Long-term Use of Wearable Health Technology by Chronic Pain Patients.

OBJECTIVES: People living with chronic pain may use wearable health technology (WHT) in conjunction with an expert-directed pain management program for up to 1 year. WHT use may be associated with improvements in key patient outcomes. METHODS: A 12-month study of WHT use among people with chronic pain was conducted, consisting of iPhone and Apple Watch applications to measure movement, sleep, and self-reported pain. Clinical outcomes among 105 patients enrolled in a multidisciplinary pain program that included WHT use were compared with 146 patients in the same program but without WHT, and to 161 patients receiving medical pain management without WHT. RESULTS: Participants used the WHT on average 143.0 (SD: 117.6) out of 365 days. Mixed-effects models revealed participants who used WHT had decreases in depression scores (-7.83, P <0.01) and prescribed morphine milligram equivalents (-21.55, P =0.04) over 1 year. Control groups also showed decreases in depression scores (-5.08, P =0.01; -5.68, P <0.01) and morphine milligram equivalents (-18.67, P =0.01; -10.99, ns). The estimated slope of change among the WHT was not statistically different than control groups. DISCUSSION: Patients who used WHT as part of their pain management program demonstrated a willingness to do so for extended periods of time despite living with chronic pain and other comorbidities. Data trends suggest that WHT use may positively impact depression and prescribed medication. Additional research is warranted to investigate the potential of WHT to improve the negative consequences of chronic pain.

Opioid Medication Use Among Chronic Non-Cancer Pain Patients Assessed with a Modified Drug Effects Questionnaire and the Association with Opioid Use Disorder.

PURPOSE: Identifying opioid use disorder (OUD) in patients prescribed opioid therapy for chronic pain is challenging but critically important. Patients may have multiple reasons for taking medications, which they may not reveal if not properly interviewed. In this study, modified Drug Effects Questionnaires (DEQ) were used to assess the liking of and desire to take prescription opioids both for reasons of pain relief and for reasons excluding pain relief. We hypothesized patients would more strongly endorse their medications for reasons of pain relief compared to reasons excluding pain relief, and patients who endorse medications for reasons excluding pain relief may be at higher risk of developing OUD. PATIENTS AND METHODS: A cross-sectional telephone survey was administered to 200 adult outpatients currently being prescribed opioids. A two-year retrospective analysis of electronic health records supplemented survey findings. RESULTS: Based on DSM-5 criteria, 9.0% (n = 18) of patients had moderate or severe OUD. The mean (SD) for drug-liking was 54 (33.4) on a 0 to 100 scale. When liking for pain relief was specified, the mean (SD) was significantly higher compared to when excluding pain relief was specified, 70 (27.8) vs 24 (31.2), p<0.001. A similar pattern was observed for patients' ratings of desire to take their medication again, and "feel good effects" of their medications. Higher scores on items that excluded pain relief were associated with other indications of drug misuse. CONCLUSION: The observed rate of OUD in this patient sample was consistent with findings from other recent research. A better understanding of patients' reasons for using opioid medication may help researchers and health care providers identify those at greatest risk for developing OUD.

Understanding factors that contribute to the disposal of unused opioid medication.

PURPOSE: Drivers of excess controlled substance disposal behaviors are not well understood. A survey of patients who had received opioid-based medications was conducted to inform the design of future innovative drug take-back programs. METHODS: This was a cross-sectional survey study conducted in 152 participants who received treatment with an opioid within the previous 2 years and had possession of unused medication following either switching to a different opioid or discontinuation of pain. RESULTS: Approximately one-third of patients had disposed of their unused opioid medication. Education about the importance of and appropriate methods for drug disposal was associated with a significantly increased likelihood of patients disposing of unused medication, and it was observed that patients prescribed an immediate-release/short-acting opioid were twice as likely to keep their medication compared to those prescribed an extended-release/long-acting opioid. The most commonly reported methods for disposal were via drug return kiosks and flushing the medication down the toilet. Some of the most impactful drivers of unused opioid disposal were routine practice of disposing of all unused drugs and instruction from a health care provider, and the most common driver of keeping unused medication was the desire to have it on-hand should there be a need to treat pain in the future. Over 80 % of patients indicated that they would be more likely to use a drug take-back service if they were offered compensation or if the kiosk was in a location that they visited frequently, and approximately half of the patients indicated that they would be willing to request an initial partial fill of an opioid prescription to reduce the volume of unused medication. CONCLUSION: There is a clear need to increase patient awareness about the importance and methods of proper medication disposal, and a great opportunity for health care providers to increase patient education efforts. These study findings also highlight key areas for improvement in drug take-back programs that may promote and incentivize more patients to utilize the services.

Evaluation of US Food and Drug Administration-recommended abuse-potential questions in chronic pain patients without history of recreational opioid use: results and plan for research.

BACKGROUND: Existing patient-reported outcome (PRO) assessments that measure the human abuse potential for opioid analgesics have been tested exclusively in experienced recreational opioid users, as required by US Food and Drug Administration (FDA) guidance. METHODS: The goals of the current studies were to modify items from FDA-recommended abuse potential PRO assessments to specify the analgesic benefits versus the euphoric effects of opioids and to ascertain the clarity, understandability, appropriateness, and validity of the modified questions. This was achieved by conducting cognitive debriefing interviews (CDIs) with patients (≥18 and <65 years) who have chronic pain, were prescribed an opioid daily dose of at least 80 morphine-equivalent milligrams (>30 days to ≤180 days from the date of interview), and did not have a history of recreational opioid use. RESULTS: Participants in study 1 (n=30) and study 2 (n=7) had a better understanding of the items designed to measure the concepts of drug liking and items designed to measure the desire to take a drug again when reasons for liking and desire to take again were included in the item wording (namely, "due to pain relief " and "excluding pain relief "). Most participants indicated no interest in taking their medication for reasons other than pain relief. CONCLUSION: Modification of questions in the PRO assessment improved patient understanding of "drug liking" and "desire to take again." Patients with chronic pain who were not recreational opioid users understood the difference between the analgesic and euphoric effects of an opioid drug. The modified questions should assist future researchers in providing a more accurate assessment of the abuse potential of an opioid, as required by regulatory agencies.

Development and validation of a new instrument to measure perceived risks associated with the use of tobacco and nicotine-containing products.

BACKGROUND: Making tobacco products associated with lower risks available to smokers who would otherwise continue smoking is recognized as an important strategy towards addressing smoking-related harm. Predicting use behavior is an important major component of product risk assessment. In this context, risk perception is a possible factor driving tobacco product uptake and use. As prior to market launch real-world actual product use cannot be observed, assessing risk perception can provide predictive information. Considering the lack of suitable validated self-report instruments, the development of a new instrument was undertaken to quantify perceived risks of tobacco and nicotine-containing products by adult smokers, former smokers and never-smokers. METHODS: Initial items were constructed based on a literature review, focus groups and expert opinion. Data for scale formation and assessment were obtained through two successive US-based web surveys (n = 2020 and 1640 completers, respectively). Psychometric evaluation was based on Rasch Measurement Theory and Classical Test Theory. RESULTS: Psychometric evaluation supported the formation of an 18-item Perceived Health Risk scale and a 7-item Perceived Addiction Risk scale: item response option thresholds were ordered correctly for all items; item locations in each scale were spread out (coverage range 75-87%); scale reliability was supported by high person separation indices > 0.93, Cronbach's alpha > 0.98 and Corrected Item-Total Correlations > 0.88; and no differential item functioning was present. Construct validity evaluations met expectations through inter-scale correlations and findings from known-group comparisons. CONCLUSIONS: The Perceived Risk Instrument is a psychometrically robust instrument applicable for general and personal risk perception measurement, for use in different types of products (including cigarettes, nicotine replacement therapy, potential Modified Risk Tobacco Products), and for different smoking status groups (i.e., current smokers with and without intention to quit, former smokers, never smokers).

Overview of Prescription Opioid Deaths in the Oklahoma State Medicaid Population, 2012-2016.

BACKGROUND: Medicaid members are predisposed to unintentional prescription opioid overdose. However, little is known about their individual risk factors. OBJECTIVES: To describe demographic and clinical characteristics, medical utilization, opioid use, concurrent use of benzodiazepines, risk factors, and substances involved in death for Oklahoma's Medicaid members who died of unintentional prescription opioid poisoning. SUBJECTS: Decedents who were Medicaid eligible in Oklahoma during the year of death, had an opioid recorded in cause of death, and had ≥1 opioid prescription claim between January 1, 2011 and June 30, 2016 were cases. Controls were living Medicaid members and were matched 3:1 to cases through propensity score matching. MEASURES: Demographics, clinical characteristics, and medical/pharmacy utilization were examined in the 12 months before the index date. RESULTS: Of 639 members with fatal unintentional prescription opioid overdoses, 321 had ≥1 opioid prescription claim in the year before death; these were matched to 963 controls. Compared with controls, decedents had significantly greater proportions of nonopioid substance use disorders, opioid abuse/dependence, hepatitis, gastrointestinal bleeding, trauma not involving motor vehicle accidents, nonopioid poisonings, and mental illness disorders. Decedents had significantly higher daily morphine milligram equivalent doses (67.2±74.4 vs. 47.2±50.9 mg) and greater opioid/benzodiazepine overlap (70.4% vs. 35.9%). Benzodiazepines were involved in 29.3% of deaths. CONCLUSIONS: Several comorbidities indicative of opioid use disorder and greater exposure to opioids and concomitant benzodiazepines were associated with unintentional prescription opioid overdose fatalities. Prescribers and state agencies should be aware of these addressable patient-level factors among the Medicaid population. Targeting these factors with appropriate policy interventions and education may prevent future deaths.

Effects of Crit-Line® monitor use on patient outcomes and epoetin alfa dosing following onset of hemodialysis: a propensity score-matched study.

BACKGROUND: The Crit-Line® monitor (CLM) is a device for monitoring hematocrit, oxygen saturation and change in intravascular blood volume during hemodialysis. Prior studies have evaluated CLM use in dialysis patients, but not specifically in those new to dialysis. METHODS: In this retrospective analysis, 199 patients initiating dialysis at 8 facilities routinely using CLM were compared with 796 propensity score-matched non-CLM patients initiating dialysis at facilities not using CLM. Outcomes were considered over the first 180 days on dialysis. RESULTS: Overall, the CLM group had higher StdKt/V (p = 0.06) and received lower doses of intravenous iron than the non-CLM group (p < 0.001). Erythropoiesis-stimulating agent doses were lower in the CLM group in months 1-5. Serum iron and transferrin saturation levels were higher overall for the CLM group than the non-CLM group (p = 0.004 and 0.01, respectively). Hemoglobin levels and time to first hospitalization were similar for both groups. CONCLUSION: Use of CLM is associated with lower erythropoiesis-stimulating agent and iron use in incident hemodialysis patients.

Reasons for phosphate binder discontinuation vary by binder type.

OBJECTIVE: Nonadherence to phosphate binder regimen is common among end-stage renal disease patients and contributes to elevated phosphorus levels. Pill burden, side effects, complex regimens, and cost all contribute to nonadherence. We retrospectively analyzed reasons for discontinuation in hemodialysis patients receiving treatment at a large U.S. dialysis organization to better understand the drivers of nonadherence for particular phosphate binders. DESIGN AND SETTING: Patient electronic medical records were reviewed to identify phosphate binder prescriptions and reasons for discontinuation. Reasons for discontinuation were categorized and the percentage of patients on each type of phosphate binder was calculated within categories. SUBJECTS: Medicare patients of age ≥18 years, receiving in-center hemodialysis treatment between July 1, 2009, and June 30, 2011, were included in the analysis. RESULTS: We classified 30,933 patient records with a stated reason for phosphate binder discontinuation for this study. Of these records, 50.1% cited that the patient discontinued the phosphate binder but contained no additional information; "lab results" were cited for 27.4% of the reasons for discontinuation and "patient-reported side effects" for 10.8%. Although patients on lanthanum carbonate accounted for 14% of the total number reasons for discontinuation assessed, they comprised 40% of the "patient-reported side effects" category and were similarly overrepresented in 4 of the 5 subcategories. CONCLUSIONS: The high percentage of patient-reported side effects resulting in discontinuation identifies an unmet need for improved phosphate binders. A disproportionate percentage of patients prescribed lanthanum carbonate reported side effects, however further work is needed to identify the relative tolerability of phosphate binders and potential explanations.

Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis.

BACKGROUND: Phosphate binders (PBs) account for about one half of the daily pill burden for US hemodialysis (HD) patients, which may reduce adherence. Adherence can be estimated by the medication possession ratio (MPR), which is defined as the proportion of time a patient had sufficient medication to have taken it as prescribed. Gaps of time between prescription fills lower the patient's MPR. We assessed the association of PB pill burden and adherence (MPR) with phosphorus goal attainment. METHODS: Using pharmacy management program data, HD patients on PB monotherapy were tracked from first PB fill during 1 January 2007-30 June 2011 for 1 year, or until PB change or censoring. Data were assessed with generalized linear models. RESULTS: We analyzed 8616 patients. Higher pill burden was associated with lower adherence. Lower adherence tended to be associated with higher mean phosphorus levels and lower percentage of patients with serum phosphorus ≤5.5 mg/dL (P < 0.001). The association between adherence and these clinical outcomes was most pronounced in the lowest and highest pill burden strata (<3, >3-6, >12-15, >15). CONCLUSIONS: Adherence, as measured by the MPR, was negatively related to higher pill burden and phosphorus levels and positively related to patients in the phosphorus target range. Within pill burden strata, phosphorus increased and patients in the target range generally decreased with decreasing adherence, suggesting that patients prescribed fewer PB pills are less likely to have treatment gaps, and may be more likely to achieve phosphorus targets.