Annals of medicine最新文献

Research objective: Medications for opioid use disorder (MOUDs) - including methadone, buprenorphine, and naltrexone - are the most effective treatments for opioid use disorder (OUD). Historically, insurers have required prior authorization for MOUD, but prior authorization is often reported as a key barrier to MOUD prescribing. Some states have passed laws prohibiting MOUD prior authorization requirements. We sought to identify the frequency of MOUD prior authorization prohibitions in state laws and to categorize types of prohibitions.

Methods: We searched for regulations and statutes present in all U.S. states and Washington DC between 2005 and 2019 using MOUD-related terms in Westlaw legal software. In qualitative software, we coded laws discussing MOUD prior authorization using template analysis - a mixed deductive/inductive approach. Finally, we used coded laws to identify frequencies of states with prior authorization prohibitions, including changes over time.

Results: No states had laws prohibiting MOUD prior authorization between 2005 and 2015, with the first prohibition appearing in 2016. By 2019, fifteen states had MOUD prior authorization prohibitions. States varied significantly in their approach to prohibiting MOUD prior authorization. In 2019, it was more common for states to have MOUD prior authorization prohibitions applying to all insurers (n = 10 states) than to only Medicaid (n = 7 states) or only non-Medicaid insurers (n = 1 state). In 2019, general prior authorization prohibitions (n = 10 states) were more common than prohibitions only applicable to medications on the formulary, prohibitions only applicable to medications on the preferred drug list, prohibitions only applicable during the first 5 days of treatment, and prohibitions only applicable during the first 30 days of treatment.

Conclusions: The number of states with an MOUD prior authorization law prohibition increased in recent years. Such laws could help expand access to life-saving OUD treatments by making it easier for clinicians to prescribe MOUD.KEY MESSAGESNo states had MOUD prior authorization prohibitions between 2005 and 2015 in state statutes or regulations, and only one state had such a prohibition in 2016.By 2019, fifteen states had an MOUD prior authorization prohibition law.States varied significantly in their approach to prohibiting MOUD prior authorization, including with respect to the insurer type, duration of the prohibition, and applicable medication.

Background: The purpose of this study was to explore the changes in blood cellular and biochemical parameters of rats in a natural environment of low pressure and low oxygen on the plateau.

Methods: Male Sprague-Dawley rats in two groups were raised in different environments from 4 weeks of age for a period of 24 weeks. They were raised to 28 weeks of age and then transported to the plateau medical laboratory of Qinghai University. Blood cellular and biochemical parameters were measured and the data of the two groups were statistically analyzed.

Results: 1. RBC in the HA group was higher than that in the Control group, but there was no significant difference between the two groups (p > 0.05), Compared with the Control group, HGB, MCV, MCH, MCHC and RDW in the HA group were significantly higher (p < 0.05). 2. Compared with the Control group, WBC, LYMP, EO, LYMP% and EO% in the HA group decreased significantly (p < 0.05), and ANC% increased significantly (p < 0.05). 3. In the platelet index, compared with the Control group, PLT in the HA group was significantly reduced (p < 0.05), PDW, MRV, P-LCR were significantly increased (p < 0.05). 4. In blood biochemical indicators, compared with the Control group, AST, TBIL, IBIL, LDH in the HA group decreased significantly (p < 0.05), CK in the HA group increased significantly (p < 0.05).

Conclusions: 1. The indexes related to red blood cells, white blood cells, platelets and some biochemical indexes in the blood of rats at high altitude have changed. 2. Under the high altitude environment, the oxygen carrying capacity of SD rats is improved, the resistance to disease may be reduced, the coagulation and hemostasis functions may be affected, and there is a risk of bleeding. The liver function, renal function, heart function and skeletal muscle energy metabolism may be affected. 3. This study can provide an experimental basis for the research on the pathogenesis of high-altitude diseases from the perspective of blood.KEY MESSAGESIn this study, red blood cells, white blood cells, platelets and blood biochemical indicators were included in the real plateau environment to comprehensively analyze the changes of blood cellular and biochemical parameters in rats under the chronic plateau hypobaric hypoxia environment.From the perspective of blood, this study can provide an experimental basis for research on the pathogenesis of high-altitude diseases.Explore the data support of oxygen-carrying capacity, disease resistance and energy metabolism of the body in the natural environment at high altitude.

Background: Multiple myeloma (MM) is an incurable malignancy. Venetoclax (VEN) shows a meaningful effect in MM patients who are relapsed or refractory (RR) to previous standard therapies.

Objective: This study aimed to assess the efficacy and safety of VEN-based treatments in RR MM patients.

Materials and methods: Comprehensive studies were searched in PubMed, Embase, Web of Science and Cochrane library. Efficacy was assessed by overall response rate (ORR), strict complete response rate (sCR), complete response rate (CR), very good partial response rate (VGPR) and partial response rate (PR).

Results: Seven studies containing 482 subjests were included. The pooled ORR, ≥ CR (sCR + CR), VGPR and PR were 68% (51%-85%), 24% (13%-35%), 25% (17%-34%) and 17% (11%-24%) respectively. Multi-drug treatments were superior to VEN ± dexamethasone (Dex) treatments in ORR (82% vs 42%, p = .003) and ≥ CR (36% vs 7%, p < 0.00001). Subgroup analysis indicated patients achieve higher ORR who harboring t(11;14) translocation or containing high BCL-2 expression.

Conclusions: VEN-containing regimens could be suggested as effective and safe treatments to RR MM patients with t(11;14) or high BCL-2 levels.

Background/objective(s)/introduction: TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine, which was developed and recently granted emergency use authorization (conditional marketing authorization) in Türkiye. The objective of this study is to assess the spectrum and the distribution of adverse events reported following the administration of the first 150,000 doses as primary and booster vaccine doses in 22 state hospitals of 17 provinces in Türkiye.

Patients/materials and methods: In this cohort study, a verbal survey was conducted via telephone calls between 10 January and 17 January 2022, utilizing a structured questionnaire algorithm on a sample group of 20,000 persons on the third- and seventh-days following vaccination. The algorithm consisted of two parts focusing on both systemic and local adverse effects. Other adverse events reported by the participants were also recorded. 6023 people and 5345 people agreed to participate in the telephone survey on the 3rd- and 7th- days of having received the first dose of the vaccine, respectively.

Results: Thirty-six-point-six percent of the participants on the 3rd day and 22.5% of the participants on the 7th day reported any adverse event following the first dose of the vaccine. On both follow-up days, the most commonly reported (29.7% for Day 3 and 13.1% for Day 7) adverse events were on the injection site. Among the local adverse events, the most frequently reported one was the pain on the injection site (27.9% for Day 3 and 12.4% for Day 7), induration (4.8% for Day 3 and 2.7% for Day 7) and swelling (3.5% for Day 3 and 2.0% for Day 7). Fatigue/weakness (9.6% for Day 3 and 8.3% for Day 7) and headache (7.9% for Day 3 and 8.0% for Day 7) were the most frequent systemic adverse events. Younger age, vaccine dose, and female sex were associated with having any adverse event and pain (on the injection site). Female sex was associated with more swelling (on the injection site), induration (on the injection site), fever, and a higher impact on daily living.

Conclusion(s): In this study, we conducted a rapid assessment of adverse events following the first dose of the TURKOVAC vaccine. The vaccine appears to have a good safety profile in the first 7 days following vaccination. Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines.

Background: Among malignant neoplasm patients taking immune checkpoint inhibitors (ICIs), it remains unknown how the systemic immune-inflammation index (SII) affects their clinical prognosis. We therefore performed the present meta-analysis by collecting the most recent data, so that SII's prognostic value among ICI-receiving carcinoma patients could be fully clarified.

Methods: For the prognostic significance evaluation of SII in ICI-receiving carcinoma patients, the combined hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated.

Results: The number of studies enrolled in the present meta-analysis totaled 17, where 1,990 patients were involved. Among the ICI-treated carcinoma patients, a high SII was linked significantly to inferior overall survival (OS) (HR = 2.62, 95% CI = 1.76-3.90), as well as progression-free survival (PFS) (HR = 2.09, 95% CI = 1.48-2.95) (p both <.001). Contrastively, SII was linked insignificantly to the age (OR = 1.08, 95% CI = 0.39-2.98, p = .881), gender (OR = 1.01, 95% CI = 0.59-1.73, p = .959), lymph node (LN) metastasis (OR = 1.41, 95% CI = 0.92-2.17, p = .117), or metastatic site quantity (OR = 1.49, 95% CI = 0.90-2.46, p = .119).

Conclusion: There are prominent associations of elevated SII with the poor survival outcomes (both short- and long-terms) among the ICIreceiving carcinoma patients. SII has potential as a reliable and cheap prognostic biomarker in the clinic for carcinoma patients receiving ICIs.

Background: At the start of the pandemic, relaxation of buprenorphine prescribing regulations created an opportunity to create new models of medications for opioid use disorder (MOUD) delivery and care. To expand and improve access to MOUD, we adapted and implemented the Tele-Harm Reduction (THR) intervention; a multicomponent, telehealth-based and peer-driven intervention to promote HIV viral suppression among people who inject drugs (PWID) accessing a syringe services program (SSP). This study examined buprenorphine initiation and retention among PWID with opioid use disorder who received the adapted THR intervention at the IDEA Miami SSP.Methods: A retrospective chart review of participants who received the THR intervention for MOUD was performed to examine the impact of telehealth on buprenorphine retention. Our primary outcome was three-month retention, defined as three consecutive months of buprenorphine dispensed from the pharmacy.Results: A total of 109 participants received the adapted THR intervention. Three-month retention rate on buprenorphine was 58.7%. Seeing a provider via telehealth at baseline or any follow up visit (aOR = 7.53, 95% CI: [2.36, 23.98]) and participants who had received an escalating dose of buprenorphine after baseline visit (aOR = 8.09, 95% CI: [1.83, 35.87]) had a higher adjusted odds of retention at three months. Participants who self-reported or tested positive for a stimulant (methamphetamine, amphetamine, or cocaine) at baseline had a lower adjusted odds of retention on buprenorphine at three months (aOR = 0.29, 95% CI: [0.09, 0.93]).Conclusions: Harm reduction settings can adapt dynamically to the needs of PWID in provision of critical lifesaving buprenorphine in a truly destigmatising approach. Our pilot suggests that an SSP may be an acceptable and feasible venue for delivery of THR to increase uptake of buprenorphine by PWID and promote retention in care.KEY MESSAGESThe Tele-Harm Reduction intervention can be adapted for initiating and retaining people who inject drugs with opioid use disorder on buprenorphine within a syringe services program settingUsing telehealth was associated with increased three-month buprenorphine retentionBaseline stimulant use was negatively associated with three-month buprenorphine retention.

Background: Sleep disturbance and fatigue are prevalent in nurses. Little is known about the characteristics of shift work nurses' sleep-wake features and their subsequent impact on work performance. The study aimed to describe the characteristics of the sleep-wake index, reaction time, saliva cortisol level, and fatigue severity among female shift work nurses.

Methods: This is a cross-sectional exploratory study. A convenience sample of 152 female nurses (8-hour day-evening-night, n = 70; 12-hour day-night, n = 82) participated in this study from nine intensive care units (ICUs) from two teaching hospitals in Beijing, China. A consecutive 7-day actigraphy data were used to analyse sleep-wake indexes, including total sleep time (TST) and circadian activity rhythms (CAR). Before and after shifts, the following data were collected, psychomotor vigilance task for reaction time, saliva cortisol for the level of alertness, and self-reported fatigue severity with the Lee Fatigue Scale-Short Form.

Results: All nurses reported clinically significant fatigue severity. Compared with the 8-hour shift nurses, the 12-hour shift nurses had significantly more TST (456 vs. 364 min), higher saliva cortisol levels before the day shift (0.54 vs. 0.31), but longer reaction time before the night shift (286 vs. 277 ms). In both shifts, those with better CAR had significantly longer TST.

Conclusion: Female nurses experienced fatigue and desynchronized CAR, especially nurses on a 12-hour shift. The CAR-friendly shift work schedule is needed to minimize the health and safety impacts of circadian misalignment for nurses.Key messagesThis is the first use of consecutive 7-day actigraphy data to explore the link between sleep disturbances as a stressor to CAR, salivary cortisol, and reaction time among clinical nurses.CAR may be a helpful indicator for overworked nurses, and it can serve as a modifiable target for interventions to enhance nurses' well-being.

Purpose: The present study aimed to construct and validate a Swedish translation (VVAS-S) of the Visual Vertigo Analogue Scale (VVAS).

Materials and methods: The original English VVAS was translated into Swedish by the two authors and back-translated by an independent professional translator. Pilot-tests were performed on two healthy participants and five patients suffering from Visually Induced Dizziness (VID). The translation was deemed understandable by all subjects. Twenty-one patients with VID were recruited to complete the VVAS-S, once in-lab and once at home after 2-3 weeks. Cronbach's alpha, inter-item consistency and internal consistency were calculated.

Results: Test-retest values were reliably strong across all items. Cronbach's alpha was 0.843, which is considered to represent very-high reliability. The corrected-item total-correlation was above 0.3 for all items, meaning they were appropriately associated with one-another. Fourteen out of 36 inter-item correlation interactions were within the 0.2-0.4 range.

Conclusions: The VVAS-S was found to be comparable to the original VVAS in terms of internal reliability. The translation was perceived as easy to implement by all participants and can be considered ready for clinical use in a Swedish-speaking setting. Item-specific correlations may be valuable for developing future vertigo questionnaires.Key messagesThe Swedish version of the Visual Vertigo Analogue Scale is a questionnaire suitable for evaluating visually induced dizziness in a Swedish population. This study found that the Swedish questionnaire was comparable to the original in terms of internal consistency. The Swedish Visual vertigo Analogue Scale can be found as an appendix to this article.

Introduction: Heterogeneity exists in sepsis-associated acute kidney injury (SA-AKI). This study aimed to perform unsupervised consensus clustering in critically ill patients with dialysis-requiring SA-AKI.

Patients and methods: This prospective observational cohort study included all septic patients, defined by the Sepsis-3 criteria, with dialysis-requiring SA-AKI in surgical intensive care units in Taiwan between 2009 and 2018. We employed unsupervised consensus clustering based on 23 clinical variables upon initializing renal replacement therapy. Multivariate-adjusted Cox regression models and Fine-Gray sub-distribution hazard models were built to test associations between cluster memberships with mortality and being free of dialysis at 90 days after hospital discharge, respectively.

Results: Consensus clustering among 999 enrolled patients identified three sub-phenotypes characterized with distinct clinical manifestations upon renal replacement therapy initiation (n = 352, 396 and 251 in cluster 1, 2 and 3, respectively). They were followed for a median of 48 (interquartile range 9.5-128.5) days. Phenotypic cluster 1, featured by younger age, lower Charlson Comorbidity Index, higher baseline estimated glomerular filtration rate but with higher severity of acute illness was associated with an increased risk of death (adjusted hazard ratio of 3.05 [95% CI, 2.35-3.97]) and less probability to become free of dialysis (adjusted sub-distribution hazard ratio of 0.55 [95% CI, 0.38-0.8]) than cluster 3. By examining distinct features of the sub-phenotypes, we discovered that pre-dialysis hyperlactatemia ≥3.3 mmol/L was an independent outcome predictor. A clinical model developed to determine high-risk sub-phenotype 1 in this cohort (C-static 0.99) can identify a sub-phenotype with high in-hospital mortality risk (adjusted hazard ratio of 1.48 [95% CI, 1.25-1.74]) in another independent multi-centre SA-AKI cohort.

Conclusions: Our data-driven approach suggests sub-phenotypes with clinical relevance in dialysis-requiring SA-AKI and serves an outcome predictor. This strategy represents further development toward precision medicine in the definition of high-risk sub-phenotype in patients with SA-AKI.Key messagesUnsupervised consensus clustering can identify sub-phenotypes of patients with SA-AKI and provide a risk prediction.Examining the features of patient heterogeneity contributes to the discovery of serum lactate levels ≥ 3.3 mmol/L upon initializing RRT as an independent outcome predictor.This data-driven approach can be useful for prognostication and lead to a better understanding of therapeutic strategies in heterogeneous clinical syndromes.

Background: In the last three decades, both medical and sports science professionals have recognized the considerable potential of digital-based interventions (DBI) to enhance the health-related outcomes of their practitioners.

Objectives: This study aimed to investigate the effectiveness and potential moderators of DBI on measures of muscular strength.

Methods: Six databases (PubMed/MEDLINE, Web of Science, SportDiscus, Embase, Cochrane Register of Controlled Trials and Google Scholar) were searched for eligible studies up to June 2022. The GRADE, PEDRO, and TIDieR checklists were used to assess the quality of evidence, methodology, and completeness of intervention descriptions, respectively.

Results: A total of 56 studies were included in the meta-analysis (n = 2346), and participants were classified as healthy (n = 918), stroke survivors (n = 572), diagnosed with other neurological disorders (n = 683), and frail (n = 173). The DBI showed a small effect (standardized mean difference [SMD] = 0.28, 95% CI 0.21 to 0.31; p < 0.001) on strength, regardless of the type of intervention, control group, or tested body part. More specifically, while splitting the studies into different subgroups, a meta-analysis of 19 studies (n = 918) showed a small effect (SMD = 0.38, 95% CI 0.12 to 0.63; p = 0.003) on strength in the asymptomatic population. Similarly, small but positive effects of DBI were observed for stroke survivors (SMD = 0.34, 95% CI 0.13 to 0.56; p = 0.002), patients diagnosed with other neurological disorders (SMD = 0.17, 95% CI 0.03 to 0.32; p = 0.021), and the frail population (SMD = 0.25, 95% CI 0.0 to 0.5; p = 0.051). Sub-group analysis and meta-regression revealed that neither variable modified the effects of the DBI on measures of strength.

Conclusions: Overall, DBI may serve as an effective method to improve measures of strength in adults, regardless of their health status as well as the type of digital device, the presence of human-computer interaction, and the age of participants. In addition, the DBI was found to be more effective than traditional training or rehabilitation methods.KEY MESSAGESDigital-based intervention (DBI) is effective in improving measures of muscular strength in adults regardless of participants' health statusDBIs were equally effective for strength improvements in lower and upper limbsAlthough, DBIs were found to be effective in improving muscular strength, most studies did not follow strength training guidelines when prescribing the interventions.