De­vice registries can be source of cru­cial data

Modern Healthcare - - COMMENT -

Re­gard­ing “FDA gets push for de­vice registries” (Sept. 8, p. 14), hip and knee im­plant registries in­cor­po­rat­ing re­fined data for com­par­a­tive ef­fec­tive­ness, qual­ity mon­i­tor­ing and pub­lic re­port­ing are clearly nec­es­sary. As im­plant de­signs and ma­te­ri­als ma­ture, and sur­vival times lengthen, pa­tient at­tributes and risk fac­tors are emerg­ing as key fac­tors in pre­dict­ing im­plant sur­vivor­ship and func­tional out­comes. In­for­ma­tion such as risk adjustment at the time of surgery—in­clud­ing pa­tient-re­ported symp­toms—to un­der­stand thresh­olds for re­vi­sion would be most use­ful.

The Func­tion and Out­comes Re­search for Com­par­a­tive Ef­fec­tive­ness in To­tal Joint Re­place­ment (FORCE-TJR) pro­gram has es­tab­lished a novel TJR reg­istry with more than 21,000 pa­tients en­rolled from 136 sur­geons in 22 states, with hun­dreds more pa­tients en­rolled weekly. FORCE-TJR is the first U.S. na­tional co­hort of TJR pa­tients rep­re­sent­ing all re­gions of the U.S., with var­ied prac­tice set­tings (e.g., ur­ban and ru­ral, high and low vol­ume) to col­lect com­pre­hen­sive TJR out­come data. Data are col­lected di­rectly from pa­tients—in­clud­ing pa­tient-re­ported out­comes of pain and func­tion, early post-oper­a­tive ad­verse events and im­plant fail­ures—as­sur­ing more than an 85% re­sponse for valid, lon­gi­tu­di­nal analy­ses.

The CMS ini­ti­ated pub­lic re­port­ing of post-TJR read­mis­sions and com­pli­ca­tions in 2014. To mon­i­tor qual­ity, arthro­plasty sur­geons need timely and riskad­justed data to mon­i­tor out­comes to meet or ex­ceed na­tional goals. Our unique na­tional data­base and riskad­just­ment mod­els al­low FORCE-TJR to pro­vide com­par­a­tive valu­able feed­back to mem­ber sur­geons to guide prac­tice, support qual­ity-im­prove­ment ef­forts and meet reg­u­la­tory re­quire­ments such as the CMS Physi­cian Qual­ity Re­port­ing Sys­tem and value-based pro­pos­als for ac­count­able care. Quar­terly re­ports ad­dress three crit­i­cal ques­tions that pre­vi­ously sur­geons could not an­swer: How do my pa­tient risk fac­tors such as BMI and co­mor­bidi­ties com­pare to other sur­geons? How does the tim­ing of pa­tient surgery as de­scribed by pain and func­tional lim­i­ta­tions com­pare to na­tional prac­tice? And is the de­gree of pain re­lief and im­proved func­tion in my pa­tients com­pa­ra­ble to the na­tional norm? Site­spe­cific com­par­isons of risk fac­tors and out­comes al­low sur­geons to un­der­stand the sim­i­lar­i­ties and dif­fer­ences among their pa­tients and prac­tices.

Dr. David Ay­ers and Dr. Pa­tri­cia Franklin Depart­ment of or­tho­pe­dics and phys­i­cal re­ha­bil­i­ta­tion Univer­sity of Mas­sachusetts Med­i­cal School, Worces­ter

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