Digital Health Information Disparities in Older Adults: a Mixed Methods Study.

Important health information including disease prevention and chronic disease self-management is increasingly packaged for digital use. The purpose of this sequential explanatory mixed methods study was to describe the extent of computer ownership, Internet access, and digital health information use in an ethnically diverse sample of older adults, comparing ownership, access, and use of digital health information (DHI) across ethnic groups and identifying the factors associated with them quantitatively. Significant differences in computer ownership, Internet access, and DHI use were found across ethnic groups (African American, Afro-Caribbean, Hispanic American, and European American). Logistic regression identified older age, less education, lower income, and minority group membership as significant predictors of limited DHI use. Older African Americans were one-fifth as likely to own a computer than were European Americans; Hispanic Americans were one-half as likely to have access to the Internet. We then conducted a series of focus groups which highlighted differences across ethnic groups. Participants in the African American/Afro-Caribbean group expressed frustration with lack of access to DHI but appreciation for alternative sources of information. Hispanic Americans critiqued information received from providers and drug inserts, some suggesting that a positive attitude and trust in God also contributed to getting well. European American participants evaluated various DHI websites, looking to providers for help in applying information to their personal situation. As the development and use of DHI continue, parallel efforts to increase access to DHI among economically disadvantaged and minority older adults are critical to prevent further disfranchisement.

Tools to Promote Shared Decision-Making in Lung Cancer Screening Using Low-Dose CT Scanning: A Systematic Review.

BACKGROUND: Decisions about lung cancer screening are inherently complex and create a need for methods to convey the risks and benefits of screening to patients. RESEARCH QUESTION: What kind of decision aids or tools are available to support shared decision-making for lung cancer screening? What is the current evidence for the effectiveness, acceptability, and feasibility of those tools? STUDY DESIGN AND METHODS: We conducted a systematic review of studies and searched PubMed, MEDLINE, EMBASE, Cochrane Clinical Trials Register, and ClinicalTrials.gov from inception to December 2019 for studies that evaluated the effectiveness and acceptability of tools to promote shared decision-making for patients who are considering lung cancer screening. RESULTS: After screening 2,427 records, we included one randomized control trial, two observational studies, 11 before/after studies of a decision aid or an educational tool. Fifteen distinct tools in various formats were evaluated in 14 studies. Most studies were of fair quality. Studies reported improvement in patients' knowledge of lung cancer screening (n = 9 studies), but improvements in specific areas of knowledge were inconsistent. Decisional conflict was low or reduced after the administration of the tools (n = 7 studies). The acceptability of tools was rated as "high" by patients (n = 7 studies) and physicians (n = 1 study). Low dose CT scan completion rates varied among studies (n = 6 studies). INTERPRETATION: Evidence from 14 studies suggests that some elements of existing tools for lung cancer screening may help to prepare patients for decision-making by improving knowledge and reducing decisional conflict. Such tools generally are acceptable to patients and providers. Further studies that use consistent measures and reporting methods and assess relevant decisional and clinical outcomes are needed to determine the comparative effectiveness and feasibility of implementation of these tools. CLINICAL TRIAL REGISTRATION: PROSPERO 2018 CRD4201874814.

Comparing Telephone Counseling With Reminding to Promote On-Time Repeated Mammography: A Randomized Trial in a Cohort With 4 Years Follow-Up.

Background. Long-term continuous adherence to biennial screening mammograms as guidelines recommend remains low. Limited evidence suggests that reminder calls may increase short-term adherence as much as telephone counseling, but research is needed comparing the long-term effects of these two approaches. Purpose. To compare the impacts of two telephone outreach interventions and mailed reminders on 4-year continuous mammography adherence. Method. A cohort of 3,215 women, age 50 to 81 years, was selected from 30,160 women from a 4-year randomized trial of three interventions to promote biennial mammography: reminder letter only (LO), letter plus reminder call (RC), and two letters plus educational material and a counseling call (CC). Women selected remained eligible for the trial all 4 years and received annual interventions as needed. The proportion with a mammogram in the last 24 months was determined at baseline and four annual time points. Results. Continuous adherence at all four time points was higher in the RC (78.8%) and CC arms (78.8%) than in the LO arm (75.1%; p < .001). Multivariable analysis confirmed this finding: CC (odds ratio = 1.27; 95% confidence interval = [1.01, 1.61]) and RC (odds ratio = 1.23; 95% confidence interval = [0.98, 1.56]). Only 27.8% of women eligible for an initial counseling call actually received counseling. Conclusions. Compared with letters alone, outreach calls can modestly increase continuous mammography adherence among insured women with consistent primary care. Telephone counseling was no more effective than a reminder call, possibly due to limited acceptance of counseling calls by women who may find them unwelcome or unnecessary.

A 4-year randomized trial comparing three outreach interventions to promote screening mammograms.

As population health has become a focus of health care payers and providers, interest has grown in mail, phone, and other forms of outreach for improving population rates of cancer screening. Translational research is needed to compare the effectiveness and cost of low- and high-intensity behavioral outreach interventions for promoting cancer screening. The purpose of the article is to compare the effectiveness in promoting biannual mammograms of three interventions delivered over 4 years to a primary care population with a high baseline mammography adherence of 83.3%. We randomized women aged 40-84 to reminder letter only (LO arm), letter + reminder call (RC arm), and two letters + counseling call (CC arm) involving tailored education and motivational interviewing. Mammography adherence (≥1 mammogram in the previous 24 months) at four time points was determined from insurance claims records. Over 4 years, 30,162 women were randomized. At the end of 4 years, adherence was highest in the RC arm (83.0%) compared with CC (80.8%) and LO (80.8%) arms (p = .03). Only 23.5% of women in the CC arm were reached and accepted full counseling. The incremental cost per additional mammogram for RC arm women was $30.45 over the LO arm cost. A simple reminder call can increase screening mammogram adherence even when baseline adherence is high. Some more complex behavioral interventions delivered by mail and phone as in this study may be less effective, due to limited participation of patients, a focus on ambivalence, lack of follow-up, and other factors.

ICU Admission Source as a Predictor of Mortality for Patients With Sepsis.

PURPOSE: Sepsis is the leading noncardiac cause of intensive care unit (ICU) death. Pre-ICU admission site may be associated with mortality of ICU patients with sepsis. This study quantifies mortality differences among patients with sepsis admitted to an ICU from a hospital ward, emergency department (ED), or an operating room (OR). METHODS: We conducted a retrospective cohort study of 1762 adults with sepsis using ICU record data obtained from a clinical database of an academic medical center. Survival analysis provided crude and adjusted hazard rate ratio (HRR) estimates comparing hospital mortality among patients from hospital wards, EDs, and ORs, adjusted for age, sex, and severity of illness. RESULTS: Mortality of patients with sepsis differed based on the pre-ICU admission site. Compared to patients admitted from an ED, patients admitted from hospital wards had higher mortality (HRR: 1.35; 95% confidence interval [CI]: 1.09-1.68) and those admitted from an OR had lower mortality (HRR: 0.37; 95% CI: 0.23-0.58). CONCLUSION: Patients with sepsis admitted to an ICU from a hospital ward experienced greater mortality than patients with sepsis admitted to an ICU from an ED. These findings indicate that there may be systematic differences in the selection of patient care locations, recognition, and management of patients with sepsis that warrant further investigation.

Persuasive Interventions for Controversial Cancer Screening Recommendations: Testing a Novel Approach to Help Patients Make Evidence-Based Decisions.

PURPOSE: We wanted to evaluate novel decision aids designed to help patients trust and accept the controversial, evidence-based, US Preventive Services Task Force recommendations about prostate cancer screening (from 2012) and mammography screening for women aged 40 to 49 years (from 2009). METHODS: We created recorded vignettes of physician-patient discussions about prostate cancer screening and mammography, accompanied by illustrative slides, based on principles derived from preceding qualitative work and behavioral science literature. We conducted a randomized crossover study with repeated measures with 27 men aged 50 to 74 years and 35 women aged 40 to 49 years. All participants saw a video intervention and a more traditional, paper-based decision aid intervention in random order. At entry and after seeing each intervention, they were surveyed about screening intentions, perceptions of benefits and harm, and decisional conflict. RESULTS: Changes in screening intentions were analyzed without regard to order of intervention after an initial analyses showed no evidence of an order effect. At baseline, 69% of men and 86% of women reported wanting screening, with 31% and 6%, respectively, unsure. Mean change on a 3-point, yes, unsure, no scale was -0.93 (P = <.001) for men and -0.50 (P = <.001) for women after seeing the video interventions vs 0.0 and -0.06 (P = .75) after seeing the print interventions. At the study end, 33% of men and 49% of women wanted screening, and 11% and 20%, respectively, were unsure. CONCLUSIONS: Our novel, persuasive video interventions significantly changed the screening intentions of substantial proportions of viewers. Our approach needs further testing but may provide a model for helping patients to consider and accept evidence-based, counterintuitive recommendations.

Implementation and process evaluation of three interventions to promote screening mammograms delivered for 4 years in a large primary care population.

The optimal form of outreach to promote repeated, on time screening mammograms in primary care has not been established. The purpose of this study is to assess the implementation process and process outcomes for three interventions for promoting biannual screening mammography in a randomized trial. In a large urban primary care practice over a 4-year period, we randomized women aged 40-85 and eligible for mammograms to three interventions: reminder letter only (LO), reminder letter + reminder call (RC), and reminder letter + counseling call (CC). We tracked information system development, staff training, patient and provider recruitment, reach, dose delivered and received, fidelity, and context measures. Ninety-three of 95 providers approved participation by 80% (23,999) of age-eligible patients, of whom only 207 (0.9%) opted not to receive any intervention. Of 9161 initial reminder letters mailed to women coming due or overdue for mammograms, 0.8% were undeliverable. Of women in the RC and CC arms unresponsive to the first reminder letter (n = 3982), 71.4% were called and reached, and of those, 49.1% scheduled a mammogram. Only 33.4% of women reached in the CC arm received full counseling, and women in the CC arm were less likely to schedule a mammogram than those in the RC arm. Implementing mail and telephone mammography reminders is feasible and acceptable in a large urban practice and reaches a majority of patients. Many schedule a mammogram when reached. A reminder letter followed by a simple reminder call if needed may be the optimal approach to promoting screening mammograms.

Does Infection Site Matter? A Systematic Review of Infection Site Mortality in Sepsis.

PURPOSE: Sepsis treatment protocols emphasize source control with empiric antibiotics and fluid resuscitation. Previous reviews have examined the impact of infection site and specific pathogens on mortality from sepsis; however, no recent review has addressed the infection site. This review focuses on the impact of infection site on hospital mortality among patients with sepsis. METHODS: The PubMed database was searched for articles from 2001 to 2014. Studies were eligible if they included (1) one or more statistical models with hospital mortality as the outcome and considered infection site for inclusion in the model and (2) adult patients with sepsis, severe sepsis, or septic shock. Data abstracted included stage of sepsis, infection site, and raw and adjusted effect estimates. Nineteen studies were included. Infection sites most studied included respiratory (n = 19), abdominal (n = 19), genitourinary (n = 18), and skin and soft tissue infections (n = 11). Several studies found a statistically significant lower mortality risk for genitourinary infections on hospital mortality when compared to respiratory infections. CONCLUSION: Based on studies included in this review, the impact of infection site in patients with sepsis on hospital mortality could not be reliably estimated. Misclassification among infections and disease states remains a serious possibility in studies on this topic.

Impact of 2012 USPSTF Screening PSA Guideline Statement: Changes in Primary Care Provider Practice Patterns and Attitudes.

INTRODUCTION: Prostate specific antigen use in prostate cancer screening has undergone significant changes since the 2012 release of the USPSTF (United States Preventive Services Task Force) guideline statement. The effect on specific primary care provider practice patterns and attitudes is not well characterized. We describe the impact of the USPSTF statement on prostate cancer screening practices, attitudes and knowledge among primary care providers. METHODS: A survey composed of 25 questions was mailed electronically to approximately 350 primary care providers within a single academic health care system. Responses were recorded and could not be traced to the respondent. RESULTS: A total of 73 primary care providers (21%) responded to the survey. Of the respondents 75% reported a change in prostate specific antigen screening practices resulting from the USPSTF recommendations and 35% reported a decrease in digital rectal examination use, although the latter test is not explicitly addressed in the guideline statement. A third of respondents believe that prostate specific antigen screening has "likely had no role" in the 2-decade decline in prostate cancer mortality and 70% agree that prostate specific antigen screening may "impart more harm than good" to the patient. Despite these opinions, there was markedly greater concern for medicolegal consequences of a missed diagnosis compared to over diagnosis. CONCLUSIONS: The results of the survey, while limited to a single large academic center, show the impact of the USPSTF 2012 statement on physician attitudes and practice patterns. The results define the need for more educational opportunities for primary care providers regarding the USPSTF statement, American Urological Association guidelines and identification of patients appropriate for prostate specific antigen screening.

Referring patients for telephone counseling to promote colorectal cancer screening.

OBJECTIVE: To determine the feasibility, acceptability, and outcomes of a telephone counseling intervention promoting colorectal cancer (CRC) screening when patients are referred for counseling by primary care providers (PCPs). STUDY DESIGN: Interventional cohort study with no formal control group. METHODS: PCPs in 3 practices were prompted to address CRC screening in patient encounters and, if appropriate, to recommend referral for telephone counseling. A telephone counselor called referred patients, made an appointment for a counseling call, and mailed an educational booklet to patients. Counseling included education about CRC and screening tests, motivational interviewing, barrier counseling, and facilitated referral for colonoscopy or mailing of a fecal occult blood testing kit. About 7 months following counseling, electronic records were searched for evidence of colonoscopy. RESULTS: PCPs addressed CRC screening with 1945 patients, most of whom were up-to-date with CRC testing, recommended counseling referral to 362, and of these 180 (49.7%) accepted the referral. A total of 140 (77.8%) of referred patients were contacted and 67 (37.2%) received counseling. After counseling 93.9% were planning on CRC screening compared with 54.6% at the beginning of the call. Of those planning a colonoscopy, 53.2% received one within 7 months. CONCLUSIONS: Referring patients for telephone counseling to promote CRC screening may be feasible and acceptable to PCPs and to some patients, and may increase CRC screening. Further evaluation of the intervention may be warranted to compare the rate of screening associated with the intervention to rates related to usual care and to other interventions.

Impact of cardiac telemetry on patient safety and cost.

BACKGROUND: With the impetus for healthcare reform and the imperative for healthcare organizations to improve efficiency and reduce waste, it is valuable to examine high-volume procedures and practices in order to identify potential overuse. At the same time, organizations must ensure that improved efficiency does not inadvertently reduce patient safety. METHODS: We undertook a multicenter analysis of the use of adult cardiac telemetry outside of the intensive care unit or step-down units at 4 teaching hospitals to determine the percentage of monitoring days that were not justified by an accepted indication and the monetary costs associated with these nonindicated days. We also assessed the safety of eliminating monitoring on days when it was not justified by looking at the incidence of arrhythmias. RESULTS: We found that in 35% of telemetry days, telemetry use was not supported by an accepted set of clinical indications. The incidence of arrhythmias on nonindicated days was low (3.1 per 100 days of monitoring per nonindicated day),and the arrhythmias detected were clinically insignificant. Eliminating monitoring on nonindicated days could save a minimum of $53 per patient per day. The average 400-bed hospital with a conservative estimate of 5000 nonindicated patientdays per year could save $250,000 per year. CONCLUSION: Reducing the use of telemetry on nonindicated days may provide an opportunity for institutions to safely reduce cost as well as staff time and effort, while maintaining and potentially increasing patient safety.

Design and methods for a randomized clinical trial comparing three outreach efforts to improve screening mammography adherence.

BACKGROUND: Despite the demonstrated need to increase screening mammography utilization and strong evidence that mail and telephone outreach to women can increase screening, most managed care organizations have not adopted comprehensive outreach programs. The uncertainty about optimum strategies and cost effectiveness have retarded widespread acceptance. While 70% of women report getting a mammogram within the prior 2 years, repeat mammography rates are less than 50%. This 5-year study is conducted though a Central Massachusetts healthcare plan and affiliated clinic. All women have adequate health insurance to cover the test. METHODS/DESIGN: This randomized study compares 3 arms: reminder letter alone; reminder letter plus reminder call; reminder letter plus a second reminder and booklet plus a counselor call. All calls provide women with the opportunity to schedule a mammogram in a reasonable time. The invention period will span 4 years and include repeat attempts. The counselor arm is designed to educate, motivate and counsel women in an effort to alleviate PCP burden.All women who have been in the healthcare plan for 24 months and who have a current primary care provider (PCP) and who are aged 51-84 are randomized to 1 of 3 arms. Interventions are limited to women who become ≥ 18 months from a prior mammogram. Women and their physicians may opt out of the intervention study.Measurement of completed mammograms will use plan billing records and clinic electronic records. The primary outcome is the proportion of women continuously enrolled for ≥ 24 months who have had ≥ 1 mammogram in the last 24 months. Secondary outcomes include the number of women who need repeat interventions. The cost effectiveness analysis will measure all costs from the provider perspective. DISCUSSION: So far, 18,509 women aged 51-84 have been enrolled into our tracking database and were randomized into one of three arms. At baseline, 5,223 women were eligible for an intervention. We anticipate that the outcome will provide firm data about the maximal effectiveness as well as the cost effectiveness of the interventions both for increasing the mammography rate and the repeat mammography rate. TRIAL REGISTRATION: http://clinicaltrials.gov/NCT01332032.

Helping men make an informed decision about prostate cancer screening: a pilot study of telephone counseling.

OBJECTIVE: Evaluate a computer-assisted telephone counseling (CATC) decision aid for men considering a prostate specific antigen (PSA) test. METHODS: Eligible men were invited by their primary care providers (PCPs) to participate. Those consenting received an educational booklet followed by CATC. The counselor assessed stage of readiness, reviewed booklet information, corrected knowledge deficits and helped with a values clarification exercise. The materials presented advantages and disadvantages of being screened and did not advocate for testing or for not testing. Outcome measures included changes in stage, decisional conflict, decisional satisfaction, perceived vulnerability and congruence of a PSA testing decision with a pros/cons score. Baseline and final surveys were administered by telephone. RESULTS: There was an increase in PSA knowledge (p<0.001), and in decisional satisfaction (p<0.001), a decrease in decisional conflict (p<0.001), and a general consistency of those decisions with the man's values. Among those initially who had not made a decision, 83.1% made a decision by final survey with decisions equally for or against screening. CONCLUSIONS: The intervention provides realistic, unbiased and effective decision support for men facing a difficult and confusing decision. PRACTICE IMPLICATIONS: Our intervention could potentially replace a discussion of PSA testing with the PCP for most men.

"They don't want anything to do with you": patient views of primary care management of chronic pain.

OBJECTIVE: Chronic pain is one of the most frequent complaints of patients in primary care, yet both patients and providers report low satisfaction with chronic pain care. This study was designed to explore the views held by a diverse sample of patients with chronic pain complaints about their care experiences to identify ways to improve care. DESIGN: Qualitative analysis of 17 patient focus groups (size 3-7 participants). Groups used structured questions and were tape recorded, transcribed, and coded using qualitative software. Eleven groups were conducted in English, six groups in Spanish. PATIENTS: Convenience sample of 72 adult patients (68% female, 44% Latino, mean age=48.1 years) recruited from four diverse primary care practices in Central Massachusetts. RESULTS: Across all 17 groups, and all gender, ethnicity, and age groups, most patients reported suboptimal interactions with their providers when seeking care for chronic pain. Subjects acknowledged feeling disrespected and distrusted, suspected of drug-seeking, and having their symptoms dismissed as trivial and/or not warranting medical care. Patients reported more satisfaction when they felt a provider listened to them, trusted them, was accessible to address pain concerns between visits, and used patient-centered approaches to establish goals and treatment plans. Patients also recommended some management techniques related to the chronic disease management model to improve pain care. CONCLUSIONS: Implementing patient-centered approaches in caring for individuals with chronic pain and using principles drawn from the chronic disease management model to improve care systems may improve both patient and provider satisfaction with chronic pain care.

Design of a handheld electronic pain, treatment and activity diary.

Effective tools for recording and analyzing data on patients' pain experience, use of pain treatments, and physical function are needed to improve communication between providers and patients with noncancer chronic pain. A handheld electronic diary (HED) that can be used throughout the day may provide more useful and accurate information about pain, treatments, and function than available paper and on-line diaries that are designed to be used once daily, weekly or less often. Based on user-specified requirements we designed and built a prototype HED with 7 modules. Diary queries are followed by multiple choice responses customized to the patients' expected responses. Usability testing confirmed user comprehension and acceptability of the queries, response sets, and interface.

Moving mammogram-reluctant women to screening: a pilot study.

BACKGROUND: Effective interventions are needed for women long overdue for screening mammography. PURPOSE: The purpose of this study is to pilot test an intervention for motivating overdue women to receive a mammogram. METHODS: Subjects aged 45-79 without a mammogram in > or =27 months and enrolled in study practices were identified from claims data. The intervention included a mailed, educational booklet, computer-assisted barrier-specific tailored counseling and motivational interviewing, and facilitated, short-interval mammography scheduling. RESULTS: Of 127 eligible women, 45 (35.4%) agreed to counseling and data collection. Most were > or =3 years overdue. Twenty-six (57.8%) of the counseled women got a mammogram within 12 months. Thirty-one (72.1%) of 43 counseled women moved > or =1 stage closer to screening, based on a modified Precaution Adoption Process Model. CONCLUSION: It is feasible to reach and counsel women who are long overdue for a mammogram and to advance their stage of adoption. The intervention should be formally evaluated in a prospective trial comparing it to control or to proven interventions.

Staging mammography nonadherent women: a qualitative study.

BACKGROUND: Few studies have related stages of mammography screening nonadherence with the rationale used by overdue women. METHODS: We used a grounded theory approach to obtain and analyze data from focus groups, telephone interviews, and surveys. Emergent specific themes were compared with emerging decision levels of nonadherence. Each decision level was then compared with the Precaution Adoption Process Model and the Transtheoretical Model. RESULTS: A total of 6 key themes influencing mammogram nonadherence emerged as did 6 decision levels. Variability within themes was associated with specific decision levels. The decision levels were not adequately classified by either stage model. CONCLUSIONS: Stage-based educational strategies may benefit by tailoring interventions to these 6 decision levels.

Using tailored telephone counseling to accelerate the adoption of colorectal cancer screening.

BACKGROUND: Few interventions to increase colorectal cancer screening have used a stage of change model to promote screening adoption. None have used computer-assisted tailored telephone counseling calls. This study's purpose was to implement and evaluate stage-based computer-assisted tailored telephone counseling to promote colorectal cancer screening in a primary care population. METHODS: This randomized controlled trial used a two-stepped intervention that included a mailed booklet on colorectal cancer screening followed by computer-assisted telephone counseling that was based on the Precaution Adoption Process Model. Chart audit was used to document completion of colonoscopy, sigmoidoscopy or fecal occult blood testing. RESULTS: Record audits were completed on 2,474 (88%) of the 2,817 eligible participants. There was no significant difference in the frequency and nature of the screening tests completed in the study arms. In a sub-analysis, stages of adoption were evaluated pre- and post-telephone counseling. Over half those receiving counseling reported a change in stage towards screening adoption. CONCLUSION: Overall, the intervention did not increase colorectal screening compared to control. Two possible reasons for the absence of a screening effect include: (a) the focus of the protocol on education for most patients rather than motivation, and (b) the requirement that patients interested in screening seek further information and a referral on their own from their providers. While those receiving telephone counseling improved their stage of adoption, we cannot rule out selection bias. Stronger physician recommendation to speak with the counselors could improve call acceptance. Future colorectal screening should address these weaknesses.

Primary care provider concerns about management of chronic pain in community clinic populations.

BACKGROUND: Chronic pain is a common patient complaint in primary care, yet providers and patients are often dissatisfied with treatment processes and outcomes. OBJECTIVE: To assess provider satisfaction with their training for and current management of chronic pain in community clinic settings. To identify perceived problems with delivering chronic pain treatment and issues with opioid prescribing for chronic pain. DESIGN: Mailed survey to primary care providers (PCPs) at 8 community clinics. RESULTS: Respondents (N=111) included attendings, residents, and nurse practioners (NPs)/physician assistants (PAs). They reported 37.5% of adult appointments in a typical week involved patients with chronic pain complaints. They attributed problems with pain care and opioid prescribing more often to patient-related factors such as lack of self-management, and potential for abuse of medication than to provider or practice system factors. Nevertheless, respondents reported inadequate training for, and low satisfaction with, delivering chronic pain treatment. CONCLUSIONS: A substantial proportion of adult primary care appointments involve patients with chronic pain complains. Dissatisfaction with training and substantial concerns about patient self-management and about opioid prescribing suggest areas for improving medical education and postgraduate training. Emphasis on patient-centered approaches to chronic pain management, including skills for assessing risk of opioid abuse and addiction, is required.