Meta-analysis of observational studies on the safety and effectiveness of robotic gynaecological surgery.

BACKGROUND: The safety and effectiveness of robotic, open and conventional laparoscopic surgery in gynaecological surgery was assessed in a systematic review of the literature. This will enable the general surgical community to understand where robotic surgery stands in gynaecology. METHODS: A search was made for previous systematic reviews in the Abstracts of Reviews of Effects, Health Technology Assessment, Cochrane Collaboration and Hayes Inc. databases. In addition, the MEDLINE, Embase and CINAHL databases were searched for primary studies. The quality of studies was assessed and meta-analyses were performed. RESULTS: Twenty-two studies were included in the review. All were controlled but none was randomized. The majority were retrospective with historical controls. The settings in which robotic surgery was used included hysterectomy for malignant and benign disease, myomectomy, sacrocolpopexy, fallopian tube reanastomosis and adnexectomy. Robotic surgery achieved a shorter hospital stay and less blood loss than open surgery. Compared with conventional laparoscopic surgery, robotic surgery achieved reduced blood loss and fewer conversions during the staging of endometrial cancer. No clinically significant differences were recorded for the other indications tested. CONCLUSION: The available evidence shows that robotic surgery offers limited advantages with respect to short-term outcomes. However, the clinical outcomes should be interpreted with caution owing to the methodological quality of the studies.

Effectiveness, safety, and cost-effectiveness of photodynamic therapy in Barrett's esophagus: a systematic review.

Barrett's esophagus, the management of which remains controversial, is the precursor condition to esophageal adenocarcinoma. A number of endoscopic treatments have been designed as an alternative to surgical resection for patients with high-grade dysplasia. One of these, photodynamic therapy, involves the light activation of a photosensitizer that causes local tissue destruction via oxidation reactions. The present work reviews the effectiveness, safety, and cost-effectiveness of this treatment. A systematic review of the literature recorded in the Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Database, and the National Health Service Economic Evaluation Database was undertaken. Articles reporting randomized clinical trials of photodynamic therapy for the treatment of Barrett's esophagus, and economic assessments of the procedure, were selected. The quality of the articles was checked. Twelve articles were included in this review: eight randomized, controlled clinical trials and four economic assessments. The clinical trials suffered from methodological limitations, but the economic assessments were considered to be good quality. Photodynamic therapy is effective for the ablation of dysplasia in Barrett's esophagus, although the frequency of adverse events is quite high. The procedure is presented as a cost-effective alternative to intense endoscopic monitoring and esophagectomy. However, the evidence regarding its effectiveness in reducing the number of patients who go on to develop cancer is only incipient. Rigorous, controlled studies with longer follow-up times, in which photodynamic therapy is compared with surgical resection and other endoscopic techniques, are needed.

Satisfaction with and psychological impact of immediate and deferred breast reconstruction.

BACKGROUND: The present work assesses the effect of immediate breast reconstruction (IBR), deferred breast reconstruction (DBR), and no breast reconstruction on the psychological impact. PATIENTS AND METHODS: Standard questionnaires were used to determine the psychological impact suffered by patients who underwent IBR, DBR and no reconstruction, their degree of satisfaction with the results achieved, and their postprocedure opinions regarding reconstruction options. RESULTS: A total of 526 women underwent mastectomy. The response rate to the questionnaires was 71.67%. A significantly greater proportion of the women who underwent no reconstruction suffered psychological problems than those who underwent reconstruction of some type (P = 0.01). Some 94.77% of the women who underwent IBR maintained a postprocedure preference for this option; in contrast, some 87.27% of the DBR and 56.14% of the no-reconstruction patients declared a postprocedure preference for IBR. In all, 63.49% of the women who underwent reconstruction were moderately very satisfied with the aesthetic results achieved, while only 22.80% of the no-reconstruction patients declared such satisfaction (P = 0.0001). CONCLUSIONS: The women who underwent no breast reconstruction suffered more emotional problems than those who underwent a reconstruction procedure. In general, all groups reported a postprocedure preference for IBR in their questionnaire answers. The aesthetic results achieved by IBR seem to be those best accepted.

[Middle molecules removal. Beyond beta2-microglobulin]. / Depuración de grandes moléculas. Más allá de la beta2-microglobulina.

The uremic toxin removal capacity mainly depends on dialyzer and hemodialysis modes. The low-flux hemodialysis only removes solutes having molecular weights less than 5.000 Da. High-flux hemodyalisis represents a form of low-volume hemodiafiltration because of the internal filtration and back-filtration that can take place within a dialyzer. Hemodiafiltration with large volumes of replacement fluid seems to be the best technique for removing all small, medium-sized and large molecules. The objective of our study was to evaluate the large molecules removal bigger than beta2-microglobuline on high flux haemodialysis and on-line hemodiafiltration with postdilutional infusion, in patients with three times a week dialysis and on short daily dialysis. We studied 24 patients, 15 males and 9 females stable on haemodialysis programme, twelve on standard four to five hours three times a week dialysis and twelve on 2 to 2 1/2 hours six times a week dialysis. All patients were dialysed with Fresenius 4008 monitor, three sessions on high flux haemodialysis (HD) and three sessions on on-line hemodiafiltration (OL-HDF). Two sessions with each filter were performed (polisulfone HF80, polyethersulfone Arylane H9 and new polisulfone APS 900). Pre and postdialysis concentrations of urea, creatinine, (beta2-microglobulin (beta2-m), myoglobin, prolactin and alpha1 microglobulin (alpha1-m) were measured. There was no difference in urea and creatinine small molecules removal. beta2m removal was 68% on HD and 81% on OL-HDF. Myoglobin and prolactin present a similar removal pattern, a higher removal with new filters (60% with Arylane and 59% with APS) in comparison with clasical polisulfone (22% with HF80). The mean alpha1-m reduction rate on HD was 6% and on OL-HDF 22%. OL-HDF with APS 900 filter was the most remove technique (35.4%), significatively higher than the other modes and filters. We can conclude that the new filters generation reach a better uremic toxins removal, specially in large molecules higher than beta2-m and on HD modality.

[Effectiveness of smoking cessation intervention in patients with cardiovascular disease]. / Efectividad de una intervención de deshabituación tabáquica en pacientes con patología cardiovascular.

INTRODUCTION AND OBJECTIVES: The incidence of coronary events descends in patients with cardiac disease who quit smoking. Only around 50% of the patients who quit smoking after an acute event remain abstinent three months after hospital discharge. The objective of this study was to evaluate the effectiveness of a tobacco dishabituation program in patients with cardiovascular disease. METHODS: We studied a cohort of smokers who started a smoking cessation program between September 1993 and June 1999. We compared 348 patients with cardiovascular disease with 1.107 smokers without disease. A twelve-month protocolized follow-up was performed, measuring carbon monoxide for evaluating relapse on every control. We calculated the abstinence in each period and estimated the odds ratio for relapse at twelve months. RESULTS: We observed a global continued abstinence at twelve months of 37.1% (129/348) in the patients with cardiovascular disease and of 39.6% (438/1.107) in the patients without disease. The consonant smokers (precontemplatives) showed a greater number of relapses, with an adjusted Odds ratio of 1.36. CONCLUSIONS: Exhaustive treatment and follow-up achieved a percentage of great abstinence in the cardiovascular patients of our study who were unable to quit smoking during hospitalisation or after diagnosis. We therefore suggest that these patients may benefit from inclusion in smoking cessation units.

Predictors of hospital admission in exacerbations of chronic obstructive pulmonary disease.

OBJECTIVE: To identify factors predictive of hospital admission among patients attending an emergency department (ED) with exacerbation of chronic obstructive pulmonary disease (COPD) and to determine if these were consistent with Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations. DESIGN: In a prospective cohort of 2487 COPD patients with exacerbations conducted in 16 EDs, clinical data were obtained and physical examination and blood gas analyses were performed on arrival at the ED and at decision time about hospitalisation. Multivariate analyses were performed using hospital admission as the dependent measure. RESULTS: In multivariate analysis, factors predictive of hospital admission on ED arrival were previous hospitalisation for COPD exacerbation (OR 2.03, 95%CI 1.32-3.11), resting dyspnoea (OR 3.05, 95%CI 2.39-3.88) and altered blood gas (PaO2 = 45-60 mmHg, OR 2.7, 95%CI 2.12-3.44; PaO2 < 45 mmHg, OR 3.24, 95%CI 2.14-4.92; PaCO2 = 56-65 mmHg, OR 2.35, 95%CI 1.58-3.51; and PaCO2 > 65 mmHg, OR 6.98, 95%CI 4.03-12.09). The predictive capacity of the model using variables available at decision time was better than for those at ED arrival (area under the receiver operating characteristic curve 0.89 and 0.83). These factors are included in the GOLD recommendations. CONCLUSION: Among COPD patients presenting to the ED with exacerbation, factors immediately associated with episode severity were independent predictors of hospitalisation. Our criteria for hospitalisation are in line with GOLD recommendations.

Relationship of sociodemographic variables with outcomes after cataract surgery.

PURPOSE: The objective of this study is to analyse the relationship between sociodemographic characteristics of patients undergoing cataract extraction and their outcomes. METHODS: The method comprised a prospective cohort study of patients recruited from 17 hospitals of different areas of Spain. Data gathered before surgery included sociodemographic variables, visual acuity, and visual function (using the Visual Function Index-14). After surgery, we assessed visual acuity and visual function at 6 weeks and at 3 months, respectively. Multivariate multilevel analysis was performed to assess the relationship of sociodemographic variables with changes in visual acuity and function, analysing whether improvements surpassed the minimal clinically important differences (MCIDs). RESULTS: Multivariate analysis showed that for visual acuity, (i) older men had a lower odds ratio (OR) of surpassing the MCID (OR: 65-75 years, 0.64; >75 years, 0.51); (ii) those with primary (1.65) or secondary (1.41) education had higher ORs than those with no formal education; and (iii) those living in a residential home had a lower OR than men living alone (0.36). In women, we found that the higher the educational level, the greater the improvement in visual acuity (primary, 1.41; secondary, 1.76), whereas socially dependent women (0.70) were less likely to exceed the MCID. With regards to predictors related to achievement of an MCID in visual function, only dependency was associated with more improvement in men (OR: 1.39), whereas in women the educational level was the only predictor (primary: 0.72; secondary: 0.61). CONCLUSIONS: This study found that patients with certain sociodemographic characteristics were less likely to experience an MCID in visual acuity or visual function after cataract surgery.

A strategy for patient involvement in clinical practice guidelines: methodological approaches.

BACKGROUND An increasing number of initiatives involve patients in the development of Clinical Practice Guidelines (CPGs). However, the method used for patient involvement is fundamental to achieving a quality patient-oriented CPG. The objective is to present a strategy for patient involvement that includes both robust patient consultation and participation. This strategy is based on the authors' experience in the development of four CPGs included in the Spanish National CPG Development Program, which deemed it a valuable nation-wide patient involvement initiative. METHODS Patient consultation in the CPG preparation phase combines quantitative and qualitative primary research techniques as well as a systematic review of patient-perspective studies. Participation relies on patients and patient representatives as members of the guideline development groups in all development phases at the same level as professionals. NVivo 8 software was used to analyse discourses of qualitative data. RESULTS Patients and patient representatives provided relevant information on their perspectives, experiences with the illness, social circumstances, habits, values and preferences. They collaborated in different CPG development phases, including setting the scope and objectives, defining key research questions, writing and reviewing recommendations, developing patients' versions and the dissemination of CPGs. CONCLUSIONS The authors' strategy allows for patient-oriented CPG development, but it requires appropriate training and knowledge of qualitative research techniques (primary research and systematic review of qualitative evidence) for developers. It is also crucial to have specific support for patients, previously selected with eligibility criteria, to facilitate an effective engagement, providing clear guidance on their roles and ensuring opportunities to attend training events.

Explicit criteria for hospital admission in exacerbations of chronic obstructive pulmonary disease.

OBJECTIVE: To develop detailed, explicit criteria for determining the appropriateness of admission for patients with exacerbations of chronic obstructive pulmonary disease (COPD). DESIGN: Using a modified Delphi process, a panel of seven pneumologists and five emergency department (ED) physicians was assembled to establish the appropriateness of hospital admission for 896 distinct theoretical scenarios. To assess the reliability of the criteria, a second national panel of five pneumologists and five ED physicians was assembled. We examined the influence of all variables on the first panel score using linear regression models. The explicit criteria developed were summarised by classification and regression tree analysis. RESULTS: The appropriateness of the hospitalisation scenarios increased with the severity of COPD. The kappa of agreement between the two panels was 0.79. Predictors of appropriate hospitalisation were severity of current COPD exacerbation, response to previous treatment and expected adherence to treatment. The panel results were synthesised and presented in three decision trees. Misclassification error in the decision trees, as compared with the panel's original ratings, was 6.1%. CONCLUSIONS: These explicit criteria can be used to help determine the appropriateness of admission for patients with exacerbations of COPD.

A systematic review of FDG-PET in breast cancer.

OBJECTIVE: To assess the safety and efficacy of FDG-PET in breast cancer in the diagnostic of primary tumours, lymph node staging, the detection of recurrent disease/metastases, and the assessment of chemotherapy treatment. METHODS: A systematic review was undertaken. A search was made for primary studies, other systematic reviews, and health technology assessment reports in different databases. RESULTS: A total of 73 reports were included. FDG-PET does not appear to be sufficiently accurate to be used in isolation for ruling out the presence of a primary tumour. In lymph gland staging, FDG-PET does not appear to be accurate enough to detect occult axillary metastases or micrometastases (sensitivity 20 and 50%, respectively); sentinel node biopsy is required for confirmation. In the detection of bone metastases, FDG-PET should be complemented with other tests such as bone gammagraphy or SPECT. The assessment of response to chemotherapy, there seems to be no uniform criterion for establishing a standardized uptake value (SUV) for FDG that would allow responders and non-responders to be distinguished. CONCLUSIONS: FDG-PET is insufficiently sensitive to rule out small primary tumours. Due to the high number of false positives returned, it cannot replace axillary dissection in axillary lymph gland staging. A complete biochemical response identified by FDG-PET should not be relied upon to mean an absence of disease since the technique cannot detect residual microscopic elements.

Systematic review of laparoscopic versus open surgery for colorectal cancer.

BACKGROUND: This study compares the efficacy and safety of laparoscopic surgery (LS) and open surgery (OS) for colorectal cancer. METHODS: An electronic search of the literature was undertaken to identify primary studies and systematic reviews. Information on the efficacy and safety of LS versus OS was analysed. A meta-analysis was conducted to examine long-term outcomes. RESULTS: A systematic review published in 2000 and 12 more recent randomized clinical trials were identified. Compared with OS, LS reduced blood loss and pain, and resulted in a faster return of bowel function and earlier resumption of normal diet. Hospital stay was up to 2 days shorter after LS. No significant differences between the techniques were noted in the incidence of complications or postoperative mortality. The time required to complete LS was significantly longer (0.5-1.0 h more). No significant differences were found between the two procedures in terms of overall mortality, cancer-related mortality or disease recurrence. CONCLUSION: LS takes longer than OS but offers several short-term benefits. However, complication rates are similar for both procedures and no differences were found in long-term outcomes.

Nitrogen fixation in the muskeg ecosystem of the James Bay Lowlands, Northern Ontario.

The acetylene-reduction assay was used for in situ and laboratory assessment of biological nitrogen fixation in the acidic, waterlogged, muskeg ecosystem of the southern James Bay area, in the region of Moosonee, Ontario. In situ assays and subsequent laboratory experimentation revealed that nitrogenase activity was predominately a function of the activities of heterocystic blue-green bacteria associated with surface water, with the phyllosphere of mosses, and with at least one lichen, a species of Peltigera. No such in situ activity was detected in the subsurface organic material, even when such material was amended with glucose. However, under laboratory conditions at 20 degrees C, nitrogenase activity was evident in the subsurface layers after an extended lag and was shown to be higher under anaerobic than under aerobic conditions, to have an optimum temperature range extending about a mean of 20 degrees C, and to be stimulated by glucose. This potential for subsurface nitrogen fixation proved to be related to the presence of microorganisms existing in anaerobic microsites within the organic layers and no microorganisms capable of fixation could be detected under aerobic incubation.