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BACKGROUND: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss. METHODS: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation. DISCUSSION: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process. TRIAL REGISTRATION: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).
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Antifibrinolíticos , Perda Sanguínea Cirúrgica , Queimaduras , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico , Ácido Tranexâmico/uso terapêutico , Humanos , Método Duplo-Cego , Antifibrinolíticos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Queimaduras/cirurgia , Queimaduras/complicações , Perda Sanguínea Cirúrgica/prevenção & controle , Fibrinólise/efeitos dos fármacos , Resultado do Tratamento , Países Baixos , Adulto , Coagulação Sanguínea/efeitos dos fármacos , Masculino , FemininoRESUMO
BACKGROUND: Value-based healthcare (VBHC) is increasingly implemented in healthcare worldwide. Transparent measurement of the outcomes most important and relevant to patients is essential in VBHC, which is supported by a core set of most important quality indicators and outcomes. Therefore, the aim of this study was to develop a VBHC-burns core set for adult burn patients. METHODS: A three-round modified national Delphi study, including 44 outcomes and 24 quality indicators, was conducted to reach consensus among Dutch patients, burn care professionals and researchers. Items were rated on a nine-point Likert scale and selected if ≥ 70% in each group considered an item 'important'. Subsequently, instruments quantifying selected outcomes were identified based on a literature review and were chosen in a consensus meeting using recommendations from the Dutch consensus-based standard set and the Dutch Centre of Expertise on Health Disparities. Time assessment points were chosen to reflect the burn care and patient recovery process. Finally, the initial core set was evaluated in practice, leading to the adapted VBHC-burns core set. RESULTS: Twenty-seven patients, 63 burn care professionals and 23 researchers participated. Ten outcomes and four quality indicators were selected in the Delphi study, including the outcomes pain, wound healing, physical activity, self-care, independence, return to work, depression, itching, scar flexibility and return to school. Quality indicators included shared decision-making (SDM), the number of patients receiving aftercare, determination of burn depth, and assessment of active range of motion. After evaluation of its use in clinical practice, the core set included all items except SDM, which are assessed by 9 patient-reported outcome instruments or measured in clinical care. Assessment time points included are at discharge, 2 weeks, 3 months, 12 months after discharge and annually afterwards. CONCLUSION: A VBHC-burns core set was developed, consisting of outcomes and quality indicators that are important to burn patients and burn care professionals. The VBHC-burns core set is now systemically monitored and analysed in Dutch burn care to improve care and patient relevant outcomes. As improving burn care and patient relevant outcomes is important worldwide, the developed VBHC-burns core set could be inspiring for other countries.
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Queimaduras , Técnica Delphi , Indicadores de Qualidade em Assistência à Saúde , Humanos , Queimaduras/terapia , Adulto , Países Baixos , Masculino , Feminino , Pessoa de Meia-Idade , Consenso , Cicatrização , Autocuidado , Retorno ao Trabalho , Dor , Avaliação de Resultados em Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , Prurido/terapia , Cuidados de Saúde Baseados em ValoresRESUMO
OBJECTIVES: We aimed to determine the relation between breast reconstruction method, patient satisfaction, and surgeon reported cosmetic outcome among women who underwent breast reconstruction after mastectomy. STUDY DESIGN: A cross-sectional study of patients treated between 2006 and 2010. MAIN OUTCOME: Women's satisfaction with cosmetic outcomes after breast reconstruction. MEASURES: Cosmetic outcomes were evaluated by (1) women using the Breast-Q to rate satisfaction with breasts outcomes, and (2) an independent panel using the Strasser score. The relationships between the Breast-Q rating, Strasser scores, and breast reconstruction methods, including laterality and timing, were evaluated by Mann-Whitney U tests, Spearman's rank correlations, and Wilcoxon signed-rank tests. RESULTS: Ninety-four women were included. Patients were more satisfied with their breasts if they had undergone autologous, unilateral, or secondary breast reconstruction compared with those who underwent alloplastic, bilateral, or primary breast reconstruction (p-values 0.008, 0.011, and 0.001, respectively). The Strasser system did not reveal significant cosmetic differences, with all breast reconstructions graded as mediocre or poor. CONCLUSIONS: Patient satisfaction with breast outcomes, as measured by the Breast-Q, was described as mediocre or poorly reflected by the Strasser score. If doctors are to support patients to make informed decisions on the optimal method of breast reconstruction, we need a more sensitive, comprehensive tool reflecting patients' cosmetic outcomes.
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Here we present the case of a 64-year-old female patient with a painful thumb. This case demonstrates how, with proper physical examination, a correct diagnosis of 'skier's thumb' with concomitant Stener lesion can be made. This condition is a tear of the ulnar collateral ligament (UCL) of the metacarpophalangeal joint with an interposition of the UCL and the aponeurosis adductor pollicis muscle. It is usually treated surgically.
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Ligamentos Colaterais/lesões , Articulação Metacarpofalângica/lesões , Polegar/lesões , Ligamentos Colaterais/cirurgia , Feminino , Humanos , Articulação Metacarpofalângica/cirurgia , Pessoa de Meia-Idade , Exame Físico , Polegar/cirurgiaRESUMO
BACKGROUND: A number of social drinkers claim that they do not experience next-day hangovers despite consuming large quantities of alcohol. The aim of this study was to investigate the characteristics of drinkers who claim to be hangover immune and compare them with drinkers who do report having hangovers. METHODS: A total of 36 social drinkers participated in a naturalistic study consisting of a hangover day (alcohol consumed) and a control day (no alcohol consumed). Data were collected on alcohol consumption, demographics, sleep, next-day adverse effects, and mood. Data from drinkers with a hangover (N=18) were compared with data from drinkers who claim to be hangover immune (N=18). RESULTS: Drinkers with a hangover reported drowsiness-related symptoms, symptoms related to reduced cognitive functioning, and classic hangover symptoms such as headache, nausea, dizziness, weakness, and stomach pain. Corresponding mood changes comprised increased feelings of depression, anger-hostility, fatigue, and reduced vigor-activity. In contrast, hangover-immune drinkers reported relatively few hangover symptoms, with only mild corresponding severity scores. The reported symptoms were limited to drowsiness-related symptoms such as sleepiness and being tired. The classic hangover symptoms were usually not reported by these drinkers. CONCLUSION: In contrast to drinkers with a hangover, for those who claim to be hangover immune, next-day adverse effects of alcohol consumption are limited to a mild increase in drowsiness-related symptoms.
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AIM: This prospective cohort study was performed to evaluate the impact of complications on quality of life (QOL) in colorectal surgery. The Clavien-Dindo complication classification (CDCC) is promising, but has not been evaluated by relating the classification to patient-reported outcome measures. METHOD: Patients undergoing colorectal surgery were evaluated prospectively 12 months postoperatively using the WHOQOL-BREF questionnaire. Patient data were prospectively recorded and complications were classified using the CDCC. Postoperative QOL in patients with minor and severe complications and patients without complications was compared using a general linear model. Relationships between CDCC and QOL were examined using correlations and multivariate regression. RESULTS: Of 218 patients, 130 (59.6%) had complications. In patients with severe complications there was a greater decrease in overall QOL (P = 0.043), QOL-physical (P < 0.001) and QOL-psychological (P = 0.013) domains in the first six postoperative weeks, whereas patients with minor complications had QOL scores comparable to those of patients without complications. QOL recovered to preoperative levels in all groups at 12 months. Change in QOL at 6 weeks was significantly correlated with CDCC grade, especially in the physical domain (Spearman's rho -0.287, P < 0.001). The presence of severe complications was an independent predictor of overall QOL, QOL-physical and QOL-psychological at 6 weeks. CONCLUSION: Severe complications are associated with reduced postoperative QOL at 6 weeks, but QOL recovers after 12 months. CDCC grade negatively correlates with change in QOL in the early postoperative period. These findings support the theoretical framework of the CDCC.
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Doenças do Colo/cirurgia , Complicações Pós-Operatórias/classificação , Qualidade de Vida , Doenças Retais/cirurgia , Idoso , Colectomia/efeitos adversos , Colectomia/estatística & dados numéricos , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Procedimentos Cirúrgicos do Sistema Digestório/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Adverse events occur in 3·8-17 per cent of hospital admissions. The purpose of this study was to analyse the incidence of medical errors and assess the feasibility of an error registry for quality improvement programmes. METHODS: Errors were recorded prospectively in a complication registry between 1 June 2005 and 31 December 2007. Events were coded according to the Trauma Registry of the American College of Surgeons; the nature of events was recorded and the severity graded using the 1992 Clavien system. Recorded events were discussed by the medical staff on a daily basis and, if by consensus judged to be errors, were saved to the registry database. RESULTS: Of 12,121 patients admitted to the surgical ward during the study interval, 2033 (16·8 per cent) had a complication and 735 (6·1 per cent) had an error documented in the registry. Of 873 recorded errors, 607 (69·5 per cent) were of little or no consequence (Clavien grade I) and 220 (25·2 per cent) required therapeutic intervention (Clavien grade IIa and IIb). Errors leading to permanent injury (Clavien grade III) occurred in 41 instances (4·7 per cent) and five patients (0·6 per cent) died (Clavien grade IV). CONCLUSION: This study shows that errors are common in surgery, and that near misses are more frequent than errors with serious consequences. It is hypothesized that registration of near misses might prevent errors with serious consequences and thus improve quality of care.
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Complicações Intraoperatórias/epidemiologia , Erros Médicos/estatística & dados numéricos , Sistema de Registros , Estudos de Viabilidade , Humanos , Incidência , Erros Médicos/efeitos adversos , Erros Médicos/prevenção & controle , Países Baixos/epidemiologia , Estudos Prospectivos , Qualidade da Assistência à SaúdeRESUMO
BACKGROUND: Because the death rate among the total trauma population is low, other performance indicators in addition to the classical dependent variable mortality are required to assess the overall quality of trauma care. The aim of this study was to develop and validate a prediction model for the occurrence of complications that can be used to adjust a measure of quality of trauma care for case mix. METHODS: Complications recorded in a trauma registry between 1997 and 2008 were analysed. Formulas for different types of complication (institution- or diagnosis-related) derived from logistic regression models were used to calculate the probability of absence of complications (PAC). Discriminative power was tested by calculating the area under the receiver operating characteristic curve (AUC) in test and validation samples. Calibration was tested using Hosmer and Lemeshow methodology. RESULTS: Some 5944 surgical trauma admissions were included in the analysis. A significant association between both institution- and diagnosis-related complications and Injury Severity Score was found. Diagnosis-related complications were also associated with Glasgow Coma Score and age. The AUCs of the PACs for institution- and diagnosis-related complications were 0·64 and 0·75 respectively in the test sample, and 0·66 and 0·76 in the validation sample. The AUCs increased when the outcomes of the models were divided into subcategories of complications. Hosmer and Lemeshow tests were not significant for all models, except that for institutional complications. CONCLUSION: To predict complications, a distinction should be made between institution- and diagnosis-related complications. The development of more detailed diagnosis-related prediction models is preferable because of better performance. The formulas predicting the PAC can be used to compare expected and observed complications.
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Ferimentos e Lesões/complicações , Adolescente , Adulto , Idoso , Análise de Variância , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Países Baixos , Qualidade da Assistência à Saúde , Medição de Risco , Sensibilidade e Especificidade , Índices de Gravidade do TraumaRESUMO
This retrospective cohort study was conducted to investigate whether operative treatment of patients with a pertrochanteric femoral fracture outside working hours is associated with an increased risk of complications and higher mortality. During the study period 165 patients were operated on outside working hours and 123 were operated on during working hours (08.00 to 17.00). There was no difference in the rate of early complications (outside working hours 33% versus working hours 33%, p = 0.91) or total complications during follow-up (outside working hours 40% versus working hours 41%, p = 0.91). Both in-hospital mortality (outside working hours 12% versus working hours 11%, p = 0.97) and mortality after one year (outside working hours 29% versus working hours 27%, p = 0.67) were comparable. Adjustment for possible confounders by multivariate logistic regression analysis revealed no increased risk of complications when patients were operated on outside working hours. On the basis of these data, there is no medical reason to postpone operative reduction and fixation in patients with a proximal femoral fracture until working hours.
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Plantão Médico , Fixação Intramedular de Fraturas/efeitos adversos , Fraturas do Quadril/cirurgia , Complicações Pós-Operatórias/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Fixação Intramedular de Fraturas/mortalidade , Fraturas do Quadril/mortalidade , Mortalidade Hospitalar , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/mortalidade , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Adulto JovemRESUMO
Two patients, a 25-year-old male and a 57-year-old female, were treated for stump appendicitis. Both patients had undergone appendicectomy 6 months previously and again presented with pain in the right lower abdominal region. On physical examination, the first patient had tenderness as well as rebound tenderness over the entire abdomen, indicative of a general peritonitis. The second patient had tenderness and rebound tenderness in the right iliac fossa alone. Both patients underwent a laparotomy. In the first patient a perforated appendiceal stump was found and removed. In the second patient an acutely inflamed appendiceal stump was found and removed. Appendicitis of a residual appendiceal stump following incomplete appendicectomy is a rare cause of abdominal pain. A lack of familiarity with this condition frequently causes a delay in diagnosis, which increases the chance of perforation and intra-abdominal sepsis. Therefore, all clinicians need to be aware of the possibility of stump appendicitis and to take appropriate measures to prevent serious complications should they suspect this.
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Apendicectomia , Apendicite/etiologia , Apendicite/cirurgia , Reoperação/métodos , Adulto , Apendicectomia/efeitos adversos , Apendicectomia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reoperação/normas , Resultado do TratamentoRESUMO
AIMS/HYPOTHESIS: A loss of sympathetic function could lead to changes in capillary fluid filtration in diabetic patients. We investigated whether a decreased sympathetically mediated vasomotion in the skin in diabetic patients with peripheral neuropathy is associated with an abnormal capillary leakage. METHODS: Three matched groups were studied: 18 diabetic patients with documented peripheral neuropathy (DN), 18 diabetic patients without peripheral neuropathy (D), and 18 healthy control subjects (C). Sensory and motor nerve function of the distal extremities were assessed by standard neurography, and expressed in a sensory-motor nerve function score. Sympathetic vasomotion of the skin microcirculation was assessed by determining the power of blood flow variability in the low-frequency (0.02-0.14 Hz) band by spectral analysis of laser Doppler flowmetry at the median ankle. Skin capillary leakage was evaluated by sodium fluorescein videodensitometry at the same site of the foot. RESULTS: Sympathetically mediated vasomotion of the foot skin microcirculation was lower in diabetic patients with documented peripheral neuropathy compared with diabetic patients without peripheral neuropathy and control subjects (p<0.001). Capillary sodium fluorescein leakage was larger in 18 diabetic patients with documented peripheral neuropathy than in diabetic patients without peripheral neuropathy (p<0.02) and C (p<0.005). Multiple regression analysis disclosed that a reduced sympathetically mediated vasomotion, together with a lower sensory-motor nerve function score, independently contributed to the variance in sodium fluorescein leakage, for 30% (p<0.001) and 17% (p<0.01), respectively. CONCLUSIONS: A loss of sympathetic tone, apart from sensory-motor nerve dysfunction, seems to be a major determinant of an increased capillary permeability in diabetic patients with neuropathy.
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Permeabilidade Capilar , Neuropatias Diabéticas/fisiopatologia , Doenças do Sistema Nervoso Periférico/fisiopatologia , Pele/irrigação sanguínea , Sistema Nervoso Simpático/fisiopatologia , Sistema Vasomotor/fisiopatologia , Estudos de Casos e Controles , Meios de Contraste/farmacocinética , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 2/complicações , Neuropatias Diabéticas/etiologia , Feminino , Fluoresceína/farmacocinética , Pé , Humanos , Fluxometria por Laser-Doppler , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso Periférico/etiologia , Fluxo Sanguíneo RegionalRESUMO
OBJECTIVE: Several lines of evidence suggest that the GH-IGF-1 axis affects capillary permeability and angiogenesis. We evaluated skin capillary permeability and capillary density in GH-deficient adults, before and after GH replacement therapy. PATIENTS: Seven normotensive, nondiabetic GH-deficient adults (two women) were matched with 14 control subjects. MEASUREMENTS: Large-window videodensitometry with sodium fluorescein was performed in all subjects. Capillary permeability was expressed as the average relative light intensity over the first 7 min after the appearance of fluorescein in the skin capillaries; Iav(7). Skin capillary density was determined by counting the visualized capillaries and was expressed as n/mm2. The GH-deficient patients were restudied after 12 months of GH replacement therapy (2 U/day). RESULTS: Both capillary permeability and capillary density were lower in untreated GH-deficient patients than in control subjects (median, interquartile range): Iav(7) in GH-deficient patients 47.1 (45.1-52.2)% vs. 57.5 (50.5-64.8)% in controls, P < 0.05; capillary density in GH-deficient patients 18 (12-24)/mm2 vs. 32 (26-36)/mm2 in controls, P < 0.05. GH treatment normalized plasma IGF-1 from 4.3 (1.0-13.4) to 22.2 (19.8-48.2) nmol/l (P < 0.05). Furthermore, both capillary permeability [Iav(7) 53.1 (48.8-58.4)%, P < 0.05] and capillary density [26 (17-34)/mm2, P < 0.05] increased to a level that was not different from that in control subjects. CONCLUSIONS: The present study demonstrates that the growth hormone deficiency syndrome is associated with microvascular alterations, which are responsive to growth hormone replacement therapy.
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Permeabilidade Capilar/efeitos dos fármacos , Hormônio do Crescimento Humano/deficiência , Hormônio do Crescimento Humano/uso terapêutico , Pele/irrigação sanguínea , Adulto , Pressão Sanguínea/efeitos dos fármacos , Capilares/patologia , Feminino , Fluoresceína , Seguimentos , Terapia de Reposição Hormonal , Humanos , Fator de Crescimento Insulin-Like I/metabolismo , Masculino , Pessoa de Meia-IdadeRESUMO
An automated sample preparation module, the ASPEC (automated sample preparation with extraction columns) was interfaced with a capillary gas chromatograph (GC) by means of a loop-type interface. The system was optimized for the determination of four benzodiazepines in plasma. Extraction from the untreated plasma was carried out on disposable C18 cartridges and involved several washing steps. The analytes were desorbed with 2 ml of ethyl acetate and a 110-microliter aliquot of the eluate was injected into the gas chromatograph via the loop-type interface using fully concurrent solvent evaporation conditions. Detection of the benzodiazepines was carried out with a nitrogen-phosphorus detector (NPD). The ASPEC-GC-NPD was fully automated and could run unattended overnight. With a sample volume of 1 ml the procedure showed good linearity and repeatability in the range 5-50 ng/ml using a sample volume of 1 ml. The limits of detection in plasma were 0.5-2 ng/ml.
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Benzodiazepinas/sangue , Cromatografia Gasosa/métodos , Acetatos , Benzodiazepinas/química , Benzodiazepinas/isolamento & purificação , Cromatografia Gasosa/instrumentação , Humanos , Nitrogênio/sangue , Fósforo/sangue , ÁguaRESUMO
Intravenous antibiotics and enteral tube feeding at home for the treatment of pulmonary exacerbations and underweight condition in cystic fibrosis (CF) patients have become tools that are used in many cystic fibrosis centres. The experience with home care programmes from different countries is quite conclusive. If the necessary preparations are made, such as training of staff and patients, and financial support is arranged, home care is easy to put into practice. Optimal patient compliance is also necessary. Home care is as effective as hospital treatment for selected patients, and less expensive. Experience has increased during many treatment periods in different cystic fibrosis centres, and only a few adverse events have been recorded, indicating that home care is safe. However, the most important gain for cystic fibrosis patients is the reduction of hospital admission time, which means a definite improvement in the quality of life.
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Fibrose Cística/terapia , Serviços de Assistência Domiciliar , Antibacterianos/administração & dosagem , Nutrição Enteral , Terapia por Infusões no Domicílio , HumanosRESUMO
OBJECTIVE: Assessment of intravenous home treatment of respiratory infections of cystic fibrosis (CF) patients. SETTING: Provinces Groningen, Drente, Friesland and Overijssel. DESIGN: Open study. PATIENTS AND METHODS: Eleven CF patients, aged 10 to 28 years participated. Thirty episodes of home i.v. treatment with antibiotics were arranged. Differences in vital capacity (VC) and forced expiratory volume in one second (FEV1) and in body weight before and after treatment were compared with the same variables obtained during hospitalisation in the year before they were treated at home. Adverse events during home treatment were recorded. RESULTS: No differences were noted in changes in VC, FEV1 and body weight between home and hospital treatments. During 30 episodes of home treatment a new intravenous catheter had to be implanted only twice. CONCLUSION: In these 11 patients, intravenous treatment of respiratory infections at home was as efficacious as in hospital. No serious adverse events were observed.
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Antibacterianos/administração & dosagem , Fibrose Cística/complicações , Serviços de Assistência Domiciliar/organização & administração , Infecções Respiratórias/tratamento farmacológico , Adolescente , Adulto , Criança , Quimioterapia Combinada/administração & dosagem , Humanos , Bombas de Infusão , Países Baixos , Pais/educação , Educação de Pacientes como Assunto , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Infecções Respiratórias/complicaçõesRESUMO
Since 1982, 229 terminally ill cancer pain patients were treated by the administration of epidural opioids. An adequate level of aid was provided by the coordinated efforts of the patients' general practitioner, the district nurse, and the anesthesiologist. Based on 9 yr of experience with this model, a project on quality improvement and organization of cancer pain control by infusion techniques in the home situation was proposed. The purpose of the study is to create a nationwide organization for cancer pain control for terminal patients on a home-care basis. Specially trained ambulatory field teams will be set up to collect and process the information necessary to make protocols and instructions.