Hot off the presses! Sep 26 Lancet

The Sep 26 issue of the Lancet is now up on Pubget (About Lancet): if you're at a subscribing institution, just click the link in the latest link at the home page. (Note you'll only be able to get all the PDFs in the issue if your institution subscribes to Pubget.)

Latest Articles Include:

• Surgical research: the reality and the IDEAL
  - Lancet 374(9695):1037 (2009)
  
• A new UN agency for women
  - Lancet 374(9695):1038 (2009)
  
• Tobacco smoking: why start?
  - Lancet 374(9695):1038 (2009)
  
• Surgical research: act 3, answers
  - Lancet 374(9695):1039-1040 (2009)
  
• Chronic subdural haematoma—to drain or not to drain?
  - Lancet 374(9695):1040-1041 (2009)
  
• Non-surgical treatment in carpal tunnel syndrome
  - Lancet 374(9695):1042-1044 (2009)
  
• Leaving invasive ventilation behind
  - Lancet 374(9695):1044-1045 (2009)
  
• Benchmarking in surgical research
  - Lancet 374(9695):1045-1047 (2009)
  
• To cement or not in hip fracture surgery?
  - Lancet 374(9695):1047-1049 (2009)
  
• New surgical thermal management guidelines
  - Lancet 374(9695):1049-1050 (2009)
  
• Fighting and drought worsen Somalia's humanitarian crisis
  - Lancet 374(9695):1051-1052 (2009)
  
• Latin America faces hurdles in health research
  - Lancet 374(9695):1053-1054 (2009)
  
• The making of modern surgery
  - Lancet 374(9695):1055-1056 (2009)
  
• Robots in the OR
  - Lancet 374(9695):1056 (2009)
  
• Ara Darzi: an innovative surgeon who led reforms of UK's NHS
  - Lancet 374(9695):1057 (2009)
  
• Unravelling ethical challenges in surgery
  - Lancet 374(9695):1058-1059 (2009)
  
• Thomas L Dao
  - Lancet 374(9695):1060 (2009)
  
• Probable fluoxetine-induced carotidynia
  - Lancet 374(9695):1061-1062 (2009)
  
• In-flight medical emergencies
  - Lancet 374(9695):1062 (2009)
  
• In-flight medical emergencies – Authors' reply
  - Lancet 374(9695):1062 (2009)
  
• In-flight medical emergencies
  - Lancet 374(9695):1062-1063 (2009)
  
• In-flight medical emergencies
  - Lancet 374(9695):1063 (2009)
  
• Mental illness in China
  - Lancet 374(9695):1063-1064 (2009)
  
• Mental illness in China
  - Lancet 374(9695):1064 (2009)
  
• Mental illness in China
  - Lancet 374(9695):1064-1065 (2009)
  
• Mental illness in China – Authors' reply
  - Lancet 374(9695):1065 (2009)
  
• Translating statistical findings into plain English
  - Lancet 374(9695):1065-1066 (2009)
  
• Translating statistical findings into plain English – Authors' reply
  - Lancet 374(9695):1066 (2009)
  
• AIDS treatment in Brazil: what kind of evidence do we need?
  - Lancet 374(9695):1066 (2009)
  
• Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial
  - Lancet 374(9695):1067-1073 (2009)
  Background Chronic subdural haematoma causes serious morbidity and mortality. It recurs after surgical evacuation in 5–30% of patients. Drains might reduce recurrence but are not used routinely. Our aim was to investigate the effect of drains on recurrence rates and clinical outcomes. Methods We did a randomised controlled trial at one UK centre between November, 2004, and November, 2007. 269 patients aged 18 years and older with a chronic subdural haematoma for burr-hole drainage were assessed for eligibility. 108 were randomly assigned by block randomisation to receive a drain inserted into the subdural space and 107 to no drain after evacuation. The primary endpoint was recurrence needing redrainage. The trial was stopped early because of a significant benefit in reduction of recurrence. Analyses were done on an intention-to-treat basis. This study is registered with the International Standard Randomised Controlled Trial Register (ISRCTN 97314294). Findings Recurrence occurred in ten of 108 (9·3%) people with a drain, and 26 of 107 (24%) without (p=0·003; 95% CI 0·14–0·70). At 6 months mortality was nine of 105 (8·6%) and 19 of 105 (18·1%), respectively (p=0·042; 95% CI 0·1–0·99). Medical and surgical complications were much the same between the study groups. Interpretation Use of a drain after burr-hole drainage of chronic subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months. Funding Academy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (Neurosciences Theme).
• Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial
  - Lancet 374(9695):1074-1081 (2009)
  Background A previous randomised controlled trial reported greater efficacy of surgery than of splinting for patients with carpal tunnel syndrome. Our aim was to compare surgical versus multi-modality, non-surgical treatment for patients with carpal tunnel syndrome without denervation. We hypothesised that surgery would result in improved functional and symptom outcomes. Methods In this parallel-group randomised controlled trial, we randomly assigned 116 patients from eight academic and private practice centres, using computer-generated random allocation stratified by site, to carpal tunnel surgery (n=57) or to a well-defined, non-surgical treatment (including hand therapy and ultrasound; n=59). The primary outcome was hand function measured by the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) at 12 months assessed by research personnel unaware of group assignment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00032227. Findings 44 (77%) patients assigned to surgery underwent surgery. At 12 months, 101 (87%) completed follow-up and were analysed (49 of 57 assigned to surgery and 52 of 59 assigned to non-surgical treatment). Analyses showed a significant 12-month adjusted advantage for surgery in function (CTSAQ function score: Δ −0·40, 95% CI 0·11–0·70, p=0·0081) and symptoms (CTSAQ symptom score: 0·34, 0·02–0·65, p=0·0357). There were no clinically important adverse events and no surgical complications. Interpretation Symptoms in both groups improved, but surgical treatment led to better outcome than did non-surgical treatment. However, the clinical relevance of this difference was modest. Overall, our study confirms that surgery is useful for patients with carpal tunnel syndrome without denervation. Funding NIH/NIAMS 5P60AR048093 and the Intramural Research Program of the NIH Clinical Center.
• Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial
  - Lancet 374(9695):1082-1088 (2009)
  Background Non-invasive ventilation can prevent respiratory failure after extubation in individuals at increased risk of this complication, and enhanced survival in patients with hypercapnia has been recorded. We aimed to assess prospectively the effectiveness of non-invasive ventilation after extubation in patients with hypercapnia and as rescue therapy when respiratory failure develops. Methods We undertook a randomised controlled trial in three intensive-care units in Spain. We enrolled 106 mechanically ventilated patients with chronic respiratory disorders and hypercapnia after a successful spontaneous breathing trial. We randomly allocated participants by computer to receive after extubation either non-invasive ventilation for 24 h (n=54) or conventional oxygen treatment (n=52). The primary endpoint was avoidance of respiratory failure within 72 h after extubation. Analysis was by intention to treat. This trial is registered with clinicaltrials.gov, identifier NCT00539708. Findings Respiratory failure after extubation was less frequent in patients assigned non-invasive ventilation than in those allocated conventional oxygen therapy (8 [15%] vs 25 [48%]; odds ratio 5·32 [95% CI 2·11–13·46]; p<0·0001). In patients with respiratory failure, non-invasive ventilation as rescue therapy avoided reintubation in 17 of 27 patients. Non-invasive ventilation was independently associated with a lower risk of respiratory failure after extubation (adjusted odds ratio 0·17 [95% CI 0·06–0·44]; p<0·0001). 90-day mortality was lower in patients assigned non-invasive ventilation than in those allocated conventional oxygen (p=0·0146). Interpretation Early non-invasive ventilation after extubation diminished risk of respiratory failure and lowered 90-day mortality in patients with hypercapnia during a spontaneous breathing trial. Routine implementation of this strategy for management of mechanically ventilated patients with chronic respiratory disorders is advisable. Funding IDIBAPS, CibeRes, Fondo de Investigaciones Sanitarias, European Respiratory Society.
• Evaluation and stages of surgical innovations
  - Lancet 374(9695):1089-1096 (2009)
  Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.
• Challenges in evaluating surgical innovation
  - Lancet 374(9695):1097-1104 (2009)
  Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures—for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.
• No surgical innovation without evaluation: the IDEAL recommendations
  - Lancet 374(9695):1105-1112 (2009)
  Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial! data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.
• Standardised metrics for global surgical surveillance
  - Lancet 374(9695):1113-1117 (2009)
  Public health surveillance relies on standardised metrics to evaluate disease burden and health system performance. Such metrics have not been developed for surgical services despite increasing volume, substantial cost, and high rates of death and disability associated with surgery. The Safe Surgery Saves Lives initiative of WHO's Patient Safety Programme has developed standardised public health metrics for surgical care that are applicable worldwide. We assembled an international panel of experts to develop and define metrics for measuring the magnitude and effect of surgical care in a population, while taking into account economic feasibility and practicability. This panel recommended six measures for assessing surgical services at a national level: number of operating rooms, number of operations, number of accredited surgeons, number of accredited anaesthesia professionals, day-of-surgery death ratio, and postoperative in-hospital death ratio. We assessed the feasib! ility of gathering such statistics at eight diverse hospitals in eight countries and incorporated them into the WHO Guidelines for Safe Surgery, in which methods for data collection, analysis, and reporting are outlined.
• Serious postoperative syncope
  - Lancet 374(9695):1118 (2009)