Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An im­por­tant tech­nol­o­gy in as­sess­ing lung func­tion, spirom­e­try of­fers cru­cial da­ta for the di­ag­no­sis and mon­i­tor­ing of pul­monary sys­tem dis­eases, as well as the on­go­ing mea­sure­ment of treat­ment ef­fi­ca­cy. But trends in the health­care in­dus­try and new chal­lenges in­tro­duced by the COVID-19 pan­dem­ic are caus­ing pro­fes­sion­als in clin­i­cal prac­tice and re­search to reeval­u­ate spirom­e­try’s de­ploy­ment meth­ods and best prac­tices.

Dig­i­tal health­care tech­nol­o­gy is see­ing height­ened ex­plo­ration as more peo­ple search for safe and ef­fec­tive ways of pro­vid­ing pa­tients care and con­duct­ing suc­cess­ful clin­i­cal tri­als. Dig­i­tal tools such as wear­ables, phys­i­cal ac­tiv­i­ty track­ers – and mo­bile spirom­e­ters – can sup­port re­mote da­ta col­lec­tion, which of­fers new op­por­tu­ni­ties to gath­er da­ta in set­tings that are more re­flec­tive of pa­tients’ dai­ly lives—a unique ben­e­fit that may help im­prove the pa­tient ex­pe­ri­ence in a va­ri­ety of sit­u­a­tions and en­cour­age greater par­tic­i­pa­tion and com­pli­ance in clin­i­cal tri­als.

In-Clin­ic vs. At-Home Spirom­e­try

Mo­bile spirom­e­try, or at-home spirom­e­try, is one of the many test­ing meth­ods across the health­care land­scape that can act as a vi­able al­ter­na­tive to doc­tor’s of­fice pro­ce­dures. Mov­ing spirom­e­try out of the clin­ic holds great po­ten­tial in the res­pi­ra­to­ry dis­ease space, where symp­toms can be im­pact­ed by sea­son­al and en­vi­ron­men­tal changes. It’s fac­tors like pollen count and air pol­lu­tion that war­rant a more de­tailed pic­ture of dis­ease fluc­tu­a­tions over time—some­thing that in-clin­ic spirom­e­try as­sess­ments can’t quite achieve.

But even with the dense da­ta that can be ac­quired through hand­held spirom­e­ters, mo­bile de­vices, and dig­i­tal tools used in oth­er ther­a­peu­tic fields, con­cerns still ex­ist about the qual­i­ty of da­ta that re­searchers and health­care providers re­ceive from pa­tients and the ca­pac­i­ty of pa­tients to com­ply with treat­ment re­quire­ments when pro­fes­sion­als aren’t pro­vid­ing su­per­vi­sion. For mo­bile spirom­e­try, it’s es­sen­tial to ad­dress sev­er­al as­pects of pa­tient-per­formed mea­sure­ment that may in­flu­ence re­mote da­ta col­lec­tion, in­clud­ing whether a pa­tient is sit­ting, stand­ing, or mov­ing when tak­ing the test and what lev­el of ef­fort they will put in­to per­form­ing the test un­su­per­vised.

What Study Re­sults Say

Re­cent stud­ies have shown that da­ta col­lect­ed through mo­bile spirom­e­try is com­pa­ra­ble to that of in-clin­ic spirom­e­try. These stud­ies have ex­am­ined el­e­ments like the re­la­tion­ship be­tween hand­held and clin­ic-based spirom­e­try in asth­ma pa­tients and the va­lid­i­ty of home-based spirom­e­try mea­sure­ments in se­vere to very se­vere chron­ic ob­struc­tive pul­monary dis­ease. One study pub­lished in the jour­nal Clin­i­cal and Trans­la­tion­al Sci­ence mon­i­tor­ing FEV1 in asth­ma pa­tients found high cor­re­la­tion be­tween mo­bile and clin­ic mea­sures, tight lim­its of agree­ment, and ex­cel­lent test-retest re­li­a­bil­i­ty.

The re­sults of these stud­ies re­vealed sig­nif­i­cant ad­van­tages to re­mote da­ta col­lec­tion for pa­tients, in­clud­ing its abil­i­ty to add new lev­els of con­ve­nience and keep pa­tients en­gaged with mo­bile de­vice alerts and re­minders. A well-de­signed mo­bile ap­pli­ca­tion de­ployed along­side a hand­held spirom­e­ter can pro­vide test in­struc­tion, au­dio coach­ing, and im­me­di­ate feed­back, all of which may em­pow­er pa­tients and clin­i­cal study par­tic­i­pants to take an ac­tive, rather than pas­sive, role in their own care. In fact, pa­tient com­pli­ance was at a high 85% for once-a-day da­ta con­tri­bu­tion in the mo­bile spirom­e­try pi­lot study on FEV1 in asth­ma pa­tients.

The dense da­ta ob­tained through this method al­so en­able doc­tors and re­searchers to take in­to con­sid­er­a­tion el­e­ments like hours of the day and sea­sons of the year as they view out­comes. Fre­quent da­ta col­lec­tion makes it pos­si­ble to track dis­ease fluc­tu­a­tion over time to make in­formed de­ci­sions on pa­tient care and avail­able treat­ments.

Go­ing Re­mote Dur­ing COVID-19

Gain­ing more in­sight in­to the uti­liza­tion and ben­e­fits of mo­bile spirom­e­try was a goal of re­searchers be­fore COVID-19 quar­an­tine re­stric­tions and con­tin­ues to be a cru­cial fo­cus area as the pan­dem­ic con­tin­ues. The Amer­i­can Tho­racic So­ci­ety (ATS) urged health­care pro­fes­sion­als to re­duce the risk of in­fec­tion to vul­ner­a­ble pa­tients by min­i­miz­ing clin­ic vis­its, and, along with rep­re­sen­ta­tives from the As­so­ci­a­tion of Pul­monary, Crit­i­cal Care, and Sleep Di­vi­sion Di­rec­tors, has re­cent­ly la­beled home spirom­e­try as “rea­son­able op­tion” for those who re­quire on­go­ing pul­monary func­tion sur­veil­lance and test­ing. They sug­gest that at-home tech­niques be sup­port­ed by video and telemed­i­cine coach­ing and ed­u­ca­tion.

Rec­om­mend­ing this ap­proach can help keep more pa­tients safe, es­pe­cial­ly when a large amount of the pop­u­la­tion re­mains un­vac­ci­nat­ed but ea­ger to re­turn to a state of nor­mal­cy. But it’s im­por­tant to em­pha­size in the re­search com­mu­ni­ty that tri­als uti­liz­ing mo­bile spirom­e­try tools must be de­signed thought­ful­ly with ap­pro­pri­ate end­points and mea­sures that are fit for pur­pose.

Mo­bile spirom­e­ters should have the abil­i­ty to mea­sure full flow vol­ume loops and meet ATS and Eu­ro­pean Tho­racic So­ci­ety (ERS) stan­dards for low air­flow mea­sure­ment, main­tain­ing those stan­dards with­out dai­ly cal­i­bra­tion. De­vices should al­so be able to in­form pa­tients whether they’ve per­formed a test ac­cord­ing to ATS or ERS re­quire­ments.

And be­yond the de­vice it­self, mo­bile da­ta col­lec­tion pro­ce­dures must of­fer tech­ni­cal sup­port that helps pa­tients be as com­pli­ant and suc­cess­ful as pos­si­ble in their ef­forts to cap­ture da­ta through spirom­e­ters and mo­bile apps. Along with easy ways to con­tact tri­al sites, this can look like il­lus­trat­ed in­struc­tion man­u­als and da­ta mon­i­tor­ing to mit­i­gate pos­si­ble is­sues.

De­ploy­ing More Dig­i­tal Clin­i­cal Mea­sures

Mo­bile spirom­e­try has much to of­fer pa­tients and re­searchers, pro­vid­ing them with a cost-ef­fi­cient, con­nect­ed, portable tool and a da­ta col­lec­tion method that re­sults in analy­ses of res­pi­ra­to­ry con­di­tions that are truer to life. As more stud­ies are con­duct­ed and fresh best prac­tices emerge, we can find new ways to pow­er im­proved out­comes by de­ploy­ing dig­i­tal clin­i­cal mea­sures and re­mote mon­i­tor­ing across clin­i­cal re­search, clin­i­cal care, and pub­lic health.

Learn more about mo­bile spirom­e­try in the whitepa­per Be­yond the Clin­ic: Re­mote Spirom­e­try Da­ta Col­lec­tion in Res­pi­ra­to­ry Dis­eases from Konek­sa, a provider of pa­tient-cen­tric dig­i­tal bio­mark­ers and dig­i­tal end­points. Dis­cov­er Konek­sa’s so­lu­tions for clin­i­cal stud­ies in res­pi­ra­to­ry dis­eases and oth­er con­di­tions at konek­sa­