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Guest editorial ‘The Sith Stu Hunter Research Conference was held March 6 ~ 8 2018 at the Roanoke Hotel in Roanoke, Visginia. The Hunter Conference strives to provide Thoroagh calls fllowed by a robust discussion among savance the research fla. Daring the conference, sit Ieynote speakers were vena forum of 90 minutes to present thelr ideas, after which two dscusants chal Tenged the ideas, and provided an eacellont basis for the pen discussion with al participants. The lasses tion ofthe conference was devoted to the late Soren Bisgard who had a tremendous impact om the Held of industrial satis, ‘his special Isue provides fll-ength papers of all six Keynote speakers Fach ofthese papers is comple rented by st lee wo discussion papers that are pro vided by the dacussnts atthe conference, x8 well by some addtional authors wna are wel respected in the fed. The speaker. thelr topics, and the invited dlscuesnts included the following ‘Dennis Lin, Pens State, “Design and Analysis for Order of- Addition Experiment” Discussant 1: Joo Voc, Rocheer Insiae of Tecnology Disusent 2: David Stenberg Tel Avr Unery aura Freeman Institue for Defoe Analysis “Design of Experiments for Refit” Diecast Dicusent 2 Zhisheng Ye, National Universty af Sgepre Sandy Fogel, Vigna Tech Cariton Schoo! of Medicine, "Doctors ate ot pilots and patents ae not seplanes: Quality improvement in medicine” Discussant: Stan tinct, Unies af Waero Doug Montgomery, Azone Discussant 2 Vitra Jordan, Emory Heal Care Stephanie Kovalchik, Tennis Australia, “Gaining an Bdge Promoting Stattial Thinking in the poms Industry” Taylor & Francis aoe Dicusant 1 State Uniersiy Kan Pander, Nor Guolina Discus 2: Steve Rigdon Saint Lous Univers Ross Sparks, CSIRO, “Disease surellnce: Disease ‘Sa Franco. James D, Wison, Univesiy. of hacen 2: Fade Mabe Vigna Tech Geoff Vining, Veginia Tech, “Soren Bisgard's Contributions to Quality Engineering” Denmark Murs Kulhcl, Tena Uniersty Diacsant 2 Roger How Union Coleg There are additional discussions in this Bsue of Quality Enginering from participants of the 2018 Hunter Conference who were not invited discussant ‘We thank Murat Caner Test, past editor of Quality Engineering, Marcus Perry the curent editor, and the staf at Taylor and Francs for allowing us the ‘opportunity to serve as guest editors and to present 5 papers in this issue ‘We are abo gratefil to the Hunter Conference ‘managing commit which consists of Stefan Steiner and Musat Kulahel, and the local commits which incuded Aane Driscol, Geoff Vining, Row Fricke, Kort Lindssy, and Jeneen Preston. Finally, we are iratefil to all sponsors of the conference, including the Stasis Division of ASQ, the Chemical and Process Industries Division of ASQ, the Quality and Produesvty section of ASA, and JM Bart De Ketuere Steven E. Rigcon Sunt Lous Unies ‘Changang Zhou Nate Univerty T Doctors are not pilots and patients are not airplanes: Qual in medicine Sandy Lewis Fogel Taylor & Francis improvement Daren Supe ig Tech iin Schou of Mei, ok, Vega tied Ta Er i Human” Wt descbed enor howls which te Yo between 44000 and ‘S000 dente per year Thi wae the “tpping pote’ tonardslfevsualon and quality orrecay soy itmpronment Nesine nar slowly deveaped Quy iprovenent methocloges tat iimrto work Suge lea the wy. Tie ae ll go trough same the metry ot “ay improvement th the caty comparing poets ond celng eutore. Steh toe Stele chang phyn teravor The challenges of mplmentng ty Tipronent scoss anette Nasa ibe demonstrate History For much ofthe history of onganied medicine in the United States, quality improvement was in the form of peer seve. This took place only when something tunexpected and sawanted occured to a patient. It sees felt that the physician In charge was solely responsible. A group ofthat physician's pers gathered ina room and discussed the negative outcome. If it wes the consensus ofthe group that something wat done incorrectly, the phyician who made the exzor fo the proverbial slap on the wrist. That physician ‘would theoretically never make that mistake agai: however, this proces dd nothing to prevent the next physic fom making the same error. Nor dd it pre ‘ent the fst physician from cresting injury 10 othar Patients ina similar but sot identical manner. This approach did nothing to address systematic erors of to provide gystematicslutons ‘The Ais Known attempt to se dite to eee sy tematic quality improvement took place in New York State in the late 1980s, The sate plished the mortal ity rte ofall howptal that performed cardiac surgery This was intendd to allow the public to know the hos pitls with the lowest morality and seek caveat those facies. Thi increased paent choice was intended to multe the other hoeptale to improve in order 10 ‘compete, Calbia Univers in New York City atthe time was generally considered o be one ofthe premier ‘nsttutons for cardiac sargey. I wat the efertal een ter for many other hospital in the cy, 8 well a in the state: It was where tbe most complicted patients were se. A sures finding inthe publication of mor tality data was that Columbia had one of the highest mortality rates in the ste, Thi engendered 2 furor of press conferences and letters to the editor intended t0 defend Columbia. When calmer heads prevaled, it ‘became obvious that of course, Columbia would have a high moray rate; they saw the sickest patient, many of wom had been turned down by other isiutions for being too high risk What the publication of the data actually accomplished was creating an inceive for hospital to tan down high-siee patients and only fperte upon the lowest rok patients inorder to ep thelr mortaity rate down. Alhowgh the term bad got yet been used in medicine, what vas mended was some form of rik adjustment to the dat. “The next development grew out ofthe aftermath of the Viemam War which ended in 1975 Returning sol ders often suffered the brunt of the anger of the “American populsee. By the middle of the 1980s, the [US Senate began lange about ow to help the vet rans. Complaints began to surface about the level of care cflered by the Veterans Adminstration (VA) hovpitals The perception was that shoddy surpcal Taree pound aS Sette mae a a a ng ee ‘Sewn afm etme the tes ne ren be sd wwe. + @ sure, care was beng offered, In 1989, the Congres: pase the US public aw 98-166 which, among its many ges da clause dat stated thet the quality of sur peal care a the VA hospitals will be Brought up to national standards within Syears. Nobody would Took tt such @ statement and believe that was not lofty snd admiable goa "The callenge of bringing this change to fation was taken up by « group le by De shukri Khari 2 Professor of Surgery at Harvard well as a PRD. in Epidemilogy. One of the Bret things this group rel- taed was hat there were no national sandards. They didnot know how eo raise the standards at the VA Hospital m an unknown bar. They also realized that they bad no way t0 meaice qualty. Without tis measure how could they determine if care had limprovee? They dlacovered that there was no way t0 compare rospitul, Hoeptals that serve « needy and Lunderserv patient population with Ile to no access to primary care cannot be compared to hospital in tan upperlse saburban neighborhood where all the Patients ae Insure, have good primary care, are well hourished exercise rgulay, ‘ake their medications felgiouly and are overal alte healthy. Finally. they realized tat there was no deflation of a quality surg- fl oatcone. The measurement of moctaly $62 705s Slapliicrion of the sue, A surgery can have 220 ‘mortality but bave a huge mumber of complications, Jong hospital say and unhappy patients, For te su fgeon, a sucessful outcome may be diferent than what the patent views as a successful outcome, ‘By 196, all 138 hospitals ln the VA gystern were entlled‘@ the progr, and Dr. Khu had overall fveright. The program installed the first nied dec tronle madical record which linked all 133 hospitals This was in essence, an Intemet where Dr. Khuri could have acces 10 the medical records of ny VA hospital while siting in his office in Boston Hundreds of variables were collected on each patient, and an ongoing statistical analysis was performed. The {group erentually found 62 preoperative arabes (Gach as patient age weight, and preexisting medial condition) and 30 intraoperative variables (uch as Aluration of operation, blood loss, and patient tem: perature that were the independent variable, affected 41 portoperatve outcome variables (such as death, Infect and other complication) as the dependent variables Stepwise logistic regression was performed to determine the maghitude of impact of each af the Independent variables upon the dependent varlables, land a nuke model was generated, This as the frst secious attempt at sak adjustment. The outcome data were presented ae observed to expected (OIE) ratios. ‘Nurses at each participating hospital were brought to a central location and trained on the definitions of cach variable and on the accurate collection and ‘uploading ofthe data Because ofthis rigorous proces Of sanderdization of definitions and trsning of data atstracters, by the Year 2000, the measurements had become reliable and reproducible over ume, and the measurements had become rlable and reproducible between oss, Hospitals could be reliably and reproducibly. compared within the dskadjused ‘mode. All 133 hospitals in the VA sytem improved signieatiy. Over the entre VA system, there was 2 2% fallin mortality and a 45% fll in the total com: plleston rate (Kharl et al. 1998) ‘The Institute of Medicine report [At sbout the sme time that De. Khus was observing resus In his VA projet, The Institute of Medicine (GoM) of the National Academy of Sciences produced f report in 1999 ened "To Ere ie Human" (Kohn, Corrigan, and Donaldson 2000). I stated tht between “44000 and 99,00 patents die in hospitals each year from preventable errors. twas a ples to Dall a safer health system. The intial reponse was a predictable voviferous denial along with attacks on the method logy tied by the TOM to determine these gues, (Over a short period of time, however, this became ccepled a6 likly true and possbly the tip. of the iceberg. ‘Shorlytherefer, « number of books designed to suldess the [oMs ell for improved safety in medicine ‘were published. One such book was ented Practicing ‘Meine in the 2st Century (Nash eal 2008) twas 1 description of how computers and other technology ould replace mach of physicn's work with algo rithms that would create far fewer ercors and lead to far fower deaths, This book, along with much other erasure, had a profound effect on the US federal goverment which eventually mandated elecironke Iedcal reconds (EMRs) in hospitals and in phys ican’ offces, Technology ceralaly prevents some errors but, unfortunatly, creates others. The final trord as fo whether or not EMRS have made bealth- Cre safer il out, but they cetaialy do pall pro vers avay fom the bedside (Higgins et al. 2017) “Another book publshed net the sime time was ent fled Overeated (Brownlee 2007). The author was a reporter who showed many examples of “why 00 much medicine is making us sicker and poor” It was 4 plea fo simply do less. This didnot x the problem. “Another example of » book in this vein was weiten by a hospital exectve whe left medicine and joined the Disney organization and war ented If Disney ‘ax Your Hosptal (Lee 2004) This fostered a move within hospitals to address the “hotel” functions. It snas felt that if the hospitals lmproved their decor food, linen service, tc, enors would diminish. They id et “There wes then a book writen by an atlorney ent- tied Why Hospitals Should Fly (Nance 2008). 1 described the vast Improvements made in the ailing industry inthe 19708 by going through a series of checklite and eliminasng the calture of deference “This worked tremendously well inthe adine industry, and it was felt a if this could also work in medicine While yng a plane, when the pilot tums the wheel to the sight, the plane goes to the sight. When the pilot pushes the landing gear lever, the wheels go down. The response ls predictable and reproduce (Quality in manufacturing may involve creating just sach 4 consistency of expectations. Patients do not respond that way. Some patints start out quite hralthy and have predictable ovtcomes, but othees Ihave complex preexisting conditions such that the response to an intervention seems random. For ccrample, patents may be malnourished or immune ‘compromised, both of which increae the expected rortalty and complication rates Obesity, diabetes, heart discase, and numerous others of the preopers: tive rik factors alter patent respons to teament [Additonaly, ao two patients have the same genetics ‘A medication that work for one patient may be toxic to another. To complicate testment rests further, ‘many ptients are not compliant withthe tcatment plan, One begins to get the ida that every patient is Ubierent, and we are not smart enough to take all of the billions of combinations of genetics, preoperative Fath, and patent withes into account to predict oxt comes, Some improvements were found by becoming Imore rigorous with checks and empowering anj- body who cares fora patient to speak up with quality conceans, especialy in preventing the “never cvets” Sich as operating on the wrong limb oF the wrong Patient, However, the impact on overall quality was Elnply too small to be the only solution (Treedwel, seas, and Toa 2014) Nsaw ‘The American College of Surgeons (ACS) ie the umbrella organization of surpeal societies in this aur aoneane 5 ‘country, The vast majority of surgeons belong, to the ACS, and iti the source of much of the information ‘we have about overall changes in surgery. In 200, the [ACS bought the rights tothe VA. quality improvement process called the Natonal Surgical Quality Improvement Program (NSQIP), A stries of alpha land then beta hospital sites tested the program and oved that it worked 3s well outside the VA (Hall f@ al 2009), By 2005, Individual hospitals were encouraged to join the program and have designated nurse reviewers trained. This was fait expensive, and the proces wat me-consuming making inital op: tion of thi program relatively slow. But overtime more and more hospitals began to join the program making the database larger and more robust. There fre currenly over 750 hospital enrolled covering the ast majority of all surgery in the country. Ris now fone of jst & few validated databases in medicine Stepwise logistic regression is used to crete risk mod: fs. with results initally presented ax observed to expected ratios and later as odds ratio. This isa valid fan robust metnod of ri adjustment tha allows hos: Dials to be compared and to work toward improve nents Although it isthe best we have is sil fr from perfect. Stepwise logistic regression will under- ‘estimate the interaction of varbles, an important fonsderaton in a system as complex as ¢ human beng (Livingston 2010). All 62 preoperative variables and 20 Inteaopertive variables are considered Inde- pendent in the stepwise logistic regression, but they fre not. The patient vith severe fection (sepsis) is flea likely to have kidney fare, cespictory fllre, fand other associated symptoms or conditions. Many ofthe variables are linked. Livingston also stated that the seprise logistic reresion process will overest mate the significance of sporadic associations that will ‘cca bese ofthe large numberof variables, Tn 2010, NSQIP changed the procedure risk sore (Rael etal 2010) This is @ factor nthe equation that takes into consideration the diferent risks inber- ct in differen surgical operations. In 2013, there wat 4 change (0 hierarchical modeling. with shrinkage tdjustnent for small sample staes (Cohen et al 2013) In 2015, i was sated tht Hf a sgnfcant variable that affects the outcome Is left ot ofthe model there Isa Jarge eet on the performance ofthe mode (Etzioni al 2015), Such a variable might be preoperative fnarctle dependence. ‘There sigaliant lterature stating. that this ads rk and. worsens outcomes (Apfel et al 2012; Lee et al 2014), but it is not Included in the NSQUP vik model In 2016, it was 6 @ street, reported that diferent modes were needed fr emer: gency versus cetve procedures (Hyder et al. 2016), The comparisons between hospitals were fest pee- sened as caterpillar plots and then were changed to being reported by docks, Woodall subsequent stated that «beter way to present data to foow an individ ual physician for Binary outcomes, such asthe pes cence or absence ofa complication, would be through 2 Bernoull-ajasted RA-CUSUM chart in assocition withthe use of the VLAD plot (Woodall, Foge), and Steiner 2015) And it has been suggested that a better vray to compare inshutions ie withthe use ofa fannel lot (Spiegelalter 2005) Cleary, the optimal method to develop risk model and to present dat in surgery 1s a moving target. Quality improvement Soy why is quality improvement so hard? Do not all physicians want to do the right things for their patents? The iajor cesson ie habit. Physicians get Fnto the habit of doing things the came way every time, Surgeons waat t0 do an operation exactly the same way, with exacly the same instruments, with the steps in exactly the sme sequence. Each surgeon all bvotely master the processes Being esed fo a par- tlclar type of opertion. That surgeon wil get reliable and predictable resus. The fact that they may not be the Dost rele is lmmaterial. Ifyou ale che surgeon to change all of «sudden that surgeon isnot the mas ter of what they’ do, A surgeon may have done a par ticular procedure $00 tates with a 2% complication rate. A new procedure may be developed that leads to 21% complication rate, Unfornatly, the fist few times a surgeon docs new procedure their inxper ence with the operation may cause the complication fate to be considerably higher than the expected 1% ‘Would you want your surgeon to do it the ew way forthe way they have done i 00 times? “The nes ese i insttional enoul An institution develops «cure that is passed down in a consistent and predictable fashion. Change in the proceses of patent care is not only changing physician behavior but also itis changing the behavior of everybody that comes in contact with the patient. The dials of ‘eueating multiple physician growps, nurses, nurse's fides, cespirstory therapists, physical therapists, et, fare extraordinary. Hospitals work 24hours a day, 7 days a weck, and 365 days a year. Thee it n0 down: time to provide employees additonal tsning. ‘To change processes frequenly means having. people ome in on off hours or pling people from thee patient cate responsibilities for waiing. That means having addtional people avalaleto replace those not feviag patient care. And this lads tothe third major eason why it is hard to improve quality in medicine ‘money, Hospitals work on rgorthin margins and ny addtional money that bs spent needs to have a return on investment It is hard to document such a return forthe prevention of complications that don’ take place in the future, These three retons deve the mated I7yeur between the time something is documented in the Ierature as the best process for fare fora particalar problem and is adoption within ‘the medical establishment (Brownson ea. 200). Because of all of the above challenges, quality Improvement in medicine is quite hard. However the processes requlted to Implement quality improvement ‘changes are being Incressingy incorporated by hosp- tals across the country, There are muliple methods to work toward quality improvement such as lean, 6 Sigma, DMAIC, and others. In one way of thinking, they are all simular, and the proceas comes down to five principal steps. The Bs 6 defining and collecting data Thre isa quote often atibuted to Drocke that fates “Wf you cannot measure, you cannot improve Ia” Although thin is probably miscuote, 1 belive this is true in medicine. Outcomes are so subjective that if we cannot put a number on improvement fffors ae jart gueawark Another quote, this one sterbuted to Deming sats "In God we trust All thers must being dita” Physicians are not very good ft data. Moet physicians do not know thee own data, fd do not want to know thir awn data: When pre sented with data related to thelr performance, phys ‘ans become very defensive and attack the valid of the data. But with continued sxe and presentation of ‘the data, most physicians eventually Bega to tas data Beng shown, The second step in the process Is the analysis of the data, Without knowing what the data mean, the data are jase arbitrary numbers. A surgeon who Is told thelr surgical site infection rate Is 25% has a ‘umber in iolation. Is that good or bad? Compared {o what? What i the benchmark? Physicians ae actu: ally quite good at analysing the dat. Once presented wth’ data st, and after the Jniual denial phase, Dhysicians understand and interpre the consequences ofthe contexvalied dat quite wel, The third step is making plans for improvement based upon the dats, Physics are moderately good at doing this. They are very good a telling other peo- ple what they need to do to get better, but not Very food looking at themecver inthe miler and Table 1 A pre st of tose inva sual quality i = =. — ome ie rests 1 enay 207 t 31 Deeb 2007. ‘on clon iso tile te 8 ay pnt is ee eo 2 3 ee 3 Aetermining what they personally need to do 10 get better However, with continued presentation of the data this ls becoming esential and accepted within the physician community. “The fourth step in 2 quality improvement process fs implementation of the plans. This is by far the ost difical step, This is where many hospital This takes a fot of time, a lot of phone calls lot of emis, a lot of meetings, and # champion for the ‘quality improvernent process that ls driven and deter ‘ined to make thie happen. This is where cooperation between the varying profesional aswell a6 ancilary staf In the hoeptal is partmount. This obviously Includes physiins and nurses but also inciades phar ‘rains, detdans, and others to numerous to count, «part Ist of which Is presented in Table 1. The final step i obtaining new data It needs to be etermined s€ the quality improvernent project has scwally improved the quali. Has the bar been moved? If i has not, then there i eltber something ‘wrong with the implementation, something wrong conmrananens 7 wth plans, something wrong with the analy, oF fomething wrong wih the dats, The team working on the quality improvement project needs to work back ‘ward and find ut where the problem lis. This needs to be adjusted, and the ve steps followed once again to assure tha the bar indeed gets moved ‘Thee is another quote attributed to Deming which rads “every system is perfectly designed to get the results it gets” This meins that you cannot just wor harder within the system to get better outcomes, The system has tobe changed. The experts at NSQIP have

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