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1.
Diagn Progn Res ; 7(1): 15, 2023 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-37537680

RESUMO

BACKGROUND: Numerous biomarkers have been proposed for diagnosis, therapeutic, and prognosis in sepsis. Previous evaluations of the value of biomarkers for predicting mortality due to this life-threatening condition fail to address the complexity of this condition and the risk of bias associated with prognostic studies. We evaluate the predictive performance of four of these biomarkers in the prognosis of mortality through a methodologically sound evaluation. METHODS: We conducted a systematic review a systematic review and meta-analysis to determine, in critically ill adults with sepsis, whether procalcitonin (PCT), C-reactive protein (CRP), interleukin-6 (IL-6), and presepsin (sCD14) are independent prognostic factors for mortality. We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials up to March 2023. Only Phase-2 confirmatory prognostic factor studies among critically ill septic adults were included. Random effects meta-analyses pooled the prognostic association estimates. RESULTS: We included 60 studies (15,681 patients) with 99 biomarker assessments. Quality of the statistical analysis and reporting domains using the QUIPS tool showed high risk of bias in > 60% assessments. The biomarker measurement as a continuous variable in models adjusted by key covariates (age and severity score) for predicting mortality at 28-30 days showed a null or near to null association for basal PCT (pooled OR = 0.99, 95% CI = 0.99-1.003), CRP (OR = 1.01, 95% CI = 0.87 to 1.17), and IL-6 (OR = 1.02, 95% CI = 1.01-1.03) and sCD14 (pooled HR = 1.003, 95% CI = 1.000 to 1.006). Additional meta-analyses accounting for other prognostic covariates had similarly null findings. CONCLUSION: Baseline, isolated measurement of PCT, CRP, IL-6, and sCD14 has not been shown to help predict mortality in critically ill patients with sepsis. The role of these biomarkers should be evaluated in new studies where the patient selection would be standardized and the measurement of biomarker results. TRIAL REGISTRATION: PROSPERO (CRD42019128790).

2.
Trials ; 23(1): 1037, 2022 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-36539800

RESUMO

BACKGROUND: The real impact of the degree of association (DoA) between endpoint components of a composite endpoint (CE) on sample size requirement (SSR) has not been explored. We estimate the impact of the DoA between death and acute myocardial infarction (AMI) on SSR of trials using use the CE of major adverse cardiac events (MACE). METHODS: A systematic review and quantitative synthesis of trials that include MACE as the primary outcome through search strategies in MEDLINE and EMBASE electronic databases. We limited to articles published in journals indexed in the first quartile of the Cardiac & Cardiovascular Systems category (Journal Citation Reports, 2015-2020). The authors were contacted to estimate the DoA between death and AMI using joint probability and correlation. We analyzed the SSR variation using the DoA estimated from RCTs. RESULTS: Sixty-three of 134 publications that reported event rates and the therapy effect in all component endpoints were included in the quantitative synthesis. The most frequent combination was death, AMI, and revascularization (n = 20; 31.8%). The correlation between death and AMI, estimated from 5 trials¸ oscillated between - 0.02 and 0.31. SSR varied from 14,602 in the scenario with the strongest correlation to 12,259 in the scenario with the weakest correlation; the relative impact was 16%. CONCLUSIONS: The DoA between death and AMI is highly variable and may lead to a considerable SSR variation in a trial including MACE.


Assuntos
Sistema Cardiovascular , Infarto do Miocárdio , Humanos , Tamanho da Amostra , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia
3.
Rev. esp. cardiol. (Ed. impr.) ; 75(1): 12-21, ene. 2022. ilus, tab, video
Artigo em Espanhol | IBECS | ID: ibc-206931

RESUMO

Introducción y objetivos: El desfibrilador automático implantable (DAI) es una alternativa coste-efectiva para la prevención secundaria de la muerte súbita cardiaca, pero sigue habiendo dudas sobre su eficiencia en prevención primaria, sobre todo en pacientes con cardiopatía no isquémica.Métodos: Análisis de coste-utilidad del DAI más tratamiento médico convencional frente a tratamiento médico convencional para la prevención primaria de arritmias cardiacas desde la perspectiva del Sistema Nacional de Salud. Se simuló el curso de la enfermedad mediante modelos de Markov en pacientes con y sin cardiopatía isquémica. Los parámetros del modelo se basaron en los resultados obtenidos mediante metanálisis de los ensayos clínicos publicados entre 1996 y 2018 en los que se comparaba el DAI con el tratamiento médico convencional, los resultados de seguridad del ensayo DANISH y el análisis de la práctica clínica habitual en un hospital terciario.Resultados: Se estimó un beneficio del DAI sobre la muerte por cualquier causa con HR = 0,70 (IC95%, 0,58-0,85) en cardiopatía isquémica y HR = 0,79 (IC95%, 0,66-0,96) en no isquémica. La razón de coste-efectividad incremental estimada mediante análisis probabilístico fue de 19.171 euros/año de vida ajustado por calidad (AVAC) en pacientes con cardiopatía isquémica, 31.084 euros/AVAC en pacientes con miocardiopatía dilatada no isquémica y 23.230 euros/AVAC en los menores de 68 años.Conclusiones: La eficiencia del DAI monocameral ha mejorado en la última década y este resulta coste-efectivo para los pacientes con disfunción ventricular izquierda de origen isquémico o no isquémico menores de 68 años considerando una disposición a pagar 25.000 euros/AVAC. En pacientes no isquémicos mayores, la razón de coste-efectividad incremental estimada se sitúa alrededor de los 30.000 euros/AVAC (AU)


Introduction and objective: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain.Methods: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital.Results: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66–0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years.Conclusions: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY (AU)


Assuntos
Humanos , Animais , Masculino , Feminino , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis/economia , Isquemia Miocárdica/terapia , Análise Custo-Benefício , Prevenção Primária , Medicina Estatal , Cadeias de Markov
4.
Rev Esp Cardiol (Engl Ed) ; 75(1): 12-21, 2022 Jan.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-34099431

RESUMO

INTRODUCTION AND OBJECTIVES: Implantable cardioverter-defibrillators (ICD) are a cost-effective alternative for secondary prevention of sudden cardiac death, but their efficiency in primary prevention, especially among patients with nonischemic heart disease, is still uncertain. METHODS: We performed a cost-effectiveness analysis of ICD plus conventional medical treatment (CMT) vs CMT for primary prevention of cardiac arrhythmias from the perspective of the national health service. We simulated the course of the disease by using Markov models in patients with ischemic and nonischemic heart disease. The parameters of the model were based on the results obtained from a meta-analysis of clinical trials published between 1996 and 2018 comparing ICD plus CMT vs CMT, the safety results of the DANISH trial, and analysis of real-world clinical practice in a tertiary hospital. RESULTS: We estimated that ICD reduced the likelihood of all-cause death in patients with ischemic heart disease (HR, 0.70; 95%CI, 0.58-0.85) and in those with nonischemic heart disease (HR, 0.79; 95%CI, 0.66-0.96). The incremental cost-effectiveness ratio (ICER) estimated with probabilistic analysis was €19 171/quality adjusted life year (QALY) in patients with ischemic heart disease and €31 084/QALY in those with nonischemic dilated myocardiopathy overall and €23 230/QALY in patients younger than 68 years. CONCLUSIONS: The efficiency of single-lead ICD systems has improved in the last decade, and these devices are cost-effective in patients with ischemic and nonischemic left ventricular dysfunction younger than 68 years, assuming willingness to pay as €25 000/QALY. For older nonischemic patients, the ICER was around €30 000/QALY.


Assuntos
Desfibriladores Implantáveis , Análise Custo-Benefício , Morte Súbita Cardíaca/prevenção & controle , Humanos , Prevenção Primária , Medicina Estatal
5.
Cochrane Database Syst Rev ; 7: CD012307, 2021 07 20.
Artigo em Inglês | MEDLINE | ID: mdl-34282853

RESUMO

BACKGROUND: Pulmonary transplantation is the final treatment option for people with end-stage respiratory diseases. Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation, helping to minimize or resolve impairments due to physical inactivity in both the pre- and post-transplant stages. However, there is a lack of detailed guidelines on how exercise training should be carried out in this specific sub-population. OBJECTIVES: To determine the benefits and safety of exercise training in adult patients who have undergone lung transplantation, measuring the maximal and functional exercise capacity; health-related quality of life; adverse events; patient readmission; pulmonary function; muscular strength; pathological bone fractures; return to normal activities and death. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register up to 6 October 2020 using relevant search terms for this review. Studies in the CKTR are identified through CENTRAL, MEDLINE, and EMBASE searches, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov. SELECTION CRITERIA: Randomised controlled trials (RCTs) were included comparing exercise training with usual care or no exercise training, or with another exercise training program in terms of dosage, modality, program length, or use of supporting exercise devices. The study population comprised of participants older than 18 years who underwent lung transplantation independent of their underlying respiratory pathology. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed all records identified by the search strategy and selected studies that met the eligibility criteria for inclusion in this review. In the first instance, the disagreements were resolved by consensus, and if this was not possible the decision was taken by a third reviewer. The same reviewers independently extracted outcome data from included studies and assessed risk of bias. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: Eight RCTs (438 participants) were included in this review. The median sample size was 60 participants with a range from 16 to 83 participants. The mean age of participants was 54.9 years and 51.9% of the participants were male. The median duration of the exercise training programs for the groups undergoing the intervention was 13 weeks, and the median duration of training in the active control groups was four weeks. Overall the risk of bias was considered to be high, mainly due to the inability to blind the study participants and the selective reporting of the results. Due to small number of studies included in this review, and the heterogeneity of the intervention and outcomes, we did not obtain a summary estimate of the results. Two studies comparing resistance exercise training with no exercise reported increases in muscle strength and bone mineral density (surrogate outcomes for pathological bone fractures) with exercise training (P > 0.05), but no differences in adverse events. Exercise capacity, health-related quality of life (HRQoL), pulmonary function, and death (any cause) were not reported. Three studies compared two different resistant training programs. Two studies comparing squats using a vibration platform (WBVT) compared to squats on the floor reported an improvement in 6-minute walk test (6MWT) (28.4 metres, 95% CI 3 to 53.7; P = 0.029; and 28.3 metres, 95% CI 10.0 to 46.6; P < 0.05) with the WBVT. Supervised upper limb exercise (SULP) program improved 6MWT at 6 months compared to no supervised upper limb exercise (NULP) (SULP group: 561.2 ± 83.6 metres; NULP group: 503.5 ± 115.2 metres; P = 0.01). There were no differences in HRQoL, adverse events, muscular strength, or death (any cause). Pulmonary function and pathological bone fractures were not reported. Two studies comparing multimodal exercise training with no exercise reported improvement in 6MWT at 3 months (P = 0.008) and at 12-months post-transplant (P = 0.002) and muscular strength (quadriceps force (P = 0.001); maximum leg press (P = 0.047)) with multimodal exercise, but no improvement in HRQoL, adverse events, pulmonary function, pathological bone fractures (lumbar T-score), or death (any cause). One study comparing the same multimodal exercise programs given over 7 and 14 weeks reported no differences in 6MWT, HRQoL, adverse events, pulmonary function, muscle strength, or death (any cause). Pathological bone fractures were not reported. According to GRADE criteria, we rated the certainty of the evidence as very low, mainly due to the high risk of bias and serious imprecision. AUTHORS' CONCLUSIONS: In adults undergoing lung transplantation the evidence about the effects of exercise training is very uncertain in terms of maximal and functional exercise capacity, HRQoL and safety, due to very imprecise estimates of effects and high risk of bias.


Assuntos
Exercício Físico , Transplante de Pulmão/reabilitação , Transplantados , Viés , Densidade Óssea , Causas de Morte , Tolerância ao Exercício , Feminino , Volume Expiratório Forçado , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular , Avaliação de Programas e Projetos de Saúde , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Treinamento Resistido , Fatores de Tempo , Teste de Caminhada
6.
Gac. sanit. (Barc., Ed. impr.) ; 34(5): 459-467, sept.-oct. 2020. tab, graf
Artigo em Inglês | IBECS | ID: ibc-198868

RESUMO

OBJECTIVE: To explore healthcare professionals' opinions about low-value practices, identify practices of this kind possibly present in the hospital and barriers and facilitators to reduce them. Low-value practices include those with little or no clinical benefit that may harm patients or lead to a waste of resources. METHOD: Using a mixed methodology, we carried out a survey and two focus groups in a tertiary hospital. In the survey, we assessed doctors' agreement, subjective adherence and perception of usefulness of 134 recommendations to reduce low-value practices from local and international initiatives. We also identified low-value practices possibly present in the hospital. In the focus groups with professionals from surgical and medical fields, using a phenomenological approach, we identified additional low-value practices, barriers and facilitators to reduce them. RESULTS: 169 doctors of 25 specialties participated (response rate: 7%-100%). Overall agreement with recommendations, subjective adherence and usefulness were 83%, 90% and 70%, respectively. Low-value practices form 22 recommendations (16%) were considered as possibly present in the hospital. In the focus groups, the professionals identified seven more. Defensive medicine and scepticism due to contradictory evidence were the main barriers. Facilitators included good leadership and coordination between professionals. CONCLUSIONS: High agreement with recommendations to reduce low-value practices and high perception of usefulness reflect great awareness of low-value care in the hospital. However, there are several barriers to reduce them. Interventions to reduce low-value practices should foster confidence in decision-making processes between professionals and patients and provide trusted evidence


OBJETIVO: Explorar las opiniones de profesionales sanitarios sobre las prácticas de poco valor, identificar aquellas posiblemente presentes en el hospital y las barreras y los facilitadores para reducirlas. Las prácticas de poco valor incluyen aquellas con poco beneficio clínico que pueden perjudicar a los pacientes o desperdiciar recursos. MÉTODO: Usando una metodología mixta se llevaron a cabo una encuesta y varios grupos focales en un hospital terciario. En la encuesta se evaluó el grado de acuerdo, la adherencia subjetiva y la percepción de utilidad de 134 recomendaciones para reducir las prácticas de poco valor de iniciativas locales e internacionales, y se identificaron aquellas que podrían estar realizándose en el hospital. En dos grupos focales con profesionales de campos médicos y quirúrgicos, utilizando un enfoque fenomenológico, se identificaron prácticas de poco valor adicionales, barreras y facilitadores para reducirlas. RESULTADOS: En la encuesta participaron 169 médicos de 25 especialidades (tasa de respuesta: 7-100%). El acuerdo con las recomendaciones, la adherencia subjetiva y la utilidad fueron del 83%, el 90% y el 70%, respectivamente. Se identificaron prácticas de poco valor de 22 recomendaciones (16%) posiblemente presentes en el hospital. En los grupos focales se identificaron siete prácticas de poco valor adicionales; la medicina defensiva y el escepticismo debido a evidencia contradictoria como principales barreras; y un buen liderazgo y la coordinación entre profesionales como facilitadores. CONCLUSIONES: El alto grado de acuerdo con las recomendaciones para reducir las prácticas de poco valor y la alta percepción de utilidad reflejan una gran concienciación sobre este problema en el hospital. Sin embargo, existen numerosas barreras para eliminarlas. Las intervenciones para reducirlas deberían fomentar la confianza en la toma de decisiones entre profesionales y pacientes, y proporcionar una evidencia confiable


Assuntos
Humanos , Atenção à Saúde/classificação , Imperícia/classificação , Padrões de Prática Médica/organização & administração , Grupos Focais , Pesquisas sobre Atenção à Saúde/estatística & dados numéricos , 25783 , Pessoal de Saúde/estatística & dados numéricos , Tomada de Decisão Clínica
7.
Gac Sanit ; 34(5): 459-467, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-30745093

RESUMO

OBJECTIVE: To explore healthcare professionals' opinions about low-value practices, identify practices of this kind possibly present in the hospital and barriers and facilitators to reduce them. Low-value practices include those with little or no clinical benefit that may harm patients or lead to a waste of resources. METHOD: Using a mixed methodology, we carried out a survey and two focus groups in a tertiary hospital. In the survey, we assessed doctors' agreement, subjective adherence and perception of usefulness of 134 recommendations to reduce low-value practices from local and international initiatives. We also identified low-value practices possibly present in the hospital. In the focus groups with professionals from surgical and medical fields, using a phenomenological approach, we identified additional low-value practices, barriers and facilitators to reduce them. RESULTS: 169 doctors of 25 specialties participated (response rate: 7%-100%). Overall agreement with recommendations, subjective adherence and usefulness were 83%, 90% and 70%, respectively. Low-value practices form 22 recommendations (16%) were considered as possibly present in the hospital. In the focus groups, the professionals identified seven more. Defensive medicine and scepticism due to contradictory evidence were the main barriers. Facilitators included good leadership and coordination between professionals. CONCLUSIONS: High agreement with recommendations to reduce low-value practices and high perception of usefulness reflect great awareness of low-value care in the hospital. However, there are several barriers to reduce them. Interventions to reduce low-value practices should foster confidence in decision-making processes between professionals and patients and provide trusted evidence.


Assuntos
Pessoal de Saúde , Hospitais , Atitude do Pessoal de Saúde , Grupos Focais , Humanos , Liderança , Pesquisa Qualitativa
8.
J Clin Nurs ; 28(21-22): 4053-4061, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31287603

RESUMO

AIMS AND OBJECTIVES: To evaluate the opinion of hospital nurses on a group of recommendations aimed at reducing low-value nursing care and, based on these results, to detect low-value practices probably existing in the hospital. BACKGROUND: Low-value nursing care refers to clinical practices with poor or no benefit for patients that may be harmful and a waste of resources. Detecting these practices and understanding nurses' perceptions are essential to developing effective interventions to reduce them. METHODS: We conducted a survey in a tertiary hospital. STROBE guidelines were followed. The questionnaire appraised nurses' agreement, subjective adherence and perception of usefulness of a group of recommendations to reduce low-value nursing care from Choosing Wisely and other initiatives. Practices described in recommendations with an agreement over 70% and a subjective adherence under 70% were categorised as low-value practices probably existing in the hospital. RESULTS: A total of 265 nurses from eight areas of care participated in the survey. The response rate by area ranged between 2%-55%. From the 38 recommendations evaluated, agreement was 96% (95% confidence interval [95%CI], 95%-97%), median subjective adherence was 80% (95%CI, 80%-85%), and usefulness was 90% (95%CI, 89%-92%). Based on these results, we detected seven (0-15) low-value practices probably existing in our hospital, mostly on general practice, pregnancy care and wound care. CONCLUSIONS: We found a great understanding of low-value care between nurses, given the high agreement to recommendations and perception of usefulness. However, several low-value practices may be present in nursing care, requiring actions to reduce them, for instance, reviewing institutional protocols and involving patients in de-implementation. RELEVANCE TO CLINICAL PRACTICE: Hospitals and other settings should be aware of low-value practices and take actions to identify and reduce them. A survey may be a simple and helpful way to start this process.


Assuntos
Recursos Humanos de Enfermagem Hospitalar/normas , Estudos Transversais , Atenção à Saúde/normas , Humanos , Processo de Enfermagem/normas , Padrões de Prática em Enfermagem/normas , Inquéritos e Questionários
9.
BMC Nephrol ; 20(1): 192, 2019 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-31138205

RESUMO

BACKGROUND: Chronic kidney disease (CKD) is a worldwide public health problem. Clinical practice guidelines (CPGs) are being developed and implemented in order to improve clinical practice related to the detection and treatment of CKD. The objective of our study was to evaluate the quality of CPGs regarding the CKD and to examine whether there are factors which influence their quality. METHODS: A systematic search was conducted to identify all CPGs regarding the early diagnosis and treatment of CKD. The CPGs quality were evaluated by three reviewers using the AGREE II instrument to decide if the guidelines are recommended for their use in clinical practice. RESULTS: In total, 13 CPGs were identified: five from America, six from Europe, one from Asia, and one from Oceania. Five CPGs were recommended for their use in clinical practice; since all their domains achieved the medium or high category. Furthermore, six CPGs were recommended with modifications, as the stakeholders' involvement, applicability, and editorial independence domains were evaluated as low category. These domains, as well as the rigor of the development domain, reached the very low category in those CPGs that were not recommended for its use in clinical practice. In all CPGs, the domains with the lowest average were the stakeholder involvement and the applicability. When comparing the domains of the CPGs according to the origin, type of developer group, the checklist used during the development and the publication period, a significantly higher average in the domain stakeholder involvement was found in the CPGs from Asia and Oceania compared to the ones in Latin America. Additionally, a significantly higher average in the applicability domain was found in the CPGs developed by CPGs developer organizations compared to those developed by medical societies. CONCLUSIONS: In total, 85% of the CPGs regarding CKD were recommended or recommended with modifications. The stakeholder involvement and applicability domains are assessed in the low category, which might affect the CPGs implementation. In order to save resources in low- and middle-income countries, an adaptation of the recommended CPGs should be considered.


Assuntos
Guias de Prática Clínica como Assunto/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/terapia , Lista de Checagem/métodos , Lista de Checagem/normas , Bases de Dados Factuais/normas , Humanos , Garantia da Qualidade dos Cuidados de Saúde/métodos , Sociedades Médicas/normas
10.
Cochrane Database Syst Rev ; 8: CD012086, 2018 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-30125049

RESUMO

BACKGROUND: Brain metastases occur when cancer cells spread from their original site to the brain and are a frequent cause of morbidity and death in people with cancer. They occur in 20% to 40% of people during the course of their disease. Brain metastases are also the most frequent type of brain malignancy. Single and solitary brain metastasis is infrequent and choosing the most appropriate treatment is a clinical challenge. Surgery and stereotactic radiotherapy are two options. For surgery, tumour resection is performed using microsurgical techniques, while in stereotactic radiotherapy, external ionising radiation beams are precisely focused on the brain metastasis. Stereotactic radiotherapy may be given as a single dose, also known as single dose radiosurgery, or in a number of fractions, also known as fractionated stereotactic radiotherapy. There is uncertainty regarding which treatment (surgery or stereotactic radiotherapy) is more effective for people with single or solitary brain metastasis. OBJECTIVES: To assess the effectiveness and safety of surgery versus stereotactic radiotherapy for people with single or solitary brain metastasis. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, March 2018), MEDLINE and Embase up to 25 March 2018 for relevant studies. We also searched trials databases, grey literature and handsearched relevant literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing surgery versus stereotactic radiotherapy, either a single fraction (stereotactic radiosurgery) or multiple fractions (fractionated stereotactic radiotherapy) for treatment of single or solitary brain metastasis. DATA COLLECTION AND ANALYSIS: Two review authors screened all references, evaluated the quality of the included studies using the Cochrane tool for assessing risk of bias, and performed data extraction. The primary outcomes were overall survival and adverse events. Secondary outcomes included progression-free survival and quality of life . We analysed overall survival and progression-free survival as hazard ratios (HRs) with 95% confidence intervals (CIs), and analysed adverse events as risk ratios (RRs). For quality of life we used mean difference (MD). MAIN RESULTS: Two RCTs including 85 participants met our inclusion criteria. One study included people with single untreated brain metastasis (n = 64), and the other included people with solitary brain metastasis (22 consented to randomisation and 21 were analysed). We identified a third trial reported as completed and pending results this may be included in future updates of this review. The two included studies were prematurely closed due to poor participant accrual. One study compared surgery plus whole brain radiotherapy (WBRT) versus stereotactic radiosurgery alone, and the second study compared surgery plus WBRT versus stereotactic radiosurgery plus WBRT. Meta-analysis was not possible due to clinical heterogeneity between trial interventions. The overall certainty of evidence was low or very low for all outcomes due to high risk of bias and imprecision.We found no difference in overall survival in either of the two comparisons. For the comparison of surgery plus WBRT versus stereotactic radiosurgery alone: HR 0.92, 95% CI 0.48 to 1.77; 64 participants, very low-certainty evidence. We downgraded the certainty of the evidence to very low due to risk of bias and imprecision. For the comparison of surgery plus WBRT versus stereotactic radiosurgery plus WBRT: HR 0.53, 95% CI 0.20 to 1.42; 21 participants, low-certainty evidence. We downgraded the certainty of the evidence to low due to imprecision. Adverse events were reported in both trial groups in the two studies, showing no differences for surgery plus WBRT versus stereotactic radiosurgery alone (RR 0.31, 95% CI 0.07 to 1.44; 64 participants) and for surgery plus WBRT versus stereotactic radiosurgery plus WBRT (RR 0.37, 95% CI 0.05 to 2.98; 21 participants). Most of the adverse events were related to radiation toxicities. We considered the certainty of the evidence from the two comparisons to be very low due to risk of bias and imprecision.There was no difference in progression-free survival in the study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT (HR 0.55, 95% CI 0.22 to 1.38; 21 participants, low-certainty evidence). We downgraded the evidence to low certainty due to imprecision. This outcome was not clearly reported for the other comparison. In general, there were no differences in quality of life between the two studies. The study comparing surgery plus WBRT versus stereotactic radiosurgery plus WBRT found no differences after two months using the QLQ-C30 global scale (MD -10.80, 95% CI -44.67 to 23.07; 14 participants, very low-certainty evidence). We downgraded the certainty of evidence to very low due to risk of bias and imprecision. AUTHORS' CONCLUSIONS: Currently, there is no definitive evidence regarding the effectiveness and safety of surgery versus stereotactic radiotherapy on overall survival, adverse events, progression-free survival and quality of life in people with single or solitary brain metastasis, and benefits must be decided on a case-by-case basis until well powered and designed trials are available. Given the difficulties in participant accrual, an international multicentred approach should be considered for future studies.


Assuntos
Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundário , Neoplasias Encefálicas/cirurgia , Radiocirurgia/métodos , Neoplasias Encefálicas/mortalidade , Terapia Combinada/métodos , Terapia Combinada/mortalidade , Irradiação Craniana/métodos , Irradiação Craniana/mortalidade , Humanos , Intervalo Livre de Progressão , Radiocirurgia/efeitos adversos , Radiocirurgia/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto
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