Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial.

BACKGROUND: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient's recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient's recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring. METHODS: This non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery. DISCUSSION: This study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period. TRIAL REGISTRATION: The 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial' is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, 'Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial', is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772).

Continuous erector spinae plane block versus thoracic epidural analgesia in video-assisted thoracic surgery: a study protocol for a prospective randomized open label non-inferiority trial.

BACKGROUND: Thoracic epidural analgesia is considered the gold standard for pain relief in video-assisted thoracoscopic surgery. This neuraxial technique blocks pain sensation by injecting a local anesthetic agent in the epidural space near the spinal cord to block spinal nerve roots. Recently, the erector spinae plane block has been introduced as a practical alternative to the thoracic epidural. This interfascial regional anesthesia technique interrupts pain sensation by injecting a local anesthetic agent in between the muscular layers of the thoracic wall. Several case series and three RCTs described it as an effective pain management technique in video-assisted thoracoscopic surgery (Scimia et al., Reg Anesth Pain Med 42:537, 2017; Adhikary et al., Indian J Anaesth 62:75-8, 2018; Kim, A randomized controlled trial comparing continuous erector spinae plane block with thoracic epidural analgesia for postoperative pain management in video-assisted thoracic surgery, n.d.; Yao et al., J Clin Anesth 63:109783, 2020; Ciftci et al., J Cardiothorac Vasc Anesth 34:444-9, 2020). The objective of this study is to test the hypothesis that a continuous erector spinae plane block incorporated into an opioid-based systemic multimodal analgesia regimen is non-inferior in terms of the quality of postoperative recovery compared to continuous thoracic epidural local anesthetic-opioid analgesia in patients undergoing elective unilateral video-assisted thoracoscopic surgery. METHODS: This is a prospective randomized open label non-inferiority trial. A total of 90 adult patients undergoing video-assisted thoracoscopic surgery will be randomized 1:1 to receive pain treatment with either (1) continuous erector spinae plane block plus intravenous patient-controlled analgesia with piritramide (study group) or (2) continuous thoracic epidural analgesia with a local anesthetic-opioid infusate (control group). All patients will receive additional systemic multimodal analgesia with paracetamol and non-steroidal anti-inflammatory drugs. The primary endpoint is the quality of recovery as measured by the Quality of Recovery-15 score. Secondary endpoints are postoperative pain as Numerical Rating Score scores, length of hospital stay, failure of analgesic technique, postoperative morphine-equivalent consumption, itching, nausea and vomiting, total operative time, complications related to surgery, perioperative hypotension, complications related to pain treatment, duration of bladder catheterization, and time of first assisted mobilization > 20 m and of mobilization to sitting in a chair. DISCUSSION: This randomized controlled trial aims to confirm whether continuous erector spinae plane block plus patient-controlled opioid analgesia can equal the analgesic effect of a thoracic epidural local anesthetic-opioid infusion in patients undergoing video-assisted thoracoscopic surgery. TRIAL REGISTRATION: Netherlands Trial Register NL6433 . Registered on 1 March 2018. This trial was prospectively registered.

The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial.

Robot-assisted radical prostatectomy causes discomfort in the immediate postoperative period. This randomised controlled trial investigated if intrathecal bupivacaine/morphine, in addition to general anaesthesia, could be beneficial for the postoperative quality of recovery. One hundred and fifty-five patients were randomly allocated to an intervention group that received intrathecal 12.5 mg bupivacaine/300 µg morphine (20% dose reduction in patients > 75 years) or a control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1 mg.kg-1 morphine. Both groups received standardised general anaesthesia and the same postoperative analgesic regimen. The primary outcome was a decrease in the Quality of Recovery-15 (QoR-15) questionnaire score on postoperative day 1. The intervention group (n = 76) had less reduction in QoR-15 on postoperative day 1; median (IQR [range]) 10% (1-8 [-60% to 50%]) vs. 13% (5-24 [-6% to 50%]), p = 0.019, and used less morphine during the admission; 2 mg (1-7 [0-41 mg]) vs. 15 mg (12-20 [8-61 mg]), p < 0.001. Furthermore, they perceived lower pain scores during exertion; numeric rating scale (NRS) 3 (1-6 [0-9]) vs. 5 (3-7 [0-9]), p = 0.001; less bladder spasms (NRS 1 (0-2 [0-10]) vs. 2 (0-5 [0-10]), p = 0.001 and less sedation; NRS 2 (0-3 [0-10]) vs. 3 (2-6 [0-10]), p = 0.005. Moreover, the intervention group used less rescue medication. Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000. We conclude that despite a modest increase in the incidence of pruritus, multimodal pain management with intrathecal bupivacaine/morphine remains a viable option for robot-assisted radical prostatectomy.

Beware of thermal epiglottis! A case report describing 'teapot syndrome'.

BACKGROUND: The type of scalding injury known as 'teapot syndrome', where hot liquid is grabbed by the child with the aim of ingestion and falls over a child causing burns on the face, upper thorax and arms, is known to cause peri-oral and facial oedema. Thermal epiglottitis following scalds to face, neck and thorax is rare and can occur even in absence of ingestion of a damaging agent or intraoral burns, Awareness of the possibility of thermal epiglottitis, also in scald burns, is imperative to ensure prompt airway protection. CASE PRESENTATION: We report the case of a child with thermal epiglottitis after a scalding burn from boiling milk resulting in mixed deep burns of the face, neck and chest, but no history of ingestion. Upon presentation there was a progressive stridor and signs of respiratory distress requiring intubation. Laryngoscopy revealed epiglottis oedema, confirming the diagnosis of thermal epiglottitis. Final extubation took place 5 days after initial burn. CONCLUSIONS: Thermal epiglottitis following scalds to face, neck and thorax is rare and can occur even in absence of ingestion and intra-oral damage. Burns to the peri-oral area should raise suspicion of additional damage to oral cavity and supraglottic structures, even in absence of intra-oral injury or initial respiratory distress. Awareness of the occurrence of thermal epiglottitis in absence of intra-oral injury is important to diagnose impending upper airway obstruction requiring intubation.

Dynamics affecting the risk of silent circulation when oral polio vaccination is stopped.

Waning immunity could allow transmission of polioviruses without causing poliomyelitis by promoting silent circulation (SC). Undetected SC when oral polio vaccine (OPV) use is stopped could cause difficult to control epidemics. Little is known about waning. To develop theory about what generates SC, we modeled a range of waning patterns. We varied both OPV and wild polio virus (WPV) transmissibility, the time from beginning vaccination to reaching low polio levels, and the infection to paralysis ratio (IPR). There was longer SC when waning continued over time rather than stopping after a few years, when WPV transmissibility was higher or OPV transmissibility was lower, and when the IPR was higher. These interacted in a way that makes recent emergence of prolonged SC a possibility. As the time to reach low infection levels increased, vaccine rates needed to eliminate polio increased and a threshold was passed where prolonged low-level SC emerged. These phenomena were caused by increased contributions to the force of infection from reinfections. The resulting SC occurs at low levels that would be difficult to detect using environmental surveillance. For all waning patterns, modest levels of vaccination of adults shortened SC. Previous modeling studies may have missed these phenomena because (1) they used models with no or very short duration waning and (2) they fit models to paralytic polio case counts. Our analyses show that polio case counts cannot predict SC because nearly identical polio case count patterns can be generated by a range of waning patterns that generate different patterns of SC. We conclude that the possibility of prolonged SC is real but unquantified, that vaccinating modest fractions of adults could reduce SC risk, and that joint analysis of acute flaccid paralysis and environmental surveillance data can help assess SC risks and ensure low risks before stopping OPV.

Dynamic Variation in Sexual Contact Rates in a Cohort of HIV-Negative Gay Men.

Human immunodeficiency virus (HIV) transmission models that include variability in sexual behavior over time have shown increased incidence, prevalence, and acute-state transmission rates for a given population risk profile. This raises the question of whether dynamic variation in individual sexual behavior is a real phenomenon that can be observed and measured. To study this dynamic variation, we developed a model incorporating heterogeneity in both between-person and within-person sexual contact patterns. Using novel methodology that we call iterated filtering for longitudinal data, we fitted this model by maximum likelihood to longitudinal survey data from the Centers for Disease Control and Prevention's Collaborative HIV Seroincidence Study (1992-1995). We found evidence for individual heterogeneity in sexual behavior over time. We simulated an epidemic process and found that inclusion of empirically measured levels of dynamic variation in individual-level sexual behavior brought the theoretical predictions of HIV incidence into closer alignment with reality given the measured per-act probabilities of transmission. The methods developed here provide a framework for quantifying variation in sexual behaviors that helps in understanding the HIV epidemic among gay men.

Medical history and the onset of complex regional pain syndrome (CRPS).

Knowledge concerning the medical history prior to the onset of complex regional pain syndrome (CRPS) might provide insight into its risk factors and potential underlying disease mechanisms. To evaluate prior to CRPS medical conditions, a case-control study was conducted in the Integrated Primary Care Information (IPCI) project, a general practice (GP) database in the Netherlands. CRPS patients were identified from the records and validated through examination by the investigator (IASP criteria) or through specialist confirmation. Cases were matched to controls on age, gender and injury type. All diagnoses prior to the index date were assessed by manual review of the medical records. Some pre-specified medical conditions were studied for their association with CRPS, whereas all other diagnoses, grouped by pathogenesis, were tested in a hypothesis-generating approach. Of the identified 259 CRPS patients, 186 cases (697 controls) were included, based on validation by the investigator during a visit (102 of 134 visited patients) or on specialist confirmation (84 of 125 unvisited patients). A medical history of migraine (OR: 2.43, 95% CI: 1.18-5.02) and osteoporosis (OR: 2.44, 95% CI: 1.17-5.14) was associated with CRPS. In a recent history (1-year before CRPS), cases had more menstrual cycle-related problems (OR: 2.60, 95% CI: 1.16-5.83) and neuropathies (OR: 5.7; 95% CI: 1.8-18.7). In a sensitivity analysis, including only visited cases, asthma (OR: 3.0; 95% CI: 1.3-6.9) and CRPS were related. Psychological factors were not associated with CRPS onset. Because of the hypothesis-generating character of this study, the findings should be confirmed by other studies.

Maximizing statistical power in group-randomized vaccine trials.

Statistical power in group-randomized vaccine trials is complex: group randomization may increase power by capturing more transmission effects but may decrease power as more individuals are affected by a common source of variance. The former effect dominates when most infections arise from within the group and the latter when most arise outside. This process is complicated further when individuals possess partial natural immunity. Vaccine trials typically compare infection frequency (as measured by agent or antibody detection) in vaccinated vs. unvaccinated groups. To assess the relative contributions to statistical power by direct agent detection vs. serological detection of recent infection, we constructed stochastic compartmental models using differential equations describing all possible discrete states of the group. We contrasted models where natural immunity was absent, altered only the susceptible state, or altered both the susceptible and infected states. We observed the effects of endemic infection levels, the fraction of infection arising from outside the group, infectiousness vs. susceptibility vaccine effects and waning rates. There was significant enhancement of statistical power when serological testing separated infected and susceptible classes into subsets by natural immunity status.

The effects of socioeconomic development on worldwide hepatitis A virus seroprevalence patterns.

BACKGROUND: Hepatitis A virus (HAV) infection confers long-term immunity, so mathematical analysis of age-specific seroprevalence in populations can reveal changes in the infection rate over time. HAV transmission is related to access to clean drinking water, personal hygiene and public sanitation. METHODS: We used an SIR (susceptible-infectious-recovered) compartmental model with age structure to fit a time-dependent logistic function for HAV force of infection for 157 published age-seroprevalence data sets. We then fit linear regression models for socioeconomic variables and infection rate. RESULTS: The proportion of the population with access to clean drinking water, the value of the human development index (HDI), and per capita gross domestic product (GDP) are all inverse predictors of HAV infection rates. Declining infection rates were observed in 65.6% of the surveys. Discussion This work demonstrates the utility of HAV seroprevalence studies to reveal patterns of change in force of infection and to assess the association between socioeconomic risk factors and transmission rates.

A stochastic model of vaccine trials for endemic infections using group randomization.

To clarify the determinants of vaccine trial power for non-typable Haemophilus influenzae, we constructed stochastic SIS models of infection transmission in small units (e.g. day-care centres) to calculate the equilibrium distribution of the number infected. We investigated how unit size, contact rate (modelled as a function of the unit size), external force of infection and infection duration affected the statistical power for detection of vaccine effects on susceptibility or infectiousness. Given a frequency-dependent contact rate, the prevalence, proportion of infections generated internally and the power to detect vaccine effects each increased slightly with unit size. Under a density-dependent model, unit size had much stronger effects. To maximize information allowing inference from vaccine trials, contact functions should be empirically evaluated by studying units of differing size and molecular methods should be used to help distinguish internal vs. external transmission.

Declining hepatitis A seroprevalence: a global review and analysis.

Hepatitis A virus (HAV) is spread by faecal-oral contact or ingestion of contaminated food or water. Lifelong immunity is conferred by infection or vaccination, so anti-HAV seroprevalence studies can be used to indicate which populations are susceptible to infection. Seroprevalence rates are highly correlated with socioeconomic status and access to clean water and sanitation. Increasing household income, education, water quality and quantity, sanitation, and hygiene leads to decreases in HAV prevalence. Japan, Australia, New Zealand, Canada, the United States, and most European nations have low anti-HAV rates. Although anti-HAV rates remain high in most Latin American, Asian, and Middle Eastern nations, average seroprevalence rates are declining. Surveys from Africa generally indicate no significant decline in anti-HAV rates. Because the severity of illness increases with age, populations with a high proportion of susceptible adults should consider targeted vaccination programmes.

Methods and measures for the description of epidemiologic contact networks.

This article describes new methods to characterize epidemiologic contact networks that involve links that are being dynamically formed and dissolved. The new social network measures are designed with an epidemiologic interpretation in mind. These methods are intended to capture dynamic aspects of networks related to their potential to spread infection. This differs from many social network measures that are based on static networks. The networks are formulated as transmission graphs (TGs), in which nodes represent relationships between two individuals and directed edges (links) represent the potential of an individual in one relationship to carry infection to an individual in another relationship. Network measures derived from transmission graphs include "source counts," which are defined as the number of prior relationships that could potentially transmit infection to a particular node or individual.

Infection transmission system models for microbial risk assessment.

Chemical risk assessments often focus on measuring exposure as if individuals were subject only to exogenous environmental sources of risk. For infectious diseases, exposure might not only depend on exogenous sources of microbes, but also on the infection status of other individuals in the population. For example, waterborne infections from agents such as Cryptosporidium parvum and Escherichia coli: O157:H7 might be transmitted from contaminated water to humans through drinking water; from interpersonal contact; or from infected individuals to the environment, and back to other susceptible individuals. These multiple pathways and the dependency of exposure on the prevalence of infection in a population suggest that epidemiological models are required to complement standard risk assessments in order to quantify the risk of infection. This paper presents new models of infection transmission systems that are being developed for the US Environmental Protection Agency as part of a project to quantify the risk of microbial infection. The models are designed to help inform water treatment system design decisions.

Bias reduction for risk ratio and vaccine effect estimators.

We examine the structural bias for established estimators of vaccine effects on susceptibility and for newer estimates of vaccine effects on infectiousness. We then propose and analyse new bias corrections for vaccine effect estimators of both susceptibility and infectiousness, as well as their combined effect on infection transmission. Each estimator is evaluated empirically with computer simulations. Of the estimators examined in this paper, those with the least bias and root mean squared error are computed by adding one to the positive count in the placebo population. We also identify a source of bias for a standard Bayesian estimator of risk ratios.

New data and tools for integrating discrete and continuous population modeling strategies.

Realistic population models have interactions between individuals. Such interactions cause populations to behave as systems with nonlinear dynamics. Much population data analysis is done using linear models assuming no interactions between individuals. Such analyses miss strong influences on population behavior and can lead to serious errors--especially for infectious diseases. To promote more effective population system analyses, we present a flexible and intuitive modeling framework for infection transmission systems. This framework will help population scientists gain insight into population dynamics, develop theory about population processes, better analyze and interpret population data, design more powerful and informative studies, and better inform policy decisions. Our framework uses a hierarchy of infection transmission system models. Four levels are presented here: deterministic compartmental models using ordinary differential equations (DE); stochastic compartmental (SC) models that relax assumptions about population size and include stochastic effects; individual event history models (IEH) that relax the SC compartmental structure assumptions by allowing each individual to be unique. IEH models also track each individual's history, and thus, allow the simulation of field studies. Finally, dynamic network (DNW) models relax the assumption of the previous models that contacts between individuals are instantaneous events that do not affect subsequent contacts. Eventually it should be possible to transit between these model forms at the click of a mouse. An example is presented dealing with Cryptosporidium. It illustrates how transiting model forms helps assess water contamination effects, evaluate control options, and design studies of infection transmission systems using nucleotide sequences of infectious agents.

Modeling contact networks and infection transmission in geographic and social space using GERMS.

BACKGROUND: Stochastic models of discrete individuals and deterministic models of continuous populations may give different answers to questions about infectious diseases. GOAL: Discrete individual model formulations are sought that extend deterministic models of infection transmission systems so that both model forms contribute cooperatively to model-based decision making. STUDY DESIGN: GERMS models are defined as stochastic processes in continuous time with parameters analogous to those in deterministic models. A GERMS model simulator was developed that insured that the rate of events depended only on the current state of model. RESULTS: The confidence intervals of long-term averages of infection level in simulated GERMS models were shown to contain the deterministic model means. CONCLUSION: GERMS models provide a convenient framework for testing the sensitivity of model-based decisions to a variety of unrealistic assumptions that are characteristic of differential equation models. GERMS especially facilitates making more realistic assumptions about contact patterns in geographic and social space.

Analysis and simulation of a stochastic, discrete-individual model of STD transmission with partnership concurrency.

Deterministic differential equation models indicate that partnership concurrency and non-homogeneous mixing patterns play an important role in the spread of sexually transmitted infections. Stochastic discrete-individual simulation studies arrive at similar conclusions, but from a very different modeling perspective. This paper presents a stochastic discrete-individual infection model that helps to unify these two approaches to infection modeling. The model allows for both partnership concurrency, as well as the infection, recovery, and reinfection of an individual from repeated contact with a partner, as occurs with many mucosal infections. The simplest form of the model is a network-valued Markov chain, where the network's nodes are individuals and arcs represent partnerships. Connections between the differential equation and discrete-individual approaches are constructed with large-population limits that approximate endemic levels and equilibrium probability distributions that describe partnership concurrency. A more general form of the discrete-individual model that allows for semi-Markovian dynamics and heterogeneous contact patterns is implemented in simulation software. Analytical and simulation results indicate that the basic reproduction number R(0) increases when reinfection is possible, and the epidemic rate of rise and endemic levels are not related by 1-1/R(0), when partnerships are not point-time processes.

Individual causal models and population system models in epidemiology.

A group of individuals behaves as a population system when patterns of connections among individuals influence population health outcomes. Epidemiology usually treats populations as collections of independent individuals rather than as systems of interacting individuals. An appropriate theoretical structure, which includes the determinants of connections among individuals, is needed to develop a "population system epidemiology." Infection transmission models and sufficient-component cause models provide contrasting templates for the needed theoretical structure. Sufficient-component cause models focus on joint effects of multiple exposures in individuals. They handle time and interactions between individuals in the definition of variables and assume that populations are the sum of their individuals. Transmission models, in contrast, model interactions among individuals over time. Their nonlinear structure means that population risks are not simply the sum of individual risks. The theoretical base for "population system epidemiology" should integrate both approaches. It should model joint effects of multiple exposures in individuals as time related processes while incorporating the determinants and effects of interactions among individuals. Recent advances in G-estimation and discrete individual transmission model formulation provide opportunities for such integration.

Condom use and first-time urinary tract infection.

We evaluated the effects of condom use, lubricated condom use, and spermicide use on risk of acquiring first urinary tract infection in a case-control study of sexually active college women ages 18-39 years. Cases (N = 144) were women with first urinary tract infection that was confirmed by culture recruited at the student health service; controls (N = 286) were women without a history of urinary tract infection who were randomly sampled from all women enrolled at the university. Participants completed a self-administered questionnaire regarding type and frequency of condom use during the previous 2 weeks. Condoms and spermicides usually were used in combination with each other or oral contraceptives. After adjusting for frequency of vaginal intercourse, using unlubricated condoms compared with using no birth control method strongly increased the risk of first urinary tract infection (odds ratio = 29.1; 95% confidence interval = 3.1-1,335). Using a lubricated condom (with or without spermicide in the lubricant) or a spermicidal cream or gel with an unlubricated condom was associated with two- to eightfold risk of first urinary tract infection. Unlubricated condom use was strongly associated with risk of first urinary tract infection, but this effect was largely neutralized by using a spermicidal cream or gel with the unlubricated condom or by using a lubricated condom.

Transmission of uropathogens between sex partners.

Epidemiologic evidence and several case reports suggest that Escherichia coli causing urinary tract infection (UTI) may be transmitted between sex partners. In order to test this hypothesis, urinary, vaginal, and fecal E. coli isolates from 19 women with UTI were compared with E. coli found in random initial voids from their most recent male sex partner. E. coli was isolated from 4 of 19 male sex partners. In each case, the E. coli isolated from the man was identical by pulsed-field gel electrophoresis and bacterial virulence profile to the urinary E. coli from his sex partner.