Restricted spirometry and cardiometabolic comorbidities: results from the international population based BOLD study.

BACKGROUND: Whether restricted spirometry, i.e. low Forced Vital Capacity (FVC), predicts chronic cardiometabolic disease is not definitely known. In this international population-based study, we assessed the relationship between restricted spirometry and cardiometabolic comorbidities. METHODS: A total of 23,623 subjects (47.5% males, 19.0% current smokers, age: 55.1 ± 10.8 years) from five continents (33 sites in 29 countries) participating in the Burden of Obstructive Lung Disease (BOLD) study were included. Restricted spirometry was defined as post-bronchodilator FVC < 5th percentile of reference values. Self-reports of physician-diagnosed cardiovascular disease (CVD; heart disease or stroke), hypertension, and diabetes were obtained through questionnaires. RESULTS: Overall 31.7% of participants had restricted spirometry. However, prevalence of restricted spirometry varied approximately ten-fold, and was lowest (8.5%) in Vancouver (Canada) and highest in Sri Lanka (81.3%). Crude odds ratios for the association with restricted spirometry were 1.60 (95% CI 1.37-1.86) for CVD, 1.53 (95% CI 1.40-1.66) for hypertension, and 1.98 (95% CI 1.71-2.29) for diabetes. After adjustment for age, sex, education, Body Mass Index (BMI) and smoking, the odds ratios were 1.54 (95% CI 1.33-1.79) for CVD, 1.50 (95% CI 1.39-1.63) for hypertension, and 1.86 (95% CI 1.59-2.17) for diabetes. CONCLUSION: In this population-based, international, multi-site study, restricted spirometry associates with cardiometabolic diseases. The magnitude of these associations appears unattenuated when cardiometabolic risk factors are taken into account.

Challenges to the Application of Integrated, Personalized Care for Patients with COPD-A Vision for the Role of Clinical Information.

Chronic Obstructive Pulmonary Disease (COPD) is a complex disease defined by airflow limitation and characterized by a spectrum of treatable and untreatable pulmonary and extra-pulmonary disease characteristics. Nonpharmacological management related to physical activity, physical capacity, body composition, breathing and energy-saving techniques, coping strategies, and self-management is as important as its pharmacological management. Most patients with COPD carry other chronic diagnoses and this poses a key challenge, as it lowers the quality of life, increases mortality, and impacts healthcare consumption. A personalized, multi-, and interprofessional approach is key. Today, healthcare is poorly organized to meet this complexity with the isolation between care levels, logic silos of the different healthcare professions, and lack of continuity of care along the patient's journey with the healthcare system. In order to meet the criteria for integrated, personalized care for COPD, the structural capabilities of healthcare to support a comprehensive approach and continuity of care needs improvement. COPD is preeminently a disease that requires a transition from a reactive single-specialty approach to a proactive interprofessional approach. In this study, we discuss the issues that need to be addressed when moving from current health care practice to a person-centered model where the care processes and information are aligned to the individual personal needs of the patient.

Functional outcomes of spasticity-reducing surgery and rehabilitation at 1-year follow-up in 30 patients.

The effects of spasticity-reducing surgery in the upper extremity were assessed in a prospective observational study of 30 consecutive patients with stroke (n = 13), incomplete spinal cord injury (n = 9), traumatic brain injury (n = 5), cerebral palsy (n = 2), and degenerative central nervous system disease (n = 1). Surgery, which included lengthening of tendons and release of muscles, was followed by early rehabilitation at three intensity levels depending on the patients' specific needs and conditions. At 12 months follow-up there were significant improvements in all outcome measures with the following mean values: spasticity decreased by 1.4 points (Modified Ashworth Scale, 0-5), visual analogue pain score by 1.3 points, and both Canadian Occupational Performance Measures increased (performance by 3.4 and satisfaction by 3.6), and most measures of joint position or mobility improved. Hand surgery combined with early and comprehensive rehabilitation improves function, activity and patients' satisfaction in patients with disabling spasticity with improvement lasting for at least 1 year.Level of evidence: II.

A 15-year follow-up of transfemoral amputees with bone-anchored transcutaneous prostheses.

AIMS: The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis. METHODS: In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years' follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded. RESULTS: The Q-TFA scores at two, five, seven, and ten years showed significantly more prosthetic use, better mobility, fewer problems, and an improved global situation, compared with baseline. The survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. A total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts. There was a positive relationship between a higher activity grade and the number of mechanical complications. CONCLUSION: Compared with before treatment, the patient-reported outcome was significantly better and remained so over time. Although osseointegration and the ability to transfer loads over a 15-year period have been demonstrated, a large number of mechanical failures in the external implant parts were found. Since these were related to higher activity, restrictions in activity and improvements to the mechanical properties of the implant system are required. Cite this article: Bone Joint J 2020;102-B(1):55-63.

Loads on Transhumeral Amputees Using Osseointegrated Prostheses.

The treatment of the upper extremities is not as prevalent as that of the lower limbs, but it is nonetheless equally important. Today, there are no load data relating to upper extremity bone-anchored prosthesis users in the literature, but they are important in order to improve the rehabilitation protocol, design aspects and confidence of the user when it comes to loading the prosthesis in daily life. The aim of the present study was to investigate, in a population of eleven transhumeral amputees with osseointegrated implants, the load levels reached during specific prosthetic movements at maximum voluntary effort and during daily activities. The data showed a wide range of maximum load levels throughout the different activities. Furthermore, the data indicate that some test subjects felt apprehensive about loading the prosthesis, resulting in relatively low loads compared with the group as a whole. Within the limits of the present study, it was concluded that loading the implant system was subject specific, which resulted in large subject-to-subject variability. Moreover, some subjects exhibited uncertainty about the levels that could damage the fixation or the implant system. The study illustrates the diversity and uncertainty that exist in a population of transhumeral amputees treated with bone-anchored prostheses in terms of loading in daily life.

Thumb Amputations Treated With Osseointegrated Percutaneous Prostheses With Up to 25 Years of Follow-up.

INTRODUCTION: Implantation of an osseointegrated percutaneous prosthesis provides a reconstruction alternative for thumb amputation without sacrificing donor tissues. METHODS: Thirteen thumb amputees received osseointegrated prostheses (1990 to 2014). The treatments were started with custom-designed implants. Since 2005, standardized implant components and structured rehabilitation protocols were introduced. The median follow-up period was 9.5 years. RESULTS: Six patients were lost to follow-up. Seven patients (including all six after the introduction of the standardized protocol) had good osseoperception, grip strength (Jamar) was 28.3 kg on the operated side versus 40.4 kg in the unaffected hand (70%), and key grip strength was 6 versus 9.1 kg. Hand function was 94% of the normal hand. The most common complications were mechanical failures necessitating changes of components (eight times in three patients) and superficial infections (seven times in five patients). Five patients had no complications. The refined implant design and new standardized treatment protocol achieved a 100% cumulative success rate with 9.5 years of follow-up so far. DISCUSSION: Treatment of thumb amputees using bone-anchored percutaneous prostheses seems to be a safe, durable method with excellent short- and medium-long follow-up results. Severe adverse events are few except for implant loosening which occurred only in the early custom-designed group.

Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow-up of Patient-reported Outcomes and Complications.

INTRODUCTION: Direct skeletal attachment of prostheses has previously been shown to improve patient-reported outcome (PRO) measures of individuals with transfemoral amputation (TFA) at 2-year follow-up. This prospective study reports the outcomes at 5-year follow-up. METHODS: A total of 51 patients (55 legs) with TFA were included in a prospective study. Complications, success rate, and PRO measures were followed for 5 years. RESULTS: The cumulative fixture survival rate at 5 years was 92%, and the revision-free survival rate was 45%. Thirty-four patients had 70 superficial infections. Eleven patients had 14 deep infections. Fifteen patients had mechanical complications. Four fixtures were removed (ie, one deep infection and three loosening). PRO measures showed significant improvements including more use of the prosthesis, better mobility, fewer issues, and improved physical health-related quality of life (all P < 0.0001) compared with baseline. CONCLUSION: Individuals with TFA at 5-year follow-up had significant improvement in PRO measures, but increases in deep infections and mechanical complications are concerning.

Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial.

INTRODUCTION: Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. METHODS AND ANALYSIS: Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. ETHICS AND DISSEMINATION: The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT03112928; Pre-results.

Touch and Hearing Mediate Osseoperception.

Osseoperception is the sensation arising from the mechanical stimulation of a bone-anchored prosthesis. Here we show that not only touch, but also hearing is involved in this phenomenon. Using mechanical vibrations ranging from 0.1 to 6 kHz, we performed four psychophysical measures (perception threshold, sensation discrimination, frequency discrimination and reaction time) on 12 upper and lower limb amputees and found that subjects: consistently reported perceiving a sound when the stimulus was delivered at frequencies equal to or above 400 Hz; were able to discriminate frequency differences between stimuli delivered at high stimulation frequencies (~1500 Hz); improved their reaction time for bimodal stimuli (i.e. when both vibration and sound were perceived). Our results demonstrate that osseoperception is a multisensory perception, which can explain the improved environment perception of bone-anchored prosthesis users. This phenomenon might be exploited in novel prosthetic devices to enhance their control, thus ultimately improving the amputees' quality of life.

Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain.

BACKGROUND: Phantom limb pain is a debilitating condition for which no effective treatment has been found. We hypothesised that re-engagement of central and peripheral circuitry involved in motor execution could reduce phantom limb pain via competitive plasticity and reversal of cortical reorganisation. METHODS: Patients with upper limb amputation and known chronic intractable phantom limb pain were recruited at three clinics in Sweden and one in Slovenia. Patients received 12 sessions of phantom motor execution using machine learning, augmented and virtual reality, and serious gaming. Changes in intensity, frequency, duration, quality, and intrusion of phantom limb pain were assessed by the use of the numeric rating scale, the pain rating index, the weighted pain distribution scale, and a study-specific frequency scale before each session and at follow-up interviews 1, 3, and 6 months after the last session. Changes in medication and prostheses were also monitored. Results are reported using descriptive statistics and analysed by non-parametric tests. The trial is registered at ClinicalTrials.gov, number NCT02281539. FINDINGS: Between Sept 15, 2014, and April 10, 2015, 14 patients with intractable chronic phantom limb pain, for whom conventional treatments failed, were enrolled. After 12 sessions, patients showed statistically and clinically significant improvements in all metrics of phantom limb pain. Phantom limb pain decreased from pre-treatment to the last treatment session by 47% (SD 39; absolute mean change 1·0 [0·8]; p=0·001) for weighted pain distribution, 32% (38; absolute mean change 1·6 [1·8]; p=0·007) for the numeric rating scale, and 51% (33; absolute mean change 9·6 [8·1]; p=0·0001) for the pain rating index. The numeric rating scale score for intrusion of phantom limb pain in activities of daily living and sleep was reduced by 43% (SD 37; absolute mean change 2·4 [2·3]; p=0·004) and 61% (39; absolute mean change 2·3 [1·8]; p=0·001), respectively. Two of four patients who were on medication reduced their intake by 81% (absolute reduction 1300 mg, gabapentin) and 33% (absolute reduction 75 mg, pregabalin). Improvements remained 6 months after the last treatment. INTERPRETATION: Our findings suggest potential value in motor execution of the phantom limb as a treatment for phantom limb pain. Promotion of phantom motor execution aided by machine learning, augmented and virtual reality, and gaming is a non-invasive, non-pharmacological, and engaging treatment with no identified side-effects at present. FUNDING: Promobilia Foundation, VINNOVA, Jimmy Dahlstens Fond, PicoSolve, and Innovationskontor Väst.