Walk­ing a fine line

Com­par­a­tive ef­fec­tive­ness panel must han­dle tricky is­sues of value, in­no­va­tion

Modern Healthcare - - Opinions Commentary - Sarah Emond and Va­lerie Fleish­man

While ex­pand­ing ac­cess to health­care has been the ma­jor fo­cus of health­care re­form un­til now, ef­forts to im­prove pa­tient care while con­fronting ris­ing costs are rapidly com­ing to the fore. One ef­fort sure to be closely watched will be an ex­panded pro­gram of com­par­a­tive clin­i­cal ef­fec­tive­ness re­search led by the new, in­de­pen­dent, non­govern­men­tal Pa­tient­Cen­tered Out­comes Re­search In­sti­tute.

The in­sti­tute’s mis­sion is sweep­ing, if daunt­ing: to help pa­tients, providers, pay­ers and pol­i­cy­mak­ers make bet­ter health­care de­ci­sions based on sci­en­tific ev­i­dence, through rig­or­ous com­par­a­tive ef­fec­tive­ness re­search and thor­ough dis­sem­i­na­tion of the find­ings. The in­sti­tute will be gov­erned by a 21-mem­ber board to be ap­pointed by the end of Septem­ber by the U.S. comptroller gen­eral and rep­re­sent­ing var­i­ous sec­tors of the health­care sys­tem: seven physi­cians, four from govern­ment, three con­sumer rep­re­sen­ta­tives, three pri­vate pay­ers, three man­u­fac­tur­ers and one health ser­vices re­searcher.

The di­verse mem­ber­ship of the board should help en­sure that re­search find­ings are dif­fused widely through the health­care sys­tem, but it could also make con­sen­sus more dif­fi­cult to reach. For the in­sti­tute to be truly ef­fec­tive, we con­sider the fol­low­ing to be es­sen­tial:

Mis­sion-driven lead­er­ship. A key com­po­nent of the in­sti­tute’s suc­cess will be cre­at­ing an in­fra­struc­ture for spon­sor­ing, con­duct­ing and dis­sem­i­nat­ing stud­ies in new and in­no­va­tive ways. To do this, the lead­er­ship of the in­sti­tute will need to be com­posed of well-re­spected, in­de­pen­dent ex­perts with ex­pe­ri­ence nav­i­gat­ing mul­ti­stake­holder or­ga­ni­za­tions and build­ing con­sen­sus. The board needs to act quickly to turn its di­ver­sity into strength and to es­tab­lish pro­ce­dures, pro­to­cols and pro­cesses that demon­strate its in­de­pen­dence and trans­parency in de­ci­sion­mak­ing.

Thought­ful dis­sem­i­na­tion. The in­sti­tute will build on ex­ist­ing pro­grams of the Agency for Health­care Re­search and Qual­ity in dis­sem­i­nat­ing com­par­a­tive re­search find­ings, yet suc­cess­ful dis­sem­i­na­tion will re­quire ac­tion that goes well be­yond AHRQ’s ca­pa­bil­i­ties. From the out­set, the in­sti­tute must com­mis­sion re­search that is truly ac­tion­able—re­search that de­ci­sion­mak­ers can quickly and seam­lessly adapt into prac­tice at the point of care.

Re­search method­olo­gies will have a crit­i­cal in­flu­ence not only on whether re­search find­ings are clin­i­cally use­ful, but also on whether pa­tients and clin­i­cians con­sider them valid in the first place. Ad­vanced an­a­lyt­i­cal meth­ods are avail­able to de­rive im­por­tant clin­i­cal find­ings from in­for­ma­tion that would oth­er­wise be deemed in­suf­fi­cient, but the use of these meth­ods must be trans­par­ent, and find­ings must be com­mu­ni­cated in ways that con­vey both clin­i­cal ef­fec­tive­ness and the strength of un­der­ly­ing ev­i­dence.

As we learned from the U.S. Pre­ven­tive Ser­vices Task Force’s mam­mog­ra­phy con­tro­versy last year, rig­or­ous re­search can prove in­ef­fec­tive and even coun­ter­pro­duc­tive if pa­tients do not ac­cept the logic or the va­lid­ity of find­ings. The in­sti­tute needs to em­brace a so­phis­ti­cated use of meth­ods that will pro­duce new ev­i­dence, and it needs to fully in­volve pa­tients and clin­i­cians in com­mu­ni­cat­ing the find­ings.

Pre­serv­ing in­no­va­tion. Most health­care tech­nolo­gies (drugs, de­vices and pro­ce­dures) must meet reg­u­la­tory thresh­olds of ef­fi­cacy (Can it work in ideal clin­i­cal set­tings?) to en­ter the mar­ket. Com­par­a­tive ef­fec­tive­ness re­search will place a new em­pha­sis on demon­stra­tions of ef­fec­tive­ness (Does it work in re­al­world set­tings?).

This shift could have a pro­found ef­fect on in­no­va­tion through­out the health­care sys­tem. Many in­no­va­tions re­quire years of mar­ket use to ac­cu­mu­late enough data to be sub­ject to ro­bust com­par­a­tive ef­fec­tive­ness eval­u­a­tion. With its in­clu­sive mem­ber­ship, the in­sti­tute has an op­por­tu­nity to de­velop guid­ance for the technology com­mu­nity that will es­tab­lish re­li­able stan­dards of ev­i­dence for the demon­stra­tion of ef­fec­tive­ness. Medi­care’s “cov­er­age with ev­i­dence devel­op­ment” pol­icy may pro­vide a rough blue­print for more ex­pan­sive poli­cies that will cre­ate clear rules of the road for tech­nol­o­gists and spur the early devel­op­ment of tech­nolo­gies de­signed to achieve demon­stra­ble ef­fec­tive­ness. The in­sti­tute should ex­plic­itly ad­dress is­sues of in­no­va­tion through­out its emerg­ing pro­gram.

Ad­dress­ing value. Law­mak­ers worded the in­sti­tute’s char­ter so that is­sues of cost and value are han­dled care­fully in the re­search. Specif­i­cally, the leg­is­la­tion pro­hibits the use of cer­tain cost-ef­fec­tive­ness mea­sures, such as qual­ity-ad­justed life years, in de­ter­min­ing if in­ter­ven­tions are cost-ef­fec­tive or rec­om­mended. The leg­is­la­tion also sets pa­ram­e­ters on the govern­ment’s abil­ity to use in­for­ma­tion from the in­sti­tute to make cov­er­age de­ci­sions.

Nev­er­the­less, is­sues of value are im­plicit in a wide range of real-life med­i­cal de­ci­sions, from de­ci­sions on ex­pen­sive life-sav­ing in­ter­ven­tions to de­ci­sions on the daily man­age­ment of chronic dis­ease that af­fect out-of­pocket costs borne by pa­tients. The con­tentious po­lit­i­cal en­vi­ron­ment around com­par­a­tive ef­fec­tive­ness re­search sug­gests that new cost-ef­fec­tive­ness stud­ies are likely to be gen­er­ated out­side of the in­sti­tute.

Yet in the pri­or­i­ties it sets for re­search on clin­i­cal ef­fec­tive­ness, the in­sti­tute has much to add to the knowl­edge base on value in med­i­cal de­ci­sion­mak­ing. Many stake­hold­ers will need to ad­dress is­sues of value in their de­ci­sions; the rel­e­vance and use­ful­ness of the in­sti­tute’s re­search may hinge on its abil­ity to nav­i­gate the is­sue of value.

The Pa­tient-Cen­tered Out­comes Re­search In­sti­tute has a broad and im­por­tant mis­sion to pro­duce, sup­port and dis­sem­i­nate com­par­a­tive ef­fec­tive­ness in­for­ma­tion. For it to be suc­cess­ful, the in­sti­tute must re­main trans­par­ent and in­clu­sive in its ac­tions so that it can en­gage de­ci­sion­mak­ers in the im­por­tant process of im­prov­ing the qual­ity and value of the ser­vices de­liv­ered across the health­care sys­tem.

Sarah Emond, left, is chief op­er­at­ing of­fi­cer of the In­sti­tute for Clin­i­cal and Eco­nomic Re­view, Bos­ton. Va­lerie Fleish­man is ex­ec­u­tive di­rec­tor of the New Eng­land Health­care In­sti­tute, Cam­bridge, Mass.

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