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Article: Rethinking the pros and cons of randomized controlled trials and observational studies in the era of big data and advanced methods: a panel discussion.

Fernainy, Pamela / Cohen, Alan A / Murray, Eleanor / Losina, Elena / Lamontagne, Francois / Sourial, Nadia

2024 Volume 18, Issue Suppl 2, Page(s) 1

Abstract: Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA ... ...

Abstract	Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA and Canada came together to debate whether the primacy of RCTs as the gold standard for medical evidence, still holds in light of recent methodological advances in data science and in the era of big data. The purpose of this manuscript, aims to raise awareness of the pros and cons of RCTs and observational studies in order to help guide clinicians, researchers, students, and decision-makers in making informed decisions on the quality of medical evidence to support their work. In particular, new and underappreciated advantages and disadvantages of both designs are contrasted. Innovations taking place in both of these research methodologies, which can blur the lines between the two, are also discussed. Finally, practical guidance for clinicians and future directions in assessing the quality of evidence is offered.
Language	English
Publishing date	2024-01-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2411867-9
ISSN	1753-6561
ISSN	1753-6561
DOI	10.1186/s12919-023-00285-8
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Article ; Online: Psychosocial Risk Stratification in Upper Extremity Transplantation Candidates.

Kinsley, Sarah E / Song, Shuang / Losina, Elena / Talbot, Simon G

Hand (New York, N.Y.)

2023 , Page(s) 15589447231184895

Abstract: Background: Candidate selection for upper extremity transplantation remains an inherently subjective process. This work evaluated the effect that psychosocial factors have on outcomes, both to standardize evaluation of potential candidates and in ... ...

Abstract	Background: Candidate selection for upper extremity transplantation remains an inherently subjective process. This work evaluated the effect that psychosocial factors have on outcomes, both to standardize evaluation of potential candidates and in optimizing these factors prior to transplantation. Our goal was to measure and quantify the risk that various psychosocial factors have on transplant outcomes. Methods: Given that we do not have sufficient post-transplant patients to examine specific factors, we chose to have experts in the field evaluate hypothetical patients based on their experience. We used a Generalized Estimating Equation to estimate and compare surgical candidacy scores using patient scenario vignettes based on the presence or absence of permutations of the following: (1) depression; (2) participation in occupational therapy (OT); (3) expectation of post-transplant function; (4) punctuality; and (5) family support were given to experts in the field. Results: This work suggests there is a decrease in predicted success with increasing numbers of negative factors with participation in OT and realistic expectations of outcomes being most important. An increase in the summarizing risk score from 0 to 1.7 was associated with a decrease in the outcome surgical candidacy score from 8.6 to 5.3, meaning candidates with 2 risk factors would often observe a large drop in surgical candidacy score. Conclusions: Focusing on optimizing psychosocial variables in transplant candidates may help improve hand transplant success.
Language	English
Publishing date	2023-07-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	2277325-3
ISSN	1558-9455 ; 1558-9447
ISSN (online)	1558-9455
ISSN	1558-9447
DOI	10.1177/15589447231184895
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Article ; Online: Trajectories of Structural Disease Progression in Knee Osteoarthritis.

Collins, Jamie E / Neogi, Tuhina / Losina, Elena

Arthritis care & research

2021 Volume 73, Issue 9, Page(s) 1354–1362

Abstract: Objective: Knee osteoarthritis (OA) is a heterogeneous disease, with most patients experiencing slow disease progression and some with rapid deterioration. We aimed to identify groups of patients with symptomatic knee OA experiencing rapid structural ... ...

Abstract	Objective: Knee osteoarthritis (OA) is a heterogeneous disease, with most patients experiencing slow disease progression and some with rapid deterioration. We aimed to identify groups of patients with symptomatic knee OA experiencing rapid structural progression. Methods: We selected participants from the Osteoarthritis Initiative with baseline Kellgren/Lawrence (K/L) grades 1-3 and knee pain, and with joint space width (JSW) on fixed-flexion knee radiographs assessed at baseline and with ≥1 follow-up over 8 years. We used latent class growth analysis to identify subgroups of JSW progression, jointly modeling time to knee replacement (KR) to account for potential informative dropouts. After identifying trajectories, we used logistic regression to assess the association between baseline characteristics and the JSW trajectory group. Results: We used data from 1,578 participants. Baseline radiographic severity was K/L grade 1 in 17%, K/L grade 2 in 50%, and K/L grade 3 in 33%. We identified 3 distinct JSW trajectories: 86% stable, 6% with stable JSW followed by late progression, and 8% with early progression. Incorporating information about KR resulted in 47% of KRs initially classified as stable being reclassified to 1 of the progressing trajectories. Prior knee surgery was associated with being in the late-progressing versus the stable trajectory, while obesity was associated with being in the early-progressing versus stable trajectory. Conclusion: In addition to a subgroup of individuals experiencing early structural progression, 8-year longitudinal data allowed the identification of a late-progressing trajectory. Incorporating information about KR was important to properly identify longitudinal structural trajectories in knee OA.
MeSH term(s)	Aged ; Arthralgia/diagnostic imaging ; Arthralgia/physiopathology ; Arthralgia/surgery ; Arthrography ; Arthroplasty, Replacement, Knee ; Disability Evaluation ; Disease Progression ; Female ; Humans ; Knee Joint/diagnostic imaging ; Knee Joint/physiopathology ; Knee Joint/surgery ; Longitudinal Studies ; Male ; Middle Aged ; Osteoarthritis, Knee/diagnostic imaging ; Osteoarthritis, Knee/physiopathology ; Osteoarthritis, Knee/surgery ; Pain Measurement ; Predictive Value of Tests ; Severity of Illness Index ; Time Factors ; United States
Language	English
Publishing date	2021-07-27
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	645059-3
ISSN	2151-4658 ; 0893-7524 ; 2151-464X
ISSN (online)	2151-4658
ISSN	0893-7524 ; 2151-464X
DOI	10.1002/acr.24340
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Article ; Online: Opioid Use Among Medicare Beneficiaries With Knee Osteoarthritis: Prevalence and Correlates of Chronic Use.

Losina, Elena / Song, Shuang / Bensen, Gordon P / Katz, Jeffrey N

Arthritis care & research

2022 Volume 75, Issue 4, Page(s) 876–884

Abstract: Objective: To determine the prevalence of chronic and occasional opioid use and identify risk factors of opioid use among persons with knee osteoarthritis (OA).: Methods: We used the Medicare Current Beneficiary Survey to select a knee OA cohort. We ... ...

Abstract	Objective: To determine the prevalence of chronic and occasional opioid use and identify risk factors of opioid use among persons with knee osteoarthritis (OA). Methods: We used the Medicare Current Beneficiary Survey to select a knee OA cohort. We obtained data on demographics characteristics, marital status, comorbidities, insurance, and prescription medication coverage from survey data and linked Medicare claims. We included all prescribed medication records classified as opioid under the First Databank therapeutic antiarthritics or analgesics categories. We stratified individuals with knee OA into 3 opioid use groups: 1) nonusers (0 prescriptions/year), 2) occasional users (1-5 prescriptions/year), and 3) chronic users (6+ prescriptions/year). We built multivariable logistic regression models using a generalized estimating equation to determine correlates of chronic opioid use. Results: Among 3,549 Medicare beneficiaries with knee OA and a mean ± SD age of 78 ± 7 years, 68% were female, 9% were chronic users, and 21% used opioids occasionally. Multivariable analysis showed that non-Hispanic ethnicity (odds ratio [OR] 4.8, 95% confidence interval [95% CI] 2.2-10.2), divorced status (vs. married; OR 2.3, 95% CI 1.5-3.5), Medicaid eligibility (OR 1.9, 95% CI 1.3-2.7), depression (OR 1.9, 95% CI 1.5-2.5), chronic obstructive pulmonary disease (OR 1.9, 95% CI 1.4-2.5), and inability to walk without assistive devices (vs. no difficulty walking; OR 2.4, 95% CI 1.5-3.7) were independently associated with chronic opioid use. Conclusion: A total of 9% of persons with knee OA use opioids chronically. Efforts to find nonopioid regimens for treating knee OA pain should be tailored to patients at high risk for chronic use.
MeSH term(s)	Humans ; Female ; Aged ; United States/epidemiology ; Aged, 80 and over ; Male ; Medicare ; Analgesics, Opioid/adverse effects ; Osteoarthritis, Knee/diagnosis ; Osteoarthritis, Knee/drug therapy ; Osteoarthritis, Knee/epidemiology ; Prevalence ; Pain/complications
Chemical Substances	Analgesics, Opioid
Language	English
Publishing date	2022-11-08
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	645059-3
ISSN	2151-4658 ; 0893-7524 ; 2151-464X
ISSN (online)	2151-4658
ISSN	0893-7524 ; 2151-464X
DOI	10.1002/acr.24844
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Article ; Online: Short-term outcomes of prehospital opioid pain management for older adults with fall-related injury.

Jarman, Molly P / Jin, Ginger / Chen, Annie / Losina, Elena / Weissman, Joel S / Berry, Sarah D / Salim, Ali

Journal of the American Geriatrics Society

2024

Abstract: Background: Opioids are recommended for pain management in patients being cared for and transported by emergency medical services, but no specific guidelines exist for older adults with fall-related injury. Prior research suggests prehospital opioid ... ...

Abstract	Background: Opioids are recommended for pain management in patients being cared for and transported by emergency medical services, but no specific guidelines exist for older adults with fall-related injury. Prior research suggests prehospital opioid administration can effectively manage pain in older adults, but less is known about safety in this population. We compared short-term safety outcomes, including delirium, disposition, and length of stay, among older adults with fall-related injury according to whether they received prehospital opioid analgesia. Methods: We linked Medicare claims data with prehospital patient care reports for older adults (≥65) with fall-related injury in Illinois between January 1, 2014 and December 31, 2015. We used weighted regression models (logistic, multinomial logistic, and Poisson) to assess the association between prehospital opioid analgesia and incidence of inpatient delirium, hospital disposition, and length of stay. Results: Of 28,150 included older adults, 3% received prehospital opioids. Patients receiving prehospital opioids (vs. no prehospital opioids) were less likely to be discharged home from the emergency department (adjusted probability = 0.30 [95% CI: 0.25, 0.34] vs. 0.47 [95% CI: 0.46, 0.48]), more likely to be discharged to a non-home setting after an inpatient admission (adjusted probability = 0.43 [95% CI: 0.39, 0.48] vs. 0.30 [95% CI: 0.30, 0.31]), had inpatient length of stay 0.4 days shorter (p < 0.001) and ICU length of stay 0.7 days shorter (p = 0.045). Incidence of delirium did not vary between treatment and control groups. Conclusions: Few older adults receive opioid analgesia in the prehospital setting. Prehospital opioid analgesia may be associated with hospital disposition and length of stay for older adults with fall-related injury. However, our findings do not provide evidence of an association with inpatient delirium. These findings should be considered when developing guidelines for prehospital pain management specific to the older adult population.
Language	English
Publishing date	2024-02-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	80363-7
ISSN	1532-5415 ; 0002-8614
ISSN (online)	1532-5415
ISSN	0002-8614
DOI	10.1111/jgs.18830
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Article ; Online: Responsiveness of Subjective and Objective Measures of Pain and Function Following Operative Interventions for Musculoskeletal Conditions: A Narrative Review.

Waddell, Lily M / Musbahi, Omar / Collins, Jamie E / Jones, Morgan H / Selzer, Faith / Losina, Elena / Katz, Jeffrey N

Arthritis care & research

2024

Abstract: Objective: Musculoskeletal (MSK) disorders affect ~50% of US adults and 75% of those over the age of 65, representing a sizable economic and disability burden. Outcome measures, both objective and subjective, help clinicians and investigators determine ... ...

Abstract	Objective: Musculoskeletal (MSK) disorders affect ~50% of US adults and 75% of those over the age of 65, representing a sizable economic and disability burden. Outcome measures, both objective and subjective, help clinicians and investigators determine whether interventions to treat MSK conditions are effective. This narrative review qualitatively compared the responsiveness of different types of outcome measures, a key measurement characteristic that assesses an outcome measure's ability to detect change in patient status. Methods: We evaluated elective orthopedic interventions as a model for assessing responsiveness because the great majority of patients improves following surgery. We searched for articles reporting responsiveness (quantified as effect size [ES]) of subjective and objective outcome measures after orthopedic surgery and included 16 articles reporting 17 interventions in this review. Results: In 14 of 17 interventions, subjective function measures had an ES 10% greater than that of objective function measures. Two reported a difference in ES of <10%. The sole intervention that demonstrated higher ES of objective function used a composite measure. Sixteen interventions reported measures of subjective pain and/or mixed measures and subjective function. In nine interventions, subjective pain had a higher ES than subjective function by >10%, in three, subjective function had a higher ES than subjective pain by >10%, and in the remaining four, the difference between pain and function was <10%. Conclusion: These findings reinforce the clinical observation that subjective pain generally changes more than function following elective orthopedic surgery. They also suggest that subjective function measures are more responsive than objective function measures, and composite scores may be more responsive than individual performance tests.
Language	English
Publishing date	2024-01-14
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	645059-3
ISSN	2151-4658 ; 0893-7524 ; 2151-464X
ISSN (online)	2151-4658
ISSN	0893-7524 ; 2151-464X
DOI	10.1002/acr.25298
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Article ; Online: Variability in life expectancy among people with HIV in Brazil by gender and sexual orientation.

Luz, Paula M / Spaeth, Hailey / Scott, Justine A / Grinsztejn, Beatriz / Veloso, Valdilea G / Freedberg, Kenneth A / Losina, Elena

The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases

2024 Volume 28, Issue 1, Page(s) 103722

Abstract: Introduction: In Brazil, though Antiretroviral Therapy (ART) is available to all, the benefits may not be experienced uniformly. We projected Life Expectancy (LE) for People Living with HIV (PLHIV) in care as currently observed and estimated the impact ... ...

Abstract	Introduction: In Brazil, though Antiretroviral Therapy (ART) is available to all, the benefits may not be experienced uniformly. We projected Life Expectancy (LE) for People Living with HIV (PLHIV) in care as currently observed and estimated the impact of guideline-concordant care. Methods: Using a microsimulation model, we projected LE for a cohort of PLHIV and for four population groups: cisgender Men who have Sex with Men (MSM), cisgender Men who have Sex with Women (MSW), Cisgender Women (CGW), and Transgender Women (TGW). Cohort data from Evandro Chagas National Institute of Infectious Diseases/Oswaldo Cruz Foundation (INI/Fiocruz) informed model parameters. We modeled five scenarios: 1) Current care: ART initiation, adherence, and retention in care as currently observed, 2) Guideline-concordant care: immediate ART initiation, full adherence to treatment, and consistent retention in care, 3) Immediate ART initiation with observed adherence to treatment and retention in care, 4) Full adherence to treatment with observed timing of ART initiation and retention in care, and 5) Consistent retention in care with observed timing of ART initiation and adherence. Results: With current care, LE from age 15 would be 45.9, 44.4, 54.2, and 42.3 years, for MSM, MSW, CGW, and TGW. With guideline-concordant care, LE would be 54.2, 54.4, 63.1, and 53.2 years, for MSM, MSW, CGW and TGW, with TGW experiencing the greatest potential increase in LE (10.9 years). When investigating the components of care separately, MSW and CGW would gain most LE with immediate ART initiation, whereas for MSM and TGW consistent retention in care would be most impactful. Conclusions: In settings like INI/Fiocruz, MSW and CGW would benefit most from interventions focused on earlier diagnosis and linkage to care, whereas TGW and MSM would benefit from interventions to sustain engagement in care. Assessment of the HIV care continuum for specific populations should inform care priorities.
MeSH term(s)	Humans ; Male ; Female ; Adolescent ; Homosexuality, Male ; Brazil/epidemiology ; Sexual and Gender Minorities ; Transgender Persons ; Sexual Behavior ; HIV Infections/epidemiology
Language	English
Publishing date	2024-02-15
Publishing country	Brazil
Document type	Journal Article
ZDB-ID	2041400-6
ISSN	1678-4391 ; 1413-8670
ISSN (online)	1678-4391
ISSN	1413-8670
DOI	10.1016/j.bjid.2024.103722
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Article ; Online: Association of Reported Nonsteroidal Anti-Inflammatory Drug (NSAID) Adverse Drug Reactions With Opioid Prescribing After Total Joint Arthroplasty.

Li, Lily / Chang, Yuchiao / Losina, Elena / Costenbader, Karen H / Chen, Antonia F / Laidlaw, Tanya M

The journal of allergy and clinical immunology. In practice

2023 Volume 11, Issue 6, Page(s) 1891–1898.e3

Abstract: Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for postoperative pain management, but use may be precluded by the report of adverse drug reactions (ADRs). The effect of NSAID ADR labeling on opioid prescribing after total joint ... ...

Abstract	Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for postoperative pain management, but use may be precluded by the report of adverse drug reactions (ADRs). The effect of NSAID ADR labeling on opioid prescribing after total joint arthroplasty (TJA) is unknown. Objective: To assess the association between NSAID ADRs and postoperative opioid prescribing after TJA, a common surgical procedure. Methods: We performed a retrospective cohort study of adults who underwent total joint (knee or hip) replacement in a single hospital network between April, 1, 2016, and December 31, 2019. Demographic information, clinical and surgical characteristics, and prescription data were obtained from the electronic health record. We studied the association between reported NSAID ADRs and postoperative opioid prescribing in a propensity score-matched sample over 1 year of follow-up. Results: NSAID ADRs were reported by 9.6% of the entire cohort (n = 584/6091). NSAID ADR was associated with 41% higher odds of receipt of opioid prescriptions at 181 to 365 days after hospital discharge (95% confidence interval: 13%-75%) in a propensity score-matched sample. Over 98% of individuals received an opioid prescription at the time of hospital discharge, with no difference in overall median opioid dose prescribed by NSAID ADR status. However, more patients with NSAID ADRs (7.6% vs 4.7%) received cumulative opioid doses ≥ 750 morphine milligram equivalents (MME) at discharge (P = .004). Conclusion: Reported NSAID ADR was associated with increased risk for prolonged receipt of opioids at 181 to 365 days postoperatively. Patients with NSAID ADRs more frequently received cumulative opioid doses ≥ 750 MME at discharge after TJA. Clarification and evaluation of reported NSAID ADRs may be particularly beneficial for surgical patients at high risk for prolonged receipt of opioids.
MeSH term(s)	Adult ; Humans ; Analgesics, Opioid/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Retrospective Studies ; Practice Patterns, Physicians' ; Pain, Postoperative/drug therapy ; Pain, Postoperative/chemically induced ; Arthroplasty/adverse effects ; Drug-Related Side Effects and Adverse Reactions
Chemical Substances	Analgesics, Opioid ; Anti-Inflammatory Agents, Non-Steroidal ; MME (78185-58-7)
Language	English
Publishing date	2023-03-21
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2023.03.017
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Article ; Online: Nonsteroidal anti-inflammatory drug "allergy" labeling is associated with increased postpartum opioid utilization.

Li, Lily / Chang, Yuchiao / Smith, Nicole A / Losina, Elena / Costenbader, Karen H / Laidlaw, Tanya M

The Journal of allergy and clinical immunology

2023 Volume 153, Issue 3, Page(s) 772–779.e4

Abstract: Background: Current guidelines recommend a stepwise approach to postpartum pain management, beginning with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), with opioids added only if needed. Report of a prior NSAID-induced adverse drug ... ...

Abstract	Background: Current guidelines recommend a stepwise approach to postpartum pain management, beginning with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), with opioids added only if needed. Report of a prior NSAID-induced adverse drug reaction (ADR) may preclude use of first-line analgesics, despite evidence that many patients with this allergy label may safely tolerate NSAIDs. Objective: We assessed the association between reported NSAID ADRs and postpartum opioid utilization. Methods: We performed a retrospective cohort study of birthing people who delivered within an integrated health system (January 1, 2017, to December 31, 2020). Study outcomes were postpartum inpatient opioid administrations and opioid prescriptions at discharge. Statistical analysis was performed on a propensity score-matched sample, which was generated with the goal of matching to the covariate distributions from individuals with NSAID ADRs. Results: Of 38,927 eligible participants, there were 883 (2.3%) with an NSAID ADR. Among individuals with reported NSAID ADRs, 49.5% received inpatient opioids in the postpartum period, compared to 34.5% of those with no NSAID ADRs (difference = 15.0%, 95% confidence interval 11.4-18.6%). For patients who received postpartum inpatient opioids, those with NSAID ADRs received a higher total cumulative dose between delivery and hospital discharge (median 30.0 vs 22.5 morphine milligram equivalents [MME] for vaginal deliveries; median 104.4 vs 75.0 MME for cesarean deliveries). The overall proportion of patients receiving an opioid prescription at the time of hospital discharge was higher for patients with NSAID ADRs compared to patients with no NSAID ADRs (39.3% vs 27.2%; difference = 12.1%, 95% confidence interval 8.6-15.6%). Conclusion: Patients with reported NSAID ADRs had higher postpartum inpatient opioid utilization and more frequently received opioid prescriptions at hospital discharge compared to those without NSAID ADRs, regardless of mode of delivery.
MeSH term(s)	Pregnancy ; Female ; Humans ; Analgesics, Opioid/adverse effects ; Retrospective Studies ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Postpartum Period ; Hypersensitivity ; Drug-Related Side Effects and Adverse Reactions ; Endrin/analogs & derivatives
Chemical Substances	Analgesics, Opioid ; MME (78185-58-7) ; Anti-Inflammatory Agents, Non-Steroidal ; Endrin (OB9NVE7YCL)
Language	English
Publishing date	2023-11-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2023.11.025
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Article ; Online: Hydroxychloroquine: Another Battle Lost in the Campaign to Find Effective Therapies for Hand Osteoarthritis.

Losina, Elena / Katz, Jeffrey N

Annals of internal medicine

2018 Volume 168, Issue 6, Page(s) 442–443

MeSH term(s)	Antirheumatic Agents ; Humans ; Hydroxychloroquine ; Osteoarthritis
Chemical Substances	Antirheumatic Agents ; Hydroxychloroquine (4QWG6N8QKH)
Language	English
Publishing date	2018-02-20
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M18-0035
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