupunctur Council Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. its wakst link. If GPs constitut th wakst link, this must b rmdid in a tchnical and vidncd-basd mannr, no lss. 1 Gnral For a guidlin that covrs many diffrnt typs of thraputic option thr should b an vidnc framwork that is rlvant to all of thm, and which is applid vnly across th board. It is critically important to rcognis and dal appropriatly with complx intrvntions (Craig t al 2008), that hav multipl, intracting componnts and largly unknown undrlying mchanisms. Physical and psychological intrvntions ar of this typ, as is acupunctur. Acupunctur involvs diagnostic procdurs, a thraputic rlationship, touch, ndl insrtion, ndl manipulation, ongoing slction of ndling locations, patint ducation and patint slf hlp masurs, all of which may b thrapy-spcific to som dgr (Patrson and Dipp 2005). Th us of sham controls is challnging for complx intrvntions: thy cannot b considrd placbos in th sam way as in drug trials. For xampl, thr is no crdibl placbo for acupunctur; vn th gold standard is sriously flawd (Lund t al 2009). Sham acupunctur intrvntions usually try to control for just on or two of th componnts, not th whol thrapy. It would b similarly inappropriat to xtract a singl CBT itm and us it to rprsnt th thrapy. Many diffrnt sham acupunctur approachs ar rprsntd in th publishd acupunctur for back pain RCTs. Most of thm ar obviously activ and non of thm ar considrd to b inrt placbos. Thy function as altrnativ forms of acupunctur, diluting it to diffring dgrs. Hnc th spcific tratmnt ffcts may b undrstimatd. On th othr sid of th balanc, poor blinding could ovr-stimat th ffct. W don t know th rlativ sizs of ths conflicting factors and th intrprtation of sham acupunctur data is fraught with difficulty and conflict. Hnc sham comparisons ar only minimally usful for assssing Dvlopr s Rspons Plas rspond to ach commnt this guidlin. Thank you for your commnt. W acknowldg th issus around slcting th appropriat comparator for acupunctur and othr complx intrvntions. Th GDG will considr th appropriat comparators, outcom masurs and study dsigns for ach rviw qustion whn th protocols ar agrd. Mthodology applid will b consistnt for all intrvntions rviwd and will b in accordanc with th NICE guidlins manual: PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 9 of 116

10 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. bnfits and harms. Ths ar pragmatic qustions that rquir pragmatic data: comparisons against waiting list, usual car or othr compting tratmnts. Sham trials answr qustions about prformanc of an intrvntion undr idal xprimntal conditions, not thos rlvant to normal clinical practic. Thy ar poorly quippd to hlp NHS commissionrs, clinicians or patints. Dvlopr s Rspons Plas rspond to ach commnt Othr non-pharmacological thrapis (.g. xrcis, manual thrapis) may also b considrd complx intrvntions with no fasibl placbo. Thy will all hav diffrnt amounts and typs of vidnc but it is crucial for th crdibility of th guidlin that thy ar all xamind consistntly: - Rsarch qustions should b of a similar form for all - Th sam dfinition of clinical ffctivnss - Th sam typ of primary data usd for rcommndations - Th sam tratmnt of data quality issus. Comparativ ffctivnss rsarch could b usd as th ovrarching framwork for th guidlin. Thr is a sound rational for favouring it ovr xplanatory rsarch for answring ral-world qustions and it is particularly wll suitd to complx intrvntions (Witt t al 2012). Hnc th rsarch qustion for all non pharmacological thrapis could b of this form (as in SIGN s currnt Chronic Pain guidlin): In patints with low back pain what is th ffctivnss of tratmnt X compard with no tratmnt X or othr intrvntions on pain scors, functional ability, quality of lif tc. 40. SH British Acupunctur Council 2 Gnral Givn th tchnical and concptual difficultis discussd abov, and givn that poor tak-up of acupunctur in primary car was a drivr for this guidlin updat, it dos not inspir confidnc to find that thr will b no plac for an acupuncturist in th main GDG. Th group looks to b top havy with doctors. To b sufficintly comptnt and crdibl in rspct of acupunctur th Thank you for your commnt. Aftr carful considration it has bn dcidd that an acupuncturist is not ndd as a full mmbr of th guidlin dvlopmnt group (GDG). Should th GDG fl that mor spcialist input is rquird for PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 10 of 116

11 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. guidlin nds an acupunctur voic in th dcision-making body. Such a prson would nd to b both an acupuncturist and an acadmically wll-rgardd rsarchr, with xprinc of quantitativ trial mthodology, systmatic rviw and conomic analysis (thr ar only half a dozn in th UK). Dvlopr s Rspons Plas rspond to ach commnt particular rviw qustions; an acupuncturist will b co-optd to th GDG and will b invitd to rlvant GDG mtings. Rfrncs Craig P, Dipp P, Macintyr S, Mitchi S, Nazarth I, Ptticrw M: Dvloping and valuating complx intrvntions: th nw Mdical Rsarch Council guidanc. BMJ 2008;337: Patrson C, Dipp P. Charactristic and incidntal (placbo) ffcts in complx intrvntions such as acupunctur. BMJ 2005;330: Lund I, Nasland J, Lundbrg T. Minimal acupunctur is not a valid placbo control in randomisd controlld trials of acupunctur: a physiologist s prspctiv. Chin Md 2009;4:1 Witt CM, Chsny M, Gliklich R, Grn L, Lwith G, Luc B, McCaffry A, Raffrty Withrs S, Sox HC, Tunis S, Brman BM. Building a stratgic framwork for comparativ ffctivnss rsarch in complmntary and intgrativ mdicin. Evid Basd Complmnt Altrnat Md. 2012;2012: SH British Acupunctur Council 42. SH British Acupunctur Council W wlcom th r-catgorisation of acupunctur from invasiv procdur to non-pharmacological intrvntion. Howvr, it rmains to b sn whthr it will b tratd appropriatly as a complx intrvntion (s discussion in commnt 1 abov) W hop that thr will b quipois in th way in which th diffrnt intrvntions ar invstigatd and thir data analysd and intrprtd, in ordr to dlivr crdibl rcommndations (s commnts in 1 abov). Thank you for your commnt. Thank you for your commnt. Data analysis in systmatic rviws will b according to th mthodology of th 2012 NICE mthods manual for all intrvntions. PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 11 of 116

12 Stakholdr 43. SH British Acupunctur Council 44. SH British Association Of Spin Surgons 45. SH British Association Of Spin Surgons 46. SH British Association Of Spin Surgons 47. SH British Association Of Spin Surgons Ordr Sction Commnts Plas insrt ach nw commnt in a nw row It is inappropriat to masur th cost-ffctivnss of acupunctur against sham, as has bn acknowldgd by NICE lswhr. Th NHS is intrstd in th practical bnfits and opportunity costs, not thos rlatd to on vrsion of acupunctur vs anothr. Furthrmor th incrmntal cost of acupunctur vrsus sham acupunctur could b zro, or vn ngativ, givn similar practitionr costs and th gratr cost of sham dvics. Thr is xisting high quality cost-ffctivnss data for LBP and acupunctur (.g. Lin t al 2011) Rfrncs Lin CW, Haas M, Mahr CG, Machado LA, van Tuldr MW. Costffctivnss of guidlin-ndorsd tratmnts for low back pain: a systmatic rviw. Eur Spin J Jul;20(7): Pg 4 W challng th contntion in th scop that th vidnc bhind surgry/intrvntion for radicular pain is limitd (3.2 Pg 4). W accpt that th rational for intrvntion in low back pain is much mor controvrsial. 2 Gnral W support th nd for a root and branch rvision of th NICE LBP guidanc, and wlcom th opportunity to contribut. W support th inclusion of radicular pain in th Guidanc, as many patints will prsnt with a mixtur of both prsntations pg 5 W support th rmoval of th artificial 12 month limit on th guidanc, and wlcom th idntification that arly intrvntion at 2 wks may b ncssary, rathr than commncing intrvntion at 6 wks. 4 Gnral W suggst that th Guidanc should focus on making a clar diagnosis of whr pain may aris, if that is possibl by history, xamination and appropriat invstigation, at an arly stag, so Dvlopr s Rspons Plas rspond to ach commnt Thank you for your commnt. W acknowldg th issus around slcting th appropriat comparator for acupunctur studis. Th GDG will considr th appropriat comparators, outcom masurs and study dsigns for ach rviw qustion whn dvloping th protocols. Thank you for your commnt. W bliv thr is uncrtainty about long trm ffctivnss and thrfor do not agr this nds rwording in this sction. W will rviw this within th guidanc. Thank you for your commnt. Thank you for your commnt. Th scop of th guidlin has now bn furthr amndd to includ popl from onst of symptoms. Thank you for your commnt. Systmatic assssmnt of low back pain is includd within th scop. PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 12 of 116

13 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. that th most appropriat tratmnt (which may b surgical in th first instanc) can b offrd. Patints in whom a clar diagnosis cannot b mad non-spcific mchanical pain should b offrd whatvr vidnc basd thrapy that is clinically and conomically viabl to dlivr. Dvlopr s Rspons Plas rspond to ach commnt 48. SH British Association Of Spin Surgons W strongly support th focus on th collction and publication of validatd outcom data. Th guidanc should mak spcific rfrnc to a clar and accurat conomic assssmnt of th rsourcs rquird to dlivr rcommndd thrapis Th guidlin dvlopmnt group will considr th clinical and cost ffctivnss of all aras rviwd for th guidlin. Following publication, NICE will dvlop a costing tool to assss th cost impact of th rcommndations and aid implmntation. 49. SH British Association Of Spin Surgons 50. SH British Chiropractic Association 51. SH British Chiropractic Association 52. SH British Chiropractic 6 Gnral W support th scop of invstigation as statd Thank you for your commnt. 1 Gnral Commnt Composition of Guidlin Dvlopmnt Group 2 Sction 1 Guidlin Titl 3 Sction 1.1 Short Titl Th BCA is concrnd that only on plac is allocatd on th GDG for manual thrapy practitionrs. Chiropractors, manipulativ physiothrapists and ostopaths ar bing commissiond as AQPs in th NHS to provid MSK srvics and sinc th majority of patints will b sn in primary car, manual thrapists hav a ky rol in th dlivry of succssful outcoms for patints. This has bn dmonstratd in th rth East Essx Cas Study. W thrfor rqust that two placs ar mad availabl on th GDG for manual thrapy practitionrs to maintain a bttr balanc btwn primary and scondary car. Th BCA would propos that th titl of th rvisd Guidlins should b changd to rflct thir scop and xtndd as follows: Low back pain, sciatica/radicular pain: arly managmnt of prsistnt non-spcific low back pain. Th BCA would propos Low Back pain/radicular pain/sciatica Thank you for your commnt. Th guidlin dvlopmnt group dos includ a physiothrapist as wll as an additional position for th thrapist with an intrst in spinal manipulation. Thank you for your commnts. W hav amndd th titl to: Low back pain and sciatica: managmnt of non-spcific low back pain and sciatica. Thank you for your commnt. W hav amndd th short titl to: Low back pain PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 13 of 116

14 Stakholdr Association Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. Dvlopr s Rspons Plas rspond to ach commnt and sciatica. 53. SH British Chiropractic Association 54. SH British Chiropractic Association 4 Sction 3 Nd for th Guidlin 3.1 Epidmiology (d) 5 Sction Currnt Practic Th sction on manual thrapis should rad manual thrapis (for xampl massag, mobilisation and joint manipulation) as undrtakn by chiropractors, manipulativ physiothrapists and ostopaths. Th sction on invasiv procdurs should rad invasiv procdurs (for xampl, fact joint, pidural injctions, dry ndling and mdical acupunctur) as ar availabl in primary halth car sttings. (a) Th BCA suggsts that this paragraph b rwordd to say Popl with low back pain may go to thir GP or othr primary halth car practitionrs for initial tratmnt and consquntly, in most cass, thir car will b managd in a primary car stting. (b) Managmnt th BCA proposs that this paragraph b rvisd as follows: managmnt (onc th atiology has bn idntifid as non-spcific) a combination of lifstyl advic, convntional tratmnt such as pharmacological thrapy and xrcis and kping activ. If pain prsists, rfr for manual thrapis, psychologically informd thrapis, xrcis and invasiv procdurs such as mdical acupunctur. Surgical intrvntion may b offrd to thos who hav compltd an optimal packag of car. (c) Th BCA proposs that this sntnc should b addd to th txt Providrs of manual thrapy may also offr mdical acupunctur as part of a packag of car. (d) chang. () Th BCA proposs that th us of th word spontanously is mislading in this contxt as this is not always th cas. Thrfor, this sction might rad In th majority of cass, symptoms causd by a Thank you for your commnt. This sction of th scop is intndd to giv an ovrviw of th broad rang of thraputic modalitis availabl rathr than spcific dtail of ach thrapy. This has thrfor not bn rwordd. Thank you for your commnt. Paragraph 3.2 (a) has bn amndd as suggstd. Paragraph 3.2 (b) (c) and () rmain unchangd as it was flt that th suggstd wording would not add furthr clarity to th prsnt wording. PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 14 of 116

15 Stakholdr 55. SH British Chiropractic Association 56. SH British Chiropractic Association 57. SH British Chiropractic Association 58. SH British Chiropractic Association 59. SH British Chiropractic Association Ordr Sction 6 Sction 4 Th Guidlin 4.1 Population Groups that will b covrd Groups that will not b covrd Managmnt Commnts Plas insrt ach nw commnt in a nw row. hrniatd disc rsolv with consrvativ managmnt including manual thrapy. (a) Th BCA nots that no sub-groups hav bn idntifid as nding spcific considration. W would propos that this should b rviwd as patints with high biopsychosocial co-morbiditis hav spcific nds which should b takn into account. (c) Th BCA blivs that th us of th word acut in this paragraph is mislading. W propos that this sntnc should b rvisd to say Popl with low back pain (lss than 2 wks duration). (d) Th BCA proposs that th sction on manual thrapis b rwordd as follows: manual thrapis, including spinal manipulation, mobilisation as practisd by chiropractors, manipulativ physiothrapist and ostopaths; and massag. Th BCA proposs that th sction on acupunctur should rad:- mdical acupunctur and dry ndling (a) Th BCA would pint that that som cass of spondylolisthsis may appar stabl and consquntly do rspond to physical thrapy. Dvlopr s Rspons Plas rspond to ach commnt Thank you for your commnt. W agr that popl with co-morbiditis rquir considration whn tratmnts ar considrd. This applis to all thraputic aras, and will b considrd by th GDG whn rcommndations ar draftd if spcific to this population. Thank you for your commnt. Th duration limit has now bn rmovd following othr stakholdr commnts and thrfor this bullt point has bn rmovd. Thank you for your commnt. W hav wordd this as manual thrapis including massag as a broad hading which may also includ spinal manipulation and mobilisation. Th spcific thrapis to b includd will b dfind by th GDG whn dvloping th rviw protocols. Acupunctur has bn also statd as a gnral hading, which may also includ dry ndling. This will also b dfind in th rviw protocols. Thank you for your commnt. Th managmnt of spondylolisthsis is byond th scop of this guidlin Main Th BCA is concrnd that th outcom masurs bing Thank you for your commnt. Th Outcom considrd do not look at psychosocial factors. Th Bournmouth qustionnairs statd ar xampls of Qustionnair (BQ) is proposd as a bttr altrnativ as it is a thos that will b includd. Othrs will wll validatd outcom masur for back pain and taks into also b includd if idntifid in th account psychosocial factors. litratur. 60. SH British Institut of b) Undr slf-managmnt stratgis w fl th scop should add Thank you for your commnt and this PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 15 of 116

16 Stakholdr Musculoskltal Mdicin Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. : including advic on Rst (dfind as a tmporary rstriction of activitis with th intntion to unload malfunctioning structurs, rduc concurrnt pain and influnc rat of rcovry). Guidanc to suffrrs on th spcific indications for rst and clar paramtrs for its us including th transition towards normal activity as impairmnt rducs. Spcific advic that avoids th mixd mssags many popl rciv that may go on to b contradictd by thir own immdiat xprinc. Dvlopr s Rspons Plas rspond to ach commnt usful information. This will b covrd by th scop of th guidlin. 61. SH British Institut of Musculoskltal Mdicin Background: ovr th last svntn yars, th data usd for guidlins and vidnc rviws of th ffcts of rst or activity on acut low back pain has uniformly rlid on a small numbr of trials. Th rlianc put on thir small or absnt ffcts has ld to a mov away from th xcssiv us of rst of th past but has gon on to assum no bnficial ffcts from rst at all. Th trials rviwd hav not bn dsignd or had th powr to shown absnc of ffct whil strong contrary vidnc has bn ignord on th basis of vidnc slction critria that wr chosn in th full knowldg of th studis availabl and thrfor not scur from bias. Commnt on th vidnc bas for this advic has com from minnt (Kos B. Evid Basd Md 2010; 15(6): ) and lss minnt sourcs (MacDonald R. Intrnational Musculoskltal Md. 2013; 35(3): 121-5). Until th issus raisd in ths commntaris hav bn addrssd, advic on rst vs activity may hav to b changd or halth practitionrs allowd to giv advic basd on thir own clinical judgmnt in individual situations Undrstanding and Slf-fficacy: Th two most common issus for thos sking tratmnt for LBP ar What's causing my pain? What can I do to gt rid of it?. Thos who fl thy undrstand th caus of thir pain ar mor compliant with subsqunt managmnt and mak fwr dmands on halthcar rsourcs. (Patint satisfaction with mdical car for low-back pain. Dyo RA, Dihl AK. Spin Thank you for your commnt and usful information. This will b covrd within th scop of th guidlin undr th hading slf-managmnt stratgis PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 16 of 116

17 Stakholdr Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. 1986;11(1): Patint Expctations of Tratmnt for Back Pain; A Systmatic Rviw of Qualitativ and Quantitativ Studis. Vrbk JMD, Sngrs M, t al Spin 2004; 29(20): ). Considrabl training and rsourcs ar aimd at nabling halth car practitionrs to provid this information. t to monitor th outcoms of this procss crtainly risks unmt nd and/or wastd rsourcs and may fail to idntify opportunitis for scondary prvntion. Dvlopr s Rspons Plas rspond to ach commnt To assss prcptions of slf fficacy, Multidimnsional Halth Locus of Control qustionnairs ar availabl mainly for rsarch purposs and would b cumbrsom in clinical us. A singl qustion in a PROMS assssing confidnc in slf-managing futur pisods of LBP could b usd. As such confidnc is sought by patints, its acquisition could b a justifiabl outcom in itslf; vidnc that it prdicts lss futur LBP is not prsntd. 62. SH British Institut of Musculoskltal Mdicin 63. SH British Institut of Musculoskltal Mdicin a) & b) Advic for thos whos backpain or radicular pain has not rsolvd within two wks is oftn contingnt on a rviw of that givn at th outst to which adhrnc may hav bn inadquat. As th principls of th rgim bing monitord will not ssntially diffr btwn th first two wks and th nsuing priod, guidanc would not b spcific to th lattr priod. Actions and information givn during th initial fortnight may initiat som of th prcptions and bhaviours that hav bn linkd to prsistnc so w rcommnd that it would b rational for th guidlin to apply from onst a) W ar uncrtain, apart from fractur, how conditions with a slct and uniform pathology of a mchanical natur (for xampl, spondylolisthsis, scoliosis, vrtbral fractur or congnital disass) can b managd outsid th scop of non-spcific back pain and or radiculopathy with which thy ar oftn comorbid. Until thir contribution to th ovrall impairmnt rachs a lvl whr surgical intrvntion is considrd, thy ar managd in conjunction with th non-spcific back pain in th causation of Thank you for your commnt. Th scop of th guidlin has now bn amndd to includ popl from onst of symptoms. Thank you for your commnt. Spondylolisthsis and spondylolysis ar diagnoss mad radiologically. Prior to radiological diagnosis, th arly managmnt of ths patints is usually th sam as for non-spcific low back pain/radicular pain and th thrapis/intrvntions proposd in th PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 17 of 116

18 Stakholdr 64. SH British Orthopadic Association 65. SH British Orthopadic Association 66. SH British Orthopadic Association Ordr Sction Commnts Plas insrt ach nw commnt in a nw row. which thy may b a contributory factor. 1 Gnral Is th titl now appropriat givn that radicular pain has bn includd? Suggst: LBRAD ( acronym) d) Th rol of ducation rmains undrstatd. Us of lctronic mdia campaigns in Australia had significant ffct in rducing consultation for LBP. It is likly that similar bnfit would rsult if this was implmntd in th UK ) Suggst ' surgical tratmnt may b considrd if spcific critria ar mt. E.g. includd for illustration : Consrvativ modalitis of tratmnt hav faild and : symptoms ar prsistnt and disabling. Th xtnt of dgnrativ changs is limitd That thr is an idntifiabl sourc of symptoms. Th patint wishs to considr surgical intrvntion. Th patint is fit to undrgo th procdur proposd. Dvlopr s Rspons Plas rspond to ach commnt scop would apply. Onc diagnosd, th dtaild managmnt of ths conditions (oftn surgical) would b outsid th currnt scop. Thank you for your commnt. W agr that th titl ndd amnding and hav changd it to: Low back pain and sciatica: managmnt of non-spcific low back pain and sciatica Thank you for your commnt. Patint ducation is includd in th scop of this guidlin and will b covrd, Howvr, population basd campaigns ar byond th scop of this guidanc. Thank you for your commnt. This sction of th scop is intndd for background information in th scoping procss only and will not b includd in th final guidlin. 67. SH British Orthopadic Association 68. SH British Orthopadic Association f) Insofar as th tratmnt options for low back pain ar idntifid in (), thr should b similar rfrnc to th availabl tratmnt modalitis for radicular syndroms and sciatica including surgry b) Is th phras 'onc non-spcific atiology has bn diagnosd' not in itslf tautologous? Should this rad 'if no caus can b idntifid for symptoms at that tim? Thank you for your commnt. This sction of th scop is intndd for background information in th scoping procss only and will not b includd in th final guidlin. Thank you for your commnt. This sction of th scop is intndd for background information in th scoping only and w thrfor do not agr this nds rwording. What is mant by Physiothrapy? This is a nonspcific trm opn to various intrprtation. 69. SH British c) Is thr any documntation of th provision of ithr high or low Thank you for your commnt. This PLEASE NOTE: Commnts rcivd in th cours of consultations carrid out by th Institut ar publishd in th intrsts of opnnss and transparncy, and to promot undrstanding of how rcommndations ar dvlopd. Th commnts ar publishd as a rcord of th submissions that th Institut has rcivd, and ar not ndorsd by th Institut, its officrs or advisory committs. 18 of 116