Four-year Follow-up Research Articles

Potentially inappropriate medication on communitydwelling older adults: Longitudinal analysis using the International Mobility in Aging Study.

Medications are a fundamental part of the treatment of multiple pathologies. However, despite their benefits, some are considered potentially inappropriate medications for older people given their safety profile. Epidemiological data differences related to potentially inappropriate medications make it difficult to determine their effects on elderly people. To estimate the prevalence and types of potentially inappropriate medications using the 2019 Beers Criteria® in a cohort of adults older than 65 years. We performed an observational, multicenter, retrospective, longitudinal study of a four-year follow-up of potentially inappropriate medications in community-dwelling older adults. We followed 820 participants from five cities for four years (2012-2016) and evaluated them in three different moments (m1 = 2012, m2 = 2014, and m3 = 2016). The average age was 69.07 years, and 50.9% were women. The potentially inappropriate medication prevalence in the participants was 40.24%. The potentially inappropriate medications' mean among the studied subjects in the first moment was 1.65 (SD = 0.963), in the second was 1.73 (SD = 1.032), and in the third was 1.62 (SD = 0.915). There were no statistical differences between measurements (Friedman test, value = 0.204). The most frequent potentially inappropriate medications categories were gastrointestinal (39.4%), analgesics (18.8%), delirium-related drugs (15.4%), benzodiazepines (15.2%), and cardiovascular (14.2%). About half of the population of the community-dwelling older adults had prescriptions of potentially inappropriate medications in a sustained manner and without significant variability over time. Mainly potentially inappropriate medications were gastrointestinal and cardiovascular drugs, analgesics, delirium-related drugs, and benzodiazepines.

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.

An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.

Evolution of Pentosan Polysulfate Maculopathy Following Medication Discontinuation

Purpose: To describe a patient receiving pentosan polysulfate (PPS) for interstitial cystitis, who developed PPS maculopathy (PPSM) that persisted and evolved for four years after medication discontinuation. Methods: Case report of one patient at a tertiary retina clinic. Results: A 48-year-old female with a history of interstitial cystitis was referred to our retina clinic with no vision complaints. She had been taking PPS for 10 years, first consuming 600mg/day for eight years, followed by 200mg/day for two years. At first presentation in 2016, examination revealed macular pigmentary clumping in both eyes. In subsequent years, pigmentary changes were confirmed by optical coherence tomography (OCT) which showed progressive macular thinning in both eyes. In 2019, the patient discontinued PPS; however, she continued to exhibit PPSM progression for years thereafter. At four-year follow-up after discontinuation of PPS, the patient returned with stable vision, but showed changes in macular lipofuscin deposits with outer retinal and retinal pigment epithelial alterations. Conclusion: This case demonstrates sustained and evolving PPSM even after drug discontinuation, suggesting that active PPS may have a prolonged half-life in the retina and retinal pigment epithelium.

Longitudinal association between the dynamic nature of depression with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH)

BackgroundDepression is associated with an increased risk of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). Whether the dynamic nature of depression affects the incidence of LUTS/BPH remains unknown. A four-year cohort study based on the China Health and Retirement Longitudinal Study (CHARLS) was conducted to assess their association.MethodsThis study included 3433 Chinese men from the CHARLS 2011, representative of > 95 million individuals. All eligible individuals underwent three assessments of LUTS/BPH and depression in 2011, 2013 and 2015. The dynamic nature of depression was classified as acute depression with remission, acute depression with recurrence, or chronic major depression. Weighted, generalized additive analyses with three binomial models were used to investigate the relationship between LUTS/BPH and the dynamic nature of depression.ResultsDuring the four-year follow-up, 11.5% (95% confidence interval [95% CI] = 9.5-13.3%) of Chinese men were diagnosed with newly incident LUTS/BPH. Meanwhile, there were 60.6% (95% CI = 58.5-62.7%) of the individuals without depression and 8.9% (95% CI = 7.9-10%) of the individuals with chronic major depression. A total of 25.1% (95% CI = 23.4-26.9%) and 5.4% (95% CI = 4.6-6.3%) of the individuals were categorized as acute depression with remission and recurrence. After weighted, adjusted all included confounding risk factors, chronic major depression (RR = 1.63, 95% CI = 1.14–2.33, P < 0.01) but not acute depression with remission (RR = 1.2, 95% CI = 0.92–1.56, P = 0.18) and recurrence (RR = 1.32, 95% CI = 0.82–2.10, P = 0.26) significantly increased the incidence of LUTS/BPH compared with no depression. The subgroup analysis showed that the above relationships appeared to be evident among Chinese men < 60 years.ConclusionsOur results suggest that the dynamic nature of depression has a different effect on the incidence of LUTS/BPH. The monitoring and treatment of depression are important in preventing LUTS/BPH.

Four-year follow-up of psychiatric and psychosomatic profile in patients with Inflammatory Bowel Disease (IBD).

Psychological characterization of patients affected by Inflammatory Bowel Disease (IBD) focuses on comorbidity with psychiatric disorders, somatization or alexithymia. Whereas IBD patients had higher risk of stable anxiety and depression for many years after the diagnosis of the disease, there is a lack of studies reporting a comprehensive psychosomatic assessment addressing factors of disease vulnerability, also in the long-term. The objective of this investigation is to fill this gap in the current literature. The aims were thus to assess: a) changes between baseline and a 4-year follow-up in psychiatric diagnoses (SCID), psychosomatic syndromes (DCPR), psychological well-being (PWB-I), lifestyle, gastrointestinal symptoms related to IBD and Irritable Bowel Syndrome (IBS)-like symptoms b) stability of psychiatric and psychosomatic syndromes at 4-year follow-up. A total of 111 IBD outpatients were enrolled; 59.5% of them participated at the follow-up. A comprehensive assessment, including both interviews and self-report questionnaires, was provided at baseline and follow-up. Results showed increased psychiatric diagnoses, physical activity, consumption of vegetables and IBS-like symptoms at follow-up. Additionally, whereas psychiatric diagnoses were no longer present and new psychopathological pictures ensued at follow-up, more than half of the sample maintained psychosomatic syndromes (particularly allostatic overload, type A behavior, demoralization) from baseline to follow-up. Long-term presence/persistence of such psychosocial burden indicates the need for integrating a comprehensive psychosomatic evaluation beyond traditional psychiatric nosography in IBD patients. Moreover, since psychosomatic syndromes represent vulnerability factors of diseases, further studies should target subgroups of patients presenting with persistent psychosomatic syndromes and worse course of the disease.

Susceptibility of optic nerve head in children with posture-related elevation of intraocular pressure

Background/AimsThis work aimed to investigate changes in optic nerve head (ONH) morphometry based on Bruch membrane opening in children with extensive nocturnal intraocular pressure (IOP) elevations.MethodsThe course of Bruch membrane opening-based optic nerve head (ONH) morphometry was analysed in thirty-two patients younger than 18 years with evaluable SD-OCT examinations of the ONH and nocturnal posture-dependent IOP elevation above 25 mmHg. Longitudinal changes in neuroretinal rim tissue, as measured by Bruch Membrane opening minimum rim width (BMO-MRW) and peripapillary retinal nerve fiber layer (RNFL) thickness, were assessed.ResultsOne year after the 24 h IOP measurement, global BMO-MRW (− 1.61 ± 16.8 µm, n.s.; p = 0.611) and RNFL (+ 0.64 ± 3.17 µm; n.s.; p = 0.292) measurements were not significantly different from the baseline. No significant BMO-MRW reduction (− 3.91 ± 24.3 µm; n.s. p = 0.458) or deviation in RNFL thickness (+ 1.10 ± 3.52 µm) was observed at the four-year follow-up. Absolute IOP values measured in the supine position did not correlate with changes in global BMO-MRW or RNFL thickness.ConclusionPosture-dependent IOP elevations do not seem to influence retinal nerve fibre layer thickness or Bruch membrane opening-based morphometric data in childhood.

Four-year follow-up of outcomes of the hybrid epicardial-endocardial ablation: A single-center experience

BackgroundThe CONVERGE trial demonstrated that hybrid epicardial and endocardial ablation was more effective than catheter ablation for the treatment of persistent atrial fibrillation (AF) at 1 year. Long-term real-world outcome data are scarce. ObjectiveWe described a single-center experience by evaluating the long-term effectiveness and safety of hybrid epicardial-endocardial ablation. MethodsThis is a retrospective single-center study. Patients were followed up to 4 years. The primary end point was the rate of AF recurrence up to 4 years postablation. Secondary end points included reduction in antiarrhythmic therapy use, the effect of the ligament of Marshall removal, epicardial posterior wall, 3-dimensional mapping during epicardial ablation, and left atrial appendage exclusion as adjunct intraoperative interventions for AF recurrence. ResultsOf the 170 patients, 86.5% had persistent AF and 13.5% had long-standing persistent AF. AF-free survival was 87.6% at 1 year, 76.9% at 2 years, 70.4% at 3 years, and 59.3% at 4 years. Antiarrhythmic drug use was 87.6% at baseline and reduced to 21%, 20.6%, 18%, and 14.1% at year 1, 2, 3, and 4, respectively (P < .01 for all). Three-dimensional epicardial mapping showed a significant reduction in combined recurrence from 42% to 25% over 4 years of follow-up (P = .023). Ligament of Marshall and left atrial appendage exclusion showed numerical reduction in AF recurrence from 35% to 26% (P = .49) and from 44% to 30% (P = .07). ConclusionThe hybrid convergent procedure reduces AF recurrence and the need for antiarrhythmic drugs and, while maintaining a good safety profile, for the treatment of persistent and long-standing persistent AF.

Abstract P156: Insurance Impact on Guideline-Directed Medical Therapy Prescription in HIV Heart Failure Patients: Past vs. Present Data From New York City's Largest Public Healthcare System

Introduction: Guideline-Directed Medical Therapy (GDMT), comprising renin-angiotensin system inhibitors, evidence-based β-blockers, mineralocorticoid inhibitors, and sodium glucose cotransporter 2 inhibitors, significantly enhances patient survival in heart failure cases. However, the impact of public insurance, private coverage, and being uninsured on GDMT for HIV heart failure patients is understudied. This research compares GDMT prescriptions across various insurance types over time. Method: This study analyzed data from the New York City Health + Hospitals HIV Heart Failure (NYC 4H) retrospective cohort, comprising records from eleven major NYC Health + Hospitals. Patients were recruited from hospital visits, both inpatient and clinic, spanning from July 2017 to June 2022. Follow-up records were reviewed between July 2022 and August 2023. Insurance types were determined based on primary insurance coverage in the medical charts. Guideline-directed medical therapy (GDMT) was reviewed at baseline and follow-up encounter. Insurance coverage and GDMT prescriptions were compared using chi-square tests. Multivariable logistic regression models, adjusted for age, sex, race, and co-morbidities, were employed to observe the association between insurance and GDMT prescriptions. Result: A total of 726 HIV heart failure patients participated in the study, including 263 with Medicare, 334 with Medicaid, 96 with private insurance, and 33 without insurance. Significant difference in GDMT prescriptions were evident at baseline, with &gt;1 and &gt;2 GDMT prescriptions being higher among uninsured (69.7% and 36.4%) and Medicare (66.2% and 37.6%) patients compared to Medicaid (54.8% and 29.9%) and private insurance patients (55.2% and 20.8%) (P&lt;0.05). Private insurance holders exhibited a 49% lower likelihood of receiving &gt;2 GDMT prescriptions than Medicare beneficiaries after adjusting for age, sex, race, and co-morbidities (adjusted odds ratio [aOR] 0.51, 95% confidence interval [CI] [0.28, 0.93], p&lt;0.05). Over the four-year follow-up, prescription rates for GDMT medications notably increased. However, disparities persisted in &gt;1 and &gt;2 GDMT prescriptions across insurance types, including 90.9% and 51.5% for uninsured, 76% and 48.3% for Medicare, 72.8% and 45.2% for Medicaid, and the lowest rates of 66.7% and 35.4% for private insurance patients, respectively (P&lt;0.05). After adjusting for covariates, no statistically significant differences in GDMT prescriptions were found across insurance type. Conclusion: GDMT prescriptions significantly improved over the follow-up period within HIV heart failure population. Although the differences diminished slightly, private insurance beneficiaries consistently exhibited the lowest GDMT prescription rates at both baseline and follow-up, in comparison to Medicare, Medicaid, and the uninsured population.

Is Less Surgical Treatment Possible in the Treatment of Degenerative Spine Diseases? Four-Year Follow-up Results of Foraminal Epidural and Facet Joint Injection Treatments

In this article, I would like to share my opinions about the article named 'Is Less Surgical Treatment Possible in the Treatment of Degenerative Spine Diseases? Four-Year Follow-up Results of Foraminal Epidural and Facet Joint Injection Treatments' (1). First of all, I would like to thank the authors. I will especially try to contribute to this article from the perspective of a physical medicine and rehabilitation physician.

Bariatric Nutritional Intervention in Obese Patients with Compensated Liver Cirrhosis: A Four-Year Prospective Study

BackgroundObesity and liver cirrhosis represent significant health challenges, often leading to various complications.AimsThis prospective study aimed to investigate the impact of a four-year bariatric intervention, focusing on adherence to the Mediterranean Diet, on anthropometric, hematologic, and biochemical parameters in obese patients with compensated liver cirrhosis. Additionally, the study evaluated the concurrent contribution of weight loss to these health indicators.MethodsThe study involved 62 patients with compensated liver cirrhosis (mean age 65.87 ± 6 years) and 44 healthy controls (mean age 59.11 ± 8 years), all with a BMI > 30 kg/m2. Both groups underwent a weight loss intervention based on the Mediterranean diet, with a four-year follow-up. Anthropometric, biochemical and hematologic parameters were evaluated at several time points during the study and their statistical significance was assessed.ResultsAnthropometric parameters, including weight, BMI, waist and hip circumference, percentage of fat mass, and handgrip strength, exhibited significant improvements (p < 0.05), particularly within the first year of the intervention. Liver function tests and lipid profiles of the patients also showed significant enhancements (p < 0.05). Hematological and biochemical indices, such as hematocrit and ferritin, experienced discreet improvements in the patient cohort (p < 0.05).ConclusionsThis study highlights the potential of a structured bariatric intervention rooted in the Mediterranean diet to positively influence the health of obese patients with compensated liver cirrhosis. The observed improvements in anthropometric, biochemical, and hematologic parameters, particularly within the first year of the intervention, suggest the importance of dietary modifications in managing the health of this patient population.

Association between Handgrip strength weakness and asymmetry with incident hip fracture among older Chinese adults

BackgroundTo evaluate the association between handgrip strength (HGS) weakness and asymmetry with incident hip fracture among older Chinese adults. MethodsData was obtained from the 2011 and 2015 waves of the China Health and Retirement Longitudinal Study (CHARLS). HGS weakness was defined as maximal HGS < 28 kg in men and < 18 kg in women. HGS asymmetry was defined as the HGS ratio < 0.9 or > 1.1. Participants were categorized into normal HGS, weakness only, asymmetry only, and both weakness and asymmetry. Given the sex differences in HGS, the association between HGS weakness and asymmetry was analyzed by sex using the multivariable logistic regression models. ResultsA total of 4789 participants aged ≥ 60 years old without hip fracture at baseline were included in the final analysis. Over the four-year follow-up, there were 152 (3.17%) participants having incident hip fractures, of which 69 (2.90%) were men and 83 (3.45%) were women. Compared to the normal group, men with both weakness and asymmetry had a significantly higher risk of incident hip fracture in the fully adjusted model (adjusted odds ratio (OR): 2.31, 95% confidence interval (CI):1.17-4.52). There was no significant association between HGS asymmetry and weakness with hip fracture in women. ConclusionsOur findings indicated that among the Chinese population, men with both HGS weakness and asymmetry were associated with increased odds of hip fracture, while no significant association was observed in women.

Interventions of Polish Emergency Medical Teams in patients with malignant tumors — a four-year follow-up (2019–2022)

Interventions of Polish Emergency Medical Teams in patients with malignant tumors — a four-year follow-up (2019–2022)

Good Short-Term Survivorship of Constrained Condylar Revision Knee Implants With Medial Pivot Kinematics: A Level IV Retrospective Study

BackgroundThe need for revision total knee arthroplasty surgery is increasing worldwide, and, in many cases, a constrained implant is required to provide joint stability. The purpose of this study was to examine the early loosening and functional outcome of a novel constrained condylar (CCK) revision total knee system designed to have medial pivot (MP) kinematics. MethodsA retrospective cohort study was performed, collecting clinical data from all patients who underwent revision total knee arthroplasty using a novel MP CCK system with a minimum four-year clinical follow-up. Patient demographics, survivorship, complications, and Forgotten Joint Score were analyzed based upon chart review. ResultsThere were 49 patients available for follow-up, who had a 100% survivorship free of aseptic loosening. All-cause revision survivorship was 92%. There were 4 patients who subsequently underwent rerevision. The causes for rerevision included periprosthetic joint infection in 2 patients, coronal plane instability in one patient, and a traumatic knee dislocation in one patient. There were 45 patients who completed the Forgotten Joint Score, who had an average of 49.8 (± 32.8, range 6.25 to 100). ConclusionsAt 4 years, mid-term follow-up, this novel CCK revision total knee system designed to have MP kinematics had good patient-reported outcomes with no revision for aseptic loosening. Future studies should evaluate the mid- and long-term survivorship of this innovative implant.

Clinical and Radiographic Outcomes of Single Implant-Supported Zirconia Crowns Following a Digital and Conventional Workflow: Four-Year Follow-Up of a Randomized Controlled Clinical Trial.

This study aimed to compare the clinical and radiographic outcomes of single posterior screw-retained monolithic implant crowns following a digital and conventional workflow and to report on the survival/complication rate after a mean 4-year follow-up. Thirty patients with a single posterior tooth missing were rehabilitated with a bone-level implant. After a healing period of ≥3 months, they were subjected to both a digital and conventional workflow to fabricate two screw-retained monolithic implant crowns. The quantitative clinical adjustments to both crowns (intrasubject comparison) and a questionnaire were recorded at try-in. Thereafter, a crown of the digital and conventional workflows was randomly inserted. At the last follow-up, the marginal bone level (MBL), peri-implant health-related parameters (bleeding on probing (BoP), plaque, pocket probing depth (PPD)), and functional implant prosthodontic score (FIPS) were assessed. Furthermore, the implant survival and success rates and technical complications were evaluated. A total of 27 patients were followed for a mean period of 4.23 ± 1.10 years. There was no significant difference between the digital and conventional workflows regarding clinical adjustments and questionnaire outcomes. More than twice as many participants recommended digital (n = 16) compared to conventional impressions (n = 7) to friends. The implant survival and success rate were 100% and 96.3%, respectively. Furthermore, two de-cementations and one fracture of the ti-base abutment occurred. There were no significant differences in BoP, plaque, and PPD metrics between the two groups. The changes in the MBL between implant crown insertion (baseline) and the last follow-up were 0.07 ± 0.19 mm and 0.34 ± 0.62 mm in the digital and conventional groups, respectively (p = 0.195). The mean overall FIPS score was 8.11 ± 1.37 (range: 5-10). The clinical and radiographic outcomes of single screw-retained monolithic implant crowns were similar between both workflows after a mean of 4 years of service. The patients did not clearly prefer an impression technique for their restoration, although they would recommend the digital impression more often to friends. Thus, decision regarding clinical workflows may be based on the patient's and/or clinician's preference.

Self-Reported Oral Diseases and Their Association with the Frailty index among Older Japanese People: Four-Year Follow-Up.

Oral health is a relevant component for overall health. Oral disease onset at an early age and may harm several health dimensions, especially among older people, and has been associated with frailty. To evaluate associations between the Frailty Index (FI) and self-reported oral diseases among older, community-dwelling Japanese people. Cross-sectional and prospective analyses were performed. We analyzed data from 2,529 participants at the baseline and four-year follow-up of the Nihon University Japanese Longitudinal Study of Aging, which had a four-year follow-up. We used the self-reported number of teeth, self-reported satisfaction with dentures, and self-reported ability to chew hard food as independent variables. We computed an FI that included 40 deficits as the dependent variable. The FI score ranged from 0 to 1, with a higher score associated with adverse health outcomes and mortality. Considering a gamma distribution and controlling for age, gender, marital status, education, working status, and residence area, we fitted generalized linear models. We found that dissatisfied denture users had a 2.1% (95% CI 1.006-3.279) higher frailty score than non-denture users at the baseline and a 2.1% (95% CI 0.629-3.690) higher frailty score than non-denture users at the four-year follow-up. In the cross-sectional analysis, with each additional reported tooth at the baseline, the FI score was lower by 1.5% (95% CI -2.878 to -0.208) at the four-year follow-up. In both the cross-sectional and the prospective analyses, the FI scores increased as the ability to chew hard food decreased. Self-reported oral diseases are associated with the FI score cross-sectionally and prospectively. Identifying factors prospectively associated with frailty may improve strategies for the next generation of older people. Considering oral diseases may help clinicians personalize treatment plans for older people.

Cognition in offspring of patients diagnosed with schizophrenia or bipolar disorder at four-year follow-up

Cognition in offspring of patients diagnosed with schizophrenia or bipolar disorder at four-year follow-up

The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial

BackgroundThe Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway.MethodsParticipants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0–10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon.ResultsOverall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and − 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94.ConclusionsThe magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years.Trial registrationISRCTN: 92,545,361.

Does brace treatment following closed reduction of developmental dysplasia of the hip improve acetabular coverage?

Abduction bracing is commonly used to treat developmental dysplasia of the hip (DDH) following closed reduction and spica casting, with little evidence to support or refute this practice. The purpose of this study was to determine the efficacy of abduction bracing after closed reduction in improving acetabular index (AI) and reducing secondary surgery for residual hip dysplasia. We performed a retrospective review of patients treated with closed reduction for DDH at a single tertiary referral centre. Demographic data were obtained including severity of dislocation based on the International Hip Dysplasia Institute (IHDI) classification, age at reduction, and casting duration. Patients were prescribed no abduction bracing, part-time, or full-time wear post-reduction and casting. AI measurements were obtained immediately upon cast removal and from two- and four-year follow-up radiographs. A total of 243 hips underwent closed reduction and 82% (199/243) were treated with abduction bracing. There was no difference between those treated with or without bracing with regard to sex, age at reduction, severity of dislocation, spica duration, or immediate post-casting AI (all p > 0.05). There was no difference in hips treated with or without abduction brace with regard to AI at two years post-reduction (32.4° (SD 5.3°) vs 30.9° (SD 4.6°), respectively; p = 0.099) or at four years post-reduction (26.4° (SD 5.2°) vs 25.4° (SD 5.1°), respectively; p = 0.231). Multivariate analysis revealed only IHDI grade predicted AI at two years post-reduction (p = 0.004). There was no difference in overall rate of secondary surgery for residual dysplasia between hips treated with or without bracing (32% vs 39%, respectively; p = 0.372). However, there was an increased risk of early secondary surgery (< two years post-reduction) in the non-braced group (11.4% vs 2.5%; p = 0.019). Abduction bracing following closed reduction for DDH treatment is not associated with decreased residual dysplasia at two or four years post-reduction but may reduce rates of early secondary surgery. A prospective study is indicated to provide more definitive recommendations.

Clinical outcomes and predictors of long-term mortality, hemorrhagic and thromboembolic events in atrial fibrillation patients at different stages of chronic kidney disease: The CRAFT trial

Background Chronic kidney disease (CKD) coexisting with atrial fibrillation (AF) increases the risk of hemorrhage and ischemia. The study aimed to determine the relationship between different CKD stages and clinical outcomes of patients suffering from both CKD and AF and to determine the predictors of outcome. Methods The data was derived from multicenter CRAFT trial (NCT02987062). We have conducted a retrospective analysis of hospital records of 2663 AF patients divided in three groups according to their estimated glomerular filtration rate (eGFR) which was <30ml/min/1,73 m2 for group I (n=63), ≥30 and <60 ml/min/1,73 m2 for group II (n=947) and ≥60 ml/min/1,73 m2 for group III (n=1653). The primary study endpoint was major adverse event (MAE) during the mean four-year follow-up. Results The highest rate of MAE was observed in group I followed by group II and III. The rate of all-cause death was 60% in group I, 32% in group II and 15% in group III (p<0.001). Bleeding complications occurred in 25% of patients from group I, 23% from group II and 21% from group III (p=0.14). Thromboembolic events occurred in those groups at the rate of 21%, 14% and 12% respectively (p=0.011). The risk of death was 5 times higher in patients with eGFR<30 treated with vitamin K antagonists (VKA) (HR: 5.016, 95% CI: 1.533-16.417; p=0.007). Conclusions AF patients with CKD are at higher risk of MAE and that risk depends on the CKD stage. VKA treatment was linked to a higher mortality in AF patients with the lowest eGFR values.

Durability of the Efficacy and Safety of Dolutegravir-Based and Low-Dose Efavirenz-Based Regimens for the Initial Treatment of Human Immunodeficiency Virus Type 1 Infection in Cameroon: Week 192 Data of the NAMSAL-ANRS-12313 Study.

A prospective study was extended to the new antiretroviral and monitoring strategies in HIV-infected adults in low-income countries (NAMSAL-ANRS)-12313 trial, a 96-week open-label, multicenter, randomized phase 3 trial comparing dolutegravir (DTG) 50 mg with efavirenz 400 mg (EFV400), both administered with tenofovir disoproxil fumarate and lamivudine (TDF/3TC) as first-line treatment for antiretroviral therapy (ART)-naive people living with human immunodeficiency virus type 1 (HIV). Noninferiority of DTG to EFV400 was demonstrated at 48-week and sustained at 96 weeks. Here, we present results at 192-week. Previous trial participants were reconsented and followed up on their initial randomization arm (1:1 DTG/TDF/3TC:EFV400/TDF/3TC). Assessments included changes in viral suppression, biological parameters, and new serious adverse events (SAEs). Among the participants enrolled in the trial, 81% (499/613) were analyzed at week 192: 84% (261/310) on DTG/TDF/3TC and 78% (238/303) on EFV400/TDF/3TC. HIV RNA suppression was maintained in 69% (214/310) on DTG/TDF/3TC-based and 62% (187/303) on EFV400/TDF/3TC-based regimens (difference, 7.3% [95% confidence interval, -.20 to 14.83]; P = .057). Five (DTG/TDF/3TC = 2; EFV400/TDF/3TC = 3) new viral failures (World Health Organization definition) without related resistance DTG mutations and 24 new SAEs were observed (DTG/TDF/3TC = 13; EFV400/TDF/3TC = 11). Mean weight gain was +9.4 kg on DTG/TDF/3TC and +5.9 kg on EFV400/TDF/3TC. The percentage of participants with obesity increased from 6.9% to 27.7% on DTG/TDF/3TC (P < .0001) and from 8.3% to 16.7% on EFV400/TDF/3TC (P = .0033). Four-year follow-up of people with HIV on DTG- and EFV400-based regimens showed long-term efficacy and safety of both ARTs, markedly among participants on DTG/TDF/3TC with high baseline viral load. However, unexpected substantial weight gain over time was prominent among participants on DTG/TDF/3TC, which should be closely monitored. Clinical Trials Registration. NCT02777229.