Tag: statistics

Bone Joint J. 2023 Mar 15;105-B(4):382-388. doi: 10.1302/0301-620X.105B4.BJJ-2022-0602.R3.

ABSTRACT

The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture.

PMID:36924175 | DOI:10.1302/0301-620X.105B4.BJJ-2022-0602.R3

Bone Joint J. 2023 Mar 15;105-B(4):400-411. doi: 10.1302/0301-620X.105B4.BJJ-2022-0947.R2.

ABSTRACT

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.

PMID:36924174 | DOI:10.1302/0301-620X.105B4.BJJ-2022-0947.R2

Bone Joint J. 2023 Mar 15;105-B(4):347-355. doi: 10.1302/0301-620X.105B4.BJJ-2023-0111.

ABSTRACT

Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents.

PMID:36924170 | DOI:10.1302/0301-620X.105B4.BJJ-2023-0111

Bone Joint J. 2023 Mar 15;105-B(4):365-372. doi: 10.1302/0301-620X.105B4.BJJ-2022-0659.R1.

ABSTRACT

This study investigates whether primary knee arthroplasty (KA) restores health-related quality of life (HRQoL) to levels expected in the general population. This retrospective case-control study compared HRQoL data from two sources: patients undergoing primary KA in a university-teaching hospital (2013 to 2019), and the Health Survey for England (HSE; 2010 to 2012). Patient-level data from the HSE were used to represent the general population. Propensity score matching was used to balance covariates and facilitate group comparisons. A propensity score was estimated using logistic regression based upon the covariates sex, age, and BMI. Two matched cohorts with 3,029 patients each were obtained for the adjusted analyses (median age 70.3 (interquartile range (IQR) 64 to 77); number of female patients 3,233 (53.4%); median BMI 29.7 kg/m² (IQR 26.5 to 33.7)). HRQoL was measured using the three-level version of the EuroQol five-dimension questionnaire (EQ-5D-3L), and summarized using the Index and EuroQol visual analogue scale (EQ-VAS) scores. Patients awaiting KA had significantly lower EQ-5D-3L Index scores than the general population (median 0.620 (IQR 0.16 to 0.69) vs median 0.796 (IQR 0.69 to 1.00); p < 0.001). By one year postoperatively, the median EQ-5D-3L Index score improved significantly in the KA cohort (mean change 0.32 (SD 0.33); p < 0.001), and demonstrated no clinically relevant differences when compared to the general population (median 0.796 (IQR 0.69 to 1.00) vs median 0.796 (IQR 0.69 to 1.00)). Compared to the general population cohort, the postoperative EQ-VAS was significantly higher in the KA cohort (p < 0.001). Subgroup comparisons demonstrated that older age groups had statistically better EQ-VAS scores than matched peers in the general population. Patients awaiting KA for osteoarthritis had significantly poorer HRQoL than the general population. However, within one year of surgery, primary KA restored HRQoL to levels expected for the patient’s age-, BMI-, and sex-matched peers.

PMID:36924161 | DOI:10.1302/0301-620X.105B4.BJJ-2022-0659.R1

J Ment Health. 2023 Mar 16:1-9. doi: 10.1080/09638237.2023.2182423. Online ahead of print.

ABSTRACT

BACKGROUND: Occupational burnout is highly prevalent in the mental healthcare workforce and associated with poorer job satisfaction, performance and outcomes.

AIMS: To evaluate the effects of the Mind Management Skills for Life Programme on burnout and wellbeing.

METHODS: N = 173 mental health nurses were recruited from the English National Health Service during the acute phase of the COVID-19 crisis. Participants were allocated to an immediate intervention or a delayed intervention control group, using a stepped wedge randomized controlled trial design. Measures of burnout (OLBI) and wellbeing (WEMWBS) were completed at four time-points: [1] baseline; [2] after the first group finished the intervention; [3] after the second group finished the intervention; and [4] six-months follow-up.

RESULTS: Between-group differences were compared at each time-point using ANCOVA adjusting for baseline severity. Statistically significant effects on burnout (d = 0.60) and wellbeing (d = -0.62) were found at time-point 2, favouring the intervention relative to waitlist control. No significant differences were found at subsequent time-points, indicating that both groups improved and maintained their gains after the intervention.

CONCLUSIONS: This intervention led to moderate improvements in burnout and wellbeing, despite the adverse circumstances of the COVID-19 pandemic at the time of the study.

PMID:36924140 | DOI:10.1080/09638237.2023.2182423

Br J Nutr. 2023 Mar 16:1-21. doi: 10.1017/S0007114523000673. Online ahead of print.

ABSTRACT

We aimed to investigate the association of metabolic obesity phenotypes with all-cause mortality risk in a rural Chinese population. This prospective cohort study enrolled 15,704 Chinese adults (38.86% men) with a median age of 51.00 (IQR: 41.00-60.00) at baseline (2007-2008) and followed up during 2013-2014. Obesity was defined by waist circumference (WC: ≥90 cm for men and ≥80 cm for women) or waist-to-height ratio (WHtR: ≥0.5). The hazard ratio (HR) and 95% confidence interval (CI) for risk of all-cause mortality related to metabolic obesity phenotypes were calculated using the Cox hazards regression model. During a median follow-up of 6.01 years, 864 deaths were identified. When obesity was defined by WC, the prevalence of participants with metabolically healthy non-obesity (MHNO), metabolically healthy obesity (MHO), metabolically unhealthy non-obesity (MUNO), and metabolically unhealthy obesity (MUO) at baseline was 12.12%, 2.80%, 41.93%, and 43.15%, respectively. After adjusting for age, sex, alcohol drinking, smoking, physical activity, and education, the risk of all-cause mortality was higher with both MUNO (HR = 1.20, 95% CI 1.14-1.26) and MUO (HR = 1.20, 95% CI 1.13-1.27) versus MHNO, but the risk was not statistically significant with MHO (HR = 0.99, 95% CI 0.89-1.10), this result remained consistent when stratified by sex. Defining obesity by WHtR gave similar results. MHO does not suggest a greater risk of all-cause mortality compared to MHNO, but participants with metabolic abnormality, with or without obesity, have a higher risk of all-cause mortality. These results should be cautiously interpreted as the representation of MHO is small.

PMID:36924137 | DOI:10.1017/S0007114523000673

Pediatrics. 2023 Mar 16:e2022059172. doi: 10.1542/peds.2022-059172. Online ahead of print.

ABSTRACT

BACKGROUND: Lesbian, gay, bisexual, and other sexual minority (LGB+) girls are more likely than heterosexual girls to be pregnant during adolescence. Nonetheless, LGB+ inclusive pregnancy prevention programming is lacking.

METHODS: Between January 2017 and January 2018, 948, 14 to 18 year-old cisgender LGB+ girls were enrolled in a national randomized controlled trial. Girls were assigned either to Girl2Girl or an attention-matched control group. They were recruited via social media and enrolled over the telephone. The 5-month intervention consisted of a 7-week program (4-12 text messages sent daily) and a 1-week booster delivered 12 weeks later. Longitudinal models of protected sex events had a negative binomial distribution and a log link function. Longitudinal models examining use of birth control assumed a Bernoulli distribution of the outcome variable and a logit link function. Models adjusted for baseline rate of the outcome, age, and a time-varying indicator of sexual experience.

RESULTS: Girl2Girl participants had higher rates of protected penile-vaginal sex events over time compared with controls. Girl2Girl participants also were more likely than control participants to report use of birth control other than condoms. Models of abstinence and pregnancy rates did not suggest statistically significant group differences across time. However, effect sizes were in the small to medium range and point estimates favored Girl2Girl versus control in both cases.

CONCLUSIONS: Girl2Girl is associated with sustained pregnancy preventive behaviors for LGB+ girls through 12 months postintervention. Text messaging could be considered as a viable method to increase access to sexual health programming to adolescents nationally.

PMID:36924134 | DOI:10.1542/peds.2022-059172

Hosp Pediatr. 2023 Mar 16:e2022006914. doi: 10.1542/hpeds.2022-006914. Online ahead of print.

ABSTRACT

OBJECTIVES: Bronchiolitis is a leading cause of pediatric hospitalization. Treatment focuses on supportive care including supplemental oxygen for hypoxemia. High-flow nasal cannula (HFNC) has emerged as a modality to provide respiratory support with or without supplemental oxygen. At a freestanding children’s hospital, inappropriate supplemental oxygen was frequently used. This study aimed to decrease the proportion of patients started on supplemental oxygen without documented hypoxemia from ∼90% to <70% and the proportion of patients weaned from HFNC without supplemental oxygen to nasal cannula with supplemental oxygen from ∼23% to <10%.

METHODS: A multidisciplinary taskforce was convened to develop an evidence-based protocol for HFNC usage. Data collection was obtained among patients aged <2 years admitted with bronchiolitis from September 2018 to September 2021. Institution-wide protocol changes occurred in November 2019 and October 2020, with ongoing education and evaluation. Data were summarized using statistical process control charts.

RESULTS: Following implementation of a revised protocol in October 2020, the percentage of patients without documented hypoxemia (defined as an oxygen saturation <90% on pulse oximetry) who were inappropriately started on supplemental oxygen decreased from a baseline of 90.2% to 57.2%. At the same time, the percentage of patients weaned from HFNC without nasal cannula oxygen decreased from a baseline of 23.1% to 4.7%.

CONCLUSIONS: Using supplemental oxygen in the absence of hypoxemia in bronchiolitis is an example of low-value care. Implementation of focused, standardized protocols with concurrent education can feasibly decrease inappropriate and unnecessary use of supplemental oxygen in children with bronchiolitis.

PMID:36924126 | DOI:10.1542/hpeds.2022-006914

J Eur Acad Dermatol Venereol. 2023 Mar 16. doi: 10.1111/jdv.19050. Online ahead of print.

ABSTRACT

BACKGROUND: Photodynamic therapy (PDT) is used to treat cutaneous cancers. It may induce cell death through direct and indirect means, including apoptosis, inflammation, and certain immune mechanisms, with the depth of penetration as a potential modifying factor.

OBJECTIVES: To examine the pathways of apoptosis in the intralesional PDT of basal cell carcinoma (BCC) and intraepidermal squamous cell carcinoma (Bowen’s disease).

METHODS: Sixteen patients with superficial or nodular BCC and Bowen’s disease were treated with intralesional aminolevulinic acid-PDT. Biopsies were taken at baseline and 24 h post-PDT and sections were examined by immunohistochemistry for expression of markers of apoptosis. such as caspase 3, involved in the intrinsic apoptotic pathway, granzyme B, a caspase-independent apoptotic mediator, and the proapoptotic markers BAX and BAK RESULTS: Apoptotic cells stained with TUNEL showed statistically significant staining at 24 h post PDT (p<0,01 in both BCC and Bowen’s lesions). Caspase 3 (p<0.01 in BCC and p<0.05 in Bowen’s) and granzyme B (p<0.01 in BCC and p<0.01 in Bowen’s) were significantly increased at 24 h post-PDT. BAX expression was apparently raised compared to baseline in Bowen’s lesions at 24 h post-PDT, whereas Bak was upregulated both in BCC and Bowen’s disease at baseline and at 24 h post-PDT.

CONCLUSION: Intralesional PDT induces apoptosis in BCC and Bowen’s disease via common and alternative apoptotic pathways involving granzyme B. Proapoptotic factors Bak in both BCC and Bowen and Bax in Bowen’s disease appear to increase by intralesional PDT at 24 hours.

PMID:36924124 | DOI:10.1111/jdv.19050

Rev Med Virol. 2023 Mar 16:e2439. doi: 10.1002/rmv.2439. Online ahead of print.

ABSTRACT

Until now, the treatment protocols for COVID-19 have been revised multiple times. The use and approval of therapeutic monoclonal antibodies (mAbs) for COVID-19 treatment represent exceptional achievements in modern science, technology and medicine. SARS-CoV-2 Omicron evasion of pre-existing immunity represents a serious public health problem nowadays. This systematic review with meta-analysis provided comprehensive and up-to-date evidence of the clinical efficacy of therapeutic anti-SARS-CoV-2 mAbs against Omicron subvariants in COVID-19 patients and included 10 articles. The prevalence of hospitalisation among Omicron-positive patients treated with anti-SARS-CoV-2 mAbs was 2.8% (89/3169) while it controls (Omicron-positive patients treated with other therapies) 11% (154/1371). There was a statistically significantly different number of hospitalisations between the two studied groups in favour of the anti-SARS-CoV-2 mAbs treated group. (OR = 0.56, 95% CI OR = 0.41-0.77, p < 0.001, respectively). Eight deaths (0.30%) out of 2619 Omicron-positive patients occurred in the anti-SARS-CoV-2 mAbs treated group, while in the control group (Omicron-positive patients treated with other therapies), 27 patients died out of 1401 (1.93%). There was a significantly different number of deaths between the two studied groups in favour of Omicron-positive patients treated with anti-SARS-CoV-2 mAbs (OR = 0.38, 95% CI OR = 0.17-0.85, p = 0.020). Using sotrovimab in treating Omicron-positive patients indicated a reduction of hospitalisation and mortality for 49% and 89% in favour of sotrovimab, respectively (OR = 0.51, 95% CI OR = 0.34-0.79, p = 0.002; OR = 0.11, 95% CI OR = 0.03-0.39, p = 0.001). We could only provide evidence of the positive impact in reducing hospitalisation and mortality rates when anti-SARS-CoV-2 mAbs were used to treat patients infected with Omicron variants BA.1 or BA.2 and not on other Omicron variants.

PMID:36924087 | DOI:10.1002/rmv.2439