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Nevin Manimala Statistics

Comparing direct-to-implant and two-stage breast reconstruction in the Australian Breast Device Registry

Plast Reconstr Surg. 2022 Dec 19. doi: 10.1097/PRS.0000000000010066. Online ahead of print.

ABSTRACT

BACKGROUND: There remains a lack of clarity surrounding the benefits, risks and outcomes between two-stage expander/implant reconstruction and single-stage direct-to-implant reconstruction. This study utilised a national dataset to examine real-world outcomes of two-stage and DTI reconstructions.

METHODS: A cohort study was conducted examining patients in the Australian Breast Device Registry from 2015-2018 who underwent prosthetic breast reconstruction post-mastectomy. Direct-to-implant and two-stage cohorts after definitive implant insertion were compared. Rate of revision surgery, reasons for revision and patient-reported outcome measures were recorded. Statistical analysis was undertaken using Fisher’s exact or chi-square, Wilcoxon rank-sum or student t-tests, Nelson-Aalen cumulative incidence estimates and Cox proportional hazards regression.

RESULTS: 5,152 breast reconstructions were recorded, including 3,093 two-stage and 2,059 direct-to-implant reconstructions. Overall revision surgery rates were 15.6% for direct-to-implant (median follow-up 24.7 months), compared with 9.7% in the two-stage cohort (median follow-up 26.5 months) (p<0.001). Most common reasons for revision for DTI and two-stage were capsular contracture (25.2% vs 26.7%, p=0.714) and implant malposition (26.7% vs 34.3%, p=0.045). Multivariate analysis found acellular dermal matrix usage (p=0.028) was significantly associated with a higher risk of revision. The influence of radiotherapy on revision rates was unable to be studied. Patient satisfaction levels were similar between reconstructive groups; however, patient experience was better in direct-to-implant than two-stage.

CONCLUSIONS: The Australian Breast Device Registry dataset demonstrated that direct-to-implant reconstruction had a higher revision rate than two-stage, but with comparable patient satisfaction and better patient experience. Capsular contracture and device malposition were leading causes of revision in both cohorts.

PMID:36729564 | DOI:10.1097/PRS.0000000000010066

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Evaluation of the revised versus original Ryan White Part A HIV Care Coordination Program in a cluster-randomized, stepped-wedge trial

J Acquir Immune Defic Syndr. 2022 Dec 15. doi: 10.1097/QAI.0000000000003139. Online ahead of print.

ABSTRACT

BACKGROUND: To address challenges with delivery of an evidence-based HIV care coordination program (CCP), the New York City (NYC) Health Department initiated a CCP redesign. We conducted a site-randomized stepped-wedge trial to evaluate effectiveness of the revised versus the original model.

SETTING: The CCP is delivered in NYC hospitals, community health centers, and community-based organizations, to people experiencing or at risk for poor HIV outcomes.

METHODS: The outcome, timely viral suppression (TVS), was defined as achievement of viral load <200 copies/mL within four months, among enrollees with unsuppressed viral load (≥200 copies/mL). Seventeen original-CCP provider agencies were randomized within matched pairs to early (August 2018) or delayed (May 2019) starts of revised-model implementation. Data from three periods were examined to compare revised versus original CCP effects on TVS. The primary analysis of the intervention effect applied fully conditional maximum likelihood estimation together with an exact, conditional P-value and an exact test-based 95% confidence interval (CI). We assigned each trial enrollee the implementation level of their site (based on a three-component measure), and tested for association with TVS, adjusting for period and study arm.

RESULTS: Over three nine-month periods, 960 individuals were eligible for trial inclusion (intention to treat). The odds ratio of TVS versus no TVS comparing revised to original CCP was 0.88 (95%CI 0.45, 1.7). Thus, the revised program yielded slightly lower TVS, though the effect was statistically non-significant. TVS was not significantly associated with revised-CCP implementation level.

CONCLUSION: Program revisions did not increase TVS, irrespective of implementation level.

PMID:36729538 | DOI:10.1097/QAI.0000000000003139

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Decisional Regret Among Caregivers of Infants with Differences of Sex Development Reared as Male

J Dev Behav Pediatr. 2022 Dec 15. doi: 10.1097/DBP.0000000000001159. Online ahead of print.

ABSTRACT

OBJECTIVE: Differences of sex development (DSD) are congenital conditions in which individuals are discordant in their chromosomal, phenotypic, and/or gonadal sex. Treatment of DSD can involve surgical intervention to external genitalia to make anatomy seem male-typical (i.e., male genitoplasty). Caregiver-perceived decisional regret regarding young boys with DSD was explored quantitatively and qualitatively.

METHOD: Participants (N = 39) were caregivers of infants (N = 23) diagnosed with DSD (mean age = 8.9 months, standard deviation = 5.9 months) reared male participating in a longitudinal investigation of psychosocial outcomes. Qualitative data were collected at 6 to 12 months after baseline enrollment to evaluate caregiver decision-making corresponding to levels of regret concerning their child’s treatment. All but one infant received genital surgery before caregiver reporting on their decisional regret. Quantitative exploratory analyses evaluated longitudinal predictors of decisional regret at 6 to 12 months.

RESULTS: When completing a write-in item inquiring about decision-making and potential regret, most caregivers (n = 16, 76%) reported that their child’s genital surgery was their first medical decision. Two caregivers referenced gender assignment as a decision point. One-third of caregivers reported some level of decisional regret (33%), with 67% reporting no regret. No hypothesized predictors of decisional regret were statistically significant.

CONCLUSION: Many caregivers of infants with DSD reared male view genital surgery as a first health care decision. Approximately one-third of caregivers reported some level of decisional regret. Further research is warranted to explore long-term decisional regret; it will be particularly important to investigate the decisional regret of patients with DSD.

PMID:36729523 | DOI:10.1097/DBP.0000000000001159

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A novel multifamily treatment targeting symptoms related to Latinx caregiver deportation

Psychol Trauma. 2023 Feb 2. doi: 10.1037/tra0001379. Online ahead of print.

ABSTRACT

OBJECTIVE: Latinx youth who have experienced caregiver deportation show higher rates of posttraumatic stress disorder (PTSD) and internalizing symptoms compared to Latinx youth who have not. Thus, there is a need for culturally and linguistically appropriate therapeutic approaches to address psychiatric needs related to caregiver deportation. Positive Adaptations for Trauma and Healing (PATH) is a manualized 10-week group therapy for Latinx youth and their caregivers that integrates trauma-informed interventions with positive psychology and resilience interventions. The present study examined PATH for reducing trauma symptomatology for Latinx youth who endured at least three traumatic experiences in their caregiving system as well as differences for Latinx youth who experienced their caregiver’s deportation.

METHOD: Self-identified Latinx youth (N = 31) and their Spanish-speaking caregivers were recruited from two urban hospitals. All youth experienced three or more traumatic events. Pre- to postintervention mean change was measured with t tests; mixed-effects analysis of variance assessed whether the program was feasible for youth who had experienced a caregiver deportation versus Latinx youth who did not.

RESULTS: Assessment with the Trauma Symptom Checklist and the UCLA PTSD Index for Youth showed statistically significant reductions on Anxiety, Depression, Anger, and PTSD subscales. Latinx youth who experienced a caregiver’s deportation exhibited larger reductions in anger symptoms and PTSD symptoms.

CONCLUSION: Study results suggest that the novel group therapy intervention was feasible and acceptable for Latinx youth and their caregivers. Despite a small sample size, the intervention proved feasible for Latinx youth who experienced caregiver deportation. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

PMID:36729520 | DOI:10.1037/tra0001379

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Demographic and Socioeconomic Determinants Are Associated with Poor Preoperative Patient-Reported Pain and Function in Primary TKA: A Cohort Study of 14,079 Patients

J Bone Joint Surg Am. 2022 Dec 19. doi: 10.2106/JBJS.22.00645. Online ahead of print.

ABSTRACT

BACKGROUND: Pain and function, as reflected by patient-reported outcome measures (PROMs), can influence improvement after total knee arthroplasty (TKA) and can reflect the extent of patient access to orthopaedic surgical care. We aimed to (1) categorize patients according to pain and function PROM phenotypes, (2) identify patient characteristics associated with poor preoperative pain and function, and (3) assess relationships between baseline characteristics and PROM phenotypes.

METHODS: A prospective cohort of 14,079 TKAs was enrolled. Demographics, comorbidities, surgical details, and preoperative PROMs were collected. Outcomes included preoperative Knee injury and Osteoarthritis Outcome Score (KOOS) Pain (P) and Physical Function (PS) subscores, stratified by demographics. Patients were then categorized into 4 PROM phenotypes defined on the basis of the cohort medians: above or equal to the median for both pain and function scores (P+PS+), below the median for both pain and function (P-PS-), above or equal to the median for pain but below the median for function (P+PS-), and below the median for pain but above or equal to the median for function (P-PS+). Descriptive statistics and multivariable regression analyses were calculated.

RESULTS: The largest PROM phenotype was P-PS- (39.4%), followed by P+PS+ (38.9%). The cohort with discordantly poor function but high pain scores (less pain) was the smallest cohort (9.9%). Preoperative KOOS-Pain and KOOS-PS scores at or below the 25th percentile were independently associated with younger age, female sex, higher body mass index (BMI), non-White race, current smoking, lower education, non-commercial insurance, and higher Charlson Comorbidity Index (CCI). Multivariate logistic regression showed that patients in the P+PS+ category were older (odds ratio [OR] = 1.56), were more likely to be male (OR = 2.00), had a lower BMI (OR = 0.67), had more education (OR = 1.63), had a lower CCI, and were less likely to be Black (OR = 0.80) or Other (OR = 0.62) race, be a current smoker (OR = 0.62), and have commercial insurance (OR = 0.74), compared with the P-PS- phenotype.

CONCLUSIONS: Younger age, obesity, non-White race, female sex, current or recent smoking, non-commercial insurance, and higher CCI were associated with worse pre-TKA PROMs and poor pain-function phenotype combinations. Such a pattern may indicate barriers to TKA access among these patient populations leading to advanced levels of impairment at the time of treatment.

LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

PMID:36729513 | DOI:10.2106/JBJS.22.00645

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Influence of Drilling Sequence and Guide-hole Design on the Accuracy of static Computer-Assisted Implant Surgery in Extraction Sockets and Healed Sites – An In Vitro Investigation

Clin Oral Implants Res. 2023 Feb 2. doi: 10.1111/clr.14042. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the effect of drilling sequence, guide-hole design, and alveolar ridge morphology on the accuracy of implant placement via static Computer-Assisted Implant Surgery (sCAIS).

MATERIALS AND METHODS: Standardized maxillary bone models including single tooth gaps with fresh extraction sockets or healed alveolar ridge morphologies were evaluated in this study. Implants were placed using different drilling sequences (i.e., complete (CDS) or minimum (MDS), and guide-hole designs (i.e., manufacturer’s sleeve (MS) or sleeveless (SL) guide-hole designs). The time for implant placement via sCAIS procedures was also recorded. The angular, crestal, and apical three-dimensional deviations between planned and final implant positions were digitally obtained. Statistical analyses were conducted by a non-parametric three-way ANOVA (α=0.05).

RESULTS: Based on a sample size analysis, a total of 72 implants were included in this study. Significantly higher implant position accuracy was found at healed sites compared to extraction sockets, and in SL compared to MS guide-hole design in angular, crestal, and apical 3D deviations, p≤0.048). A tendency for higher accuracy was observed for the CDS compared to the MDS, although the effect was not statistically significant (p=0.09). The MDS required significantly shorter preparation times compared with CDS (p<0.0001).

CONCLUSION: Implant placement via sCAIS resulted in higher accuracy in healed sites than extraction sockets, when using SL compared to MS guides, and tended to be more accurate when using CDS compared to MDS. Therefore, even though surgery time was shorter with MDS, its use should be limited to strictly selected cases.

PMID:36727584 | DOI:10.1111/clr.14042

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Access to healthcare for people with sickle cell disease: Views of healthcare professionals on policies and practices

Mol Genet Genomic Med. 2023 Feb 2:e2142. doi: 10.1002/mgg3.2142. Online ahead of print.

ABSTRACT

INTRODUCTION: Sickle cell disease is a genetic disorder with its highest prevalence in Nigeria. The condition causes red blood cells to turn rigid, and consequently, results to several complications including organ damage. This study aimed at assessing views of health practitioners in Nigeria on policies and practices in the area of access to healthcare services for sickle cell disease.

METHODS: A cross-sectional study was undertaken amongst healthcare professionals in Nigeria. Data were collected using a self-administered questionnaire, and analyses were undertaken using Statistical Package for Social Sciences software.

RESULTS: A significant proportion of the participants (42.8%) disagreed that relevant legislative framework exists to facilitate optimal access to high-quality healthcare services for persons with sickle cell disorder in Nigeria. Two-thirds of the study cohort were of the opinion that public health surveillance towards sickle cell disease was suboptimal (61.2%). Also, more than three-quarters of the respondents (78.7%) indicated that the cost of managing sickle cell disease was not affordable to majority of affected Nigerians.

CONCLUSION: This study provides critical insights into access to healthcare services for sickle cell disease. As such, challenges preventing access to healthcare services for sickle cell patients which have been identified in this study can underpin the development of contextual policies to address them.

PMID:36727575 | DOI:10.1002/mgg3.2142

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Movies, stigma and choice: Evidence from the pharmaceutical industry

Health Econ. 2023 Feb 2. doi: 10.1002/hec.4653. Online ahead of print.

ABSTRACT

Do movies reduce stigma, increasing healthcare product choices offered by firms? We provide causal evidence on this question in the context of Indian pharmaceutical markets. For unpacking these effects, we use an exogenous shock to the market due to the release of a Bollywood blockbuster movie – My Name is Khan (MNIK) where the protagonist, superstar Shahrukh Khan, suffers from Asperger’s Syndrome (AS). Using a difference-in-differences design, we find a positive and statistically significant effect of MNIK (between 14% and 22% increase in variety sold and prescribed) on product differentiation and choices in the market for antipsychotic medicines used to clinically treat AS. Results are consistent using alternative controls, a placebo treatment-based test and with a variety of other robustness checks. Our findings document likely for the first-time, supply side responses to edutainment and suggests potential associated welfare effects in healthcare markets characterized by sticky demand. Implications for global health and public policy given worldwide concerns around a mental wellness epidemic with Covid-19 are discussed.

PMID:36727570 | DOI:10.1002/hec.4653

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Association between PD-1 inhibitor-related adverse events and frailty assessed by frailty index in lung cancer patients

Cancer Med. 2023 Feb 2. doi: 10.1002/cam4.5669. Online ahead of print.

ABSTRACT

BACKGROUND: The programmed cell death protein 1 (PD-1) inhibitor, as one of the immune checkpoint inhibitors (ICIs), is the standard treatment for advanced lung cancer. However, immune-related adverse events (irAEs) remain poorly understood toxicities. It is unclear whether frailty plays a role in the occurrence of irAEs. Thus, we assess whether irAEs occur more often in frail patients than in non-frail patients according to the Frailty Index (FI).

METHODS: A retrospective study was conducted. Medical records from lung cancer patients treated with PD-1 inhibitors (Sintilimab, Camrelizumab, Tislelizumab, and Pembrolizumab) at Peking University First Hospital (May 2018-June 2022). Patients were categorized into non-frail and frail groups according to a cut-point of 0.25 by FI. The FI calculation included 28 baseline variables, all of which were health deficits measured by questionnaires and body measurements.

RESULTS: The statistical analysis included 114 advanced lung cancer patients. The median age was 66 years, and the male/female ratio was 4.7:1 (94/20). Approximately 39 (34%) were classified as frail. PD-1 inhibitor-related adverse events occurred in 17.5% of patients, and 6.1% experienced irAEs of grade ≥3. There was no significant difference in the occurrence of irAEs (14.7% vs. 23.1%, p = 0.26), grade ≥ 3 irAEs (5.3% vs. 7.7%, p = 0.93), and treatment discontinuation due to irAEs (12.0% vs. 17.9%, p = 0.39) between non-frail and frail patients. However, frail patients are more likely to have more than one type of irAEs and are more possibly to have checkpoint inhibitor pneumonitis (CIP) than non-frail patients when they use PD-1 inhibitors (p < 0.05). Frail patients had a longer hospital stay (6 vs. 3 days, p = 0.01).

CONCLUSIONS: Frailty is not associated with severe irAEs, but is related to CIP. Meanwhile, it predicts more than one type of irAEs and a longer hospital stay. Frailty screening has added value to the decision-making process for frail patients eligible for PD-1 inhibitors.

PMID:36727563 | DOI:10.1002/cam4.5669

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A library of quantitative markers of seizure severity

Epilepsia. 2023 Feb 2. doi: 10.1111/epi.17525. Online ahead of print.

ABSTRACT

OBJECTIVE: Understanding fluctuations in seizure severity within individuals is important for determining treatment outcomes and responses to therapy, as well as assessing novel treatments for epilepsy. Current methods for grading seizure severity rely on qualitative interpretations from patients and clinicians. Quantitative measures of seizure severity would complement existing approaches, for electroencephalographic (EEG) monitoring, outcome monitoring, and seizure prediction. Therefore, we developed a library of quantitative EEG markers that assess the spread and intensity of abnormal electrical activity during and after seizures.

METHODS: We analysed intracranial EEG (iEEG) recordings of 1009 seizures from 63 patients. For each seizure we computed 16 markers of seizure severity that capture the signal magnitude, spread, duration, and post-ictal suppression of seizures.

RESULTS: Quantitative EEG markers of seizure severity distinguished focal vs. subclinical seizures across patients. In individual patients 53% had a moderate to large difference (ranksum r>0.3, p<0.05) between focal and subclinical seizures in three or more markers. Circadian and longer-term changes in severity were found for the majority of patients.

SIGNIFICANCE: We demonstrate the feasibility of using quantitative iEEG markers to measure seizure severity. Our quantitative markers distinguish between seizure types and are therefore sensitive to established qualitative differences in seizure severity. Our results also suggest that seizure severity is modulated over different timescales. We envisage that our proposed seizure severity library will be expanded and updated in collaboration with the epilepsy research community to include more measures and modalities. © 2023 International League Against Epilepsy.

PMID:36727552 | DOI:10.1111/epi.17525