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Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis.

ABSTRACT: Synthesizing evidence from comparative effectiveness trials can be difficult because multiple outcomes of different importance are to be considered. The goal of this study was to demonstrate an approach to conducting quantitative benefit-harm assessment that considers patient preferences.We conducted a benefit-harm assessment using data from the Multicenter Uveitis Steroid Treatment Trial that compared corticosteroid implant versus systemic corticosteroids and immunosuppression in non-infectious intermediate, posterior, and panuveitis. We focused on clinical outcomes considered important to patients, including visual acuity, development of cataracts/glaucoma, need for eye surgery, prescription-requiring hypertension, hyperlipidemia, and infections. Patient preferences elicited in a recent survey were then incorporated into our assessment of the benefit-harm balance.Benefit-harm metrics were calculated for each time point that summarized the numbers of outcomes, caused or prevented by implant therapy versus systemic therapy if 1000 patients were treated. The benefit-harm metric was -129 (95% confidence interval: -242 to -14), -317 (-436 to -196), -390 (-514 to -264), and -526 (-687 to -368) at 6, 12, 18, and 24?months follow up, respectively, suggesting that systemic therapy may have a better benefit-harm balance. However, measures of quality of life for patients treated with implant therapy were found to be better than patients treated with systemic therapy over the same time period.Results of benefit-harm assessment were different from the prospectively collected quality of life data during trial follow up. Future studies should explore the reasons for such discrepancies and the strength and weakness of each method to assess treatment benefits and harms.

SUBMITTER: Yu T

PROVIDER: S-EPMC5535264 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis.

Yu Tsung T Holbrook Janet T JT Thorne Jennifer E JE Puhan Milo A MA

Pharmacoepidemiology and drug safety 20160122 4

<h4>Background</h4>Synthesizing evidence from comparative effectiveness trials can be difficult because multiple outcomes of different importance are to be considered. The goal of this study was to demonstrate an approach to conducting quantitative benefit-harm assessment that considers patient preferences.<h4>Methods</h4>We conducted a benefit-harm assessment using data from the Multicenter Uveitis Steroid Treatment Trial that compared corticosteroid implant versus systemic corticosteroids and ...[more]

PMID: 26798977

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Project description:Objectives/hypothesisTo explore possible factors that might impact a patient's choice to pursue endoscopic sinus surgery (ESS) or continue with medical management for treatment of refractory chronic rhinosinusitis (CRS).Study designCross-sectional evaluation of a multicenter prospective cohort.MethodsTwo hundred forty-two subjects with CRS were prospectively enrolled within four academic tertiary care centers across North America with ongoing symptoms despite prior medical treatment. Subjects either self-selected continued medical management (n = 62) or ESS (n = 180) for treatment of sinonasal symptoms. Differences in demographics, comorbid conditions, and clinical measures of disease severity between subject groups were compared. Validated metrics of social support, personality, risk aversion, and physician-patient relationships were compared using bivariate analyses, predicted probabilities, and receiver operating characteristic curves at the 0.05 alpha level.ResultsNo significant differences were found between treatment groups for any demographic characteristic, clinical cofactor, or measure of social support, personality, or the physician-patient relationship. Subjects electing to pursue sinus surgery did report significantly worse average quality-of-life (QOL) scores on the 22-item Sinonasal Outcome Test (SNOT-22; P < .001) compared to those electing continued medical therapy (54.6 ± 18.9 vs. 39.4 ± 17.7), regardless of surgical history or polyp status. SNOT-22 score significantly predicted treatment selection (odds ratio, 1.046; 95% confidence interval, 1.028-1.065; P < .001) and was found to accurately discriminate between subjects choosing endoscopic sinus surgery and those electing medical management 72% of the time.ConclusionsWorse patient-reported disease severity, as measured by the SNOT-22, was significantly associated with the treatment choice for CRS. Strong consideration should be given for incorporating CRS-specific QOL measures into routine clinical practice.Level of evidence2b.

Project description:BackgroundPoor patient-provider communication, among other reasons, is a notable barrier to contraceptive decision-making among Latinas. Patient-centered approaches to contraceptive counseling that optimize communication align with shared decision-making (SDM) -which is associated with satisfaction and continued contraceptive use among various populations.ObjectiveTo examine associations of patient-provider communication and importance of SDM tenets with consistent contraceptive use among a population of Latinas.Patient involvementFormative work for this study included prior qualitative and quantitative research with Latinas who expressed the importance of patient-provider communication during contraceptive counseling and therefore were instrumental in problem definition.MethodsCross-sectional surveys were administered to Latinas ages 15-29 years. Patient-provider communication, patient-reported importance of specific SDM tenets, and consistent contraception use were measured and analyzed for associations.Results103 Latinas (mean age = 21.4) participated. 33% of participants<21 years were using contraception consistently vs. 67% for those ≥ 21 (p = 0.003). Among participants ≥ 21, consistent users reported higher communication scores compared to inconsistent users and non-users (p = 0.042). For participants< 21, consistent users were more likely than inconsistent users and non-users to report that 2 SDM tenets (discussion of contraceptive preferences and avoidance of race/ethnic-based judgement) are important (p = 0.052, 0.028, respectively).DiscussionPatient-provider communication was especially important for Latinas ≥ 21 while using an SDM approach during counseling was highly valued by those<21. Patient-centered approaches to contraceptive counseling provide opportunities to optimize healthcare delivery for this vulnerable population.Practical valueResults from this research demonstrate that patient-centered communication is highly valued by Latina study participants and is an important consideration in their contraceptive counseling. Clinicians should consider employing techniques such as SDM as they seek to provide patient-centered care during contraceptive counseling for this patient population.

Project description:ImportanceRandomized clinical trials (RCTs) currently apply the same statistical threshold of alpha = 2.5% for controlling for false-positive results or type 1 error, regardless of the burden of disease or patient preferences. Is there an objective and systematic framework for designing RCTs that incorporates these considerations on a case-by-case basis?ObjectiveTo apply Bayesian decision analysis (BDA) to cancer therapeutics to choose an alpha and sample size that minimize the potential harm to current and future patients under both null and alternative hypotheses.Data sourcesWe used the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) database and data from the 10 clinical trials of the Alliance for Clinical Trials in Oncology.Study selectionThe NCI SEER database was used because it is the most comprehensive cancer database in the United States. The Alliance trial data was used owing to the quality and breadth of data, and because of the expertise in these trials of one of us (D.J.S.).Data extraction and synthesisThe NCI SEER and Alliance data have already been thoroughly vetted. Computations were replicated independently by 2 coauthors and reviewed by all coauthors.Main outcomes and measuresOur prior hypothesis was that an alpha of 2.5% would not minimize the overall expected harm to current and future patients for the most deadly cancers, and that a less conservative alpha may be necessary. Our primary study outcomes involve measuring the potential harm to patients under both null and alternative hypotheses using NCI and Alliance data, and then computing BDA-optimal type 1 error rates and sample sizes for oncology RCTs.ResultsWe computed BDA-optimal parameters for the 23 most common cancer sites using NCI data, and for the 10 Alliance clinical trials. For RCTs involving therapies for cancers with short survival times, no existing treatments, and low prevalence, the BDA-optimal type 1 error rates were much higher than the traditional 2.5%. For cancers with longer survival times, existing treatments, and high prevalence, the corresponding BDA-optimal error rates were much lower, in some cases even lower than 2.5%.Conclusions and relevanceBayesian decision analysis is a systematic, objective, transparent, and repeatable process for deciding the outcomes of RCTs that explicitly incorporates burden of disease and patient preferences.

Project description:ImportanceHistorically, opioid pain medications have been overprescribed following thyroid and parathyroid surgery. Many narcotic prescriptions are incompletely consumed, creating waste and opportunities for abuse.ObjectiveTo determine whether limiting opioid prescriptions after outpatient thyroid and parathyroid surgery to patients who opt in to narcotic treatment reduces opioid consumption without increasing postoperative pain compared with usual care (routine narcotic prescriptions).Design, setting, and participantsA randomized clinical trial of Postoperative Opt-In Narcotic Treatment (POINT) or routine narcotic prescription (control) was conducted at a single tertiary referral center from June 1 to December 30, 2020. A total of 180 adults undergoing ambulatory cervical endocrine surgery, excluding patients currently receiving opioids, were assessed for eligibility. POINT patients received perioperative pain management counseling and were prescribed opioids only on patient request. Patients reported pain scores (0-10) and medication use through 7 daily postoperative surveys. Logistic regression was used to determine factors associated with opioid consumption.InterventionsPatients in the POINT group were able to opt in or out of receiving prescriptions for opioid pain medication on discharge. Control patients received routine opioid prescriptions on discharge.Main outcomes and measuresDaily peak pain score through postoperative day 7 was the primary outcome. Noninferiority was defined as a difference less than 2 on an 11-point numeric rating scale from 0 to 10. Analysis was conducted on the evaluable population.ResultsOf the 180 patients assessed for eligibility, the final study cohort comprised 102 patients: 48 randomized to POINT and 54 to control. Of these, 79 patients (77.5%) were women and median age was 52 (interquartile range, 43-62) years. A total of 550 opioid tablets were prescribed to the control group, and 230 tablets were prescribed to the POINT group, in which 23 patients (47.9%) opted in for an opioid prescription. None who opted out subsequently required rescue opioids. In the first postoperative week, 17 POINT patients (35.4% of survey responders in the POINT group) reported consuming opioids compared with 27 (50.0%) control patients (P = .16). Median peak outpatient pain scores were 6 (interquartile range, 4-8) in the control group vs 6 (interquartile range, 5-7) in the POINT group (P = .71). In multivariate analysis, patients with a history of narcotic use were 7.5 times more likely to opt in (95% CI, 1.61-50.11; P = .02) and 4.8 times more likely to consume opioids (95% CI, 1.04-1.52; P = .01). Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption.Conclusions and relevanceIn this trial, an opt-in strategy for postoperative narcotics reduced opioid prescription without increasing pain after cervical endocrine surgery.Trial registrationClinicalTrials.gov Identifier: NCT04710069.

Project description:Study objectivesPerson-centered obstructive sleep apnea (OSA) care is a collaborative approach that is respectful of an individual's health priorities. Informed decision-making is essential to person-centered care, especially as patients age. In a feasibility study, we evaluated the effects of a new decision aid (Decide2Rest) on OSA treatment decision-making in older adults.MethodsPatients (aged ≥ 60 years) with newly diagnosed OSA were recruited from two health care systems and randomized either to Decide2Rest or to a control program. Postintervention outcomes included 1) Decisional Conflict Scale (0-100, where 0 = low and 100 = high conflict), which measures perceptions of uncertainty, whether decisions reflect what matters most to patients, and whether patients feel supported in decision-making; 2) Preparation for Decision-Making scale (0-100, where 0 = least and 100 most prepared); and 3) OSA knowledge (0-100, where 0 = poor and 100 = outstanding). Multivariable linear regression models examined relationships between Decide2Rest and outcomes (Decisional Conflict Scale, Preparation for Decision-Making, OSA knowledge).ResultsSeventy-three patients were randomized to Decide2Rest (n = 36; mean age, 69 years; 72% male) vs control (n = 37; mean age, 69 years; 70% male). Results from the regressions, controlling for study site, indicate that the Decide2Rest program resulted in less decisional conflict (20.5 vs 32.7 on the Decisional Conflict Scale; P = .014), more preparedness for decision-making (87.8 vs 66.2 on the Preparation for Decision-Making scale; P < .001), and greater OSA knowledge (75.1 vs 65.3 OSA knowledge score; P = .04) scores than in the control group.ConclusionsThe Decide2Rest program promotes person-centered OSA decision-making for older patients with newly diagnosed OSA. Future studies are needed to optimize implementation of the program.Clinical trial registrationRegistry: ClinicalTrials.gov, Name: Improving Older Adults' Decision-Making for OSAT (eDecide2Rest); URL: https://clinicaltrials.gov/ct2/show/NCT03138993; Identifier: NCT03138993.

Dataset Information

Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis.

Publications

Using a patient-centered approach to benefit-harm assessment in treatment decision-making: a case study in uveitis.

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