Clinical Stability Criteria Research Articles

Reassessing Halm's clinical stability criteria in community-acquired pneumonia management.

Halm's clinical stability criteria have long guided antibiotic treatment and hospital discharge decisions for patients hospitalised with community-acquired pneumonia (CAP). Originally introduced in 1998, these criteria were established based on a relatively small and select patient population. Consequently, our study aims to reassess their applicability in management of CAP in a contemporary real-world setting. This cohort study included 2918 immunocompetent patients hospitalised with CAP from three hospitals in Denmark between 2017-2020. The primary outcome was time to achieve clinical stability as defined by Halm's criteria. Additionally, we examined recurrence of clinical instability and severe complications. Cumulative incidence function or Kaplan-Meier survival curves were used to analyse these outcomes, considering competing risks. The study population primarily comprised elderly individuals (median age: 75 years) with significant comorbidities. The median time to clinical stability according to Halm's criteria was 4 days, with one-fifth experiencing recurrence of instability after early clinical response (stability within 3 days). Severe complications within 30 days mainly comprised mortality, with rates of 5.1% (64/1257) overall in those with early clinical response, 1.7% (18/1045) in the subgroup without do-not-resuscitate orders, and 17.3% (276/1595) among the rest. Halm's clinical stability criteria effectively classify CAP patients with different disease courses, yet achieving stability required more time in this aging population with substantial comorbidities and more severe disease. Early clinical response indicates reduced risk of complications, especially in those without do-not-resuscitate orders.

1213. Application of Short Course Criteria for Community-Acquired Pneumonia (CAP) Among Patients Admitted Within a 17-community Hospital Telehealth Antimicrobial Stewardship Program (Tele-ASP)

Abstract Background A recent randomized controlled trial by Dinh et al. found three days of antibiotics was appropriate for certain community-acquired pneumonia (CAP) patients, but the real-world applicability of this study remains to be evaluated. In February 2022, a telehealth antimicrobial stewardship program (Tele-ASP) intervention was implemented across 17 small community hospitals to identify patients meeting clinical stability criteria used by Dinh et al. for short course therapy (3 days). An alert was implemented to notify the infectious diseases telehealth (Tele-ID) pharmacist of patients on room air for whom an antibiotic was ordered for pneumonia. Methods This IRB-approved study aimed to evaluate feasibility and impact of the intervention. Patients with severe or complicated CAP, known immunosuppression, or who were transferred were excluded. The primary outcome was total antibiotic duration. Secondary outcomes included whether the total duration was greater than 5 and 7 days and total IV antibiotic duration. Continuous antibiotic duration endpoints were assessed using Mann Whitney U and Fisher's Exact tests were used for categorical endpoints. Results Of 480 patients screened, only 148 (31%) patients met early clinical stability criteria. The primary reason for not meeting criteria was requirement of supplemental oxygen on Day 3 or greater on antibiotics (n=145). This proportion is far lower than previous studies, including that by Dinh et al., which found 60-70% patients met stability criteria. Of the 90 patients included, 27 patients had a Tele-ID review. Patients with an intervention were less likely to receive > 5 days of antibiotics (59% vs 73%) and > 7 days of antibiotics (19% vs. 32%), although these differences were not statistically significant. Conclusion This study relied on accuracy of oxygen charting, which may partly explain relatively lower proportion of patients meeting strict clinical stability criteria and likely limits feasibility of a scalable intervention. A pragmatically modified approach for this Tele-ASP intervention (i.e. allowance for no more than 1 unmet criterion) is an important area for further exploration and could improve the feasibility of a scalable telehealth intervention. Disclosures All Authors: No reported disclosures

Earlier is Better. New Options for Acute Heart Failure: When, Who, How Much?

Abstract Heart failure (HF) is a major public health problem characterised by a high rate of hospitalisation and death. The risk is maximal for patients admitted with acute heart failure (AHF). New therapies with solid proof of mortality reduction in both groups of patients with reduced and preserved ejection fraction (EF) are now available (valsartan/sacubitril and SGLT2 inhibitors). The purpose of this article is to review the main data available and to clarify the role of these new therapies in AHF. The precise moment of initiating these therapies is still a matter of debate. This paper presents the recommended criteria for clinical stability that the clinician could use in deciding to initiate therapy. There is a growing amount of evidence that initiating these therapies sooner provides more benefits to patients.

Analysis of adherence to an early mobilization protocol in an intensive care unit: Data collected prospectively over a period of three years by the clinical information system

ObjectiveTo determinate the adherence and barriers of our early mobilization protocol in patients who had received mechanical ventilation >48h in routine daily practice through clinical information system during all Intensive Care Unit (ICU) stay. DesignObservational and prospective cohort study. SettingPolyvalent ICU over a three-year period (2017–2019). PatientsAdult patients on mechanical ventilation >48h who met the inclusion criteria for the early mobilization protocol. InterventionsNone. Main variables of interestDemographics, adherence to the protocol and putative hidden adherence, total number of mobilizations, barriers, artificial airway/ventilatory support at each mobilization level and adverse events. ResultsWe analyzed 3269 stay-days from 388 patients with median age of 63 (51–72) years, median APACHE II 23 (18–29) and median ICU stay of 10.1 (6.2–16.5) days. Adherence to the protocol was 56.6% (1850 stay-days), but patients were mobilized in only 32.2% (1472) of all stay-days. The putative hidden adherence was 15.6% (509 stay-days) which would increase adherence to 72.2%. The most common reasons for not mobilizing patients were failure to meeting the criteria for clinical stability in 241 (42%) stay-days and unavailability of physiotherapists in 190 (33%) stay-days. Adverse events occurred in only 6 (0.4%) stay-days. ConclusionsData form Clinical Information System showed although adherence was high, patients were mobilized in only one-third of all stay-days. Knowing the specific reason why patient were not mobilized in each stay-day allow to develop concrete decisions to increase the number of mobilizations.

Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial

Shortening the duration of antibiotic therapy for patients admitted to hospital with community-acquired pneumonia should help reduce antibiotic consumption and thus bacterial resistance, adverse events, and related costs. We aimed to assess the need for an additional 5-day course of β-lactam therapy among patients with community-acquired pneumonia who were stable after 3 days of treatment. We did this double-blind, randomised, placebo-controlled, non-inferiority trial (the Pneumonia Short Treatment [PTC]) in 16 centres in France. Adult patients (aged ≥18 years) admitted to hospital with moderately severe community-acquired pneumonia (defined as patients admitted to a non-critical care unit) and who met prespecified clinical stability criteria after 3 days of treatment with β-lactam therapy were randomly assigned (1:1) to receive β-lactam therapy (oral amoxicillin 1 g plus clavulanate 125 mg three times a day) or matched placebo for 5 extra days. Randomisation was done using a web-based system with permuted blocks with random sizes and stratified by randomisation site and Pneumonia Severity Index score. Participants, clinicians, and study staff were masked to treatment allocation. The primary outcome was cure 15 days after first antibiotic intake, defined by apyrexia (temperature ≤37·8°C), resolution or improvement of respiratory symptoms, and no additional antibiotic treatment for any cause. A non-inferiority margin of 10 percentage points was chosen. The primary outcome was assessed in all patients who were randomly assigned and received any treatment (intention-to-treat [ITT] population) and in all patients who received their assigned treatment (per-protocol population). Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT01963442, and is now complete. Between Dec 19, 2013, and Feb 1, 2018, 706 patients were assessed for eligibility, and after 3 days of β-lactam treatment, 310 eligible patients were randomly assigned to receive either placebo (n=157) or β-lactam treatment (n=153). Seven patients withdrew consent before taking any study drug, five in the placebo group and two in the β-lactam group. In the ITT population, median age was 73·0 years (IQR 57·0-84·0) and 123 (41%) of 303 participants were female. In the ITT analysis, cure at day 15 occurred in 117 (77%) of 152 participants in the placebo group and 102 (68%) of 151 participants in the β-lactam group (between-group difference of 9·42%, 95% CI -0·38 to 20·04), indicating non-inferiority. In the per-protocol analysis, 113 (78%) of 145 participants in the placebo treatment group and 100 (68%) of 146 participants in the β-lactam treatment group were cured at day 15 (difference of 9·44% [95% CI -0·15 to 20·34]), indicating non-inferiority. Incidence of adverse events was similar between the treatment groups (22 [14%] of 152 in the placebo group and 29 [19%] of 151 in the β-lactam group). The most common adverse events were digestive disorders, reported in 17 (11%) of 152 patients in the placebo group and 28 (19%) of 151 patients in the β-lactam group. By day 30, three (2%) patients had died in the placebo group (one due to bacteraemia due to Staphylococcus aureus, one due to cardiogenic shock after acute pulmonary oedema, and one due to heart failure associated with acute renal failure) and two (1%) in the β-lactam group (due to pneumonia recurrence and possible acute pulmonary oedema). Among patients admitted to hospital with community-acquired pneumonia who met clinical stability criteria, discontinuing β-lactam treatment after 3 days was non-inferior to 8 days of treatment. These findings could allow substantial reduction of antibiotic consumption. French Ministry of Health.

Does a 5-day course of antibiotics in elderly patients with community-acquired pneumonia achieve the established criteria of clinical stability?

ObjectiveWe aimed to determine the proportion of elderly patients hospitalised for community-acquired pneumonia (CAP) in whom a 5-day antibiotic therapy would achieve clinical stability according to American Thoracic Society (ATS) criteria. MethodsPatients aged≥75 years, hospitalised for CAP between November 2018 and August 2019, were analysed retrospectively. The American Thoracic Society (ATS) clinical stability criteria (temperature≤37°C, heart rate≤100/min, respiratory rate≤24/min, systolic blood pressure≥90mmHg, oxygen saturation≥90% in room air) were assessed after five days of antibiotic therapy. ResultsSeventy-five patients (mean age 88 years, 49% requiring oxygen therapy) were included. Six died, and at day 5, 36/69 (52%) fulfilled 4/5 stability criteria. The median duration of treatment was 9 days. In 28 patients (41%), it was ≤7 days. ConclusionIn 52% of elderly patients with CAP, a 5-day treatment regimen resulted in clinical stability.

Impact of reducing the duration of antibiotic treatment on the long-term prognosis of community acquired pneumonia

BackgroundThe optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) is not well established. The aim of this study was to assess the impact of reducing the duration of antibiotic treatment on long-term prognosis in patients hospitalized with CAP.MethodsThis was a multicenter study assessing complications developed during 1 year of patients previously hospitalized with CAP who had been included in a randomized clinical trial concerning the duration of antibiotic treatment. Mortality at 90 days, at 180 days and at 1 year was analyzed, as well as new admissions and cardiovascular complications. A subanalysis was carried out in one of the hospitals by measuring C-reactive protein (CRP), procalcitonin (PCT) and proadrenomedullin (proADM) at admission, at day 5 and at day 30.ResultsA total of 312 patients were included, 150 in the control group and 162 in the intervention group. Ninety day, 180 day and 1-year mortality in the per-protocol analysis were 8 (2.57%), 10 (3.22%) and 14 (4.50%), respectively. There were no significant differences between both groups in terms of 1-year mortality (p = 0.94), new admissions (p = 0.84) or cardiovascular events (p = 0.33). No differences were observed between biomarker level differences from day 5 to day 30 (CRP p = 0.29; PCT p = 0.44; proADM p = 0.52).ConclusionsReducing antibiotic treatment in hospitalized patients with CAP based on clinical stability criteria is safe, without leading to a greater number of long-term complications.

1561. Omadacycline Pharmacokinetics: Influence of Mortality Risk Score Among Patients with Community-Acquired Bacterial Pneumonia

BackgroundOmadacycline is a novel aminomethylcycline with activity against Gram-positive and -negative organisms, including tetracycline-resistant pathogens. Omadacycline was recently approved in the United States for treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections. Analyses were undertaken to determine whether PORT risk class and CURB-65 score influence the pharmacokinetics of omadacycline in patients with CABP.MethodsOmadacycline pharmacokinetic data were available from omadacycline-treated patients with CABP enrolled in the Phase 3 OPTIC Study. Patients received omadacycline 100 mg IV q12h on Day 1 followed by 100 mg IV q24h. After Day 3, patients could be switched to 300 mg PO q24h if predefined clinical stability criteria were met. Four pharmacokinetic samples per patient were collected between Days 2 and 5. These data were previously utilized in the development of a population pharmacokinetic model describing the disposition of omadacycline [Microbe 2018; Abstr SAT-628]. Individual post-hoc parameter estimates for patients enrolled in the OPTIC study were utilized to compute Day 1 total-drug plasma area under the concentration-time curve (AUC) values following administration of omadacycline 100 mg IV q12h. Differences among these AUC values by PORT risk class and CURB-65 score were assessed using a one-way ANOVA.ResultsA total of 187 pharmacokinetic samples were available from 50 patients. Among the patients classified as PORT risk class II, III, and IV (n = 12, 28, and 10, respectively), mean Day 1 omadacycline AUC values were 10.2, 11.0, and 12.0 mg L/h, respectively. Among patients with CURB-65 scores of 0, 1, and 2 (n = 23, 23, and 4, respectively), mean Day 1 omadacycline AUC values were 10.6, 11.6, and 9.7 mg L/h, respectively. The differences in mean AUC values were not statistically significant among patients by PORT risk class (P = 0.248) and CURB-65 score groups (P = 0.745). Moreover, variability was similar across these groups as displayed in Figure 1.ConclusionOmadacycline exposures were similar across PORT risk class and CURB-65 score groups; thus, omadacycline dose adjustments based on these classifications are likely not warranted. Disclosures All authors: No reported disclosures.

Extending Visit Intervals for Clinically Stable Patients on Antiretroviral Therapy: Multicohort Analysis of HIV Programs in Southern Africa.

The World Health Organization recommends differentiated antiretroviral therapy (ART) delivery with longer visit intervals for clinically stable patients. We examined time trends in visit frequency and associations between criteria for clinical stability and visit frequency in ART programs in Southern Africa. We included adults on ART from 4 programs with viral-load monitoring, 2 programs with CD4 monitoring, and 4 programs with clinical monitoring of ART. We classified patients as clinically stable based on virological (viral load <1000 copies/mL), immunological (CD4 >200 cells/µL), or clinical (no current tuberculosis) criteria. We used Poisson regression and survival models to examine associations between criteria for clinical stability and the rate of clinic visits. We included 180,837 patients. There were trends toward fewer visits in more recent years and with longer ART duration. In all ART programs, clinically stable patients were seen less frequently than patients receiving failing ART, but the strength of the association varied. Adjusted incidence rate ratios comparing visit rates for stable patients with patients on failing ART were 0.82 (95% confidence interval: 0.73 to 0.90) for patients classified based on the virological criterion, 0.81 (0.69 to 0.93) for patients classified based on the clinical criterion, and 0.90 (0.85 to 0.96) for patients classified based on the immunological criterion for stability. Differences in visit rates between stable patients and patients failing ART were variable and modest overall. Larger differences were seen in programs using virological criteria for clinical stability than in programs using immunological criteria. Greater access to routine viral-load monitoring may increase scale-up of differentiated ART delivery.

Appropriate Duration of Intravenous Treatment of Candidemia and Timing of Step Down to Oral Therapy in Non-neutropenic Patients.

In this review, we have analyzed the available literature pertaining to the total duration of intravenous (IV) therapy and the appropriate timing of step down to oral therapy in the management of candidemia. Overview of the guidelines and literature seem to indicate that a minimum of 14 days of antifungal therapy is required in the treatment of candidemia without deeply seated infection. However, this was never based on evidence. Furthermore, step down to oral therapy seems to be dependent on the clinical stability criteria of the patient with candidemia after 4 to 7 days of IV therapy. Further studies are required to evaluate the appropriate total duration of IV therapy, appropriate timing of step down to oral therapy and to validate the clinical criteria that would allow the switch to happen.

Biological variation of extracellular matrix biomarkers in patients with stable chronic heart failure

Extracellular matrix (ECM) biomarkers such as matrix metalloproteinases (MMPs) and their inhibitors (TIMPs) are pathophysiological key, prognostic marker and therapeutic target in chronic heart failure (HF). Serial measurements of MMPs and TIMPs may be useful for guidance of these applications. However, interpretation of time-dependent changes requires knowledge about the biological variation of ECM biomarkers. We performed measurements of MMP-2, MMP-9, TIMP-1, and TIMP-4 in 50 patients with chronic HF who met rigid criteria for clinical stability at 3-h, 6-h, 1-week and 2-week time intervals. In addition, clinical and haemodynamic assessment was performed at baseline, at 1- and 2-week intervals. Haemodynamic variables were measured using inert gas rebreathing and impedance cardiography. Heart rhythm was monitored with external ECG event recorders throughout the complete study. Reference change values (RCVs) and minimal important differences (MIDs) were determined for MMP-2, MMP-9, TIMP-1, and TIMP-4. Clinical and haemodynamic variables were stable over time. Depending on the time-interval, RCVs ranged between 4.9 and 11.7% for MMP-2, 26.4 and 56.7% for MMP-9, 10.8 and 30.7% for TIMP-1, and 16.0 and 47.4% for TIMP-4, respectively. The MIDs varied between 43.38 and 65.22ng/ml for MMP-2, 28.71 and 40.96ng/ml for MMP-9, 52.32 and 156.07ng/ml for TIMP-1, and 293.92 and 798.04pg/ml for TIMP-4, respectively. The biological variation of ECM biomarkers differs with respect to individual biomarkers and time intervals. MMP-2 may be most suitable for serial biomarker measurements, as the biological variation is low irrespective of the time interval between measurements.

Hemodynamic Determinants of the Biologic Variation of N-Terminal Pro–B-Type Natriuretic Peptide in Patients With Stable Systolic Chronic Heart Failure

Background ContextBiologic variation of N-terminal pro–B-type natriuretic peptide (NT-proBNP) in chronic heart failure (CHF) may affect blood levels and risk stratification. The sources of NT-proBNP variation are unknown. Methods and ResultsWe performed NT-proBNP measurements and clinical and hemodynamic assessments in 50 patients with heart failure with reduced ejection fraction (HFrEF) who met criteria for clinical stability over 2 time intervals. Hemodynamic variables were measured with the use of inert gas rebreathing and impedance cardiography. Heart rhythm was monitored with the use of external electrocardiographic event recorders throughout the study. Determinants of NT-proBNP-levels and both absolute (ΔNT-proBNPabs) and relative (ΔNT-proBNP%) changes at 1-week and 2-week intervals were identified with the use of univariable and multivariable linear mixed-effects models and linear regression analyses, respectively.Clinical and hemodynamic variables did not significantly change between study visits. The individual variation of NT-proBNP at 2 weeks was 9.2% (range 3.9%–18.6%). Weight and glomerular filtration rate were independently associated with baseline NT-proBNP concentrations (P = .01 and P = .005, respectively). There was no relationship between absolute and relative changes of NT-proBNP at 1-week intervals and changes in clinical and hemodynamic variables. Absolute change of NT-proBNP at 2-week intervals was associated with absolute change in left cardiac work index (P = .008), and relative change in NT-proBNP at 2-week intervals was determined by relative change of thoracic fluid content index (P = .008) and diastolic blood pressure (P = .01). The coefficients of determination (R2) for the multivariable models with Δ1wkNT-proBNPabs, Δ2-weeksNT-proBNPabs, Δ1wkNT-proBNP%, and Δ2wksNT-proBNP% as dependent variables were 0.21, 0.19, 0.10, and 0.32, respectively. ConclusionsIn patients with stable HFrEF, changes in clinical and hemodynamic variables only marginally contribute to the variation of NT-proBNP.

Duration of Antibiotic Treatment in Community-Acquired Pneumonia: A Multicenter Randomized Clinical Trial.

The optimal duration of antibiotic treatment for community-acquired pneumonia (CAP) has not been well established. To validate Infectious Diseases Society of America/American Thoracic Society guidelines for duration of antibiotic treatment in hospitalized patients with CAP. This study was a multicenter, noninferiority randomized clinical trial performed at 4 teaching hospitals in Spain from January 1, 2012, through August 31, 2013. A total of 312 hospitalized patients diagnosed as having CAP were studied. Data analysis was performed from January 1, 2014, through February 28, 2015. Patients were randomized at day 5 to an intervention or control group. Those in the intervention group were treated with antibiotics for a minimum of 5 days, and the antibiotic treatment was stopped at this point if their body temperature was 37.8°C or less for 48 hours and they had no more than 1 CAP-associated sign of clinical instability. Duration of antibiotic treatment in the control group was determined by physicians. Clinical success rate at days 10 and 30 since admission and CAP-related symptoms at days 5 and 10 measured with the 18-item CAP symptom questionnaire score range, 0-90; higher scores indicate more severe symptoms. Of the 312 patients included, 150 and 162 were randomized to the control and intervention groups, respectively. The mean (SD) age of the patients was 66.2 (17.9) years and 64.7 (18.7) years in the control and intervention groups, respectively. There were 95 men (63.3%) and 55 women (36.7%) in the control group and 101 men (62.3%) and 61 women (37.7%) in the intervention group. In the intent-to-treat analysis, clinical success was 48.6% (71 of 150) in the control group and 56.3% (90 of 162) in the intervention group at day 10 (P = .18) and 88.6% (132 of 150) in the control group and 91.9% (147 of 162) in the intervention group at day 30 (P = .33). The mean (SD) CAP symptom questionnaire scores were 24.7 (11.4) vs 27.2 (12.5) at day 5 (P = .10) and 18.6 (9.0) vs 17.9 (7.6) at day 10 (P = .69). In the per-protocol analysis, clinical success was 50.4% (67 of 137) in the control group and 59.7% (86 of 146) in the intervention group at day 10 (P = .12) and 92.7% (126 of 137) in the control group and 94.4% (136 of 146) in the intervention group at day 30 (P = .54). The mean (SD) CAP symptom questionnaire scores were 24.3 (11.4) vs 26.6 (12.1) at day 5 (P = .16) and 18.1 (8.5) vs 17.6 (7.4) at day 10 (P = .81). The Infectious Diseases Society of America/American Thoracic Society recommendations for duration of antibiotic treatment based on clinical stability criteria can be safely implemented in hospitalized patients with CAP. clinicaltrialsregister.eu Identifier: 2011-001067-51.

Total duration of antimicrobial therapy in veterans hospitalized with uncomplicated pneumonia: Results of a national medication utilization evaluation

Practice guidelines recommend the shortest duration of antimicrobial therapy appropriate to treat uncomplicated pneumonia be prescribed to reduce the emergence of resistant pathogens. A national evaluation was conducted to assess the duration of therapy for pneumonia. Retrospective medication utilization evaluation. Thirty Veterans Affairs medical centers. Inpatients discharged with a diagnosis of pneumonia. A manual review of electronic medical records of inpatients discharged with uncomplicated community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) was conducted. Appropriate CAP therapy duration was defined as at least 5 days, and up to 3 additional days beginning the first day the patient achieved clinical stability criteria; the appropriate HCAP therapy duration was defined as 8 days. The duration of antimicrobial therapy for intravenous (IV) and oral (PO) inpatient administration, PO therapy dispensed upon discharge, Clostridium difficile infection (CDI), hospital readmission, and death rates were measured. Of 3881 pneumonia admissions, 1739 met inclusion criteria (CAP [n = 1195]; HCAP [n = 544]). Overall, 13.9% of patients (CAP [6.9%], HCAP [29.0%]) received therapy duration consistent with guideline recommendations. The median (interquartile range) days of therapy were 4 days (3-6 days), 1 day (0-3 days), and 6 days (4-8 days) for inpatient IV, inpatient PO, and outpatient PO antimicrobials, respectively. CDI was rare but more common in patients who received therapy duration consistent with guidelines. Therapy duration was not associated with the readmission or mortality rate. Antimicrobials were commonly prescribed for a longer duration than guidelines recommend. The majority of excessive therapy was completed upon discharge, identifying the need for strategies to curtail unnecessary use postdischarge. Journal of Hospital Medicine 2015;11:832-839. © 2015 Society of Hospital Medicine.

Serviços de atenção domiciliar: critérios de elegibilidade, inclusão, exclusão e alta

Objective: To describe the aspects involving eligibility, inclusion, exclusion and discharge in home care from the perspective of home care managers and coordinators. Methods: This is qualitative descriptive exploratory study. Interviews were conducted with five managers and 17 coordinators from 16 municipalities of Minas Gerais between January and September 2015. Results: Respondents reported following the criteria proposed in the national guidelines of the home care service, but with some exceptions. With regard to eligibility, most managers reported that patients undergo clinical evaluation performed by the physician who determines whether or not the patient is eligible for home care. Inclusion criteria refer to the assessment of the patient’s conditions, the identification of the caregiver, social and environmental issues, team access and adaptation of the home to the patient’s needs. Exclusion criteria point to the structural conditions of the home, the lack of caregiver and safety for professionals. The discharge is referenced by clinical stability criteria and the end of treatment. Conclusion: Although home care services criteria are set by the Ministry of Health, managers and coordinators make exceptions to the inclusion and discharge criteria considering: the fragility of the network regarding discharge and referral to another point of care and the patient’s reality. Home care should be performed when the clinical and administrative conditions of the user are just right, considering the eligibility, inclusion, exclusion and discharge criteria.

A double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance of efficacy in patients with schizophrenia

Objective:To evaluate the effectiveness of lurasidone as maintenance treatment for schizophrenia.Method:Adults experiencing an acute exacerbation of schizophrenia initially received 12–24 weeks of open-label treatment with lurasidone (40–80 mg/d, flexibly dosed). Patients who maintained clinical stability for ⩾12 weeks were randomized in double-blind fashion to placebo or lurasidone (40–80 mg/d, flexibly dosed) for an additional 28-week treatment period. The primary efficacy endpoint was time to relapse (based on Kaplan–Meier survival analysis).Results:A total of 676 patients enrolled in the open-label phase; 285 met protocol-specified stabilization criteria and were randomized to lurasidone (N=144) or placebo (N=141). During the open-label phase, mean Positive and Negative Syndrome Scale total score decreased from 90.1 to 54.4 in patients who met clinical stability criteria and were randomized. In the double-blind phase, lurasidone significantly delayed time to relapse compared with placebo (log-rank test, p=0.039), reflecting a 33.7% reduction in risk of relapse (Cox hazard ratio (95% confidence interval), 0.663 (0.447–0.983); p=0.041). Probability of relapse at the double-blind week 28 endpoint (based on Kaplan–Meier analysis) was 42.2% in the lurasidone group and 51.2% in the placebo group. Minimal changes in weight, lipid, glucose, and prolactin were observed throughout the study.Conclusions:This multicenter, placebo-controlled, randomized withdrawal study demonstrated the efficacy of lurasidone for the maintenance treatment of patients with schizophrenia.

Duration of Antibiotic Treatment in Community-Acquired Pneumonia

The optimal duration of antibiotic treatment in communityacquired pneumonia (CAP) has not been completely established, and there are discrepancies even between various clinical guidelines published to date. The British Thoracic Society1 recommends 7 days of antibiotic treatment in patients with uncomplicated mild to moderate CAP. In 2011, the ERS2 published guidelines recommending that treatment should not exceed 8 days in responding patients defined by clinical stability criteria. However, as far back as 2007, the IDSA/ATS3 recommended a minimum treatment of 5 days, providing that the patient remained a febrile for 48–72 h, with no more than 1 sign of clinical instability. Efforts to cut back on widespread antibiotic use have been associated with multiple benefits, such as a decrease in microbial resistance, fewer adverse effects, and improved treatment adherence. The use of low-dose and long-duration (>5 days) betalactamics is associated with an increase in pharyngeal carriage of penicillin-resistant Streptococcus pneumoniae.4 Despite this, reducing the duration of antibiotic treatment in CAP can be complicated in routine clinical practice. In this respect, Moussaoui et al.5 conducted a clinical trial in 186 patients with CAP and a pneumonia severity score (PSI) of less than 110 points, who were given amoxicillin. In patients who presented an initial improvement after 72 h, 3 days of amoxicillin was equivalent to continuing the treatment for 8 days. Clinical cure was achieved after 10 days in 93% of cases in both groups. In view of the concentration-dependent bactericide activity and prolonged post-antibiotic effect of quinolones, it is logical to presume that by increasing the dose, and therefore the peak concentration and area under the curve, the duration of antibiotic treatment can be reduced without affecting efficacy. Dunbar et al.6 compared a 5-day course of levofloxacin 750 mg versus a 10-day course of 500 mg of the same antibiotic in patients with CAP PSI I–IV. He found that both were at least equally effective, and that fever was resolved earlier in the first group. Macrolides are known to have a long half-life and excellent lung penetration, which undoubtedly facilitates their use in short

Biological variation of the cardiac index in patients with stable chronic heart failure: inert gas rebreathing compared with impedance cardiography.

AimsIn chronic heart failure (CHF), changes in cardiac function define the course of the disease. The cardiac index (CI) is the most adequate indicator of cardiac function. Interpretation of serial CI measurements, however, requires knowledge of the biological variation of CI. Because measurements of CI can be confounded by the clinical situation or the method applied, biological variation might be subject to the same confounders.Methods and resultsWe prospectively included 50 CHF patients who met rigid criteria for clinical stability. CI was measured by both inert gas rebreathing (IGR) and impedance cardiography (ICG) in weekly intervals over 3 weeks—each measurement performed at rest (IGRrest/ICGrest) and during low‐exercise 10 Watt pedalling (IGR10W/ICG10W). Intra‐class correlation coefficients (ICCs), reference change values, and minimal important differences of CI were determined for IGRrest, ICGrest, IGR10W, and ICG10W. Impedance cardiography and IGR showed moderate agreement at rest (20% (6–36)) and good agreement at 10 Watt (−4% (−23–16)). Depending on time interval, measurement modality for CI, and mode, ICC ranged between 0.42 and 0.78, ICC values for IGR were lower than those for ICG. Reference change value ranged between 3 and 15%, and minimal important difference ranged between 0.2 and 0.5 L/min/m2. Values for IGR were lower at rest and higher at 10 Watt than those for ICG.ConclusionNon‐invasive measurements of CI are stable over time. Measurement modalities for CI, however, are not interchangeable. Biological variation is less pronounced when obtained by ICG. The influence of low‐level exercise on stability of CI depends on the measurement modality.

An evaluation of clinical stability criteria to predict hospital course in community-acquired pneumonia

AbstractA number of different methods exist to assess clinical stability, a key component of pneumonia management. We compared the prognostic value of different stability criteria through a secondary analysis of the Edinburgh pneumonia study database. We studied four clinical stability criteria (Halm's criteria, the ATS criteria, CURB and 50% or more decrease in C-reactive protein from baseline). Outcomes included 30-day mortality, need for mechanical ventilation or vasopressor support (MV/VS), development of a complicated pneumonia, and a combined outcome of the above. A total of 1079 patients (49.8% male), with a median age of 68 years (IQR 53–80), were included. Ninety-three patients (8.6%) died by day 30, 91 patients (8.4%) required MV/VS and 99 patients (9.2%) developed a complicated pneumonia. Patients with increasing severity of pneumonia on admission, assessed by both CURB-65 and PSI, took a progressively longer time to achieve clinical stability assessed by any method (p < 0.001 for all criteria). Halm's criteria had the highest area under the curve (AUC) for prediction of 30-day mortality (AUC 0.95 (0.94–0.96)), need for MV/VS (AUC 0.96 (0.95–0.97)) and combined adverse outcome (AUC 0.96 (0.95–0.97)). C-reactive protein had the highest area under the curve for complicated pneumonia (AUC 0.96 (0.95–0.97)). Adding C-reactive protein to Halm's criteria increased the area under the curve, but the difference was only statistically significant for complicated pneumonia. All of the criteria performed well in predicting adverse outcomes in patients with pneumonia. Halm's criteria performed best when identifying patients at low risk of complications.

Criteria for clinical stability in hospitalised patients with community-acquired pneumonia

The American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) suggested two sets of criteria in 2001 and 2007 to define clinical stability in community-acquired pneumonia (CAP). The present study aimed to evaluate the level of agreement between these two sets of criteria and how well they can predict clinical outcomes. A retrospective cohort study was carried out of 487 consecutive patients hospitalised with CAP. Level of agreement was tested using a survival curve analysis, while prediction of outcomes at 30-day follow-up was evaluated through receiver operating characteristic (ROC) analysis. A discrepancy between ATS 2001 and ATS/IDSA 2007 criteria in identifying clinical stability was detected in 62% of the patients. The median (interquartile range) time to clinical stability was 2 (1-4) days based on ATS 2001 and 3 (2-5) days based on ATS/IDSA 2007 criteria (p = 0.012). The daily distribution of patients who reached clinical stability evaluated with both sets was different (p = 0.002). The ROC analysis showed an area under the curve of 0.705 for the ATS 2001 criteria and 0.714 for ATS/IDSA 2007 criteria (p = 0.645). ATS 2001 and ATS/IDSA 2007 criteria for clinical stability in hospitalised patients with CAP are clinically equivalent and both can be used in clinical practice as well as in clinical research.