Mental health symptoms and patient-reported diabetes symptom burden: implications for medication regimen changes

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1 Fmily Prctice, 2015, Vol. 32, No. 3, doi: /fmpr/cmv014 Advnce Access publiction 5 April 2015 Helth Service Reserch Mentl helth symptoms nd ptient-reported dibetes symptom burden: implictions for mediction regimen chnges Dr H. Sorkin, *, John Billimek, Kristin J. August b, Quyen Ngo-Metzger, Sherrie H. Kpln, Andrew R. Reikes nd Sheldon Greenfield Division of Generl Internl Medicine nd Primry Cre nd Helth Policy Reserch Institute, University of Cliforni, Irvine, CA, nd b Deprtment of Psychology, Rutgers University, Cmden, NJ, USA. *Correspondence to Dr H. Sorkin, UCI Helth Policy Reserch Institute, 100 Theory, Suite 110, Irvine, CA 92617, USA. E-mil: dsorkin@uci.edu Abstrct Aims. To exmine the reltive contribution of glycemic control (HbA1C) nd depressive symptoms on dibetes-relted symptom burden (hypoglycemi nd hyperglycemi) in order to guide mediction modifiction. Methods. Secondry nlysis of medicl records dt nd questionnires collected from rcilly/ ethniclly diverse smple of dult ptients with type 2 dibetes (n = 710) from seven outptient clinics ffilited with n cdemic medicl centre over 1-yer period s prt of the Reducing Rcil Disprities in Dibetes: Coched Cre (R2D2C2) study. Results. Results from liner regression nlysis reveled tht ptients with high levels of depressive symptoms hd more dibetes-relted symptom burden (both hypoglycemi nd hyperglycemi) thn ptients with low levels of depressive symptoms (βs = , Ps < 0.02). Furthermore, results from two logistic regression nlyses suggested tht the odds of regimen intensifiction t 1-yer follow-up ws mrginlly ssocited with ptient-reported symptoms of hypoglycemi [djusted odds rtio (OR) = 1.24, 95% CI: ; P = 0.08] nd hyperglycemi (OR = 1.21, 95% CI: ; P = 0.05), fter controlling for ptients HbA1C, comorbidity, insulin use nd demogrphics. These ssocitions, however, were diminished for ptients with high self-reported hypoglycemi nd high levels of depressive symptoms, but not low depressive symptoms (interction terms for hypoglycemi by depressive symptoms, OR = 0.98, 95% CI: ; P = 0.03). Conclusions. Mentl helth symptoms re ssocited with higher levels of ptient-reported of dibetes-relted symptoms, but the ssocition between dibetes-relted symptoms nd subsequent regimen modifictions is diminished in ptients with greter depressive symptoms. Clinicins should focus ttention on identifying nd treting ptients mentl helth concerns in order to ddress the role of dibetes-relted symptom burden in guiding physicin mediction prescribing behviour. Key words: Dibetes-relted symptom burden, mentl helth, physicin mediction prescribing behviour, type 2 dibetes. Introduction Comorbid depression hs been observed in over 20% of ptients with dibetes lmost double the prevlence observed in the nondibetic popultion (1). While some cross-sectionl studies tht hve primrily focused on non-hispnic white ptients suggest tht depression is significntly ssocited with incresed self-reported hypoglycemi nd hyperglycemi in type 2 dibetes ptients (2), other studies hve found tht this ssocition ws not significnt The Author Published by Oxford University Press. All rights reserved. For permissions, plese e-mil: journls.permissions@oup.com. 317

2 318 Fmily Prctice, 2015, Vol. 32, No. 3 (3). Furthermore, depression hs been found to be ssocited with non-specific symptom mplifiction in ptients with chronic medicl illness (4), which suggests n incresed potentil for dibetes-relted symptom reporting mong dibetic ptients who re lso depressed. In Asin nd Ltino cultures, in prticulr, mentl helth problems often re mnifested s somtic symptoms (5,6). Thus, rcilly/ethniclly diverse dibetic ptients with depression my hve lower threshold for reporting physicl symptoms, including common dibetes symptoms. Becuse physicins mke tretment decisions bsed, in prt, on ptient symptoms, this tendency mong some depressed ptients to report greter dibetes-relted symptoms my influence the prescribing hbits of providers. Thus there is need for reserch tht exmines the extent to which self-rted outcome, such s dibetes-relted symptom reporting, is ssocited with ptients psychologicl sttus, nd in turn, with physicin prescribing behviour. Given the dverse effect of depression on dibetes-relted symptoms nd ssocited complictions (3,7), treting ptients depressive symptoms my led to more ccurte ssessment of symptom burden, nd therefore, better guidnce for tretment. Although there is support for the effectiveness of treting depressive symptoms in ptients with dibetes (8,9), little is known bout how the somtic mnifesttions of mentl helth issues re ssocited with dibetes-relted symptoms mong rcilly/ethniclly diverse smples of ptients with type 2 dibetes. In this study, we hypothesized tht in ddition to ctul glycemic control, ptients mentl helth symptoms would be ssocited with their reports of dibetes-relted symptom burden (i.e. hypoglycemic nd hyperglycemic symptoms). We lso sought to exmine whether ptient-reported dibetesrelted symptom burden ws ssocited with physicins prescribing behviours bove nd beyond clinicl indictor of glycemic control (i.e. ptients hemoglobin A1C; HbA1C). Ptients nd methods Reserch design Cross-sectionl dt were collected t seven university-ffilited primry cre clinics in Southern Cliforni. Ptients were excluded if they were ge <18 or 80, hd dignosis of schizophreni, or could not spek English, Spnish or Vietnmese. Of the eligible ptients pproched (N = 1971), 75.3% provided written informed consent to complete bseline questionnire nd llowed ccess to their medicl record informtion, lbortory nd dministrtive dt. A subset of ptients with HbA1c >7.5% were followed longitudinlly, nd comprise the nlytic smple for this secondry nlysis (N = 710). Medicl records were bstrcted for the 12-month period leding up to the dte the questionnire ws completed (bseline), nd for the 12-month period following the bseline dte (yer 1). The reserch design nd ll study procedures were pproved by the University of Cliforni, Irvine s Institutionl Review Bord. Mesures Glycemic control Ptients HbA1C levels were mesured by the centrl lbortory t the University of Cliforni Irvine Medicl Center using the D-10 Hemoglobin Testing System (Bio-Rd Lbortories, Hercules, CA), nd were bstrcted from ptients medicl records for the yer prior to the strt of the study through the entire study period. Ptient-reported dibetes-relted symptom burden Symptoms of glucose dysregultion were ssessed in the bseline questionnire by sking ptients how often they experienced dibetes-relted symptoms in the following res: hypoglycemi nd hyperglycemi. Hyperglycemi ws ssessed by sking respondents how often they experienced symptoms of high blood sugr (e.g. thirst or frequent urintion). Rtings were mde on fivepoint scle (1 = never, 5 = every week or more). Hypoglycemi ws ssessed by sking ptients how often they experienced symptoms of low blood sugr episodes (e.g., sweting, wekness, trembling, shkiness, or n insulin rection ). Rtings were mde on fivepoint scle (1 = never, 5 = every week or more). These two items were originlly developed s prt of the Ptient Outcome Reserch Tem (PORT) study, longitudinl observtionl study of ptients with type 2 dibetes (10). Single item rtings of perceived frequency of hypoglycemi nd hyperglycemi, such s the ones used in this study, hve been shown to be ssocited with low helth-relted qulity of life (11) nd incresed mortlity risk (12). Mentl helth symptoms A 10-item version of the Center for Epidemiologicl Studies Depression (CES-D) scle (13) ws used to ssess severity of depressive symptoms. Items tht re typiclly used to ssess somtic symptoms ssocited with depressive symptomtology, nd tht might overlp with dibetes-relted symptom burden, were removed from the scle (e.g. sleep ws restless, ppetite ws poor). This bbrevited version, dpted from the full 20-item CES-D, hs been vlidted ginst other psychitric mesures of depression in ethniclly diverse smples (5), nd exhibited good internl consistency for ech rcil/ethnic group (Cronbch s α rnged between 0.90 nd 0.92). Scores on the bbrevited mesure were rescled to hve the sme rnge of vlues s the full mesure. A cut-off score of 22, which hs been shown to hve good sensitivity nd specificity for screening for mjor depressive disorder mong chroniclly ill ptients (14), ws used to indicte cliniclly relevnt levels of depressive symptoms. Physicin mediction prescribing behviours To determine if providers hd chnged ptients dibetes-relted medictions (e.g. glucose lowering medictions) in the 12 months following the bseline questionnire, prticipnts medicl chrts were exmined using structured chrt bstrction form to record ll medictions noted s either being currently tken by the ptient or prescribed by provider, nd the presence of ny chnges in mediction in ptients medicl records (including in the problem list, chrt notes or in referrls). We coded for eight clsses of medictions prescribed to tret hyperglycemi [i.e. bigunides, sulfonylures, thizolidinediones (TZDs), DPP-4 inhibitors, α-glucosidse inhibitors, meglitinides, GLP-1 gonists nd insulin] (15). A binry summry score ws retined for nlysis for ech person s positive bsed on ny intensifiction of the ptient s dibetes mediction, including n increse in dose, chnge in clss of dibetes-relted mediction, or initition of new dibetes mediction. Covrites Burden from comorbid illness ws mesured using 59-item version of the Totl Illness Burden Index (TIBI) (16), summry mesure of the presence nd severity of the ptient s diseses nd symptoms tht hs been previously modified to reflect different index conditions. TIBI scores rnged from 0 to 16. Other covrites included stndrd demogrphic chrcteristics, such s rce/ethnicity (non-hispnic white, Mexicn Americn, Vietnmese Americn), sex (femle, mle), ge nd eduction (less thn high school eduction, t lest high school eduction). All covrites were ssessed s prt of the bseline questionnire.

3 Mentl helth nd dibetes symptom burden 319 Dt nlysis The dt nlysis ws completed in three phses. First, we compred the demogrphic nd clinicl chrcteristics of the ptients with high versus low depressive symptoms using independent smples t-tests (for continuous vribles) nd χ 2 tests (for ctegoricl vribles). We then conducted two hierrchicl ordinry lest-squres regressions to exmine the independent nd dditive min effects of HbA1C nd depressive symptoms on dibetes-relted symptom burden. Specificlly, the independent min effect of HbA1C ws exmined s predictor of dibetesrelted symptom burden, djusting for ll covrites in step 1 of the model; depressive symptoms ws dded s predictor of dibetes-relted symptom burden in step 2 of the model, djusting for ll covrites in the model. Finlly, the differentil ssocitions between dibetes-relted symptom burden nd subsequent physicin prescribing behviours (the ddition of new dibetes-relted mediction in the following yer) for ptients with vrying levels of depressive symptoms (high versus low scores on the CES-D) were exmined using logistic regression models including depressive symptom by dibetes-relted symptom burden interction term. Models were djusted for stndrd demogrphic chrcteristics, including rce/ethnicity, gender, ge nd eduction. All nlyses were performed using SPSS Sttistics version 21.0 (IBM Corportion, Armonk, NY), nd two-tiled P vlues less thn or equl to 0.05 were considered to be sttisticlly significnt. Role of the funding source The study ws funded by the Ntionl Institute of Dibetes nd Digestive nd Kidney Disese (NIDDK). The funding gency hd no role in the design, conduct or nlysis of the study or in the decision to submit the mnuscript for publiction. Results Tble 1 compres the demogrphic nd helth chrcteristics of the smple for ptients with low versus high depressive symptoms. In generl, there were very few significnt demogrphic or helth sttus differences between these two groups. However, ptients with high depressive symptoms generlly hd greter burden from comorbid illness (3.3 versus 5.6, P < 0.001). Finlly, ptients with higher depressive symptoms reported more frequent hypoglycemi (2.8 versus 1.9, P < 0.001) nd hyperglycemi (3.4 versus 2.7, P < 0.001) compred to ptients with low depressive symptoms. As shown in Tble 2 (left side), results from hierrchicl liner regression nlysis tht djusted for ptients sociodemogrphic chrcteristics reveled tht HbA1C ws inversely ssocited with ptientreported hypoglycemic symptoms (β = 0.11, P = 0.01). Insulin use (β = 0.14, P < 0.001), burden from comorbid illness (β = 0.23, P < 0.001) nd depressive symptoms (β = 0.17, P < 0.001) were positively ssocited with ptient-reported hypoglycemic symptoms. As shown on the right side of Tble 2, insulin use (β = 0.10, P = 0.01), HbA1C (β = 0.11, P = 0.008) burden from comorbid illness (β = 0.29, P < 0.001) nd depressive symptoms (β = 0.09, P = 0.02) were ech positively ssocited with hyperglycemic symptoms. Logistic regression models reveled tht the ssocition between ptient-reported hypoglycemi nd physicin prescribing behviours vried s function of the ptient s level of depressive symptoms (see Tble 3, Model 1). Overll, there ws trend suggesting mrginl ssocition between ptient-reported hypoglycemi nd subsequent regimen intensifiction [djusted odds rtio (OR) = 1.24, 95% CI: ; P =0.08) nd significnt ssocition between depressive symptoms nd regimen intensifiction (OR = 1.03, 95% CI: ; P = 0.01). Further more, there ws significnt interction between ptient-reported hypoglycemi nd depressive symptoms (OR = 0.98, 95% CI: ; P = 0.03), suggesting the ssocition between hypoglycemi nd regimen intensifiction ws diminished with every unit increse in depressive symptoms. A similr pttern ws observed for ptient reported hyperglycemi (Tble 3, Model 2). There ws trend suggesting mrginl ssocition between ptient-reported hyperglycemi nd regimen intensifiction in the next yer (OR = 1.21, 95% CI: ; P = 0.05), nd significnt ssocition between depressive symptoms nd regimen intensifiction (OR = 1.03, 95% CI: ; P = 0.04). The interction between hyperglycemi nd depressive symptoms ws not significnt (OR=0.99, 95% CI: ; P = 0.09). Discussion The findings from this study suggest tht both ptients glycemic control nd mentl helth symptoms hve importnt nd independent ssocitions with dibetes-relted symptom burden. Findings Tble 1. Bseline ptient sociodemogrphic nd helth sttus chrcteristics [percent or count/men (SD), N=710 ] Ptient chrcteristics b,c Low depressive symptoms (n = 325) d High depressive symptoms (n = 385) P vlue Age, yers 58.0 (11.2) 57.7(11.2) 0.69 Rce, % Non-Hispnic white % Hispnic % Vietnmese Gender, % mle Eduction, % more thn high school Burden from comorbid illness, men 3.0 (2.2) 5.6 (3.3) <.001 HbA1C, % 8.0 (1.7) 8.3 (1.6) 0.19 Hypoglycemic symptoms 1.9 (1.2) 2.8 (1.4) <.001 Hyperglycemic symptoms 2.7 (1.6) 3.4 (1.4) <.001 Of the 773 eligible ptients who completed the yer 1 follow-up, 63 ptients were missing dt on HbA1C. Thus, the smple size used for ll nlyses noted in the mnuscript is 710. b Vlues presented s mens with stndrd devitions in prenthesis for continuous vribles nd s percentges for ctegoricl vribles. P vlues for group comprisons were computed using independent smples t-tests for continuous vribles nd χ 2 tests for ctegoricl vribles. c Age, rce/ethnicity, gender, eduction, burden from comorbid illness nd hypoglycemic nd hyperglycemic symptoms were derived from the ptient questionnire. HbA1c ws derived from the bseline medicl record bstrction. d Depressive symptomtology ws derived from the ptient questionnire. A cut-off score of 22 ws used to indicte high depressive symptoms, which hs been used mong chroniclly ill ptients (14) to indicte cliniclly relevnt levels of depressive symptoms.

4 320 Fmily Prctice, 2015, Vol. 32, No. 3 Tble 2. Reltive contribution of mentl helth symptoms to dibetes-relted symptom burden: findings from two hierrchicl liner regressions predicting ptient-reported hypoglycemi (Model 1) nd hyperglycemi (Model 2) Dibetes-relted symptom burden,b Model 1 (N = 625): hypoglycemic symptoms Model 2 (N = 643):hyperglycemic symptoms Step 1: Step 2: Step 1: Step 2: β (t) P vlue β (t) P vlue β (t) P vlue β (t) P vlue Insulin use by ptient c 0.15 (3.78) < (3.56) < (2.68) (2.54) 0.01 Hemoglobin A1C 0.10 ( 2.33) ( 2.46) (2.70) (2.66) Burden from co-morbid illness 0.31 (8.39) < (5.50) < (9.54) < (7.27) <0.001 Depressive symptoms 0.17 (3.94) < (2.22) 0.02 Model fit, djusted R 2 (P vlue) 0.15, P < , P < , P < , P < Two seprte hierrchicl liner regressions were conducted to exmine dibetes-relted symptom burden s ssessed by ptient reports of hypoglycemi nd hyperglycemi. Stndrized β s reported. b Anlyses lso included the following vribles s covrites: rce/ethnicity, gender, ge nd eduction level. c Insulin use ws ssessed from review of medicl records from the bseline yer. Tble 3. Predicting physicin mediction prescribing behviours from dibetes-relted symptom burden for ptients with high versus low depressive symptoms Any intensifiction of dibetes-relted mediction in yer 1 Adjusted odds rtio (95% CI) P vlue Model 1 Hemoglobin A1C 1.24 (1.10, 1.39) <0.001 Ptient-reported 1.24 (0.98, 1.58) 0.08 hypoglycemi Depressive symptoms 1.03 (1.00, 1.05) 0.01 Hypoglycemi depressive 0.98 (0.97, 0.99) 0.03 symptoms Model 2 Hemoglobin A1C 1.23 (1.09, 1.39) <0.001 Ptient-reported 1.21 (1.00, 1.46) 0.05 hyperglycemi Depressive symptoms 1.03 (1.01, 1.05) 0.04 Hyperglycemi depressive symptoms 0.99 (0.98, 1.00) 0.09 Two seprte logistic regressions were conducted to exmine ny intensifiction of dibetes-relted mediction in the yer following the bseline ssessment. b Anlyses included djustment for stndrd demogrphic chrcteristics (including rce/ethnicity, gender, ge nd eduction), insulin use by ptient nd burden from comorbid illness. from this study lso suggest tht physicins decisions to djust ptients medictions my differentilly be ssocited with ptientreported dibetes-relted symptom burden for ptients with lower versus higher levels of depressive symptoms. Specificlly, the findings suggested tht the likelihood of hving physicin intensify the dibetes tretment ws lowest for ptients who experienced both high frequency of hypoglycemic symptoms nd high depressive symptoms. Wht remins unnswered is the extent to which physicins were wre of ptients mentl helth sttus, nd thus whether this difference reflected conscious choice, or whether physicins were cting cutiously for nother reson. In contrst, ptients who experienced high frequency of hyperglycemic symptoms were more likely to hve their mediction intensified, independently of ctul level of glycemic control nd their level of depressive symptoms. Tken together, these findings highlight the importnce of physicins ddressing the connection between dibetes nd comorbid mentl helth to ensure tht ptients reports of dibetes-relted symptoms re interpreted ppropritely. Previous studies hve shown tht, mong ptients with dibetes, comorbid depression contributes to poor metbolic control, decresed qulity of life nd incresed morbidity nd mortlity (7,17 19). Evidence from prospective nd cross-sectionl studies indictes tht depressive symptoms hve been ssocited with fctors relted to glucose dysregultion (20,21), including obesity nd non-dherence to dietry nd mediction tretment recommendtions, which, in turn, increse ptients risk of dibetic complictions (22). This study suggests tht incresed dibetes-relted symptom burden my lso ply n importnt role in this link between depressive symptomotology nd suboptiml dibetes outcomes. For exmple, providers pper to mke different choices bout intensifying ptient s medictions s function of both ptients symptom burden, prticulrly ptient reports of hypoglycemi, s well s ptients mentl helth sttus, t similr HbA1c level. Over time, most people will require progressively intensified phrmcologic therpy to chieve recommended glycemic trgets (23). In the present study, physicins decisions to modify therpy were found to be driven, in prt, by ptients reports of their dibetes-relted symptoms, independent of the level of glycemic control. Addressing depressive symptoms my help physicins better guge the pproprite response to elevted dibetes-relted symptoms with respect to the dibetes mediction regimen. This is of prticulr importnce mong rcil/ethnic minorities, given tht primry cre physicins often re the first point of professionl contct with whom ptients discuss mentl helth concerns (24,25) nd tht somtizing mentl helth symptoms is common (5,6). Limittions Limittions of this study should be noted. First, depressive symptoms were ssessed using the CES-D, which my reflect generl psychologicl distress, rther thn clinicl dignosis of mjor depressive disorder. Given tht ptients who exhibit high levels of depressive symptoms experienced worse dibetes-relted symptoms, efforts to tret these symptoms re importnt nonetheless in order to llevite the dverse effects on dibetes outcomes. Furthermore, it is difficult to determine whether the cuses of somtic symptoms re psychologicl or orgnic. Despite the underlying cuse of these symptoms,

5 Mentl helth nd dibetes symptom burden 321 they contribute significntly to dibetes-relted complictions nd thus require ttention. Second, both hypoglycemi nd hyperglycemi were not objectively verified, nd the self-report ws elicited on single occsion, sking respondents to reflect bck over 6-month time period. Nonetheless, work by McCoy nd collegues hs shown tht self-reported severe hypoglycemi hs been ssocited with 3.4-fold greter risk of 5-yer mortlity compred with mild or no hypoglycemi, highlighting the importnce of considering ptient-reported symptom burden s n unique nd importnt prt of ptients helth informtion (12). Third, specific resons why ptients medictions were chnged re not known. In ddition to responding to chnges in ptients glycemic control, other fctors, such s reported side effects nd cost, influence providers decision to chnge ptients medictions (26). Finlly, findings from this study exmining the ssocitions between depressive symptoms nd ptient-reported symptom burden re cross-sectionl, nd thus preclude our bility to determine the cusl order of these two reltionships under investigtion. For exmple, the cuse-nd-effect reltionship between ntidepressnts nd glucose metbolism is still uncler, with there being some evidence of the hyperglycemic effects of some ntidepressnts (27). Most ntidepressnt medictions, including tricyclic ntidepressnts (TCAs), selective serotonin reuptke inhibitors (SSRIs), serotonin norepinephrine reuptke inhibitors (SNRIs) nd mirtzpine, increse levels of monominergic serotonin nd norepinephrine, nd modify the blnce of the hypothlmuspituitry-drenl (HPA) xis known to be ssocited with depression s well s insulin resistnce (28). Further efforts re needed to disentngle the temporl order of effects of mediction, HbA1C, nd mentl helth symptoms on dibetes-relted symptom burden. Poor glycemic control my dversely ffect mood nd thereby reinforce the reltionship between dibetes nd depression (20,29). Implictions/relevnce for dibetes eductors In summry, the findings from this study suggest tht mong ptients with type 2 dibetes, physicins need to focus on identifying nd treting mentl helth symptoms. Given the interconnection of depression nd dibetes-relted symptoms (3,7), treting ptients depressive symptoms my led to more ccurte ssessment of symptom burden, nd therefore, better guidnce for tretment. Evidence suggests, however, tht the rtes of dignosis nd tretment of depression in primry cre is low, prticulrly mong rcil/ethnic minorities (5). These low rtes my be further compounded by lnguge brriers to effective ptient provider communiction of mentl helth concerns (30). Thus, interventions should be both culturlly nd linguisticlly tilored to improve the discussion of mentl helth issues of ll ptients with dibetes. Addressing these mentl helth concerns cn help guide tretment to mximize ptient outcomes. Declrtion Funding: Robert Wood Johnson Foundtion ( nd 59758); the NovoNordisk Foundtion, nd the Ntionl Institute of Dibetes, Digestive nd Kidney Diseses (R18DK69846 nd K01DK078939). Ethicl pprovl: the reserch design nd ll study procedures were pproved by the University of Cliforni, Irvine s Institutionl Review Bord. All potentil prticipnts were informed bout the purpose of the study nd sked to give written consent prior to survey commencement. Prticipnts received $40 incentive for prticiption. Conflict of interest: none. References 1. Anderson R, Freedlnd K, Clouse R et l. The prevlence of co-morbid depression in dults with dibetes: met-nlysis. Dibetes Cre 2001; 24: Ciechnowski PS, Kton WJ, Russo JE et l. The reltionship of depressive symptoms to symptom reporting, self-cre nd glucose control in dibetes. Gen Hosp Psychitry 2003; 25: Lustmn PJ, Anderson RJ, Freedlnd KE et l. 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