Impact of chronic obstructive pulmonary disease in patients with atrial fibrillation: an analysis from the GLORIA-AF registry.

AIMS: Chronic obstructive pulmonary disease (COPD) may influence management and prognosis of atrial fibrillation (AF), but this relationship has been scarcely explored in contemporary global cohorts. We aimed to investigate the association between AF and COPD, in relation to treatment patterns and major outcomes. METHODS AND RESULTS: From the prospective, global GLORIA-AF registry, we analysed factors associated with COPD diagnosis, as well as treatment patterns and risk of major outcomes in relation to COPD. The primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACEs). A total of 36 263 patients (mean age 70.1 ± 10.5 years, 45.2% females) were included; 2,261 (6.2%) had COPD. The prevalence of COPD was lower in Asia and higher in North America. Age, female sex, smoking, body mass index, and cardiovascular comorbidities were associated with the presence of COPD. Chronic obstructive pulmonary disease was associated with higher use of oral anticoagulant (OAC) [adjusted odds ratio (aOR) and 95% confidence interval (CI): 1.29 (1.13-1.47)] and higher OAC discontinuation [adjusted hazard ratio (aHR) and 95% CI: 1.12 (1.01-1.25)]. Chronic obstructive pulmonary disease was associated with less use of beta-blocker [aOR (95% CI): 0.79 (0.72-0.87)], amiodarone and propafenone, and higher use of digoxin and verapamil/diltiazem. Patients with COPD had a higher hazard of primary composite outcome [aHR (95% CI): 1.78 (1.58-2.00)]; no interaction was observed regarding beta-blocker use. Chronic obstructive pulmonary disease was also associated with all-cause death [aHR (95% CI): 2.01 (1.77-2.28)], MACEs [aHR (95% CI): 1.41 (1.18-1.68)], and major bleeding [aHR (95% CI): 1.48 (1.16-1.88)]. CONCLUSION: In AF patients, COPD was associated with differences in OAC treatment and use of other drugs; Patients with AF and COPD had worse outcomes, including higher mortality, MACE, and major bleeding.

Safety and efficacy of transcranial direct current stimulation in upper extremity rehabilitation after tetraplegia: protocol of a multicenter randomized, clinical trial.

STUDY DESIGN: A multisite, randomized, controlled, double-blinded phase I/II clinical trial. OBJECTIVE: The purpose of this clinical trial is to evaluate the safety, feasibility and efficacy of pairing noninvasive transcranial direct current stimulation (tDCS) with rehabilitation to promote paretic upper extremity recovery and functional independence in persons living with chronic cervical spinal cord injury (SCI). SETTING: Four-site trial conducted across Cleveland Clinic, Louis Stokes Veterans Affairs Medical Center of Cleveland and MetroHealth Rehabilitation Rehabilitation Institute of Ohio, and Kessler Foundation of New Jersey. METHODS: Forty-four adults (age ≥18 years) with tetraplegia following cervical SCI that occurred ≥1-year ago will participate. Participants will be randomly assigned to receive anodal tDCS or sham tDCS given in combination with upper extremity rehabilitation for 15 sessions each over 3-5 weeks. Assessments will be made twice at baseline separated by at least a 3-week interval, once at end-of-intervention, and once at 3-month follow-up. PRIMARY OUTCOME MEASURE(S): Primary outcome measure is upper extremity motor impairment assessed using the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) scale. Functional abilities will be assessed using Capabilities of Upper Extremity-Test (CUE-T), while functional independence and participation restrictions will be evaluated using the self-care domain of Spinal Cord Independent Measure (SCIM), and Canadian Occupational Performance Measure (COPM). SECONDARY OUTCOME MEASURES: Treatment-associated change in corticospinal excitability and output will also be studied using transcranial magnetic stimulation (TMS) and safety (reports of adverse events) and feasibility (attrition, adherence etc.) will also be evaluated. TRIAL REGISTRATION: ClincalTrials.gov identifier NCT03892746. This clinical trial is being performed at four sites within the United States: Cleveland Clinic (lead site), Louis Stokes Cleveland Veterans Affairs Medical Center (VAMC) and MetroHealth Rehabilitation Institute in Ohio, and Kessler Foundation in New Jersey. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office.

Measurement error and reliability of TMS metrics collected from biceps and triceps in individuals with chronic incomplete tetraplegia.

Transcranial magnetic stimulation (TMS) is used to investigate corticomotor neurophysiology associated with functional recovery in individuals with spinal cord injury (SCI). There is insufficient evidence about test-retest measurement properties of TMS in SCI. Therefore, we investigated test-retest agreement and reliability of TMS metrics representing corticomotor excitability, output, gain, map (representation), and inhibition in individuals with cervical SCI. We collected TMS metrics from biceps and triceps muscles because of the relevance of this proximal muscle pair to the cervical SCI population. Twelve individuals with chronic C3-C6 SCI participated in two TMS sessions separated by ≥ 2 weeks. Measurement agreement was evaluated using t tests, Bland-Altman limits of agreement and relative standard error of measurement (SEM%), while reliability was investigated using intra-class correlation coefficient (ICC) and concordance correlation coefficient (CCC). We calculated the smallest detectable change for all TMS metrics. All TMS metrics except antero-posterior map coordinates and corticomotor inhibition were in agreement upon repeated measurement though limits of agreement were generally large. Measures of corticomotor excitability, output and medio-lateral map coordinates had superior agreement (SEM% < 10). Metrics representing corticomotor excitability, output, and inhibition had good-to-excellent reliability (ICC/CCC > 0.75). The smallest detectable change for TMS metrics was generally high for a single individual, but this value reduced substantially with increase in sample size. We recommend use of corticomotor excitability and recruitment curve area owing to their superior measurement properties. A modest group size (20 or above) yields more stable measurements, which may favor use of TMS metrics in group level modulation after SCI.

Hyperenhancement of the Pericardium on Cardiac Magnetic Resonance Imaging: A Marker of Acute Inflammation and Neovascularization or a Chronic Fibrotic State.

In cardiac magnetic resonance imaging, hyperenhancement of the pericardium post gadolinium administration in acute chest pain often signifies pericarditis with an acute inflammatory response and neovascularization. In the context of constrictive pericarditis, case series have indicated that the intensity of hyperenhancement and the thickness of the pericardium imply reversibility of the physiology of the constrictive pericarditis. We present a case of intense hyperenhancement and marked thickening of the pericardium in a patient with constrictive pericarditis with antecedent chest pain. Surgical resection of the pericardium and microscopy revealed a chronic fibrotic state with no evidence of inflammation or neovascularization, thus clarifying the failure of initial medical/anti-inflammatory treatment. Our case highlights the fact that hyperenhancement of the pericardium post gadolinium is non-specific for histology and does not necessarily imply the reversibility of pericardial constriction.

Risk of Death and Cardiovascular Events in Asian Patients With Atrial Fibrillation and Chronic Obstructive Pulmonary Disease: A Report From the Prospective APHRS Registry.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is associated with an increased risk of adverse events in patients with atrial fibrillation (AF); however, few data are available on this topic in Asian populations. METHODS AND RESULTS: Prospective observational study conducted on patients with AF enrolled in the Asia-Pacific Heart Rhythm Society (APHRS) AF Registry. The diagnosis of COPD was based on data reported in the case report form by the investigators. Cox-regression models were used to assess the 1-year risk of a primary composite outcome of all-cause death, thromboembolic events, acute coronary syndrome, and heart failure. Analysis on single outcomes and cardiovascular death was also performed. Interaction analysis was used to assess the risk of composite outcome and all-cause death in different subgroups. The study included 4094 patients with AF (mean±SD age 68.5±12 years, 34.6% female), of whom 112 (2.7%) had COPD. Patients with COPD showed a higher incidence of the primary composite outcome (25.1% versus 6.3%, P<0.001), all-cause death (14.9% versus 2.6%, P<0.001), cardiovascular death (2.0% versus 0.6%, P<0.001), and heart failure (8.3% versus 6.0%, P<0.001). On multiple Cox-regression analysis, COPD was associated with a higher risk of the primary composite outcome (hazard ratio [HR], 3.17 [95% CI, 2.05-4.90]), all-cause death (HR, 3.59 [95% CI, 2.04-6.30]), and heart failure (HR, 3.32 [95% CI, 1.56-7.03]); no statistically significant differences were found for other outcomes. The association between COPD and mortality was significantly modified by the use of beta blockers (Pint=0.018). CONCLUSIONS: In Asian patients with AF, COPD is associated with worse prognosis. In patients with AF and COPD, the use of beta blockers was associated with a lower mortality. REGISTRATION INFORMATION: clinicaltrials.gov Identifier: NCT04807049.

Challenges and opportunities in the development of novel antimicrobial therapeutics for cystic fibrosis.

Chronic respiratory infection is the primary driver of mortality in individuals with cystic fibrosis (CF). Existing drug screening models utilised in preclinical antimicrobial development are unable to mimic the complex CF respiratory environment. Consequently, antimicrobials showing promising activity in preclinical models often fail to translate through to clinical efficacy in people with CF. Model systems used in CF anti-infective drug discovery and development range from antimicrobial susceptibility testing in nutrient broth, through to 2D and 3D in vitro tissue culture systems and in vivo models. No single model fully recapitulates every key aspect of the CF lung. To improve the outcomes of people with CF (PwCF) it is necessary to develop a set of preclinical models that collectively recapitulate the CF respiratory environment to a high degree of accuracy. Models must be validated for their ability to mimic aspects of the CF lung and associated lung infection, through evaluation of biomarkers that can also be assessed following treatment in the clinic. This will give preclinical models greater predictive power for identification of antimicrobials with clinical efficacy. The landscape of CF is changing, with the advent of modulator therapies that correct the function of the CFTR protein, while antivirulence drugs and phage therapy are emerging alternative treatments to chronic infection. This review discusses the challenges faced in current antimicrobial development pipelines, including the advantages and disadvantages of current preclinical models and the impact of emerging treatments.

Establishing analytical validity of BeadChip array genotype data by comparison to whole-genome sequence and standard benchmark datasets.

BACKGROUND: Clinical use of genotype data requires high positive predictive value (PPV) and thorough understanding of the genotyping platform characteristics. BeadChip arrays, such as the Global Screening Array (GSA), potentially offer a high-throughput, low-cost clinical screen for known variants. We hypothesize that quality assessment and comparison to whole-genome sequence and benchmark data establish the analytical validity of GSA genotyping. METHODS: To test this hypothesis, we selected 263 samples from Coriell, generated GSA genotypes in triplicate, generated whole genome sequence (rWGS) genotypes, assessed the quality of each set of genotypes, and compared each set of genotypes to each other and to the 1000 Genomes Phase 3 (1KG) genotypes, a performance benchmark. For 59 genes (MAP59), we also performed theoretical and empirical evaluation of variants deemed medically actionable predispositions. RESULTS: Quality analyses detected sample contamination and increased assay failure along the chip margins. Comparison to benchmark data demonstrated that > 82% of the GSA assays had a PPV of 1. GSA assays targeting transitions, genomic regions of high complexity, and common variants performed better than those targeting transversions, regions of low complexity, and rare variants. Comparison of GSA data to rWGS and 1KG data showed > 99% performance across all measured parameters. Consistent with predictions from prior studies, the GSA detection of variation within the MAP59 genes was 3/261. CONCLUSION: We establish the analytical validity of GSA assays using quality analytics and comparison to benchmark and rWGS data. GSA assays meet the standards of a clinical screen although assays interrogating rare variants, transversions, and variants within low-complexity regions require careful evaluation.

Is continuous positive airway pressure (CPAP) a new standard of care for type 1 respiratory failure in COVID-19 patients? A retrospective observational study of a dedicated COVID-19 CPAP service.

The aim of this case series is to describe and evaluate our experience of continuous positive airway pressure (CPAP) to treat type 1 respiratory failure in patients with COVID-19. CPAP was delivered in negative pressure rooms in the newly repurposed infectious disease unit. We report a cohort of 24 patients with type 1 respiratory failure and COVID-19 admitted to the Royal Liverpool Hospital between 1 April and 30 April 2020. Overall, our results were positive; we were able to safely administer CPAP outside the walls of a critical care or high dependency unit environment and over half of patients (58%) avoided mechanical ventilation and a total of 19 out of 24 (79%) have survived and been discharged from our care.

The use of STarT back screening tool to predict functional disability outcomes in patients receiving physical therapy for low back pain.

BACKGROUND CONTEXT: The STarT Back Screening Tool (SBST) categorizes risk of future disability in patients with low back pain (LBP). Previous studies evaluating the use of SBST in physical therapy (PT) populations do not reflect the ethnic and socioeconomic diversity occurring in clinical practice and lack statistical power to evaluate factors associated with outcomes within each SBST risk category. PURPOSE: The purpose of this study is to further refine SBST risk categorization for predicting improvements in functional disability with attention toward patient level factors that might guide SBST use in routine outpatient physical therapy practice. STUDY DESIGN/SETTING: This was a retrospective cohort study that took place within a large academic, tertiary-care health system. PATIENT SAMPLE: The study cohort consisted of 1,169 patients with LBP who completed a course of outpatient physical therapy from June 1, 2014 to May 31, 2015 and who completed the patient-reported SBST and modified low back pain disability questionnaire (MDQ) questionnaires as part of standard of care. OUTCOME MEASURES: Improvement in functional disability defined as decrease in 10 or more points in the MDQ. METHODS: Multivariable logistic regression was performed to evaluate independent predictors of improvement after PT, which included SBST risk category, baseline MDQ, a two-way interaction term between SBST category and baseline MDQ, prior level of function (independent vs. required assistance), demographic characteristics, number of completed PT visits, and duration of PT episode of care. In exploratory analyses, additional two-way interaction terms between SBST category and the significant predictors were added to the regression model. RESULTS: Mean age of patients in the study cohort was 55.1 years (SD 16.1); 657 (56.2%) were female, 117 (10.0%) were black race, 127 (10.9%) had Medicaid insurance, and 353 (30.2%) had previously received PT for back pain. In all, 35.8% (n=419) patients categorized as low risk SBST category, 40.7% (n=476) medium risk SBST category, and 23.4% (n=274) high risk SBST category. There was an interaction between baseline MDQ and SBST risk category and improvement with PT. For all three SBST categories, higher baseline MDQ was associated with higher probability of improvement, but the effect was less pronounced as SBST risk category increased. Additional factors independently associated with reduced odds of improvement after PT included black race (odds ratio [OR] 0.44, 95% confidence interval [CI] 0.28-0.72), Medicaid insurance (OR=0.58, 95% CI 0.36-0.95), and prior PT (OR=0.48, 95% CI 0.34-0.67). In exploratory analyses, there was a significant interaction between insurance type and SBST risk category in predicting functional improvement after PT. Patients with Medicare and Medicaid insurance had similar rates of improvement in low and high risk SBST categories but different rates of improvement in the medium risk categories. CONCLUSIONS: The SBST tool predicts outcomes of PT in a cohort of patients receiving outpatient PT for LBP. The odds of improvement varied according to baseline disability and SBST risk status. Race, insurance type, and history of previous PT influenced prediction independent of SBST risk status. Incorporating these variables and the interaction between SBST and baseline disability in outcome models has the potential to refine prediction of outcomes after PT.

Increasing Mobility via In-hospital Ambulation Protocol Delivered by Mobility Technicians: A Pilot Randomized Controlled Trial.

BACKGROUND: Ambulating medical inpatients may improve outcomes, but this practice is often overlooked by nurses who have competing clinical duties. OBJECTIVE: This study aimed to assess the feasibility and effectiveness of dedicated mobility technician-assisted ambulation in older inpatients. DESIGN: This study was a single-blind randomized controlled trial. SETTING: Patients aged ≥60 years and admitted as medical inpatients to a tertiary care center were recruited. INTERVENTION: Patients were randomized into two groups to participate in the ambulation protocol administered by a dedicated mobility technician. Usual care patients were not seen by the mobility technician but were not otherwise restricted in their opportunity to ambulate. MEASUREMENTS: Primary outcomes were length of stay and discharge disposition. Secondary outcomes included change in mobility measured by six-clicks score, daily steps measured by Fitbit, and 30-day readmission. RESULTS: Control (n = 52) and intervention (n = 50) groups were not significantly different at baseline. Of patients randomized to the intervention group, 74% participated at least once. Although the intervention did not affect the primary outcomes, the intervention group took nearly 50% more steps than the control group (P = .04). In the per protocol analysis, the six-clicks score significantly increased (P = .04). Patients achieving ≥400 steps were more likely to go home (71% vs 46%, P = .01). CONCLUSIONS: Attempted ambulation three times daily overseen by a dedicated mobility technician was feasible and increased the number of steps taken. A threshold of 400 steps was predictive of home discharge. Further studies are needed to establish the appropriate step goal and the effect of assisted ambulation on hospital outcomes.

Self-inflicted finger injury in individuals with spinal cord injury: an analysis of 5 cases.

OBJECTIVE: To describe the occurrence of finger autophagia in 5 persons with traumatic spinal cord injury and to present a discussion of putative causes and potential treatments. BACKGROUND: Minor self-mutilating actions, such as nail biting and hair pulling, are common in humans and usually benign. In some circumstances, these behaviors are associated with obsessive-compulsive personality traits. In humans, self-injurious biting behaviors are well described in the setting of mental retardation and psychosis and in persons with Lesch-Nyhan syndrome. Rare cases of human autophagia in persons with intact cognition have been reported, most commonly in the setting of acquired nervous system lesions. After spinal cord injury, it has been suggested that this behavior constitutes a human variant of animal autotomy and a response to neuropathic pain. DESIGN: Case presentation narrative. MAIN OUTCOME MEASURES: Photographic and radiological study, administration of Yale-Brown Obsessive-Compulsive Scale (YBOCS). FINDINGS: In 5 patients with complete tetraplegia, pain in the hands was present in only one instance. The severity of autoamputation varied from minor to extreme. In all cases, damage was confined to analgesic body parts. In 3 cases, autophagia behavior was discovered in progress. Treatments included pharmacotherapy, counseling, and behavioral therapy, with mixed results. All patients were intelligent, willing to discuss their issues, and able to identify conditions of stress and isolation in their lives. Mild preinjury obsessive-compulsive behaviors, such as nail biting, were universal. On the YBOCS, only 1 patient scored in a range indicative of mild obsessive-compulsive symptomatology. CONCLUSIONS: This group exhibited heterogeneous medical, social, and cultural characteristics. A link between pain and self-injurious behavior could not be demonstrated. This behavior may be viewed as an extreme variant of nail biting, with potential ominous complications. Treatment strategies have been employed with mixed results.

Failed Removal of Indwelling Urinary Catheters in Patients With Acute Stroke: Incidence and Risk Factors.

BACKGROUND: Reducing the incidence of indwelling urinary catheter (IUC) use and early removal of the devices that are inserted are appropriate priorities for quality patient care. Just like symptomatic bacteriuria, failed catheter removal as a complication of IUC use is associated with considerable morbidity. In the ideal setting, patients who need IUCs have them, and patients who do not need them will have them removed safely, with the goal of reducing medical complications and facilitating the rehabilitation phase of care. OBJECTIVE: To determine the incidence of failed removal of IUCs and the factors associated with failed removal in persons hospitalized with acute stroke. DESIGN: Retrospective review of medical records and associated clinical data collection platforms. SETTING: Comprehensive stroke center at a tertiary care hospital. PATIENTS: The study cohort included 175 stroke patients admitted to the hospital and managed with IUCs. Mean age was 66.1 years (standard deviation = 15), 55% were female. METHODS: Univariable and multiple logistic regression analyses were performed. Variables assessed included age, gender, race, duration of hospital stay, stroke subtype, National Institutes of Health Stroke Scale, and 6-Clicks Scale, which is a measure of functional status. MAIN OUTCOME MEASUREMENTS: The dependent variable was occurrence of a failed attempt at removal of an IUC, defined as removal followed by a catheter reinsertion. RESULTS: During the study period, 175 of 432 patients with acute hospital admission for new stroke had an IUC removal event. Of these patients, 46 (26%) experienced a failed catheter removal. On univariate analysis, factors significantly associated with failed removal included presence of a hemorrhagic stroke (P = .005), lower level of physical function (by 6-Clicks and NIHSS scores), hospital length of stay (P < .001), and discharge location (P = .005). Bedside bladder ultrasound testing by nursing staff was used more frequently in the group of patients who had unsuccessful IUC removals (95% confidence interval 4.56-21.67, P < .001). Length of stay (P < .001), white race (P = .001), and hemorrhagic stroke (P = .009) were associated independently with failed catheter removal after adjustment for other clinical variables. CONCLUSIONS: This single-site study identified a high incidence of failed urinary catheter removal in patients with stroke, along with factors associated with failed removal. This is the first step in developing a predictive model that could reduce the incidence of this adverse event. Policies, penalties, and protocols designed to reduce catheter days must be sensitive to the special situations in which IUCs are medically necessary and equal consideration given to identifying the patients for which catheter removal poses a greater risk than continued catheter use. LEVEL OF EVIDENCE: III.

Transcranial direct current stimulation (tDCS) paired with massed practice training to promote adaptive plasticity and motor recovery in chronic incomplete tetraplegia: A pilot study.

OBJECTIVE: Our goal was to determine if pairing transcranial direct current stimulation (tDCS) with rehabilitation for two weeks could augment adaptive plasticity offered by these residual pathways to elicit longer-lasting improvements in motor function in incomplete spinal cord injury (iSCI). DESIGN: Longitudinal, randomized, controlled, double-blinded cohort study. SETTING: Cleveland Clinic Foundation, Cleveland, Ohio, USA. PARTICIPANTS: Eight male subjects with chronic incomplete motor tetraplegia. INTERVENTIONS: Massed practice (MP) training with or without tDCS for 2 hrs, 5 times a week. OUTCOME MEASURES: We assessed neurophysiologic and functional outcomes before, after and three months following intervention. Neurophysiologic measures were collected with transcranial magnetic stimulation (TMS). TMS measures included excitability, representational volume, area and distribution of a weaker and stronger muscle motor map. Functional assessments included a manual muscle test (MMT), upper extremity motor score (UEMS), action research arm test (ARAT) and nine hole peg test (NHPT). RESULTS: We observed that subjects receiving training paired with tDCS had more increased strength of weak proximal (15% vs 10%), wrist (22% vs 10%) and hand (39% vs. 16%) muscles immediately and three months after intervention compared to the sham group. Our observed changes in muscle strength were related to decreases in strong muscle map volume (r=0.851), reduced weak muscle excitability (r=0.808), a more focused weak muscle motor map (r=0.675) and movement of weak muscle motor map (r=0.935). CONCLUSION: Overall, our results encourage the establishment of larger clinical trials to confirm the potential benefit of pairing tDCS with training to improve the effectiveness of rehabilitation interventions for individuals with SCI. TRIAL REGISTRATION: NCT01539109.

Functional Magnetic Stimulation of Inspiratory and Expiratory Muscles in Subjects With Tetraplegia.

BACKGROUND: Respiratory complications are major causes of morbidity and mortality in persons with a spinal cord injury, partly because of respiratory muscle paralysis. Earlier investigation has demonstrated that functional magnetic stimulation (FMS) can be used as a noninvasive technology for activating expiratory muscles, thus producing useful expiratory functions (simulated cough) in subjects with spinal cord injury. OBJECTIVE: To evaluate the effectiveness of FMS for conditioning inspiratory and expiratory muscles in persons with tetraplegia. DESIGN: A prospective before and after trial. SETTING: FMS Laboratory, Louis Stokes Cleveland VA Medical Center, Cleveland, OH. PARTICIPANTS: Six persons with tetraplegia. METHOD: Each subject participated in a 6-week FMS protocol for conditioning the inspiratory and expiratory muscles. A magnetic stimulator was used with the center of a magnetic coil placed at the C7-T1 and T9-T10 spinous processes, respectively. Pulmonary function tests were performed before, during, and after the protocol. MAIN OUTCOME MEASUREMENTS: Respiratory variables included maximal inspiratory pressure (MIP), inspiratory reserve volume (IRV), peak inspiratory flow (PIF), maximal expiratory pressure (MEP), expiratory reserve volume (ERV), and peak expiratory flow (PEF). RESULTS: After 6 weeks of conditioning, the main outcome measurements (mean ± standard error) were as follows: MIP, 89.6 ± 7.3 cm H2O; IRV, 1.90 ± 0.34 L; PIF, 302.4 ± 36.3 L/min; MEP, 67.4 ± 11.1 cm H2O; ERV, 0.40 ± 0.06 L; and PEF, 372.4 ± 31.9 L/min. These values corresponded to 117%, 107%, 136%, 109%, 130%, and 124% of pre-FMS conditioning values, respectively. Significant improvements were observed in MIP (P = .022), PIF (P = .0001), and PEF (P = .0006), respectively. When FMS was discontinued for 4 weeks, these values showed decreases from their values at the end of the conditioning protocol, which suggests that continual FMS may be necessary to maintain improved respiratory functions. CONCLUSION: FMS conditioning of the inspiratory and expiratory muscles improved voluntary inspiratory and expiratory functions. FMS may be a noninvasive technology for respiratory muscle training in persons with tetraplegia.

Interrater Reliability of AM-PAC "6-Clicks" Basic Mobility and Daily Activity Short Forms.

BACKGROUND: The interrater reliability of 2 new inpatient functional short-form measures, Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" basic mobility and daily activity scores, has yet to be established. OBJECTIVE: The purpose of this study was to examine the interrater reliability of AM-PAC "6-Clicks" measures. DESIGN: A prospective observational study was conducted. METHODS: Four pairs of physical therapists rated basic mobility and 4 pairs of occupational therapists rated daily activity of patients in 1 of 4 hospital services. One therapist in a pair was the primary therapist directing the assessment while the other therapist observed. Each therapist was unaware of the other's AM-PAC "6-Clicks" scores. Reliability was assessed with intraclass correlation coefficients (ICCs), Bland-Altman plots, and weighted kappa. RESULTS: The ICCs for the overall reliability of basic mobility and daily activity were .849 (95% confidence interval [CI]=.784, .895) and .783 (95% CI=.696, .847), respectively. The ICCs for the reliability of each pair of raters ranged from .581 (95% CI=.260, .789) to .960 (95% CI=.897, .983) for basic mobility and .316 (95% CI=-.061, .611) to .907 (95% CI=.801, .958) for daily activity. The weighted kappa values for item agreement ranged from .492 (95% CI=.382, .601) to .712 (95% CI=.607, .816) for basic mobility and .251 (95% CI=.057, .445) to .751 (95% CI=.653, .848) for daily activity. Mean differences between raters' scores were near zero. LIMITATIONS: Raters were from one health system. Each pair of raters assessed different patients in different services. CONCLUSIONS: The ICCs for AM-PAC "6-Clicks" total scores were very high. Levels of agreement varied across pairs of raters, from large to nearly perfect for physical therapists and from moderate to nearly perfect for occupational therapists. Levels of agreement for individual item scores ranged from small to very large.

Validity of the AM-PAC "6-Clicks" inpatient daily activity and basic mobility short forms.

BACKGROUND: Standardized assessment of patients' activity limitations in acute care settings can provide valuable information. Existing measures have not been widely implemented. OBJECTIVES: The aim of this study was to provide evidence for validity of scores on Activity Measure for Post-Acute Care (AM-PAC) "6-Clicks" measures of basic mobility and daily activity in acute care. DESIGN: A retrospective measurement study was conducted. METHODS: The study used a database from one health system containing "6-Clicks" scores from first and last physical therapist and occupational therapist visits for 84,446 patients. Validity was analyzed by examining differences in "6-Clicks" scores across categories of patient characteristics; the ability of "6-Clicks" scores to predict patients' having more than one therapy visit; correlation of "6-Clicks" scores with Functional Independence Measure (FIM) scores; and internal responsiveness over the episode of care. Internal consistency reliability also was determined. RESULTS: The "6-Clicks" scores differed across patients' age, preadmission living situation, and number of therapy visits. The areas under receiver operating characteristic curves derived using "6-Clicks" scores at the first visit to predict patients receiving more than one visit were 0.703 and 0.652 using basic mobility and daily activity scores, respectively. The "6-Clicks" scores at the final visit were correlated with scores on subscales of the FIM completed on admission to inpatient rehabilitation facilities (r=.65 and .69). Standardized response means were 1.06 and 0.95 and minimal detectable changes with 90% confidence level (MDC90) were 4.72 and 5.49 for basic mobility and daily activity scores, respectively. Internal consistency reliability of basic mobility and daily activity scores was .96 and .91, respectively. LIMITATIONS: Using clinical databases for research purposes has limitations, including missing data, misclassifications, and selection bias. Rater reliability is not known. CONCLUSIONS: This study provides evidence for the validity of "6-Clicks" scores for assessing patients' activity limitations in acute care settings.

AM-PAC "6-Clicks" functional assessment scores predict acute care hospital discharge destination.

BACKGROUND: Physical therapists and occupational therapists practicing in acute care hospitals play a crucial role in discharge planning. A standardized assessment of patients' function could be useful for discharge recommendations. OBJECTIVES: The study objective was to determine the accuracy of "6-Clicks" basic mobility and daily activity measures for predicting discharge from an acute care hospital to a home or institutional setting. DESIGN: The study was retrospective and observational. METHODS: "6-Clicks" scores obtained at initial visits by physical therapists or occupational therapists and patients' discharge destinations were used to develop and validate receiver operating characteristic curves for predicting discharge destination. Positive predictive values (PPV), negative predictive values (NPV), and likelihood ratios were calculated. RESULTS: Areas under the receiver operating characteristic curves for basic mobility scores were 0.857 (95% confidence interval [CI]=0.852, 0.862) and 0.855 (95% CI=0.850, 0.860) in development and validation samples, respectively. Areas under the curves for daily activity scores were 0.846 (95% CI=0.841, 0.851) and 0.845 (95% CI=0.840, 0.850) in development and validation samples, respectively. Cutoff scores providing the best accuracy for determining discharge destination were 42.9 for basic mobility and 39.4 for daily activity. For basic mobility, the PPV was 0.748 and the NPV was 0.801 in both development and validation samples. For daily activity, the PPVs were 0.787 and 0.784 and the NPVs were 0.748 and 0.746 in development and validation samples, respectively. LIMITATIONS: Limitations included lack of information on the rater reliability of "6-Clicks" instruments, use of surrogate data for some discharge designations, and use of a clinical database for research purposes. CONCLUSIONS: This study provides evidence of the accuracy of "6-Clicks" scores for predicting destination after discharge from an acute care hospital.