Abstract:
OBJECTIVE:To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain. DESIGN:A prospective randomised multicentre study. SETTING:Five university hospitals in Norway. PARTICIPANTS:173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007. INTERVENTIONS:Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days. MAIN OUTCOME MEASURES:The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients' satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up. RESULTS:The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of -8.4 points (95% confidence interval -13.2 to -3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference -12.2, -21.3 to -3.1), patients' satisfaction (63% (n = 46) v 39% (n = 26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5). CONCLUSIONS:Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making. Trial registration NCT 00394732.
journal_name
BMJjournal_title
BMJ (Clinical research ed.)authors
Hellum C,Johnsen LG,Storheim K,Nygaard OP,Brox JI,Rossvoll I,Rø M,Sandvik L,Grundnes O,Norwegian Spine Study Group.doi
10.1136/bmj.d2786subject
Has Abstractpub_date
2011-05-19 00:00:00pages
d2786eissn
0959-8138issn
1756-1833journal_volume
342pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVE:To determine whether elderly people can learn to use the inhaler used to deliver zanamivir (Relenza Diskhaler) as effectively as the Turbohaler and to identify which aspects of inhaler technique are most problematic. DESIGN:Randomised, controlled, intervention study. SETTING:Wards for acute elderly care in ...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.322.7286.577
更新日期:2001-03-10 00:00:00
abstract::The development of a molecular genetics diagnostic service over a three year period was studied in a National Health Service region with a population of three million. Starting from a time when few diagnostic applications were possible, the number of disorders and the overall demand had grown rapidly. Conditions for w...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.297.6652.843
更新日期:1988-10-01 00:00:00
abstract:OBJECTIVE:To determine the association between exposure to radiotherapy for the treatment of prostate cancer and subsequent second malignancies (second primary cancers). DESIGN:Systematic review and meta-analysis of observational studies. DATA SOURCES:Medline and Embase up to 6 April 2015 with no restrictions on year...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,meta分析,评审
doi:10.1136/bmj.i851
更新日期:2016-03-02 00:00:00
abstract:OBJECTIVE:To investigate the intrinsic effects of individually prescribed homoeopathic medicines. DESIGN:Randomised double blind placebo controlled study. SETTING:Paediatric outpatient department of university hospital. PATIENTS:175 children with frequently recurring upper respiratory tract infections. Of the 170 ch...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.309.6965.1329
更新日期:1994-11-19 00:00:00
abstract::Lifetime fertility, abortion rates, and the proportion of pregnancies resulting in induced abortion were investigated in 105 district health authorities in England. In 1995, a total of 147,851 abortions occurred among women living in England, compared with 613,257 live births; a ratio of 1:4. This was equivalent to ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.316.7146.1711
更新日期:1998-06-06 00:00:00
abstract:OBJECTIVE:To identify additional factors, such as maternal age or factors related to previous reproductive outcome or family history, and the corresponding probability of carrying a chromosome abnormality in couples with two or more miscarriages. DESIGN:Nested case-control study. SETTING:Six centres for clinical gene...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.38498.669595.8F
更新日期:2005-07-16 00:00:00
abstract:OBJECTIVE: To measure the association between a surgeon's degree of specialization in a specific procedure and patient mortality. DESIGN: Retrospective analysis of Medicare data. SETTING: US patients aged 66 or older enrolled in traditional fee for service Medicare. PARTICIPANTS: 25 152 US surgeons who performed one...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.i3571
更新日期:2016-07-21 00:00:00
abstract:OBJECTIVES:To investigate the association between four sociodemographic measures (unemployment, overcrowding, low social class, and the proportion of migrants from areas of high prevalence of tuberculosis) and average level and rate of change of notification rates for tuberculosis. DESIGN:Ecological analysis of both t...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.310.6985.963
更新日期:1995-04-15 00:00:00
abstract:OBJECTIVE:To determine how the UK National Health Service (NHS) is performing relative to health systems of other high income countries, given that it is facing sustained financial pressure, increasing levels of demand, and cuts to social care. DESIGN:Observational study using secondary data from key international org...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.l6326
更新日期:2019-11-27 00:00:00
abstract::Objective To estimate the incidence and prevalence of resistant hypertension among a UK population treated for hypertension from 1995 to 2015.Design Cohort study.Setting Electronic health records from the UK Clinical Practice Research Datalink in primary care.Participants 1 317 290 users of antihypertensive drugs with...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.j3984
更新日期:2017-09-22 00:00:00
abstract:OBJECTIVE:To determine the outcome of administration of neuroleptics to patients with senile dementia of Lewy body type confirmed at necropsy. DESIGN:Retrospective analysis of clinical notes blind to neuropathological diagnosis. SETTING:Specialist psychogeriatric assessment units referring cases for necropsy to a tea...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.305.6855.673
更新日期:1992-09-19 00:00:00
abstract:OBJECTIVE:To determine the value of short course, high dose albendazole chemotherapy in the treatment of persistent diarrhoea related to HIV in unselected patients in urban Zambia. DESIGN:A randomised double blind placebo controlled trial of albendazole 800 mg twice daily for two weeks. Patients were monitored intensi...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.312.7040.1187
更新日期:1996-05-11 00:00:00
abstract:AIM:To compare perinatal morbidity and mortality for babies delivered in water with rates for babies delivered conventionally (not in water). DESIGN:Surveillance study (of all consultant paediatricians) and postal survey (of all NHS maternity units). SETTING:British Isles (surveillance study); England and Wales (post...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.319.7208.483
更新日期:1999-08-21 00:00:00
abstract:OBJECTIVE:To assess whether a late evening meal would improve nitrogen balance in patients with cirrhosis of the liver. DESIGN:Randomised crossover study of meal schedules comparing three meals a day with four or six meals a day, the four and six meal schedules both including a late evening meal (2300). SETTING:Metab...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.299.6709.1202
更新日期:1989-11-11 00:00:00
abstract:OBJECTIVE:To examine the extent of uptake of medication for secondary prevention of coronary heart disease in older British men and women before (1998-2001) and after (2003) the implementation of the national service framework. DESIGN:Two population based, longitudinal studies of men and women aged 60-79 in 1998-2001,...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.38704.770127.BE
更新日期:2006-01-21 00:00:00
abstract:OBJECTIVE:To systematically determine the impact of growth hormone therapy on adult height of children with idiopathic short stature. DESIGN:Systematic review. DATA SOURCES:Cochrane Central Register of Controlled Trials, Medline, and the bibliographic references from retrieved articles of randomised and non-randomise...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.c7157
更新日期:2011-03-11 00:00:00
abstract:OBJECTIVE:To characterise the percentage of available outcome data being presented in reports of randomised clinical trials with continuous outcome measures, thereby determining the potential for incomplete reporting bias. DESIGN:Descriptive cross sectional study. DATA SOURCES:A random sample of 200 randomised trials...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.e8486
更新日期:2012-12-18 00:00:00
abstract::A study was performed to assess whether the existing differential capitation fees for general practitioners accurately assess differential workloads. Data from the third morbidity study in general practice were used to compare capitation fees with relative workload in differing age and sex groups. The population mix w...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.297.6654.966
更新日期:1988-10-15 00:00:00
abstract:UNLABELLED:OBJECTIVE-To assess the risk of cardiorespiratory symptoms and mortality in non-smokers who were passively exposed to environmental smoke. DESIGN:Prospective study of cohort from general population first screened between 1972 and 1976 and followed up for an average of 11.5 years, with linkage of data from p...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.299.6696.423
更新日期:1989-08-12 00:00:00
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journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.319.7219.1241
更新日期:1999-11-06 00:00:00
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journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,随机对照试验
doi:10.1136/bmj.c5729
更新日期:2010-11-16 00:00:00
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journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.f4240
更新日期:2013-07-23 00:00:00
abstract::Managed care has entered the lexicon of healthcare reform, but confusion and ignorance surround its meaning and purpose. It seeks to cut the costs of health care while maintaining its quality, but the evidence that it is able to achieve these aims is mixed. As well as raising awareness and understanding of the issues ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,评审
doi:10.1136/bmj.314.7097.1823
更新日期:1997-06-21 00:00:00
abstract:OBJECTIVE:To report the percentage of graduates from British medical schools who eventually practise medicine in the British NHS. DESIGN:Cohort studies using postal questionnaires, employment data, and capture-recapture analysis. SETTING:Great Britain. SUBJECTS:32 430 graduates from all British medical schools in ni...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.b1977
更新日期:2009-06-03 00:00:00
abstract:OBJECTIVE:To determine whether use of tinzaparin, a low molecular weight heparin introduced for prophylactic management of deep vein thrombosis, increases the risk of serious postoperative bleeding leading to a higher than expected 28 day readmission rate after discharge for hysterectomy. DESIGN:Retrospective case-con...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.38783.624444.55
更新日期:2006-04-08 00:00:00
abstract:OBJECTIVE:To determine the global capacity (availability, accessibility, quality, and affordability) to deliver kidney replacement therapy (dialysis and transplantation) and conservative kidney management. DESIGN:International cross sectional survey. SETTING:International Society of Nephrology (ISN) survey of 182 cou...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.l5873
更新日期:2019-10-31 00:00:00
abstract:OBJECTIVES:To assess the compliance of Asian intensive care units and hospitals to the Surviving Sepsis Campaign's resuscitation and management bundles. Secondary objectives were to evaluate the impact of compliance on mortality and the organisational characteristics of hospitals that were associated with higher compli...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.d3245
更新日期:2011-06-13 00:00:00
abstract::Objective To improve the selection of patients with acute ischaemic stroke for intra-arterial treatment using a clinical decision tool to predict individual treatment benefit.Design Multivariable regression modelling with data from two randomised controlled clinical trials.Setting 16 hospitals in the Netherlands (deri...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.j1710
更新日期:2017-05-03 00:00:00
abstract:OBJECTIVE:To determine whether patients with unexpected prehospital cardiac arrest could be identified in whom ambulance resuscitation attempts would be futile. DESIGN:Review of ambulance and hospital records; detailed review of automated external defibrillator rhythm strips of patients in whom no shock was advised. ...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
doi:10.1136/bmj.311.6996.49
更新日期:1995-07-01 00:00:00
abstract:OBJECTIVE:To determine the effects of perineal massage in the second stage of labour on perineal outcomes. DESIGN:Randomised controlled trial. PARTICIPANTS:At 36 weeks' gestation, women expecting normal birth of a singleton were asked to join the study. Women became eligible to be randomised in labour if they progres...
journal_title:BMJ (Clinical research ed.)
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/bmj.322.7297.1277
更新日期:2001-05-26 00:00:00