Category: Statistics

Exp Clin Psychopharmacol. 2022 May 23. doi: 10.1037/pha0000566. Online ahead of print.

ABSTRACT

The status of remission in patients with major depressive disorder treated with selective serotonin reuptake inhibitors (SSRIs) is mostly evaluated with clinical rating scales. Morphological correlates of the remission status remain a rare event. Addressing this challenge, we investigated functional correlates of remission by assessment of serotonin and dopamine transporter availability (SERT and DAT) using single-photon emission computed tomography (SPECT). Our purpose was to identify changes in the SERT/DAT binding potential in accordance with the clinical improvement. Nineteen drug-naïve patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of major depression were included. [¹²³I]2β-carbomethoxy-3β-(4-iodophenyl)tropane(β-CIT) SPECT was obtained from each participant before (baseline) and after 6 weeks (follow-up) of standardized treatment with escitalopram. The [¹²³I]β-CIT-SPECT recordings were acquired 4 hr (SERT-weighted) and 20-24 hr p.i (DAT-weighted), and binding potentials (˜BP_ND: baseline, follow-up, and rate of change) were calculated for thalamus, midbrain, pons (SERT), and striatum (DAT). From all study participants, neuropsychiatric symptoms were assessed using Hamilton depression (HAM-D) and Beck Depression Inventory scores. At follow-up, patients were divided into responders and nonresponders (as well as remitters and nonremitters). Compared to nonremitted, remitted patients showed over the course of 6 weeks a significantly higher loss of SERT binding potential in the thalamus (p = .036) and in the midbrain (p = .019). Additionally, the correlation of HAM-D with SERT binding potential in the thalamus showed a trend toward significance (p = .057) with higher HAM-D scores (at baseline) leading to lower SERT binding potential. No significant associations were identified for the analysis of baseline prediction of therapy response with SERT and DAT. Our results suggest that patients who remit from their depressive symptoms under escitalopram are characterized by stronger decreases of SERT, indicating that escitalopram blocking of SERT leads to clinical improvement. Therefore, this study shows that measuring SERT availability with SPECT could be an efficient and applicable technique to illustrate a possible underlying pathophysiology of symptom remission in response to treatment. In addition, the present results could help to stimulate new treatment approaches based on SERT and DAT binding. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:35604719 | DOI:10.1037/pha0000566

Law Hum Behav. 2022 Jun;46(3):214-226. doi: 10.1037/lhb0000486.

ABSTRACT

OBJECTIVE: Cross-cultural research into risk assessment instruments has often identified comparable levels of discrimination. However, cross-cultural fairness is rarely addressed. Therefore, this study explored the discrimination and fairness of the Level of Service/Risk, Need, Responsivity (LS/RNR) within a sample of Aboriginal and Torres Strait Islander and non-Aboriginal and Torres Strait Islander males.

HYPOTHESES: We hypothesized that discrimination would not be significantly different for Aboriginal and Torres Strait Islander individuals and non-Aboriginal and Torres Strait Islander individuals. We further hypothesized that some fairness definitions would be unsatisfied.

METHOD: The study included 380 males (Aboriginal and Torres Strait Islander, n = 180) from Australia. Discrimination was assessed with the area under the curve (AUC) and cross AUC (xAUC). To determine fairness, error rate balance, calibration, predictive parity, and statistical parity were used.

RESULTS: The discrimination of the LS/RNR was not statistically different (p = .61) between groups. The xAUC identified disparities (p < .001), with the LS/RNR being unable to discriminate between Aboriginal and Torres Strait Islander nonreoffenders and non-Aboriginal and Torres Strait Islander reoffenders (xAUC = .46, 95% CI [.35, .57]). Disparities among certain fairness definitions were identified, with Aboriginal and Torres Strait Islander individuals scoring higher on the LS/RNR (d = 0.52) and nonreoffenders being classified as high risk more often.

CONCLUSIONS: The findings suggest that the LS/RNR may not be a cross-culturally fair risk assessment instrument for Australian individuals, and standard discrimination indices with comparable levels do not imply that a risk assessment instrument is cross-culturally fair. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:35604707 | DOI:10.1037/lhb0000486

Law Hum Behav. 2022 Jun;46(3):201-213. doi: 10.1037/lhb0000484.

ABSTRACT

OBJECTIVES: The present research examined homelessness, race/ethnicity, and pretrial detention in the plea bargaining process.

HYPOTHESES: We predicted that homelessness, Hispanic ethnicity, and pretrial detention would be positively associated with unfavorable plea bargaining outcomes.

METHOD: We coded defendant characteristics and plea bargaining variables for a random sample (N = 500) of criminal cases from 2016 in Santa Cruz County, California. We analyzed the associations between these variables using binary logistic and ordinal regressions.

RESULTS: Homeless defendants were much more likely to be held in pretrial detention (odds ratio [OR] = 5.05), less likely to post bail (OR = 0.17), more likely to accept a “credit for time served” plea offer (OR = 2.26), more likely to have cases dismissed as part of a plea bargain (OR = 5.63), and more likely to receive a longer custodial sentence (OR = 2.60) than housed defendants. Defendants who did not post bail received longer custodial sentences than those who did (OR = 3.40), and pretrial detention mediated the relationship between homelessness and longer custodial sentences. White-versus-Hispanic comparisons were not statistically significant.

CONCLUSIONS: Homelessness and pretrial detention were associated with significant adverse effects on plea-bargained case outcomes. Findings regarding homeless defendants suggest that they have divergent enough experiences from other defendants to make them a distinct defendant population whose specific experiences warrant further study. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

PMID:35604706 | DOI:10.1037/lhb0000484

JAMA Netw Open. 2022 May 2;5(5):e2212921. doi: 10.1001/jamanetworkopen.2022.12921.

ABSTRACT

IMPORTANCE: Standard exercise interventions targeting underlying physiologic system impairments have limited success in improving walking. Augmenting standard interventions with timing and coordination training, which incorporates the principles of motor learning and integrates multiple systems, may be more successful.

OBJECTIVE: To determine whether a standard strength and endurance program incorporating timing and coordination training (standard-plus) improves gait speed more than strength and endurance training alone.

DESIGN, SETTING, AND PARTICIPANTS: The Program to Improve Mobility in Aging (PRIMA) study was an assessor-blinded, randomized, 2-group intervention trial that included a 12-week intervention and 24-week follow-up period. The trial was conducted at a university research clinic from 2016 to 2020. Participants included 249 community-dwelling older adults (aged ≥65 years) with gait speed between 0.60 and 1.20 m/s. Statistical analysis was performed from December 2020 to March 2021.

INTERVENTIONS: Participants were randomized to standard strength and endurance (n = 125) or standard-plus, including timing and coordination training (n = 124), 50 to 60 minutes, twice a week for 12 weeks.

MAIN OUTCOMES AND MEASURES: Primary outcome of gait speed and secondary outcomes representing components of the intervention (leg strength and power, 6-minute walk test, chair sit-and-reach test, and figure of 8 walk test) and activity and participation (Late Life Function and Disability Instrument and daily physical activity measured by accelerometry) were measured at 12, 24, and 36 weeks.

RESULTS: Among 249 randomized participants, 163 (65.5%) were female, 22 (8.8%) were Black, 219 (88.0%) were White; mean (SD) age was 77.4 (6.6) years; mean (SD) gait speed was 1.07 (0.16) m/s; and 244 (98.0%) completed the intervention. The 2 groups did not have significantly different improvements in gait speed or secondary outcomes representing the components of the intervention at any time point. For gait speed, individuals in the standard-plus group had a mean (SD) improvement of 0.079 (0.135) m/s over 12 weeks, 0.065 m/s (0.141) over 24 weeks, and 0.059 (0.150) m/s over 36 weeks; individuals in the standard group improved gait speed by 0.081 (0.124) m/s over 12 weeks, 0.051 (0.129) m/s over 24 weeks, and 0.065 (0.148) m/s over 36 weeks.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found no difference in gait speed change between the standard and standard-plus intervention groups, and both groups showed sustained improvements in mobility 24 weeks after the intervention.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02663778.

PMID:35604689 | DOI:10.1001/jamanetworkopen.2022.12921

JAMA Netw Open. 2022 May 2;5(5):e2213261. doi: 10.1001/jamanetworkopen.2022.13261.

ABSTRACT

IMPORTANCE: Acupoint hot compress during the early postpartum period may benefit patients after a vaginal delivery, but the evidence of this effect is limited.

OBJECTIVE: To assess whether acupoint hot compress involving the abdominal, lumbosacral, and plantar regions could reduce the incidence of postpartum urinary retention, relieve postpartum uterine contraction pain, prevent emotional disorders, and promote lactation.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial was conducted at 12 hospitals in China. Pregnant patients were screened for eligibility (n = 13 949) and enrolled after vaginal delivery (n = 1200) between January 17 and August 15, 2021; data collection was completed on August 18, 2021. After vaginal delivery, these participants were randomized 1:1 to either the intervention group or control group. Statistical analysis was based on per-protocol population.

INTERVENTIONS: Participants in the control group received routine postpartum care. Participants in the intervention group received routine postpartum care plus 3 sessions of a 4-hour acupoint hot compress involving the abdominal, lumbosacral, and plantar regions within 30 minutes, 24 hours, and 48 hours after delivery.

MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of postpartum urinary retention, defined as the first urination occurring more than 6.5 hours after delivery and/or use of an indwelling catheter within 72 hours after delivery. The secondary outcomes were postpartum uterine contraction pain intensity (assessed with the visual analog scale [VAS]), depressive symptoms (assessed with the Edinburgh Postnatal Depression Scale), and lactation conditions (including lactation initiation time, breastfeeding milk volume, feeding mood and times, and newborn weight).

RESULTS: Of the 1200 participants randomized, 1085 completed the study (537 in the intervention group and 548 in the control group, with a median [IQR] age of 26.0 [24.0-29.0] years). Participants in the intervention group compared with the control group had significantly decreased incidence of postpartum urinary retention (relative risk [RR], 0.58; 95% CI, 0.35-0.98; P = .03); improved postpartum uterine contraction pain when measured at 6.5 hours (median [IQR] VAS score, 1 [1-2] vs 2 [1-2]; P < .001), 28.5 hours (median [IQR] VAS score, 1 [0-1] vs 1 [1-2]; P < .001), 52.5 hours (median [IQR] VAS score, 1 [0-1] vs 1 [0-1]; P < .001), and 76.5 hours (median [IQR] VAS score, 0 [0-1] vs 0 [0-1]; P = .01) after delivery; reduced depressive symptoms (RR, 0.73; 95% CI, 0.54-0.98; P = .01); and increased breastfeeding milk volume measured at 28.5, 52.5, and 76.5 hours after delivery. No adverse events occurred in either of the 2 groups.

CONCLUSIONS AND RELEVANCE: Results of this trial showed that acupoint hot compress after vaginal delivery decreased postpartum urinary retention, uterine contraction pain, and depressive symptoms and increased breastfeeding milk volume. Acupoint hot compress may be considered as an adjunctive intervention in postnatal care that meets patient self-care needs.

TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2000038417.

PMID:35604687 | DOI:10.1001/jamanetworkopen.2022.13261

Eur J Heart Fail. 2022 May 23. doi: 10.1002/ejhf.2558. Online ahead of print.

ABSTRACT

AIMS: To report data from EMPEROR-Preserved according to prespecified endpoints of DELIVER.

METHODS AND RESULTS: To assess the impact of DELIVER-like definition on EMPEROR-Preserved outcomes, the following differences were reconciled: 1) primary outcome in DELIVER added urgent HF visits to cardiovascular death or HF hospitalizations; 2) EMPEROR-Preserved trial did not require documentation of physical findings or laboratory tests for confirming a HF hospitalization and it included events of 12-24 hours if intensification of treatment was not only oral diuretics; 3) DELIVER excluded undetermined causes of deaths from primary endpoint; 4) The composite renal endpoint in DELIVER included a sustained reduction of ≥50% eGFR and incorporated renal death; and 5): DELIVER will assess outcomes in the total population and in EF <60% separately. Using the endpoint definitions from DELIVER, the primary outcome overall occurred in 13.1% in the empagliflozin and 16.8% in the placebo group (HR 0.76 [0.67, 0.87]; P<0.001). The relative risk reduction (RRR) changed from 21% to 24% when urgent HF visits were added, and undetermined death was eliminated. Compared to overall population RRR of 24%, it was 28% in patients with EF <60%. Death from cardiovascular causes excluding undetermined causes occurred in 6.2% in the empagliflozin and in 7.1% in the placebo group (HR 0.88 [0.73, 1.07]). The RRR for the renal endpoint (changed from 22% in the overall population (HR 0.78; 95% CI, 0.54 to 1.13) to 40% when patients with EF <60% were assessed (P=0.037).

CONCLUSION: Findings from the EMPEROR-Preserved were modestly altered when analyzed using cardiovascular trial endpoint definitions of the DELIVER trial. For the composite renal endpoint, the effect of empagliflozin became statistically significant in patients with LVEF <60% using the DELIVER definition.

PMID:35604680 | DOI:10.1002/ejhf.2558

JAMA Netw Open. 2022 May 2;5(5):e2213269. doi: 10.1001/jamanetworkopen.2022.13269.

ABSTRACT

IMPORTANCE: The association between geographic diversity of medical journal editorial staff and publications reporting research conducted in low- and middle-income countries (LMICs) is unclear.

OBJECTIVE: To examine the association between having editorial staff members affiliated with LMICs and publishing research articles from LMICs in leading biomedical journals.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included biomedical journals in fields representing the largest disease burden globally from January 1 to December 31, 2020. Websites of the 5 leading journals in general medicine, pediatrics, surgery, obstetrics and gynecology, cancer, cardiovascular diseases, infectious diseases, psychiatry, and nutrition were reviewed to obtain the country affiliations of editorial staff members. To determine article study countries, original research articles in each journal were reviewed through MEDLINE. Editorial staff country affiliations and study country locations were classified according to World Bank income brackets and regions.

EXPOSURE: Editorial staff country affiliation.

MAIN OUTCOMES AND MEASURES: Descriptive statistics of the proportion of editorial staff affiliated with each income bracket and region and Spearman rank correlation coefficients were used to assess the association between the proportion of editorial staff affiliated with LMICs and the proportion of published articles reporting work conducted in these countries.

RESULTS: There were 3819 editorial staff members in the 45 included journals: 3637 (95.2%) were affiliated with high-income countries, 140 (3.7%) with upper-middle-income countries, 37 (1.0%) with lower-middle-income countries, and 5 (0.1%) with low-income countries. All 48 editors-in-chief were affiliated with a high-income country. Editorial staff members were mostly affiliated with North American countries (n = 2120 [55.5%]) and European or Central Asian countries (n = 1256 [32.9%]). Of the 10 096 original research articles included in our analysis, 7857 (77.8%) reported research conducted in high-income countries, 1562 (15.5%) reported research conducted in upper-middle-income countries, 507 (5.0%) reported research conducted in lower-middle-income countries, and 170 (1.7%) reported research conducted in low-income countries. Greater editorial staff representation correlated moderately with more published articles reporting research conducted in LMICs (Spearman ρ = 0.51; 95% CI, 0.25-0.70; P < .001).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, editorial staff in leading biomedical journals were largely composed of individuals affiliated with high-income countries in North America and Europe. A correlation was found between greater editorial staff representation and publication of research focused on LMICs, suggesting that the inclusion of editorial staff affiliated with LMICs may promote the publication of research conducted in those countries.

PMID:35604686 | DOI:10.1001/jamanetworkopen.2022.13269

JAMA Pediatr. 2022 May 23. doi: 10.1001/jamapediatrics.2022.1516. Online ahead of print.

NO ABSTRACT

PMID:35604677 | DOI:10.1001/jamapediatrics.2022.1516

JAMA Intern Med. 2022 May 23. doi: 10.1001/jamainternmed.2022.1563. Online ahead of print.

ABSTRACT

IMPORTANCE: The association between physician fatigue and patient outcomes is important to understand but has been difficult to examine given methodological and data limitations. Surgeons frequently perform urgent procedures overnight and perform additional procedures the following day, which could adversely affect outcomes for those daytime operations.

OBJECTIVE: To examine the association between an attending surgeon operating overnight and outcomes for operations performed by that surgeon the next day.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, a retrospective analysis of a large multicenter registry of surgical procedures was done using a within-surgeon analysis to address confounding, with data from 20 high-volume US institutions. This study included 498 234 patients who underwent a surgical procedure during the day (between 7 am and 5 pm) between January 1, 2010, and August 30, 2020.

EXPOSURES: Whether the attending surgeon for the current day’s procedures operated between 11 pm and 7 am the previous night. Two exposure measures were examined: whether the surgeon operated at all the previous night and the number of hours spent operating the previous night (including having performed no work at all).

MAIN OUTCOMES AND MEASURES: The primary composite outcome was in-hospital death or major complication (sepsis, pneumonia, myocardial infarction, thromboembolic event, or stroke). Secondary outcomes included operation length and individual outcomes of death, major complications, and minor complications (surgical site infection or urinary tract infection).

RESULTS: Among 498 234 daytime operations performed by 1131 surgeons, 13 098 (2.6%) involved an attending surgeon who operated the night before. The mean (SD) age of the patients who underwent an operation was 55.3 (16.4) years, and 264 740 (53.1%) were female. After adjusting for operation type, surgeon fixed effects, and observable patient characteristics (ie, age and comorbidities), the adjusted incidence of in-hospital death or major complications was 5.89% (95% CI, 5.41%-6.36%) among daytime operations when the attending surgeon operated the night before compared with 5.87% (95% CI, 5.85%-5.89%) among daytime operations when the same surgeon did not (absolute adjusted difference, 0.02%; 95% CI, -0.47% to 0.51%; P = .93). No significant associations were found between overnight work and secondary outcomes except for operation length. Operating the previous night was associated with a statistically significant decrease in length of daytime operations (adjusted length, 112.7 vs 117.4 minutes; adjusted difference, -4.7 minutes; 95% CI, -8.7 to -0.8, P = .02), although this difference is unlikely to be meaningful.

CONCLUSIONS AND RELEVANCE: The findings of this cross-sectional study suggest that operating overnight was not associated with worse outcomes for operations performed by surgeons the subsequent day. These results provide reassurance concerning the practice of having attending surgeons take overnight call and still perform operations the following morning.

PMID:35604661 | DOI:10.1001/jamainternmed.2022.1563

Eur J Pain. 2022 May 23. doi: 10.1002/ejp.1975. Online ahead of print.

ABSTRACT

BACKGROUND: There is limited research on the long-term effectiveness of epidural steroid injections (ESI) in older adults despite the high prevalence of back and leg pain in this age group. We tested the hypotheses that older adults undergoing ESI, compared to patients not receiving ESI: 1) have worse pain, disability and quality of life (“outcomes”) pre-ESI, 2) have improved outcomes after ESI, and 3) have improved outcomes due to a specific ESI effect.

METHODS: We prospectively studied patients ≥65 years old presenting to primary care with new episodes of back pain in three US healthcare systems (BOLD registry). Outcomes were leg and back pain intensity, disability and quality of life, assessed at baseline and 3-, 6-, 12- and 24-month follow-ups. We categorized participants as: 1) ESI within 6 months from the index visit (n=295); 2) no ESI within 6 months (n=4,809); 3) no ESI within 6 months, propensity-score matched to group 1 (n=483). We analyzed the data using linear regression and Generalized Estimating Equations.

RESULTS: Pain intensity, disability and quality of life at baseline were significantly worse at baseline in ESI patients (group 1) than in group 2. The improvement from baseline to 24 months in all outcomes was statistically significant for group 1. However, no statistically significant differences were observed between outcome trajectories for the propensity-score matched groups 1 and 3.

CONCLUSIONS: Older adults treated with ESI have long-term improvement. However, the improvement is unlikely the result of a specific ESI effect.

PMID:35604636 | DOI:10.1002/ejp.1975