RESUMO
Surgical site infections (SSI) substantially increase costs for healthcare providers because of additional treatments and extended patient recovery. The objective of this study was to assess the cost and health-related quality of life impact of SSI, from the perspective of a large teaching hospital in England. Data were available for 144 participants undergoing clean or clean-contaminated vascular surgery. SSI development, length of hospital stay, readmission, and antibiotic use were recorded over a 30-day period. Patient-reported EQ-5D scores were obtained at baseline, day 7 and day 30. Linear regressions were used to control for confounding variables. A mean SSI-associated length of stay of 9.72 days resulted in an additional cost of £3776 per patient (including a mean antibiotic cost of £532). Adjusting for age, smoking status, and procedure type, SSI was associated with a 92% increase in length of stay (P < 0.001). The adjusted episode cost was £3040. SSI reduced patient utility between baseline and day 30 by 0.156 (P = 0.236). Readmission rates were higher with SSI (P = 0.017), and the rate to return to work within 90 days was lower. Therefore, strategies to reduce the risk of surgical site infection for high-risk vascular patients should be investigated.
Assuntos
Custos de Cuidados de Saúde , Qualidade de Vida , Infecção da Ferida Cirúrgica , Inglaterra , Humanos , Tempo de Internação , Masculino , Fatores de Risco , Infecção da Ferida Cirúrgica/economia , Infecção da Ferida Cirúrgica/terapia , Procedimentos Cirúrgicos VascularesRESUMO
BACKGROUND: Intermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. METHODS: Patients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. RESULTS: Thirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. CONCLUSIONS: ESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.
Assuntos
Tratamento por Ondas de Choque Extracorpóreas , Claudicação Intermitente/terapia , Músculo Esquelético/irrigação sanguínea , Doença Arterial Periférica/terapia , Idoso , Índice Tornozelo-Braço , Método Duplo-Cego , Inglaterra , Tolerância ao Exercício , Tratamento por Ondas de Choque Extracorpóreas/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/fisiopatologia , Perna (Membro) , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Estudos Prospectivos , Qualidade de Vida , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , CaminhadaRESUMO
Objectives Peripheral arterial disease most commonly presents as intermittent claudication (IC). Early evidence has suggested that extracorporeal shockwave therapy is efficacious in the short term for the management of intermittent claudication. The objective of this pilot trial was to evaluate the medium-term efficacy of this treatment. Methods This double-blind randomised placebo-controlled pilot trial randomised patients with unilateral intermittent claudication in a 1:1 fashion to receive extracorporeal shockwave therapy or a sham treatment for three sessions per week over three weeks. Primary outcomes were maximum walking distance and intermittent claudication distance using a fixed-load treadmill test. Secondary outcomes included pre- and post-exertional ankle-brachial pressure indices, safety and quality of life assessed using generic (SF36, EQ-5D-3L) and disease-specific (vascular quality of life) measures. All outcome measures were assessed at 12 months post-treatment. Results Thirty participants were included in the study (extracorporeal shockwave therapy, n = 15; sham, n = 15), with 26 followed up and analysed at 12 months (extracorporeal shockwave therapy, n = 13; sham, n = 13). Intragroup analysis demonstrated significant improvements in maximum walking distance, intermittent claudication distance and post-exertional ankle-brachial pressure indices ( p < 0.05) in the active treatment group, with no improvements in pre-exertional ankle-brachial pressure indices. Significant improvements in quality of life were observed in 3 out of 19 domains assessed in the active group. A re-intervention rate of 26.7% was seen in both groups. Conclusions These findings suggest that extracorporeal shockwave therapy is effective in improving walking distances at 12 months. Although this study provides important pilot data, a larger study is needed to corroborate these findings and to investigate the actions of this treatment. ISRCTN: NCT02652078.
Assuntos
Tratamento por Ondas de Choque Extracorpóreas , Claudicação Intermitente/terapia , Doença Arterial Periférica/terapia , Idoso , Índice Tornozelo-Braço , Método Duplo-Cego , Inglaterra , Teste de Esforço , Tolerância ao Exercício , Tratamento por Ondas de Choque Extracorpóreas/efeitos adversos , Feminino , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/fisiopatologia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Qualidade de Vida , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The short form 36 (SF36) questionnaire is used for assessment of generic quality of life. Responses to the individual question in SF36 are also used for calculation of the SF6D index score. This score is used for calculation of quality adjusted-life years (QALYs) in economical analyses. As the individual patient questionnaires are not always available for performing systematic reviews and meta-analyses, a new formula has been developed for derivation of SF6D index score from the reported SF36-domain scores. This study aimed to evaluate the validity of this formula for use in patients with intermittent claudication. METHODS: A retrospective review of a prospectively collected database of a randomized controlled trial was performed. A total of 178 patients were recruited. Clinical indicators of ischemia were recorded. All patients completed SF36 questionnaires. Response and domain-based SF6D scores (R-SF6D and D-SF6D) and QALYs were calculated. Correlation and agreement analysis were performed. RESULTS: Response rate was 88% (n = 781) over a 1-year follow-up period. Domain-based SF6D score (mean, 0.684; standard deviation [SD] 0.110) was significantly higher (paired t-test, P = 0.001) than the response-based score (mean, 0.627; SD, 0.110) with a mean difference of 0.056 (95% confidence interval, 0.053-0.060). Mean QALY calculated using D-SF6D score (0.503; SD, 0.116) was also significantly higher than the QALY calculated from the R-SF6D score (0.467; SD, 0.121). Bland-Altman comparison showed strong agreement (limit of agreement -0.167 to 0.054) between the 2 methods with equal variances (Pitman's test, P = 0.629). D-SF6D scores showed stronger correlation with clinical indicators of ischemia (r = 0.246-0.602) compared with that of R-SF6D scores (r = 0.233-0.549). CONCLUSIONS: Domain-based estimation of SF6D score is a valid and reliable method with strong agreement to the gold standard response-based scores in claudicants. However, adjustments may be required in studies using a mixture of D-SF6D and R-SF6D scores for QALY calculation.
Assuntos
Claudicação Intermitente/diagnóstico , Preferência do Paciente , Qualidade de Vida , Inquéritos e Questionários , Idoso , Bases de Dados Factuais , Feminino , Humanos , Claudicação Intermitente/economia , Claudicação Intermitente/fisiopatologia , Claudicação Intermitente/psicologia , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de TempoRESUMO
BACKGROUND: A double-blind, randomized controlled trial was carried out to study the effects of statins on matrix metalloproteinases (MMPs) and tissue inhibitors of matrix metalloproteinases (TIMPs) in areas of peak and low abdominal aortic aneurysm (AAA) wall stress. METHODS: A total of 40 patients undergoing elective open AAA repair were randomized to receive either atorvastatin 80 mg (n = 20) or placebo (n = 20) for 4 weeks preoperatively. Finite element analysis was used to determine AAA wall stress distribution. Full thickness aortic samples were obtained at surgery from areas of low and peak wall stress, snap-frozen, and stored at -80°C for subsequent MMP-2, -8, and -9 and TIMP-1 and -2 analyses. Statistical analysis was performed using SPSS 16.0 (SPSS Inc, Chicago, IL). RESULTS: Both groups were well matched (p > 0.05) regarding age, gender, comorbidities, and duration of hospital stay. There were no statistically significant differences in levels of MMPs and TIMPs between the statin and placebo group and between areas of low and peak AAA wall stress. CONCLUSION: The short-term use of statins is not associated in reducing levels of MMP 2, 8, and 9 and TIMP-1 and -2 in areas of low and peak wall stress in patients with AAA.
Assuntos
Aorta Abdominal/efeitos dos fármacos , Aneurisma da Aorta Abdominal/tratamento farmacológico , Ácidos Heptanoicos/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Metaloproteinases da Matriz/metabolismo , Pirróis/administração & dosagem , Inibidores Teciduais de Metaloproteinases/metabolismo , Procedimentos Cirúrgicos Vasculares , Idoso , Idoso de 80 Anos ou mais , Aorta Abdominal/enzimologia , Aorta Abdominal/patologia , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/enzimologia , Aneurisma da Aorta Abdominal/patologia , Aneurisma da Aorta Abdominal/cirurgia , Atorvastatina , Distribuição de Qui-Quadrado , Método Duplo-Cego , Esquema de Medicação , Procedimentos Cirúrgicos Eletivos , Inglaterra , Feminino , Análise de Elementos Finitos , Humanos , Masculino , Metaloproteinase 2 da Matriz/metabolismo , Metaloproteinase 8 da Matriz/metabolismo , Metaloproteinase 9 da Matriz/metabolismo , Pessoa de Meia-Idade , Efeito Placebo , Cuidados Pré-Operatórios , Estresse Mecânico , Fatores de Tempo , Inibidor Tecidual de Metaloproteinase-1/metabolismo , Inibidor Tecidual de Metaloproteinase-2/metabolismo , Resultado do TratamentoRESUMO
Conventional supervised exercise programs (SEPs) for claudicants are traditionally based on time-constrained, group-based structured programs usually at a hospital site. Uptake of an SEP is poor, despite the high-level evidence demonstrating its clinical effectiveness; therefore, alternative forms of exercise programs are needed which are more acceptable to patients. This study aimed to explore a range of exercise modalities to determine patient preferences for exercise delivery on a national level. This was a questionnaire survey to identify and incorporate patient preferences when designing a multicenter nationwide health-service evaluation of patient preference to exercise in the United Kingdom's National Health Service (the PREFER study). Patients with documented stable intermittent claudication who were suitable for an SEP were given a questionnaire to fill out at their clinic visit. Data were recorded using the Bristol Online Survey tool (http://www.survey.bris.ac.uk/) and analyzed descriptively. Thirty complete questionnaires were analyzed. Participants were generally unilateral claudicants (80%) with symptoms for over 1 year (64%). Only 6 of the 30 patients had engaged in a lifelong routine of exercise. Eighty-seven percent of patients indicated that they had not taken part in an exercise program, but 73% of those indicated that they would be willing to participate to improve their walking. Most patients expressed a preference for a home exercise program (50%) followed by a hospital SEP. The majority of patients (43%) were happy to exercise 3 days per week using a walking-based program (53%). There was however no consensus on the duration or intensity of the exercise program. The SEP is the recommended first-line treatment for intermittent claudication patients; however, the vast majority of patients fail to engage with or complete an exercise program. This study demonstrates that exercise therapy should be individualized and take a patient-centered approach. Commissioning groups should incentivize hospitals and clinicians to engage with their patient populations to understand their needs and deliver an appropriate service.
Assuntos
Terapia por Exercício , Claudicação Intermitente/terapia , Preferência do Paciente , Idoso , Feminino , Humanos , Internet , Masculino , Qualidade de Vida , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Reino Unido , CaminhadaRESUMO
Intermittent claudication (IC) is a common condition which has severe impacts on quality of life, physical function, and mental health. Supervised exercise is the recommended first-line treatment for patients with this condition; however, these are not always feasible or accessible to patients. As the proportion of patients who have this treatment remains suboptimal, it is important to better understand the perception of exercise in this population. A gap in the literature exists about the barriers and facilitators to exercise in patients completing, dropping out of, or declining an exercise program. A qualitative analysis was undertaken to understand this further. Twenty-five patients were interviewed face to face, 10 who had completed exercise, 10 who had declined, and 5 who had dropped out of an exercise program. Three major themes emerged from the data, IC, and perception to exercise and experience or beliefs of the exercise program.Addressing the barriers and facilitators to exercise in patients with IC is crucial in optimizing the delivery and uptake of exercise programs. More education or time investment is needed with these patients during initial diagnostic to help overcome perceived barriers and emphasis healthy behavioral changes.