Evaluation of a Pharmacist-Managed Nonsteroidal Anti-Inflammatory Drugs Deprescribing Program in an Integrated Health Care System.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat symptoms of chronic inflammatory diseases such as osteoarthritis and rheumatoid arthritis; however, they are also associated with various adverse effects, including gastrointestinal (GI) bleeding and renal harm. As patients get older, some medications may no longer be beneficial or may even cause harm. Deprescribing is defined as the planned and supervised process of dose reduction or discontinuation of medications. While there are studies showing that deprescribing strategies with several classes of medications positively affects outcomes in elderly patients, there is a lack of strong evidence and guidance to deprescribe NSAIDs. OBJECTIVE: To evaluate the effectiveness, safety, and economic impact of pharmacists deprescribing NSAIDs under the guidance of a standardized deprescribing program compared with usual care within an integrated health care system. METHODS: This retrospective, propensity score-matched cohort study included patients aged ≥ 65 years who were eligible for the NSAID deprescribing program from July 2016 to June 2018. Those patients in the deprescribing group were assessed by pharmacists and had their medications deprescribed. Patients who were eligible for the deprescribing program but did not receive any interventions were matched to the deprescribed group using propensity score matching at a 4:1 ratio and became the usual care group. Patients were followed for 6 months, until end of membership, or until death, whichever occurred first. The effectiveness and safety outcomes included rates of 3 adverse events: GI bleeds, acute kidney injuries (AKI), and exacerbation of pain triggering a hospitalization or emergency room visit. The economic outcome was the change in monthly NSAID cost. Descriptive statistics, t-tests, chi-square tests, and conditional logistic regression models were used for analysis. RESULTS: There were 431 patients in the deprescribed group and 1,724 patients in the usual care group, with similar baseline characteristics after propensity score matching. The adjusted results showed no significant difference between the deprescribed and usual care groups for GI bleed events (OR = 0.65, 95% CI = 0.36-1.16, P = 0.15) and AKI (OR = 0.53, 95% CI = 0.24-1.16, P = 0.11). The deprescribed group experienced a significant 2-fold decrease in the odds of exacerbation of pain versus the deprescribed group (OR = 0.50, 95% CI = 0.33-0.77, P < 0.01). Finally, there was no significant difference in the change in monthly NSAIDs costs between the 2 groups (median change, IQR: -$0.29, -$2.37 to -$0.11 for deprescribed group; -$0.23, -2.59 to 0.00 for usual care group, P = 0.054). CONCLUSIONS: Although this study did not find any difference in the rate of GI bleed or AKI, we found a significant decrease in the rate of exacerbation of pain in the deprescribed group versus the usual care group. This result suggests that deprescribing NSAIDs did not cause harm during the 6-month follow-up. Further long-term studies are necessary to validate these outcomes. DISCLOSURES: No funding was provided to support this research study. The authors of this study have no actual or potential conflicts of interest to report. Parts of this study were presented in a nonreviewed resident poster at the AMCP Managed Care and Specialty Pharmacy Annual Meeting; March 25-28, 2019; San Diego, CA.

Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers?

OBJECTIVES: The objective of this study was to compare perceptions and barriers between Spanish-speaking and English-speaking women in public and private hospitals being treated for pelvic organ prolapse (POP). METHODS: Eight focus groups, 4 in English and 4 in Spanish, were conducted at 3 institutions with care in female pelvic medicine and reconstructive surgery. Standardized questions were asked regarding patients' emotions to when they initially noticed the POP, if they sought family support, and their response to the diagnosis and treatment. Transcripts were analyzed using grounded theory qualitative methods. RESULTS: Thirty-three women were Spanish-speaking and 25 were English-speaking. Spanish speakers were younger (P = 0.0469) and less likely to have a high school diploma (P < 0.0001) than English speakers. Spanish-speaking women had more concerns that the bulge or treatments could lead to cancer, were more resistant to treatment options, and were less likely to be offered surgery. Women in the private hospital desired more information, were less embarrassed, and were more likely to be offered surgery as first-line treatment. The concept emerged that patient care for POP varied based on socioeconomic status and language and suggested the presence of disparities in care for underserved women with POP. CONCLUSIONS: The discrepancies in care for Spanish-speaking women and women being treated at public hospitals suggest that there are disparities in care for POP treatment for underserved women. These differences may be secondary to profit-driven pressures from private hospitals or language barriers, low socioeconomic status, low health literacy, and barriers to health care.

The Quality of Care Provided to Women with Urinary Incontinence in 2 Clinical Settings.

PURPOSE: Our aim was to test the feasibility of a set of quality of care indicators for urinary incontinence and at the same time measure the care provided to women with urinary incontinence in 2 clinical settings. MATERIALS AND METHODS: This was a pilot test of a set of quality of care indicators. A total of 20 quality of care indicators were previously developed using the RAND Appropriateness Method. These quality of care indicators were used to measure care received for 137 women with a urinary incontinence diagnosis in a 120-physician hospital based multispecialty medical group. We also performed an abstraction of 146 patient records from primary care offices in Southern California. These charts were previously used as part of ACOVE (Assessing Care of Vulnerable Elders Project). As a post-hoc secondary analysis, the 2 populations were compared with respect to quality, as measured by compliance with the quality of care indicators. RESULTS: In the ACOVE population, 37.7% of patients with urinary incontinence underwent a pelvic examination vs 97.8% in the multispecialty medical group. Only 15.6% of cases in the multispecialty medical group and 14.2% in ACOVE (p = 0.86) had documentation that pelvic floor exercises were offered. Relatively few women with a body mass index of greater than 25 kg/m(2) were counseled about weight loss in either population (20.9% multispecialty medical group vs 26.1% ACOVE, p = 0.76). For women undergoing sling surgery, documentation of counseling about risks was lacking and only 9.3% of eligible cases (multispecialty medical group only) had documentation of the risks of mesh. CONCLUSIONS: Quality of care indicators are a feasible means to measure the care provided to women with urinary incontinence. Care varied by population studied and yet deficiencies in care were prevalent in both patient populations studied.

Measuring the quality of care provided to women with pelvic organ prolapse.

OBJECTIVE: Health care providers are increasingly being evaluated by the quality of care they provide. Our aim was to assess the feasibility of recently developed quality indicators (QIs) for pelvic organ prolapse (POP) and identify possible deficits in care. STUDY DESIGN: A panel ranked 14 QIs based on the RAND appropriateness method assessing screening and diagnosis, pessary management, and surgery for POP. Retrospective chart abstraction was performed after identifying patients with a diagnosis of POP evaluated within a hospital-based multispecialty group using International Classification of Diseases, ninth edition, diagnosis codes. RESULTS: Of 283 patients identified, 98% of those with a new complaint of vaginal bulge had a pelvic examination. The POP was described but not staged in 6% and not documented at all in 25.1%. Among those managed with pessaries, 98% had vaginal examinations at least every 6 months. Forty-nine percent of the patients who had surgery had complete preoperative POP staging. Only 20% of women undergoing apical surgery had documentation of counseling regarding different surgical options, and of the women who underwent a hysterectomy for POP, only 48% had a concomitant vault suspension. Although 71% had documentation about the risk of postoperative stress incontinence, only 14.5% had documented counseling regarding risks of mesh. Only 37% of patients implanted with mesh for POP had documented follow-up at 1 year. An intraoperative cystoscopy was performed in 86% undergoing cystocele repair or apical surgery. CONCLUSION: The quality of care for women with POP can be feasibly measured with QIs. Processes of care were deficient in many areas, and our findings can serve as a basis for quality improvement interventions.

Readability of common health-related quality-of-life instruments in female pelvic medicine.

OBJECTIVES: The average American adult reads below the eighth-grade level. To determine whether self-reported health-related quality-of-life questionnaires used for pelvic floor disorders are appropriate for American women, we measured reading levels of questionnaires for urinary incontinence (UI), pelvic organ prolapse (POP), and fecal incontinence (FI). METHODS: An online literature search identified questionnaires addressing UI, POP, and FI. Readability was assessed using Flesch-Kincaid reading level and ease formulas. Flesch-Kincaid grade level indicates the average grade one is expected to completely and lucidly comprehend the written text. Flesch-Kincaid reading ease score, from 0 to 100, indicates how easy the written text can be read. RESULTS: Questionnaires were categorized by UI, POP, FI, and combined pelvic floor symptoms. The median Flesch-Kincaid reading level was 7.2, 10.1, 7.6, and 9.7, for UI, POP, FI, and combined pelvic floor symptoms, respectively. Reading levels varied greatly between questionnaires, with only 54% of questionnaires written below the eighth-grade level. CONCLUSIONS: We identified significant variation in reading levels among the questionnaires and found the 2 most commonly used questionnaires per survey in 2008 at Society of Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction were above the recommended eighth-grade reading level. As specialty societies focus on standardizing questionnaires for research, reading levels should be considered so they are generalizable to larger populations of women with pelvic floor disorders.

Communication barriers among Spanish-speaking women with pelvic floor disorders: lost in translation?

OBJECTIVES: The purpose of our study was to evaluate barriers in communication and disease understanding among office staff and interpreters when communicating with Spanish-speaking women with pelvic floor disorders. METHODS: We conducted a qualitative study to evaluate barriers to communication with Spanish-speaking women with pelvic floor disorders among office staff and interpreters. Sixteen office staff and interpreters were interviewed; interview questions focused on experiences with Spanish-speaking patients with pelvic floor disorders in the clinic setting. Interview transcripts were analyzed qualitatively using grounded theory methodology. RESULTS: Analysis of the interview transcripts revealed several barriers in communication as identified by office staff and interpreters. Three major classes were predominant: patient, interpreter, and system-related barriers. Patient-related barriers included a lack of understanding of anatomy and medical terminology and inhibited discussions due to embarrassment. Provider-related barriers included poor interpreter knowledge of pelvic floor vocabulary and the use of office staff without interpreting credentials. System-related barriers included poor access to information. From these preliminary themes, an emergent concept was revealed: it is highly likely that Spanish-speaking women with pelvic floor disorders have poor understanding of their condition owing to multiple obstacles in communication. CONCLUSIONS: There are many levels of barriers to communications with Latin women treated for pelvic floor disorders, arising from the patient, interpreter, and the system itself. These barriers contribute to a low level of understanding of their diagnosis, treatment options, and administered therapies.

Defining and managing overactive bladder: disagreement among the experts.

OBJECTIVE: To better understand experts' perceptions of the definition of overactive bladder (OAB) and the evaluation and treatment of OAB in women. MATERIALS AND METHODS: OAB has been defined by the International Continence Society as "urinary urgency, with or without urge urinary incontinence, usually with frequency and nocturia." Under the current definition, people with very different clinical conditions are included under the OAB umbrella. In the present study, 12 interviews with leading urologic, gynecologic, and geriatric practitioners in urinary incontinence and OAB were performed. Questions were asked about their perception and agreement with the current definition of OAB. The interviews were audiotaped and transcribed verbatim. The grounded theory method was used to analyze the data. RESULTS: Overall, a great amount of variability was found in the definition and management of OAB. Four categories of definitions were derived from the qualitative analysis: the current OAB definition is adequate, OAB is a constellation of symptoms, OAB should include the fear of leakage, and OAB is a marketing term. Although some consensus has been reached on the evaluation, several areas have demonstrated disagreement over elements of the evaluation. Experts also believed that OAB is a chronic condition, with symptom variability, and has no cure. Managing patient expectations is essential, because OAB is challenging to treat. A focus was placed on behavioral therapy. CONCLUSION: The experts disagreed over the definition and workup of OAB. However, the experts agreed that OAB is a chronic condition with a low likelihood of cure.

How dry is "OAB-dry"? Perspectives from patients and physician experts.

PURPOSE: Overactive bladder is subtyped into overactive bladder-wet and overactive bladder-dry, based on the presence or absence, respectively, of urgency incontinence. To better understand patient and physician perspectives on symptoms among women with overactive bladder-wet and overactive bladder-dry, we performed patient focus groups and interviews with experts in urinary incontinence. MATERIALS AND METHODS: Five focus groups totaling 33 patients with overactive bladder symptoms, including 3 groups of overactive bladder-wet and 2 groups of overactive bladder-dry patients, were conducted. Topics addressed patient perceptions of overactive bladder symptoms, treatments and outcomes. A total of 12 expert interviews were then done in which experts were asked to describe their views on overactive bladder-wet and overactive bladder-dry. Focus groups and expert interviews were transcribed verbatim. Qualitative data analysis was performed using grounded theory methodology, as described by Charmaz. RESULTS: During the focus groups sessions, women screened as overactive bladder-dry shared the knowledge that they would probably leak if no toilet were available. This knowledge was based on a history of leakage episodes in the past. Those few patients with no history of leakage had a clinical picture more consistent with painful bladder syndrome than overactive bladder. Physician expert interviews revealed the belief that many patients labeled as overactive bladder-dry may actually be mild overactive bladder-wet. CONCLUSIONS: Qualitative data from focus groups and interviews with experts suggest that a spectrum exists between very mild overactive bladder-wet and severe overactive bladder-wet. Scientific investigations are needed to determine whether urgency without fear of leakage constitutes a unique clinical entity.