Col­lab­o­ra­tive ef­forts

PCORI com­par­a­tive-ef­fec­tive­ness awards add a new twist: pa­tient in­put

Modern Healthcare - - THE WEEK IN HEALTHCARE - Paul Barr

Pa­tients are re­ceiv­ing the care, so it only makes sense to have them help de­sign it. That’s the phi­los­o­phy be­ing adopted by the fed­eral gov­ern­ment with $120 mil­lion in fund­ing for com­par­a­tive-ef­fec­tive­ness re­search that was un­veiled last week.

The gov­ern­ment-sup­ported Pa­tient-cen­tered Out­comes Re­search In­sti­tute out­lined de­tails on how providers, re­searchers and pa­tients can ap­ply for $96 mil­lion of that money and promised up to $24 mil­lion more, while in­clud­ing a re­quire­ment that all of the re­search in­clude the ac­tive par­tic­i­pa­tion of both clin­i­cians and pa­tients, a move that was praised by ex­perts in health ser­vices re­search.

“It’s a new day for re­search,” said Lucy Savitz, di­rec­tor of re­search and ed­u­ca­tion at the In­sti­tute for Health Care De­liv­ery Re­search at In­ter­moun­tain Health­care and di­rec­tor of the com­mu­nity en­gage­ment core at the Univer­sity of Utah’s Cen­ter for Clin­i­cal and Trans­la­tional Sci­ence, both in Salt Lake City. “We’re very, very much in sup­port of this kind of re­search,” and hav­ing the gov­ern- ment back it with so much gusto is a wel­come de­vel­op­ment, Savitz said.

The PCORI, cre­ated as a re­sult of the Pa­tient Pro­tec­tion and Af­ford­able Care Act, grouped the $96 mil­lion in awards into four cat­e­gories, al­lo­cat­ing three-quar­ters of the funds to clini-

“It’s re­quir­ing a com­pletely dif­fer­ent world view to an­swer the kind of re­search they’re call­ing for.” —Jef­frey Lerner, pres­i­dent and CEO of the ECRI In­sti­tute

cal-care stud­ies and health sys­tems re­search. Clin­i­cal com­par­a­tive-ef­fec­tive­ness stud­ies will eval­u­ate pa­tient-care meth­ods that have not been ad­e­quately stud­ied against al­ter­na­tives and will not be limited to med­i­cal or sur­gi­cal ther­apy or ex­clude self-care, ac­cord­ing to the fund­ing an­nounce­ment.

A cat­e­gory for health sys­tems re­search, mean­while, might tackle the ef­fec­tive­ness of such things as med­i­cal homes or ac­count­able care or­ga­ni­za­tions, an emerg­ing area of study. “That is a re­ally ripe area where many more pa­tients are be­gin­ning to get their care,” said Dr. Joseph Selby, ex­ec­u­tive di­rec­tor of the PCORI.

In all, up to 109 con­tracts will be awarded in the four cat­e­gories, which would pro­duce an av­er­age award of about $890,000 if all the con­tracts and money were doled out. An­other round of up to $24 mil­lion in awards ad­dress­ing re­search that could ac­cel­er­ate pa­tient-cen­tered out­comes re­search and method­olog­i­cal re­search is ex­pected to be an­nounced over the sum­mer.

Selby said the ap­pli­ca­tions can be ini­ti­ated by pa­tients, clin­i­cians or re­searchers, but the ap­pli­ca­tion and re­search has to in­clude all of them on a team.

The May 23 an­nounce­ment fol­lowed pre­vi­ous ap­proval of 50 pi­lot project pro­gram awards worth $30 mil­lion over two years for re­search de­signed to help the PCORI build a method­olog­i­cal foun­da­tion for its re­search agenda and pro­gram.

The large size of the awards, the re­quire­ment that pa­tients be in­volved and the open na­ture of the re­search re­quested have caught the at­ten­tion of health­care re­searchers. “This is a real 180 from what health ser­vices re­search usu­ally is,” said Jef­frey Lerner, pres­i­dent and CEO of the ECRI In­sti­tute. “It’s re­quir­ing a com­pletely dif­fer­ent world view to an­swer the kind of re­search they’re call­ing for.”

For a while, some were not sure what kind of re­search op­por­tu­ni­ties would come from the in­sti­tute af­ter it got caught up in the po­lit­i­cal de­bate about so-called death pan­els and ob­jec­tions to com­par­a­tive-ef­fec­tive­ness stud­ies were raised, but the an­nounce­ment ex­tin­guished those fears.

Early in its life, the PCORI was “a lit­tle un­clear about what they wanted to do,” and ap­peared to not want to rock the boat po­lit­i­cally speak­ing, said Dr. Ed­ward Havranek, di­rec­tor of health ser­vices re­search for Den­ver Health. “I think they wanted to go nowhere near that (com­par­a­tive-ef­fec­tive­ness) de­bate.”

But the award an­nounce­ment re­quire­ments show that pol­i­tics were not get­ting in the way of their mis­sion, he said. “I think they take this ‘Pa­tient-cen­tered’ part of their name very se­ri­ously,” Havranek said. They re­ally want to in­clude the “pa­tient’s voice, the pa­tient’s needs, the pa­tient’s wishes. It’s the right thing to do,” he said.

The PCORI’S Selby said noth­ing is off the ta­ble in terms of fund­ing clin­i­cal com­par­a­tive-ef­fec­tive­ness re­search that might face po­lit­i­cal op­po­si­tion pro­vid­ing it meets the ba­sic cri­te­ria set out by the in­sti­tute.

“As long as it’s a clin­i­cal ques­tion and a clin­i­cal out­come, we’re in­ter­ested,” he said.

Pos­ing per­haps a much greater threat is the 26-state law­suit op­pos­ing the Af­ford­able Care Act that is un­der con­sid­er­a­tion by the U.S. Supreme Court. Even a par­tial strike-down of the law could re­move the fund­ing source for this re­search, Lerner said.

Re­searchers such as Savitz and Havranek are ex­pected to ap­ply for the fund­ing in droves. “From what I know and peo­ple I’ve talked to, I think there will be a very strong re­sponse,” Savitz said.

Sim­i­larly, Havranek pre­dicted: “The com­pe­ti­tion is go­ing to be fierce.”

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