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This article is about current challenges to evidence-based medicine (EMB) in Italy. The authors, who share a 20-year commitment to the field of clinical research, discuss what they define as a phase of "stagnation" in practicing and teaching methods and research tactics, both in clinical and academic settings. Early success of EBM cultural movement was not persistent. The authors reason about how the teaching of EBM has remained a niche, concerning few professionals compared to the needs of the country. The authors identify some reasons that might have led to inconsistent attention to research methodology and address ways to strengthen the contribution of academic medicine to clinical research.
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Medicina Basada en la Evidencia , Proyectos de Investigación , Medicina Basada en la Evidencia/métodos , Humanos , ItaliaRESUMEN
INTRODUCTION: The potential advantages of oncoplastic breast conserving surgery (BCS) have not been validated in robust studies that constitute high levels of evidence, despite oncoplastic techniques being widely adopted around the globe. There is hence the need to define the precise role of oncoplastic BCS in the treatment of early breast cancer, with consensual recommendations for clinical practice. METHODS: A panel of world-renowned breast specialists was convened to evaluate evidence, express personal viewpoints and establish recommendations for the use of oncoplastic BCS as primary treatment of unifocal early stage breast cancers using the GRADE approach. RESULTS: According to the results of the systematic review of literature, the panelists were asked to comment on the recommendation for use of oncoplastic BCS for treatment of operable breast cancer that is suitable for breast conserving surgery, with the GRADE approach. Based on the voting outcome, the following recommendation emerged as a consensus statement: Oncoplastic breast conserving surgery should be recommended versus standard breast conserving surgery for the treatment of operable breast cancer in adult women who are suitable candidates for breast conserving surgery (with very low certainty of evidence). DISCUSSION: This review has revealed a low level of evidence for most of the important outcomes in oncoplastic surgery with lack of any randomized data and absence of standard tools for evaluation of clinical outcomes and especially patients' values. Despite areas of controversy, about one-third (36%) of panel members expressed a strong recommendation in support of oncoplastic BCS. Presumably, this reflects a synthesis of views on the relative complexity of these techniques, associated complications, impact on quality of life and costs.
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Neoplasias de la Mama/cirugía , Mastectomía Segmentaria , Neoplasias de la Mama/patología , Estudios Transversales , Femenino , Enfoque GRADE , Humanos , Estudios Prospectivos , Calidad de VidaRESUMEN
About 75% of colorectal cancers are diagnosed as early stage, in which radical surgery is achievable. In the last decade, in Italy, the overall incidence of colorectal cancer has remained stable, while mortality gradually decreased, which is attributable to early diagnosis and improved medical, surgical and locoregional treatments. The Italian Medical Oncology Association formulated guidelines to manage early-stage colon cancer, including screening, diagnosis, treatment and follow-up, which we herein present.
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Neoplasias del Colon , Oncología Médica , Humanos , Incidencia , Italia , Estadificación de NeoplasiasRESUMEN
BACKGROUND: The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM). METHODS: The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes. RESULTS: Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low. CONCLUSIONS: NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.
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Terapia Neoadyuvante , Neoplasias del Recto , Protocolos de Quimioterapia Combinada Antineoplásica , Quimioradioterapia , Supervivencia sin Enfermedad , Enfoque GRADE , Humanos , Italia , Oncología Médica , Recurrencia Local de Neoplasia/terapia , Estadificación de Neoplasias , Neoplasias del Recto/patología , Resultado del Tratamiento , EscrituraRESUMEN
PURPOSE: Cardiac late effects are responsible for a significant burden of mortality and morbidity among pediatric Hodgkin's lymphoma (HL) survivors (HLS). The aim of our study was to assess clinical and subclinical cardiac sequelae in a cohort of childhood HLS treated in the 1980s with doxorubicin, bleomycin, vinblastine, and dacarbazine (the ABVD regimen) and limited-field radiotherapy (RT). METHODS: We retrospectively examined a series of HLS treated from 1979 to 1989. We searched for subtle cardiac abnormalities in a subgroup of asymptomatic individuals, who underwent rest and exercise echocardiography at least 20 years after completing their therapies. Their cardiac assessment included physical examination, electrocardiogram (ECG), and resting and postexercise echocardiograms. RESULTS: On thorough cardiac assessment a mean of 21 years after their diagnosis, none of the 53 unselected asymptomatic HLS showed physical signs or significant ECG abnormalities during or after the stress echo test. Twenty-two (41%) of the 53 patients revealed valvular abnormalities, with mitral regurgitation in 28%, aortic regurgitation in 9%, and both in 4%. No significant myocardial dysfunction as a result of previous combined doxorubicin treatment and chest RT was identified. Only 2 individuals had mild pericardial alterations. CONCLUSIONS: The present study shows that long-term cardiac effects are common in HLS treated with the ABVD regimen and RT. The most frequent complications observed in this sample were essentially coronary artery disease and valvular abnormalities. None of the survivors in this sample showed overt congestive heart failure, a finding in contrast with larger studies.
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Quimioradioterapia/efectos adversos , Cardiopatías/epidemiología , Cardiopatías/etiología , Enfermedad de Hodgkin/terapia , Sobrevivientes/estadística & datos numéricos , Adolescente , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Bleomicina/efectos adversos , Niño , Preescolar , Dacarbazina/efectos adversos , Doxorrubicina/efectos adversos , Femenino , Corazón/efectos de los fármacos , Corazón/efectos de la radiación , Humanos , Masculino , Estudios Retrospectivos , Vinblastina/efectos adversosRESUMEN
The development of premature ovarian failure and subsequent infertility are possible consequences of chemotherapy use in pre-menopausal women with early-stage breast cancer. Among the available strategies for fertility preservation, pharmacological protection of the ovaries using luteinising hormone-releasing hormone analogues (LHRHa) during chemotherapy has the potential to restore ovarian function and fertility after anticancer treatments; however, the possible efficacy and clinical application of this strategy has been highly debated in the last years. Following the availability of new data on this controversial topic, the Panel of the Italian Association of Medical Oncology (AIOM) Clinical Practice Guideline on fertility preservation in cancer patients decided to apply the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methodology around the relevant and current question on the clinical utility of temporary ovarian suppression with LHRHa during chemotherapy as a strategy to preserve ovarian function and fertility in breast cancer patients. To answer this question, preservation of ovarian function and fertility were judged as critical outcomes for the decision-making. Three possible outcomes of harm were identified: LHRHa-associated toxicities, potential antagonism between concurrent LHRHa and chemotherapy, and lack of the prognostic impact of chemotherapy-induced premature ovarian failure. According to the GRADE evaluation conducted, the result was a strong positive recommendation in favour of using this option to preserve ovarian function and fertility in breast cancer patients. The present manuscript aims to update and summarise the evidence for the use of this strategy in light of the new data published up to January 2016, according to the GRADE process.
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Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Preservación de la Fertilidad/métodos , Hormona Liberadora de Gonadotropina/análogos & derivados , Insuficiencia Ovárica Primaria/prevención & control , Quimioterapia Adyuvante , Femenino , Fertilidad/efectos de los fármacos , HumanosRESUMEN
BACKGROUND: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. This is an update of a Cochrane review first published in 2000. OBJECTIVES: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for stage I, II or III breast cancer. SEARCH METHODS: For this 2014 review update, we searched the Cochrane Breast Cancer Group's Specialised Register (4 July 2014), MEDLINE (4 July 2014), Embase (4 July 2014), CENTRAL (2014, Issue 3), the World Health Organization (WHO) International Clinical Trials Registry Platform (4 July 2014) and ClinicalTrials.gov (4 July 2014). References from retrieved articles were also checked. SELECTION CRITERIA: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility for inclusion in the review and risk of bias. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses were conducted by age, tumour size and lymph node status. MAIN RESULTS: Since 2000, one new trial has been published; the updated review now includes five RCTs involving 4023 women with breast cancer (clinical stage I, II or III).Two trials involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.84 to 1.15, two studies, 2563 participants, high-quality evidence), or disease-free survival (HR 0.84, 95% CI 0.71 to 1.00, two studies, 2563 participants, low-quality evidence) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. In 1999, 10-year follow-up data became available for one trial of these trials, and no significant differences in overall survival were found. No difference was noted in quality of life measures (one study, 639 participants, high-quality evidence).The new included trial, together with a previously included trial involving 1264 women compared follow-up performed by a hospital-based specialist versus follow-up performed by general practitioners. No significant differences were noted in overall survival (HR 1.07, 95% CI 0.64 to 1.78, one study, 968 participants, moderate-quality evidence), time to detection of recurrence (HR 1.06, 95% CI 0.76 to 1.47, two studies, 1264 participants, moderate-quality evidence), and quality of life (one study, 356 participants, high-quality evidence). Patient satisfaction was greater among patients treated by general practitioners. One RCT involving 196 women compared regularly scheduled follow-up visits versus less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of general practitioners's consultations. AUTHORS' CONCLUSIONS: This updated review of RCTs conducted almost 20 years ago suggests that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life.In two RCTs, follow-up care performed by trained and not trained general practitioners working in an organised practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of overall survival, recurrence detection, and quality of life.
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Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/terapia , Recurrencia Local de Neoplasia/diagnóstico , Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Femenino , Estudios de Seguimiento , Medicina General , Humanos , Mamografía , Oncología Médica , Recurrencia Local de Neoplasia/mortalidad , Estadificación de Neoplasias , Examen Físico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: The publication of clinical prediction rules (CPRs) studies has risen significantly. It is unclear if this reflects increasing usage of these tools in clinical practice or how this may vary across clinical areas. AIM: To review clinical guidelines in selected areas and survey GPs in order to explore CPR usefulness in the opinion of experts and use at the point of care. DESIGN AND SETTING: A review of clinical guidelines and survey of UK GPs. METHOD: Clinical guidelines in eight clinical domains with published CPRs were reviewed for recommendations to use CPRs including primary prevention of cardiovascular disease, transient ischaemic attack (TIA) and stroke, diabetes mellitus, fracture risk assessment in osteoporosis, lower limb fractures, breast cancer, depression, and acute infections in childhood. An online survey of 401 UK GPs was also conducted. RESULTS: Guideline review: Of 7637 records screened by title and/or abstract, 243 clinical guidelines met inclusion criteria. CPRs were most commonly recommended in guidelines regarding primary prevention of cardiovascular disease (67%) and depression (67%). There was little consensus across various clinical guidelines as to which CPR to use preferentially. SURVEY: Of 401 responders to the GP survey, most were aware of and applied named CPRs in the clinical areas of cardiovascular disease and depression. The commonest reasons for using CPRs were to guide management and conform to local policy requirements. CONCLUSION: GPs use CPRs to guide management but also to comply with local policy requirements. Future research could focus on which clinical areas clinicians would most benefit from CPRs and promoting the use of robust, externally validated CPRs.
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Enfermedades Cardiovasculares , Técnicas de Apoyo para la Decisión , Diabetes Mellitus , Fracturas del Fémur , Medicina General , Ataque Isquémico Transitorio , Fracturas Osteoporóticas , Accidente Cerebrovascular , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/prevención & control , Neoplasias de la Mama/terapia , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/terapia , Depresión/diagnóstico , Depresión/prevención & control , Depresión/terapia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/prevención & control , Diabetes Mellitus/terapia , Femenino , Fracturas del Fémur/diagnóstico , Fracturas del Fémur/prevención & control , Fracturas del Fémur/terapia , Encuestas Epidemiológicas , Humanos , Ataque Isquémico Transitorio/diagnóstico , Ataque Isquémico Transitorio/prevención & control , Ataque Isquémico Transitorio/terapia , Fracturas Osteoporóticas/diagnóstico , Fracturas Osteoporóticas/prevención & control , Fracturas Osteoporóticas/terapia , Sistemas de Atención de Punto , Guías de Práctica Clínica como Asunto , Medición de Riesgo , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/terapia , Encuestas y Cuestionarios , Fracturas de la Tibia/diagnóstico , Fracturas de la Tibia/prevención & control , Fracturas de la Tibia/terapia , Reino UnidoRESUMEN
BACKGROUND: Inguinal hernia repair is the most frequent operation in general surgery. There are several techniques: the Shouldice technique is sometimes considered the best method but different techniques are used as the "gold standard" for open hernia repair. Outcome measures, such as recurrence rates, complications and length of post operative stay, vary considerably among the various techniques. OBJECTIVES: To evaluate the efficacy and safety of the Shouldice technique compared to other non-laparoscopic techniques for hernia repair. SEARCH METHODS: We searched MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL), April 2008 and updated the searches September 2011, for relevant randomised controlled trials. SELECTION CRITERIA: Any randomised or quasi-randomised controlled trials (RCT) on the treatment of primary inguinal hernia in adults were considered for inclusion. DATA COLLECTION AND ANALYSIS: All abstracts identified by the search strategies were assessed by two independent researchers to exclude studies that did not meet the inclusion criteria. The full publications of all possibly relevant abstracts were obtained and formally assessed. Missing or updated informations was sought by contacting the authors. MAIN RESULTS: Sixteen trials contributed to this review. A total of 2566 hernias were analysed in the Shouldice group with 1121 mesh and 1608 non-mesh techniques. The recurrence rate with Shouldice techniques was higher than mesh techniques (OR 3.80, 95% CI 1.99 to 7.26) but lower than non-mesh techniques (OR 0.62, 95% CI 0.45 to 0.85). There were no significant differences in chronic pain, complications and post-operative stay. Female were nearly 3% of included patients. AUTHORS' CONCLUSIONS: Shouldice herniorrhaphy is the best non-mesh technique in terms of recurrence, though it is more time consuming and needs a slightly longer post-operative hospital stay. The use of mesh is associated with a lower rate of recurrence. The quality of included studies, assessed with jaded scale, were low. Patients have similar characteristic in the treatment and control group but seems more healthy than in general population, this features may affect the dimension of effect in particularly recurrence rate could be higher in general population. Lost to follow-up were similar in the treatment and control group but the reasons were often not reported. The length of follow-up vary broadly among the studies from 1 year to 13.7 year.
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Fasciotomía , Hernia Inguinal/cirugía , Técnicas de Sutura , Adulto , Femenino , Hernia Inguinal/prevención & control , Humanos , Conducto Inguinal/cirugía , Tiempo de Internación , Masculino , Complicaciones Posoperatorias/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Prevención Secundaria , Mallas QuirúrgicasRESUMEN
OBJECTIVE: To evaluate the ability of international point of care information summaries to update evidence relevant to medical practice. DESIGN: Prospective cohort bibliometric analysis. SETTING: Top five point of care information summaries (Clinical Evidence, EBMGuidelines, eMedicine, Dynamed, UpToDate) ranked for coverage of medical conditions, editorial quality, and evidence based methodology. MAIN OUTCOME MEASURES: From June 2009 to May 2010 we measured the incidence of research findings relating to potentially eligible newsworthy evidence. As samples, we chose systematic reviews rated as relevant by international research networks (such as, Evidence-Based Medicine, ACP Journal Club, and the Cochrane Collaboration). Every month we assessed whether each sampled review was cited in at least one chapter of the five summaries. The cumulative updating rate was analysed with Kaplan-Meier curves. Results From April to December 2009, 128 reviews were retrieved; 53% (68) from the literature surveillance journals and 47% (60) from the Cochrane Library. At nine months, Dynamed had cited 87% of the sampled reviews, while the other summaries had cited less than 50%. The updating speed of Dynamed clearly led the others. For instance, the hazard ratios for citations in EBM Guidelines and Clinical Evidence versus the top performer were 0.22 (95% confidence interval 0.17 to 0.29) and 0.03 (0.01 to 0.05). Conclusions Point of care information summaries include evidence relevant to practice at different speeds. A qualitative analysis of updating mechanisms is needed to determine whether greater speed corresponds to more appropriate incorporation of new information.
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Bibliometría , Sistemas de Atención de Punto , Edición/estadística & datos numéricos , Estudios de Cohortes , Medicina Basada en la Evidencia , Sistemas en Línea , Estudios Prospectivos , Factores de TiempoRESUMEN
OBJECTIVE: To assess the reporting of monitoring recommendations in guidelines on the prevention and treatment of cardiovascular disease. DATA SOURCES: Medline, Trip database, National Guideline Clearinghouse, and databases containing guidelines published from January 2002 to February 2010. Data selection Three major risk factors for cardiovascular disease: cholesterol level, smoking, and hypertension. The primary outcome was the frequency with which the guidelines dealt with monitoring of risk factors. Secondary outcomes were completeness of monitoring recommendations, defined by the presence of what to monitor, when to monitor, what to do if the targets or variables were not met, and the reported level or strength of the evidence. RESULTS: 117 guidelines were identified, 84 (72%) of which contained a section on lipids. Of those guidelines with a section on lipids, 53% (n = 44) provided no information or specific recommendations on what to monitor, 51% (n = 43) provided no information on when to monitor, and 64% (n = 54) provided no guidance on what to do if the target was out of range. Guidelines for hypertension (n = 79) and smoking (n = 65) were little better, with 63% (n = 50) and 54% (n = 35), respectively, providing no recommendation for what to monitor. The number of guidelines that explicitly referenced the level of evidence for monitoring was low, with most of the recommendations based on weak levels of evidence. CONCLUSION: Many guidelines for cardiovascular disease do not report clearly what to monitor and what to do if a change is detected. If no evidence is available to support a specific monitoring schedule, this should be explicit in the guideline, with a description of the new research that would fill the gap.
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Enfermedades Cardiovasculares/prevención & control , Guías de Práctica Clínica como Asunto , Enfermedades Cardiovasculares/etiología , Humanos , Hipertensión/prevención & control , Lípidos/sangre , Factores de Riesgo , Prevención del Hábito de FumarRESUMEN
BACKGROUND: Busy clinicians need easy access to evidence-based information to inform their clinical practice. Publishers and organizations have designed specific tools to meet doctors' needs at the point of care. OBJECTIVE: The aim of this study was to describe online point-of-care summaries and evaluate their breadth, content development, and editorial policy against their claims of being "evidence-based." METHODS: We searched Medline, Google, librarian association websites, and information conference proceedings from January to December 2008. We included English Web-based point-of-care summaries designed to deliver predigested, rapidly accessible, comprehensive, periodically updated, evidence-based information to clinicians. Two investigators independently extracted data on the general characteristics and content presentation of summaries. We assessed and ranked point-of-care products according to: (1) coverage (volume) of medical conditions, (2) editorial quality, and (3) evidence-based methodology. We explored how these factors were associated. RESULTS: We retrieved 30 eligible summaries. Of these products, 18 met our inclusion criteria and were qualitatively described, and 16 provided sufficient data for quantitative evaluation. The median volume of medical conditions covered was 80.6% (interquartile range, 68.9%-84.2%) and varied for the different products. Similarly, differences emerged for editorial policy (median 8.0, interquartile range 5.8-10.3) and evidence-based methodology scores (median 10.0, interquartile range 1.0-12.8) on a 15-point scale. None of these dimensions turned out to be significantly associated with the other dimensions (editorial quality and volume, Spearman rank correlation r = -0.001, P = .99; evidence-based methodology and volume, r = -0.19, P = .48; editorial and evidence-based methodology, r = 0.43, P =.09). CONCLUSIONS: Publishers are moving to develop point-of-care summary products. Some of these have better profiles than others, and there is room for improved reporting of the strengths and weaknesses of these products.
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Medicina Basada en la Evidencia/tendencias , Sistemas en Línea , Sistemas de Atención de Punto/tendencias , Políticas Editoriales , Estudios de Evaluación como Asunto , Medicina Basada en la Evidencia/normas , Investigación sobre Servicios de Salud/organización & administración , Investigación sobre Servicios de Salud/normas , Humanos , MEDLINE/normas , Médicos/normas , Sistemas de Atención de Punto/organización & administración , Sistemas de Atención de Punto/normasRESUMEN
BACKGROUND: Inguinal hernia repair is the most frequent operation in general surgery. There are several techniques: the Shouldice technique is sometimes considered the best method but different techniques are used as the "gold standard" for open hernia repair. Outcome measures, such as recurrence rates, complications and length of post operative stay, vary considerably among the various techniques. OBJECTIVES: To evaluate the efficacy and safety of the Shouldice technique compared to other non-laparoscopic techniques for hernia repair. SEARCH STRATEGY: We searched MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (CENTRAL), April 2008, for relevant randomised controlled trials. SELECTION CRITERIA: Any randomised or quasi-randomised controlled trials (RCT) on the treatment of primary inguinal hernia in adults were considered for inclusion. DATA COLLECTION AND ANALYSIS: All abstracts identified by the search strategies were assessed by two independent researchers to exclude studies that did not meet the inclusion criteria. The full publications of all possibly relevant abstracts were obtained and formally assessed. Missing or updated informations was sought by contacting the authors. MAIN RESULTS: Sixteen trials contributed to this review. A total of 2566 hernias were analysed in the Shouldice group with 1121 mesh and 1608 non-mesh techniques. The recurrence rate with Shouldice techniques was higher than mesh techniques (OR 3.80, 95% CI 1.99 to 7.26) but lower than non-mesh techniques (OR 0.62, 95% CI 0.45 to 0.85). There were no significant differences in chronic pain, complications and post-operative stay. Female were nearly 3% of included patients. AUTHORS' CONCLUSIONS: Shouldice herniorrhaphy is the best non-mesh technique in terms of recurrence, though it is more time consuming and needs a slightly longer post-operative hospital stay. The use of mesh is associated with a lower rate of recurrence. The quality of included studies, assessed with jaded scale, were low. Patients have similar characteristic in the treatment and control group but seems more healthy than in general population, this features may affect the dimension of effect in particularly recurrence rate could be higher in general population. Lost to follow-up were similar in the treatment and control group but the reasons were often not reported. The length of follow-up vary broadly among the studies from 1 year to 13.7 year.
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Hernia Inguinal/cirugía , Mallas Quirúrgicas , Adulto , Femenino , Hernia Inguinal/prevención & control , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Prevención Secundaria , Técnicas de SuturaRESUMEN
BACKGROUND: Since September 2005 the International Committee of Medical Journal Editors has required that trials be registered in accordance with the World Health Organization (WHO) minimum dataset, in order to be considered for publication. The objective is to evaluate registries' and individual trial records' compliance with the 2006 version of the WHO minimum data set. METHODS: A retrospective evaluation of 21 online clinical trial registries (international, national, specialty, pharmaceutical industry and local) from April 2005 to February 2007 and a cross-sectional evaluation of a stratified random sample of 610 trial records from the 21 registries. RESULTS: Among 11 registries that provided guidelines for registration, the median compliance with the WHO criteria were 14 out of 20 items (range 6 to 20). In the period April 2005-February 2007, six registries increased their compliance by six data items, on average. None of the local registry websites published guidelines on the trial data items required for registration. Slightly more than half (330/610; 54.1%, 95% CI 50.1% - 58.1%) of trial records completed the contact details criteria while 29.7% (181/610, 95% CI 26.1% - 33.5%) completed the key clinical and methodological data fields. CONCLUSION: While the launch of the WHO minimum data set seemed to positively influence registries with better standardisation of approaches, individual registry entries are largely incomplete. Initiatives to ensure quality assurance of registries and trial data should be encouraged. Peer reviewers and editors should scrutinise clinical trial registration records to ensure consistency with WHO's core content requirements when considering trial-related publications.
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Ensayos Clínicos como Asunto , Adhesión a Directriz , Sistema de Registros , Organización Mundial de la Salud , Estudios Transversales , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits. The aims of this trial are to establish whether the e-learning program (ECCE) increases physicians' basic knowledge about common clinical scenarios, and whether ECCE is superior to the passive diffusion of information through the printed version of Clinical Evidence. DESIGN: All Italian doctors naïve to ECCE will be randomised to three groups. Group one will have access to ECCE for Clinical Evidence chapters and vignettes lot A and will provide control data for Clinical Evidence chapters and vignettes lot B; group two vice versa; group three will receive the concise printed version of Clinical Evidence. There are in fact two designs: a before and after pragmatic trial utilising a two by two incomplete block design (group one versus group two) and a classical design (group one and two versus group three). The primary outcome will be the retention of Clinical Evidence contents assessed from the scores for clinical vignettes selected from ECCE at least six months after the intervention. To avoid test-retest effects, we will randomly select vignettes out of lot A and lot B, avoiding repetitions. In order to preserve the comparability of lots, we will select vignettes with similar, optimal psychometric characteristics.
Asunto(s)
Instrucción por Computador , Educación Médica Continua , Medicina Basada en la Evidencia , Internet , Adulto , Actitud del Personal de Salud , Humanos , Italia , Estudios del Lenguaje , Medicina/estadística & datos numéricos , Persona de Mediana Edad , Especialización , Encuestas y CuestionariosRESUMEN
BACKGROUND: Human albumin solutions are used in a range of medical and surgical problems. Licensed indications are the emergency treatment of shock and other conditions where restoration of blood volume is urgent, burns, and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids. OBJECTIVES: To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients. SEARCH STRATEGY: We searched the Cochrane Injuries Group trials register, Cochrane Central Register of Controlled Trials, Medline, Embase and BIDS Index to Scientific and Technical PROCEEDINGS: Reference lists of trials and review articles were checked, and authors of identified trials were contacted. The search was last updated in August 2004. SELECTION CRITERIA: Randomised controlled trials comparing albumin/PPF with no albumin/PPF, or with a crystalloid solution, in critically ill patients with hypovolaemia, burns or hypoalbuminaemia. DATA COLLECTION AND ANALYSIS: We collected data on the participants, albumin solution used, mortality at the end of follow up, and quality of allocation concealment. Analysis was stratified according to patient type. MAIN RESULTS: We found 32 trials meeting the inclusion criteria and reporting death as an outcome. There were 1632 deaths among 8452 trial participants. For hypovolaemia, the relative risk of death following albumin administration was 1.01 (95% confidence interval 0.92-1.10). This estimate was heavily influenced by the results of the SAFE trial, which contributed 91% of the information (based on the weights in the meta-analysis). For burns, the relative risk was 2.40 (1.11-5.19) and for hypoalbuminaemia the relative risk was 1.38 (0.94-2.03). There was no substantial heterogeneity between the trials in the various categories (chi2 = 21.86, df = 25, p = 0.64). The pooled relative risk of death with albumin administration was 1.04 (0.95-1.13). CONCLUSIONS: For patients with hypovolaemia there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trial. PLAIN LANGUAGE SUMMARY: There is no evidence that giving human albumin to replace lost blood in critically ill or injured people improves survival when compared to giving saline. Trauma, burns or surgery can cause people to lose large amounts of blood. Fluid replacement, giving fluids intravenously (into a vein), is used to help restore blood volume and hopefully reduce the risk of dying. Blood products (including human albumin), non-blood products or combinations can be used. The review of trials found no evidence that albumin reduces the risk of dying. Albumin is very expensive in which case it may be better to use cheaper alternatives such as saline for fluid resuscitation.
Asunto(s)
Albúminas/uso terapéutico , Proteínas Sanguíneas/uso terapéutico , Enfermedad Crítica/mortalidad , Enfermedad Crítica/terapia , Resucitación/métodos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Albúmina Sérica , Albúmina Sérica Humana , Seroglobulinas , SolucionesRESUMEN
In this paper we try to define the future goals of the clinical research, with particular reference to methodological and policy issues. There is an increasing tension between the real drivers of clinical research and its scientific and ethical aims. To consumers the goal is to strengthen the relevance and usefulness of clinical research. This is possible only if consumers are empowered and actively involved. For the health care systems it is mandatory to re-engineer the process, enforcing national and international legislation. This should help to fill the research-clinical practice gap and to balance the research agenda, better reflecting health priorities. Finally the scientific community should reflect on its own conflicts of interests and analyse the causes of the ethical divide between the needs and the market. Scientists too often seem to loose sight of the original cumulative nature of research and of the idea of research as a collective good. More non-commercial research is needed, integrated with the health care systems, to support a transparent, more realistic and valid information useful for patient care, scientific information.