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OBJECTIVE: The aim of this study was to evaluate the benefit of inpatient treatment in reducing disease activity in patients with complex regional pain syndrome (CRPS) who have exhausted outpatient options. Furthermore, the study sought to identify patient-related outcome variables that predict a reduction in disease activity. METHODS: The primary outcome was disease severity (CRPS Severity Score, range 0-16 points). Secondary outcomes included depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and the ability to participate in social roles and activities, all of which were assessed using the PROMIS-29. Furthermore, pain catastrophizing, neuropathic pain, quality of life, pain self-efficacy, medication intake, and the patient's global impression of change were examined in accordance with current international agreed recommendations, assessed at discharge, 3-month, and 6-month post-discharge. Mixed-effects models were conducted to identify baseline variables associated with CRPS severity. RESULTS: Twenty-five patients completed the program (mean age 49.28 [SD 11.23] years, 92% females, mean symptom duration 8.5 [SD 6.5] months). Results showed a significant reduction between baseline and discharge of disease activity (CSS -2.36, P < .0001), pain (PROMIS-29 pain -0.88, P = .005), and emotional function (PROMIS-29 depression -5.05, P < .001; fatigue -4.63, P = .002). Moderate evidence for a reduction between baseline and discharge could be observed for pain interference (+2.27, P = .05), social participation (PROMIS-29 + 1.93, P = .05), anxiety (PROMIS-29 -3.32, P = .02) and physical function (PROMIS-29 + 1.3, P = .03). On discharge, 92% of patients (23 of 25) reported improvement in their overall condition. In the follow-up period, medication intake could be reduced after 3 (MQS -8.22, P = .002) and 6 months (MQS -8.69, P = .001), and there was further improvement in social participation after 3 months (PROMIS-29 + 1.72, 0.03) and sleep after 6 months (PROMIS-29 + 2.38, 0.008). In the mixed models, it was demonstrated that patients experiencing less pain at baseline also exhibited lower disease activity. CONCLUSION: The results of this study confirm that inpatient interdisciplinary treatment of CRPS patients improves disease activity, pain, physical function, emotional function, and social participation. Most improvements were maintained for up to 6 months after discharge. The majority of patients reported that their overall condition had improved during the study period.
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Síndromes de Dolor Regional Complejo , Humanos , Femenino , Masculino , Síndromes de Dolor Regional Complejo/terapia , Persona de Mediana Edad , Estudios Prospectivos , Adulto , Pacientes Internos , Estudios de Cohortes , Calidad de Vida , Resultado del TratamientoRESUMEN
OBJECTIVE: To identify and quantify risk factors for in-hospital falls in medical patients. DATA SOURCES: Six databases (MEDLINE, Embase, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) were systematically screened until April 11, 2023, to identify relevant articles. STUDY SELECTION: All titles and abstracts of the retrieved articles were independently screened by 2 researchers who also read the full texts of the remaining articles. Quantitative studies that assessed risk factors for falls among adult patients acutely hospitalized were included in the review. Publications that did not capture internal medicine patients or focused on other specific populations were excluded. DATA EXTRACTION: Information on study characteristics and potential risk factors were systematically extracted. Risk of bias was assessed using the Quality in Prognosis Studies tool. Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analyses of Observational Studies in Epidemiology guidelines were followed for reporting. DATA SYNTHESIS: The main outcome was any in-hospital falls. Using a random-effects meta-analysis model, association measures for each risk factor reported in 5 or more studies were pooled. Separate analyses according to effect measure and studies adjusted for sex and age at least were performed. Of 5067 records retrieved, 119 original publications from 25 countries were included. In conclusion, 23 potential risk factors were meta-analyzed. Strong evidence with large effect sizes was found for a history of falls (odds ratio [OR], 2.54; 95% confidence interval [CI], 1.63-3.96; I2, 91%), antidepressants (pooled OR, 2.25; 95% CI, 1.92-2.65; I2, 0%), benzodiazepines (OR, 1.97; 95% CI, 1.68-2.31; I2, 0%), hypnotics-sedatives (OR, 1.90; 95% CI, 1.53-2.36; I2, 46%), and antipsychotics (OR, 1.61; 95% CI, 1.33-1.95; I2, 0%). Furthermore, evidence of associations with male sex (OR, 1.22, 95% CI, 0.99-1.50; I2, 65%) and age (OR, 1.17, 95% CI, 1.02-1.35; I2, 72%) were found, but effect sizes were small. CONCLUSIONS: The comprehensive list of risk factors, which specifies the strength of evidence and effect sizes, could assist in the prioritization of preventive measures and interventions.
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PURPOSE: Musculoskeletal (MSK) injuries are a major contributing factor for chronic pain. To date, little is known how pain medication use in MSK injuries has changed over time. We assessed pain medication prescription for MSK injuries in a representative sample of Swiss workers between 2008 and 2018. METHODS: Retrospective analysis of the Swiss Accident Insurance Fund (Suva) data. We calculated annual pain medication use, treatment days, and costs associated with pain medication use in minor and major MSK injuries. RESULTS: In total, 1,921,382 cases with MSK injuries with ≥ 1 pain medication were analyzed. Whereas MSK injuries with ≥ 1 pain medication increased by 9.4%, we observed a larger increase in metamizole (+ 254%), strong opioids (+ 88.4%), coxibs (+ 85.8%), and paracetamol (+ 28.1%). Strong opioids were increasingly used in minor (+ 91.4%) and major (+ 88.3%) injuries. The increase in metamizole (+ 390.6%) and coxibs (+ 115.5%) was larger in minor injuries compared to major injuries (+ 238.7% and + 80.6%, respectively). Medical expenses decreased in all medications except for strong opioids where a substantial increase was observed (+ 192.4% in minor; + 34% in major injuries). CONCLUSIONS: We observed a disproportionate increase in metamizole, strong opioids, coxibs, and paracetamol prescriptions even in minor MSK injuries between 2008 and 2018. Whereas treatment costs decreased for all pain medications, there was a substantial increase in strong opioids. A more liberal prescription practice of opioids conflict with current evidence-based practice recommendations and need to be addressed by physicians and policy makers.
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Dolor Crónico , Dipirona , Humanos , Dipirona/uso terapéutico , Analgésicos Opioides/uso terapéutico , Acetaminofén/uso terapéutico , Suiza/epidemiología , Inhibidores de la Ciclooxigenasa 2/uso terapéutico , Estudios RetrospectivosRESUMEN
BACKGROUND: Low mobility during an acute hospitalization is frequent and associated with adverse effects, including persistent functional decline, institutionalization and death. However, we lack effective interventions to improve mobility that are scalable in everyday practice. The INTOMOB trial - INtervention to increase MOBility in older hospitalized medical patients - will test the effect of a multilevel intervention to improve mobility of older hospitalized patients on functional mobility. METHODS: The INTOMOB multicenter superiority parallel cluster randomized controlled trial will enroll in total 274 patients in Swiss hospitals. Community-dwelling adults aged ≥ 60 years, admitted to a general internal medicine ward with an anticipated length of hospital stay of ≥ 3 days, will be eligible for participation. Unit of randomization will be the wards. A multilevel mobility intervention will be compared to standard of care and target the patients (information and exercise booklets, mobility diary, iPad with exercise videos), healthcare professionals (e-learning, oral presentation, mobility checklist), and environment (posters and pictures on the wards). The primary outcome will be life-space level, measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (LSA), at 30 days after enrollment. The LSA is a measure of functional mobility, i.e., how far participants move from bedroom to outside town. Secondary outcomes include, among others, LSA at 180 days, mobility and falls during hospitalization, muscle strength at discharge, and falls, emergency room visits, readmissions, and death within 180 days. DISCUSSION: This study has the potential to improve outcomes of older hospitalized patients through an intervention that should be scalable in clinical practice because it fosters patient empowerment and does not require additional resources. The tools provided to the patients can help them implement better mobility practices after discharge, which can contribute to better functional outcomes. The choice of a functional patient-reported outcome measure as primary outcome (rather than a "simple" objective mobility measure) reinforces the patient-centeredness of the study. TRIAL REGISTRATION: clinicaltrials.gov (NCT05639231, released on December 19 2022); Swiss National Clinical Trial Portal (SNCTP000005259, released on November 28 2022).
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Hospitalización , Alta del Paciente , Humanos , Anciano , Tiempo de Internación , Pacientes Internos , Ejercicio Físico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
We present the reflections of three clinical practitioners on ethical considerations when caring for individuals experiencing incarceration needing in-patient hospital services. We examine the challenges and critical importance of adhering to core principles of medical ethics in such settings. These principles encompass access to a physician, equivalence of care, patient's consent and confidentiality, preventive healthcare, humanitarian assistance, professional independence, and professional competence. We strongly believe that detained persons have a right to access healthcare services that are equivalent to those available in the general population, including in-patient services. All the other established standards to uphold the health and dignity of people experiencing incarceration should also apply to in-patient care, whether this takes place outside or inside the prison boundaries. Our reflection focuses on the principles of confidentiality, professional independence, and equivalence of care. We argue that the respect for these three principles, although they present specific implementation challenges, is foundational for implementing the other principles. Critically important are respect for the distinct roles and responsibilities of healthcare and security staff as well as transparent and non-hierarchical dialogue between them to ensure optimal health outcomes and functioning of hospital wards while balancing the ongoing tensions between care and control.
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Confidencialidad , Ética Médica , Humanos , Atención a la Salud , Autonomía Profesional , HospitalesRESUMEN
The majority of patients with acute back pain have no serious underlying disease; however, many internal diseases can be manifested as acute or chronic back pain. Therefore, in the assessment of patients with back pain the clinical history and clinical examination are important in order to detect indications for a possible underlying disease. Particularly red flags that indicate an acute or life-threatening disease should not be missed. In most cases where such red flags, risk factors or clinical indications are not present, no systematic search for internal underlying diseases is necessary. This article summarizes the most relevant differential diagnoses and clinical indications as well as warning symptoms.
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Dolor de la Región Lumbar , Humanos , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/etiología , Diagnóstico Diferencial , Dolor de Espalda/diagnóstico , Dolor de Espalda/etiología , Factores de Riesgo , Examen Físico/efectos adversosRESUMEN
INTRODUCTION/AIMS: Prognostic factors in Duchenne muscular dystrophy (DMD) predict the disease course and may help individualize patient care. The aim was to summarize the evidence on prognostic factors that may support treatment decisions. METHODS: We searched six databases for prospective studies that each included ≥50 DMD patients with a minimum follow-up of 1 y. Primary outcomes were age at loss of ambulation (LoA), pulmonary function (forced vital capacity percent of predicted, FVC%p), and heart failure. RESULTS: Out of 5074 references, 59 studies were analyzed. Corticosteroid use was associated with a delayed LoA (pooled effect hazard ratio [HR] 0.42, 95% confidence interval [CI] 0.23-0.75, I2 94%), better pulmonary function tests (higher peak FVC%, prolonged time with FVC%p > 50%, and reduced need for assisted ventilation) and delayed cardiomyopathy. Longer corticosteroid treatment was associated with later LoA (>1 y compared to <1 y; pooled HR: 0.50, 95% CI 0.27-0.90) and early treatment start (aged <5 y) may be associated with early cardiomyopathy and higher fracture risk. Genotype appeared to be an independent driver of LoA in some studies. Higher baseline physical function tests (e.g., 6-minute walk test) were associated with delayed LoA. Left ventricular dysfunction and FVC <1 L increased and the use of angiotensin-converting enzyme (ACE) inhibitors reduced the risk of heart failure and death. Fusion surgery in scoliosis may potentially preserve pulmonary function. DISCUSSION: Prognostic factors that may inform clinical decisions include age at corticosteroid treatment initiation and treatment duration, ACE-inhibitor use, baseline physical function tests, pulmonary function, and cardiac dysfunction.
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Cardiomiopatías , Insuficiencia Cardíaca , Distrofia Muscular de Duchenne , Corticoesteroides/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina , Angiotensinas/uso terapéutico , Cardiomiopatías/complicaciones , Progresión de la Enfermedad , Humanos , Distrofia Muscular de Duchenne/diagnóstico , Distrofia Muscular de Duchenne/tratamiento farmacológico , Pronóstico , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: To compare guideline recommendations for hip and knee osteoarthritis (OA) and their level of evidence. DATA SOURCES: MEDLINE, Embase, the Cochrane Library, and websites of professional societies were searched in June 2020 using keywords such as knee or hip osteoarthritis, degenerative arthritis, guideline, and practice guideline. STUDY SELECTION: General treatment guidelines for OA of the hip or knee published in English. After 461 abstracts were screened, 31 publications (17 guidelines from 10 professional societies) were included for analysis. DATA EXTRACTION: Three reviewers assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II tool. The rating of evidence and strength of recommendation was extracted and standardized into the Grading of Recommendations Assessment, Development, and Evaluation criteria. DATA SYNTHESIS: Of the 17 guidelines included, 6 (35%) were of high quality, 10 (59%) of moderate quality, and 1 (6%) of low quality. Guidelines published after 2017 were of good quality. Although guidelines generally agreed on a nonsurgical multimodal concept, including patient education, exercise, and weight loss in obese, some recommendations remained vague and the level of evidence varied widely. In pharmacologic treatment, oral nonsteroidal anti-inflammatory drugs were the mainstay for pain management. Guidelines published after 2017 were more cautious in their recommendation for the use of paracetamol and strong opioids. Disagreement was observed for chondroitin sulfate, glucosamine, and intra-articular hyaluronic acid injections. Recommendations were conflicting for the use of insoles, braces, and transcutaneous electrical stimulation. The main indications for hip/knee arthroplasty were severe, persisting pain and loss of function despite nonsurgical treatment. No guideline defined a minimum time of conservative treatment before surgery. CONCLUSIONS: We found a wide variation in evidence and strength of recommendations for OA treatment. Recommendations on when to refer patients for surgery remained unclear.
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Osteoartritis de la Cadera , Osteoartritis de la Rodilla , Estudios Transversales , Humanos , Inyecciones Intraarticulares , Osteoartritis de la Cadera/terapia , Osteoartritis de la Rodilla/terapia , Modalidades de Fisioterapia , Guías de Práctica Clínica como AsuntoRESUMEN
BACKGROUND: In patients with diabetes, hospitalization can complicate the achievement of recommended glycemic targets. There is increasing evidence that a closed-loop delivery system (artificial pancreas) can improve glucose control in patients with type 1 diabetes. We wanted to investigate whether a closed-loop system could also improve glycemic control in patients with type 2 diabetes who were receiving noncritical care. METHODS: In this randomized, open-label trial conducted on general wards in two tertiary hospitals located in the United Kingdom and Switzerland, we assigned 136 adults with type 2 diabetes who required subcutaneous insulin therapy to receive either closed-loop insulin delivery (70 patients) or conventional subcutaneous insulin therapy, according to local clinical practice (66 patients). The primary end point was the percentage of time that the sensor glucose measurement was within the target range of 100 to 180 mg per deciliter (5.6 to 10.0 mmol per liter) for up to 15 days or until hospital discharge. RESULTS: The mean (±SD) percentage of time that the sensor glucose measurement was in the target range was 65.8±16.8% in the closed-loop group and 41.5±16.9% in the control group, a difference of 24.3±2.9 percentage points (95% confidence interval [CI], 18.6 to 30.0; P<0.001); values above the target range were found in 23.6±16.6% and 49.5±22.8% of the patients, respectively, a difference of 25.9±3.4 percentage points (95% CI, 19.2 to 32.7; P<0.001). The mean glucose level was 154 mg per deciliter (8.5 mmol per liter) in the closed-loop group and 188 mg per deciliter (10.4 mmol per liter) in the control group (P<0.001). There was no significant between-group difference in the duration of hypoglycemia (as defined by a sensor glucose measurement of <54 mg per deciliter; P=0.80) or in the amount of insulin that was delivered (median dose, 44.4 U and 40.2 U, respectively; P=0.50). No episode of severe hypoglycemia or clinically significant hyperglycemia with ketonemia occurred in either trial group. CONCLUSIONS: Among inpatients with type 2 diabetes receiving noncritical care, the use of an automated, closed-loop insulin-delivery system resulted in significantly better glycemic control than conventional subcutaneous insulin therapy, without a higher risk of hypoglycemia. (Funded by Diabetes UK and others; ClinicalTrials.gov number, NCT01774565 .).
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Glucemia/análisis , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Sistemas de Infusión de Insulina , Insulina/administración & dosificación , Páncreas Artificial , Anciano , Diabetes Mellitus Tipo 2/sangre , Femenino , Hospitalización , Humanos , Infusiones Subcutáneas , Sistemas de Infusión de Insulina/efectos adversos , Masculino , Persona de Mediana Edad , Páncreas Artificial/efectos adversosRESUMEN
BACKGROUND: Psychological factors may impact recovery in patients undergoing treatment for shoulder complaints. The aim of this review is to systematically analyse the evidence for the effect of modifiable psychological factors (MPF) on outcome, for patients with musculoskeletal shoulder disorders undergoing conservative or surgical treatment. MPF refers to factors that may change with intervention. METHODS: This is a systematic literature review. Five databases searched (MEDLINE, CINAHL, Cochrane Library, Embase and PsycInfo), for longitudinal studies investigating the influence of MPF on prognosis of patients with shoulder disorders, all diagnoses, undergoing clinical interventions (conservative or surgical). Level of evidence was determined using Scottish Intercollegiate Guidelines Network (SIGN) methodology. Moderate and high quality evidence was included. We extracted all MPF, categorized constructs into the following domains: beliefs (self-efficacy, expectation of recovery), coping (catastrophizing, avoidant coping), and affect (depression, anxiety). We evaluated constructs for its predictive value of at least one outcome. Outcomes were informed by this review. Evidence was classified into three categories: evidence for, inconclusive evidence, and evidence against. RESULTS: Of 1170 references, 40 distinct publications based on 35 datasets were included (intervention type: 20 surgical; 20 conservative). Overall, 22 studies (20 cohort studies and 2 RCTs) were classified as high quality and 18 studies (16 cohort studies, 2 RCTs) were classified as moderate quality. Outcomes reported included pain, disability/function, perceived recovery, physical and mental health, and work status. Based on the review, of the psychological constructs explored, these data would suggest that expectation of recovery, catastrophizing, avoidant coping, depression, and anxiety may predict outcome for patients managed surgically. In patients undergoing conservative intervention the evidence was either against (catastrophizing, depression, anxiety) or inconclusive (self-efficacy, expectation of recovery, avoidant coping) for the predictive value of psychological factors on outcome. CONCLUSIONS: Five constructs were predictive of outcome for surgically managed patients. This suggests that implementing the biopsychosocial approach (i.e., preoperative screening, intervention by a trained clinician) may be advantageous for patients recommended for shoulder surgery,,. The same is not indicated for conservatively managed patients as no conclusive association of MPF with outcomes was noted. The importance of other MPF on outcome requires further investigation.
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Ansiedad , Hombro , Adaptación Psicológica , Catastrofización , Humanos , Salud MentalRESUMEN
PURPOSE: To investigate if the presence or absence of preoperative endplate Modic changes (MC) is predictive for clinical outcomes in degenerative lumbar spinal stenosis (DLSS) patients undergoing decompression-alone or decompression with instrumented fusion surgery. METHODS: Two hundred five patients were included and categorized into four groups; 102 patients into the decompression-alone group with MCs, 41 patients into the fusion group with MCs, 46 patients into the decompression-alone group without MCs, and 16 patients into the fusion group without MCs. Clinical outcome was quantified with changes in spinal stenosis measure (SSM) symptoms, SSM function, NRS pain, and EQ-5D-3L sum score over time (measured at baseline, 12-, 24-, and 36-month follow-up) and minimal clinically important difference (MCID) in SSM symptoms, SSM function, and NRS pain from baseline to 36-month follow-up. To investigate if possible effects of MCs had been modified or hidden by confounding variables, we used the group LASSO method to search for good prognostic models. RESULTS: There were no obvious differences in any of the clinical outcome measures between groups at baseline. At 12 months, most patients have improved in all outcomes and maintained improved conditions over time (no significant group differences). Between 70 and 90 percent of the patients maintained a clinically important improvement up to 36 months. CONCLUSIONS: Endplate MCs have no significant influence on clinical outcome parameters in patients with lumbar spinal stenosis compared to patients without MCs, independent of the chosen surgical strategy. All patients benefitted from surgical therapy up to 36-month follow-up. These slides can be retrieved under Electronic Supplementary Material.
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Fusión Vertebral , Estenosis Espinal , Descompresión Quirúrgica , Humanos , Vértebras Lumbares/cirugía , Estudios Prospectivos , Estenosis Espinal/cirugía , Suiza , Resultado del TratamientoRESUMEN
PURPOSE: Spinal epidural lipomatosis (SEL) is defined as an abnormal and extensive accumulation of unencapsulated adipose tissue within the spinal epidural space. To date, there is a lack of high-level evidence studies reporting the outcome of surgical treatment of symptomatic SEL in patients with lumbar spinal stenosis (LSS). The aim was to compare clinical outcomes in patients with symptomatic LSS with and without SEL who underwent decompression surgery alone at the 12- and 24-month follow-up. METHODS: One hundred and eighty-three patients met the inclusion criteria, of which 14 had mainly SEL on at least one level operated in addition to possible degenerative changes on other levels and 169 degenerative LSS only. The main outcomes were pain (Spinal Stenosis Measure (SSM) symptoms), disability (SSM function), and quality of life [EQ-5D-3L summary index (SI)] at 24-month follow-up, and minimal clinically important difference (MCID) in SSM symptoms, SSM function, and EQ-5D-3L SI. RESULTS: The multiple regression linear models showed that SEL was associated with worse SSM symptoms (p = 0.045) and EQ-5D-3L SI scores (p = 0.026) at 24-month follow-up, but not with worse SSM function scores. Further, depression (in all models) was negatively associated with better clinical outcomes at 24-month follow-up. In the outcomes SSM symptoms and EQ-5D-3L SI, distinctly more patients in the classical LSS group reached MCID than in the SEL group (71.3% and 62.3% vs. 50.0% and 42.9%). CONCLUSIONS: Our study demonstrated that decompression alone surgery was associated with significant improvement in disability in both groups at 2 years, but not in pain and quality of life in patients with SEL.
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Lipomatosis , Estenosis Espinal , Descompresión Quirúrgica , Humanos , Lipomatosis/cirugía , Vértebras Lumbares/cirugía , Estudios Prospectivos , Calidad de Vida , Estenosis Espinal/cirugía , Suiza , Resultado del TratamientoRESUMEN
We evaluated the efficacy and safety of short-term fully closed-loop insulin delivery using faster versus standard insulin aspart in type 2 diabetes. Fifteen adults with insulin-treated type 2 diabetes underwent 22 hours of closed-loop insulin delivery with either faster or standard insulin aspart in a double-blind randomized crossover design. Basal-bolus regimen was replaced by model predictive control algorithm-directed insulin delivery based on sensor glucose levels. The primary outcome was time with plasma glucose in target range (5.6-10.0 mmol/L) and did not differ between treatments (mean difference [95% CI] 3.3% [-8.2; 1.7], P = 0.17). Mean glucose and glucose variability were comparable, as was time spent below and above target range. Hypoglycaemia (<3.5 mmol/L) occurred once with faster insulin aspart and twice with standard insulin aspart. Mean total insulin dose was higher with faster insulin aspart (mean difference [95% CI] 3.7 U [0.7; 6.8], P = 0.021). No episodes of severe hypoglycaemia or other serious adverse events occurred. In conclusion, short-term fully closed-loop in type 2 diabetes may require higher dose of faster insulin aspart compared with standard insulin aspart to achieve comparable glucose control.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Insulina Aspart/administración & dosificación , Sistemas de Infusión de Insulina , Adulto , Glucemia/análisis , Método Doble Ciego , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Insulina Aspart/efectos adversos , Insulina Aspart/uso terapéuticoRESUMEN
PURPOSE: To assess the impact of manual lymphatic drainage (MLD) on the health-related quality of life (HRQoL) of adults with lymphoedema or mixed oedema, through a systematic review of randomised controlled trials (RCTs). METHODS: MEDLINE, EMBASE, PsycINFO, CENTRAL, the Cochrane Database of Systematic Reviews and ClinicalTrials.gov were searched to identify RCTs evaluating HRQoL after a MLD intervention compared to non-MLD interventions (PROSPERO 2016:CRD42016042255). We extracted the effect of the interventions on the HRQoL (primary outcome) as well as data on volume and functional changes, and adverse events when available (secondary outcomes). RESULTS: Eight studies were eligible. The studies were heterogeneous in the aetiology of oedema, schemes of MLD applied, additional treatments offered with MLD, length of follow-up, instruments used to assess HRQoL and interventions offered to the control group. Five studies included patients with breast cancer-related arm lymphoedema; one study reported increased HRQoL among patients randomised to the MLD group. The two RCTs that involved patients with leg mixed oedema due to chronic venous insufficiency did not find between-group differences in the overall HRQoL. One trial included patients with hand oedema from systemic sclerosis and showed higher HRQoL in the group that received MLD. No studies reported reductions in HRQoL, or severe adverse events after MLD. The small numbers of patients analysed in all studies may have resulted in lack of power to detect between-group differences in HRQoL. CONCLUSIONS: The effect of MLD on the HRQoL of patients with chronic oedema is unclear.
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Edema/terapia , Linfedema/terapia , Drenaje Linfático Manual/métodos , Calidad de Vida/psicología , Adulto , Edema/patología , Femenino , Humanos , Linfedema/patología , Masculino , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
PURPOSE: Patient-reported outcome measures (PROM) are used to measure treatment efficacy in clinical trials. The impact of the choice of a PROM and the cut-off values for 'meaningful important differences' (MID) on the study results in patients with lumbar spinal stenosis (LSS) is unclear. OBJECTIVE: The objective is to study the consequences of applying different PROMs and values for MID for pain and disability on the proportions of patients with improvement. DESIGN: Prospective multi-center cohort study. METHODS: Proportions of patients with improvement using established MID cut-off values were calculated and compared for PROMs for pain and disability. RESULTS: 466 patients with LSS completed a baseline and 6-month follow-up assessment and were analyzed. Treatment modalities included surgery (65 %), epidural steroid injections (15 %), or conservative care (20 %). The prevalence of patients fulfilling the criteria for MID ranged from 40 to 70 % across all outcome measures and cut-offs. The agreement of the spinal stenosis outcome measure (SSM) symptom subscale with other pain scales, and the SSM function subscale with other function scales was fair to moderate (Cohen's κ value between 0.24 and 0.5). Disagreement in the assessment of MID (MID reported by patients in one scale but not the other) was found in at least one-third of the patients. CONCLUSION: The MID in outcome scores for this population varied from 40 to 70 %, depending on the measure or cut-off score used. Further, the disagreement between domain specific measures indicates that differences between studies may be also related to the choice of an outcome measures. An international consensus on the use and reporting of outcome measures in studies on lumbar spinal stenosis is needed.
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Vértebras Lumbares , Medición de Resultados Informados por el Paciente , Estenosis Espinal/terapia , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Evaluación de la Discapacidad , Femenino , Humanos , Vértebras Lumbares/cirugía , Masculino , Dimensión del DolorRESUMEN
BACKGROUND: In Europe, scant information is available about prescription practices for pain medications. The aim of this research was to assess changes in prescription rates of non-opioid, weak opioid, and strong opioid medications between 2006 and 2013 in the Swiss population. METHODS: Using insurance claims data covering one-sixth of the Swiss population, we analyzed the numbers of reimbursed pain medications, the number of reimbursements per persons, and the cumulative dose in milligrams. For opioids, the morphine equivalent dose and treatment days were calculated. Data were extrapolated to the dose per day per 100'000 population stratified by age, gender, and canton. RESULTS: In total, 4'746'942 paracetamol, 2'156'620 NSAIDs or Coxibs, 931'129 metamizole, 1'322'272 weak opioid, and 807'835 strong opioid claims were analyzed. Between 2006 and 2013, the increase in claims per 100'000 persons was 32% for paracetamol, 242% for metamizole, 107% for NSAIDS, 86% for Coxibs, 13% for weak opioids, and 121% for strong opioids. For strong opioids the total MED in mg /100'000 increased by 117%, the treatment days /100'000 by 101%. For strong opioids, fentanyl was most frequently used (increase between 2006 and 2013 by 91% for MED/100'000 persons and 94% treatment days / 100'000) followed by buprenorphine and oxycodone. The highest proportional increase in MED / 100'000 was observed for methadone (+1414%) and oxycodone (+313%). Marked geographical variation was detected in the use of metamizole, paracetamole, and strong opioids in different cantons. CONCLUSION: The analysis of insurance claims data provides evidence that the prescription rates for pain medications increased in Switzerland within the last ten years, in particular for metamizole and strong opioids. Furthermore, the prescription rates for metamizole, paracetamol, and strong opioids varied substantially between different cantons in Switzerland.
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Analgésicos Opioides/administración & dosificación , Antiinflamatorios no Esteroideos/administración & dosificación , Prescripciones de Medicamentos , Dolor/tratamiento farmacológico , Pautas de la Práctica en Medicina , Adulto , Anciano , Anciano de 80 o más Años , Europa (Continente) , Femenino , Humanos , Revisión de Utilización de Seguros , Masculino , Persona de Mediana Edad , SuizaRESUMEN
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most frequently prescribed drugs for the treatment of sciatica. A previous Cochrane review on the efficacy of NSAIDs summarised findings for acute and chronic low back pain (LBP) and sciatica. This is an update of the original review (2008) focusing on people suffering from sciatica. OBJECTIVES: To determine the efficacy of NSAIDs in pain reduction, overall improvement, and reported side effects in people with sciatica. SEARCH METHODS: We performed electronic searches up to 24 June 2015 in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PubMed, and two trials registers. We searched reference lists of included studies and relevant reviews on the topics for additional trials. SELECTION CRITERIA: We included randomised controlled trials (double-blind, single-blind, and open-label) that assessed the efficacy of NSAIDs in sciatica. We included all trials that compared NSAIDs to placebo, to other NSAIDs, or to other medication. Additional interventions were allowed if there was a clear contrast for the treatment with NSAIDs in the trial. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed the risk of bias and extracted the data. Where feasible we calculated pooled results using Review Manager 5.3. We reported pain relief outcomes using mean difference (MD) with 95% confidence intervals (95% CI). We used risk ratios (RR) with 95% CI to report global improvement of treatment, adverse effects, and additional medication. We performed a meta-analysis if possible. We assessed level of evidence using the GRADE approach. We used standard methodological procedures recommended by The Cochrane Collaboration. MAIN RESULTS: We included 10 trials reported in 9 publications (N = 1651). Only one trial out of 10 was assessed at low risk of bias. Five trials used the currently recommended daily dose for the drug, and two trials used lower daily doses available over the counter. Three trials investigated NSAIDs no longer approved for human use. The follow-up duration was short in all studies but one.Three trials (n = 918) compared the effects of NSAIDs to those of placebo on pain reduction. The pooled mean difference showed comparable pain reduction (visual analogue scale, 0 to 100) in the NSAIDs and placebo groups (MD -4.56, 95% CI -11.11 to 1.99). Heterogeneity was high (I2 = 82%), and the quality of the evidence was very low. When we excluded one trial with a short follow-up of eight hours, the mean difference further decreased (MD -0.09, 95% CI -9.89 to 9.71). Three trials (n = 753) compared NSAIDs to placebo regarding global improvement. We found low-quality evidence that NSAIDs are more effective than placebo with a risk ratio of 1.14 (95% CI 1.03 to 1.27). One trial (n = 214) studied the effect of NSAIDs on disability, finding very low-quality evidence that NSAIDs are no more effective than placebo on disability. Four trials (n = 967) comparing NSAIDs to placebo reported adverse effects, with low-quality evidence that the risk for adverse effects is higher in the NSAID group than in the placebo group (RR 1.40, 95% CI 1.02 to 1.93). The adverse effects reported in this review are consistent with those previously reported in the literature. AUTHORS' CONCLUSIONS: This updated systematic review including 10 trials evaluating the efficacy of NSAIDs versus placebo or other drugs in people with sciatica reports low- to very low-level evidence using the GRADE criteria. The efficacy of NSAIDs for pain reduction was not significant. NSAIDs showed a better global improvement compared to placebo. These findings must be interpreted with caution, as the level of evidence according to the GRADE classification was very low for the outcome pain reduction and low for global improvement due to small study samples, inconsistent results, imprecision, and a high risk of bias in the included trials. While the trials included in the analysis were not powered to detect potential rare side effects, we found an increased risk for side effects in the short-term NSAIDs use. As NSAIDs are frequently prescribed, the risk-benefit ratio of prescribing the drug needs to be considered.
Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Ciática/tratamiento farmacológico , Inhibidores de la Ciclooxigenasa/uso terapéutico , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
PURPOSE: The estimated prevalence of poor sleep in patients with non-specific chronic low back pain is estimated to 64% in the adult population. The annual cost for musculoskeletal pain and reported poor sleep is estimated to be billions of dollars annually in the US. The aim of this cohort study with one-year follow-up was to explore the role of impaired sleep with daytime consequence on the prognosis of non-specific neck and/or back pain. METHODS: Secondary analysis of a randomized controlled trial, including 409 patients. RESULTS: Patients with good sleep at baseline were more likely to experience a minimal clinically important difference in pain [OR 2.03 (95% CI 1.22-3.38)] and disability [OR 1.85 (95% CI 1.04-3.30)] compared to patients with impaired sleep at one-year follow-up. CONCLUSION: Patients with non-specific neck and/or back pain and self-reported good sleep are more likely to experience a minimal clinically important difference in pain and disability compared to patients with impaired sleep with daytime consequence.
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Dolor de Espalda/psicología , Dolor de Cuello/psicología , Trastornos del Sueño-Vigilia/etiología , Adulto , Dolor de Espalda/diagnóstico , Dolor de Espalda/rehabilitación , Estudios de Cohortes , Evaluación de la Discapacidad , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Manipulaciones Musculoesqueléticas/métodos , Dolor de Cuello/diagnóstico , Dolor de Cuello/rehabilitación , Dimensión del Dolor/métodos , Pronóstico , Trastornos del Sueño-Vigilia/psicología , Resultado del TratamientoRESUMEN
BACKGROUND: The influence on the treatment response in patients with low back pain (LBP) and neck pain (NP) is unknown. The aim of the study was to investigate the influence of body weight in patients with low back pain (LBP) and neck pain (NP) on baseline and end of treatment disability. METHODS: Cross-sectional analysis of baseline factors. Longitudinal analysis of prospectively collected patient information at an outpatient physical therapy registry (data from June 2010 to December 2012). WHO-BMI classification was used: underweight, lean, overweight, obesity class I, obesity class II and III. The influence of body weight and a predefined set of confounders was analyzed by multiple regression models. RESULTS: In LBP, disability increased with increasing BMI [lean = reference, obesity class I Beta 5.41 (95 % CI 0.75; 10.07), obesity class II-III Beta 7.58 (95 % CI 2.13; 13.03)]. Compared to lean patients, disability after treatment improved in overweight subjects [Beta -3.90 (95 % CI -7.4; -0.41)] but not in subjects with obesity class II-III [Beta 3.43 (95 % CI -3.81; 10.68)]. There were insufficient patients in the sample with severe obesity and therefore this trend has to be confirmed. The likelihood for meaningful important change (MID) was similar in all BMI subgroups. For patients with NP, BMI was not associated with baseline disability, and did not predict end of treatment disability or the likelihood of a MID. These findings must be interpreted with caution as BMI subgroups did not meet the required sample size. CONCLUSION: Overweight and obesity are associated with higher levels of disability before treatment in LBP patients, but not in NP. In severely obese patients class II-III with LBP the rate of MID was lowest indicating that these patients experienced the least treatment response compared to the other groups. Further studies should address the impact of severe obesity on the prognosis of LBP. In patients with LBP, severe obesity may be an important factor to consider during the physical therapy treatment. In particular, combined treatment strategies combining weight management, cardiovascular fitness, and low back pain rehabilitation should be investigated.
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Evaluación de la Discapacidad , Dolor de la Región Lumbar/terapia , Dolor de Cuello/terapia , Obesidad/complicaciones , Adulto , Índice de Masa Corporal , Estudios Transversales , Femenino , Humanos , Dolor de la Región Lumbar/complicaciones , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/fisiopatología , Masculino , Persona de Mediana Edad , Dolor de Cuello/complicaciones , Dolor de Cuello/diagnóstico , Dolor de Cuello/fisiopatología , Obesidad/diagnóstico , Obesidad/fisiopatología , Dimensión del Dolor , Sistema de Registros , Factores de Riesgo , Índice de Severidad de la Enfermedad , Suiza , Resultado del TratamientoRESUMEN
BACKGROUND: Lumbar spinal stenosis is the most common reason for spinal surgery in elderly patients. However, the surgical management of spinal stenosis is controversial. The aim of this review was to list aspects a surgeon considers when choosing a specific type of treatment. METHODS: Appraisal of arguments reported in randomized controlled trials (RCTs) included in systematic reviews published or indexed in the Cochrane library studying surgical treatments in patients with spinal stenosis. RESULTS: Eight out of nine RCTs listed arguments for the choice of their treatments under investigation. The argument for decompression alone was the high success rate, the argument against was a potential increase in vertebral instability. The argument for decompression and fusion without instrumentation was that it is a well-established technique with a high fusion success rate, the argument against it was that the indication for fusion in spinal stenosis has remained unclear. The argument for decompression and fusion with instrumentation was an increased fusion rate compared to decompression and fusion without instrumentation, the argument against this was that the invasive procedure is associated with more complications. CONCLUSIONS: The main argument identified in this appraisal for and against decompression alone in patient with lumbar spinal stenosis was whether or not instability should be treated with (instrumented) fusion procedures. However, there is disagreement on how instability should be defined. In a first step it is important that researchers and clinicians agree on definitions for important key concepts such as instability and reoperations.