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G B Smedshaug,
E Kvaavik,
J A Falch,
A Tverdal,
J I Pedersen,
H Raphael,
P Maslin,
S Crozier,
E R Larsen,
A Foldspang, [......],
L. Saxon,
E. Steele,
T. Aspray,
M. Baverstock,
Y. Birks,
J. Dumville,
C Iglesias,
S. Puffer,
A. Sutcliffe,
I Watt
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ABSTRACT: OBJECTIVES: To identify participants' characteristics that influence the anti-fracture efficacy of vitamin D or vitamin D plus calcium with respect to any fracture, hip fracture, and clinical vertebral fracture and to assess the influence of dosing regimens and co-administration of calcium. DESIGN: Individual patient data analysis using pooled data from randomised trials. DATA SOURCES: Seven major randomised trials of vitamin D with calcium or vitamin D alone, yielding a total of 68 517 participants (mean age 69.9 years, range 47-107 years, 14.7% men). STUDY SELECTION: Studies included were randomised studies with at least one intervention arm in which vitamin D was given, fracture as an outcome, and at least 1000 participants. DATA SYNTHESIS: Logistic regression analysis was used to identify significant interaction terms, followed by Cox's proportional hazards models incorporating age, sex, fracture history, and hormone therapy and bisphosphonate use. RESULTS: Trials using vitamin D with calcium showed a reduced overall risk of fracture (hazard ratio 0.92, 95% confidence interval 0.86 to 0.99, P=0.025) and hip fracture (all studies: 0.84, 0.70 to 1.01, P=0.07; studies using 10 microg of vitamin D given with calcium: 0.74, 0.60 to 0.91, P=0.005). For vitamin D alone in daily doses of 10 microg or 20 microg, no significant effects were found. No interaction was found between fracture history and treatment response, nor any interaction with age, sex, or hormone replacement therapy. CONCLUSION: This individual patient data analysis indicates that vitamin D given alone in doses of 10-20 microg is not effective in preventing fractures. By contrast, calcium and vitamin D given together reduce hip fractures and total fractures, and probably vertebral fractures, irrespective of age, sex, or previous fractures.
BMJ British medical journal 01/2010; 340:b5463. · 13.66 Impact Factor
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ABSTRACT: To identify obstetric and other risk factors for urinary incontinence that occurs during pregnancy or after childbirth.
Questionnaire survey of women.
Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand).
A total of 3405 primiparous women with singleton births delivered during 1 year.
Questionnaire responses and obstetric case note data were analysed using multivariate analysis to identify associations with urinary incontinence.
Urinary incontinence at 3 months after delivery first starting in pregnancy or after birth.
The prevalence of urinary incontinence was 29%. New incontinence first beginning after delivery was associated with older maternal age (oldest versus youngest group, OR 2.02, 95% CI 1.35-3.02) and method of delivery (caesarean section versus spontaneous vaginal delivery, OR 0.28, 95% CI 0.19-0.41). There were no significant associations with forceps delivery (OR 1.18, 95% CI 0.92-1.51) or vacuum delivery (OR 1.16, 95% CI 0.83-1.63). Incontinence first occurring during pregnancy and still present at 3 months was associated with higher maternal body mass index (BMI>25, OR 1.68, 95% CI 1.16-2.43) and heavier babies (birthweight in top quartile, OR 1.56, 95% CI 1.12-2.19). In these women, caesarean section was associated with less incontinence (OR 0.39, 95% CI 0.27-0.58) but incontinence was not associated with age.
Women have less urinary incontinence after a first delivery by caesarean section whether or not that first starts during pregnancy. Older maternal age was associated with new postnatal incontinence, and higher BMI and heavier babies with incontinence first starting during pregnancy. The effect of further deliveries may modify these findings.
BJOG An International Journal of Obstetrics & Gynaecology 03/2006; 113(2):208-17. · 3.41 Impact Factor
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A M Grant,
D G Altman,
A B Babiker,
M K Campbell,
F J Clemens,
J H Darbyshire,
D R Elbourne,
S K McLeer,
M K B Parmar,
S J Pocock,
D J Spiegelhalter,
M R Sydes,
A E Walker,
S A Wallace
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ABSTRACT: To address issues about data monitoring committees (DMCs) for randomised controlled trials (RCTs).
Electronic databases. Handsearching of selected books. Personal contacts with experts in the field.
Systematic literature reviews of DMCs and small group processes in decision-making; sample surveys of: reports of RCTs, recently completed and ongoing RCTs and policies of major organisations involved in RCTs; case studies of four DMCs; and interviews with experienced DMC members. All focused on 23 prestated questions.
Although still a minority, RCTs increasingly have DMCs. There is wide agreement that nearly all trials need some form of data monitoring. Central to the role of the DMC is monitoring accumulating evidence related to benefit and toxicity; variation in emphasis has been reflected in the plethora of names. DMCs for trials performed for regulatory purposes should be aware of any special requirements and regulatory consequences. Advantages were identified for both larger and smaller DMCs. There is general agreement that a DMC should be independent and multidisciplinary. Consumer and ethicist membership is controversial. The chair is recognised as being particularly influential, and likely to be most effective if he or she is experienced, understands both statistical and clinical issues, and is facilitating in style and impartial. There is no evidence available to judge suggested approaches to training. The review suggested that costs should be covered, but other rewards must be so minimal as to not affect decision-making. It is usual to have a minimum frequency of DMC meetings, with evidence that face-to-face meetings are preferable. It is common to have open sessions and a closed session. A report to a DMC should cover benefits and risks in a balanced way, summarised in an accessible style, avoiding excessive detail, and be as current as possible. Disadvantages of blinded analyses seem to outweigh advantages. Information about comparable studies should be included, although interaction with the DMCs of similar ongoing trials is controversial. A range of formal statistical approaches can be used, although this is only one of a number of considerations. DMCs usually reach decisions by consensus, but other approaches are sometimes used. The general, but not unanimous, view is that DMCs should be advisory rather than executive on the basis that it is the trial organisers who are ultimately responsible for the conduct of the trial.
Some form of data monitoring should be considered for all RCTs, with reasons given where there is no DMC or when any member is not independent. An early DMC meeting is helpful, determining roles and responsibilities; planned operations can be agreed with investigators and sponsors/funders. A template for a DMC charter is suggested. Competing interests should be declared. DMC size (commonly three to eight people) is chosen to optimise performance. Members are usually independent and drawn from appropriate backgrounds, and some, particularly the chair, are experienced. A minimum frequency of meetings is usually agreed, with flexibility for more if needed. The DMC should understand and agree the statistical approach (and guidelines) chosen, with both the DMC statistician and analysis statistician competent to apply the method. A DMC's primary purpose is to ensure that continuing a trial according to its protocol is ethical, taking account of both individual and collective ethics. A broader remit in respect of wider ethical issues is controversial; arguably, these are primarily the responsibility of research ethics committees, trial steering committees and investigators. The DMC should know the range of recommendations or decisions open to it, in advance. A record should be kept describing the key issues discussed and the rationale for decisions taken. Errors are likely to be reduced if a DMC makes a thorough review of the evidence and has a clear understanding of how it should function, there is active participation by all members, differences are resolved through discussion and there is systematic consideration of the various decision options. DMCs should be encouraged to comment on draft final trial reports. These should include information about the data monitoring process and detail the DMC membership. It is recommended that groups responsible for data monitoring be given the standard name 'Data Monitoring Committee' (DMC). Areas for further research include: widening DMC membership beyond clinicians, trialists and statisticians; initiatives to train DMC members; methods of DMC decision-making; 'open' data monitoring; DMCs covering a portfolio of trials rather than single trials; DMC size and membership, incorporating issues of group dynamics; empirical study of the workings of DMCs and their decision-making, and which trials should or should not have a DMC.
Health technology assessment (Winchester, England) 04/2005; 9(7):1-238, iii-iv. · 4.26 Impact Factor
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ABSTRACT: The choice of approach to the laparoscopic repair of inguinal hernia is controversial. There is a scarcity of data comparing the laparoscopic transabdominal preperitoneal (TAPP) approach with the laparoscopic totally extraperitoneal (TEP) approach and questions remain about their relative merits and risks.
To compare the clinical effectiveness and relative efficiency of laparoscopic TAPP and laparoscopic TEP for inguinal hernia repair.
We searched Medline Extra, Embase, Biosis, Science Citation Index, Cochrane Central Register of Controlled Trials (CENTRAL), Journals@ Ovid Full Text and the electronic version of the journal, Surgical Endoscopy. Recent conference proceedings by the following organisations were hand searched: Association of Endoscopic Surgeons of Great Britain & Ireland; International Congress of the European Association for Endoscopic Surgery; Scientific Session of the Society of American Gastrointestinal & Endoscopic Surgeons (SAGES); and the Italian Society of Endoscopic Surgery. In addition, specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials, relevant websites were searched and reference lists of the all included studies were checked for additional reports.
All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic TAPP with laparoscopic TEP for inguinal hernia repair were eligible for inclusion. Non-randomised prospective studies were also eligible for inclusion to provide further comparative evidence of complications and adverse events.
Statistical analyses were performed using the fixed effects model and the results expressed as relative risk (RR) for dichotomous outcomes and weighted mean difference (WMD) for continuous outcomes with 95% confidence intervals (CI).
The search identified one RCT which reported no statistical difference between TAPP and TEP when considering duration of operation, haematoma, length of stay, time to return to usual activity and recurrence. The eight non-randomised studies suggest that TAPP is associated with higher rates of port-site hernias and visceral injuries whilst there appear to be more conversions with TEP. Vascular injuries and deep/mesh infections were rare and there was no obvious difference between the groups. No studies reporting economic evidence were identified. Very limited data were available on learning effects but these data suggest that operators become experienced at between 30 and 100 procedures.
There is insufficient data to allow conclusions to be drawn about the relative effectiveness of TEP compared with TAPP. Efforts should be made to start and complete adequately powered RCTs, which compare the different methods of laparoscopic repair.
Cochrane database of systematic reviews (Online) 02/2005; · 5.72 Impact Factor
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ABSTRACT: This systematic review assesses the efficacy and safety of sacral nerve stimulation (SNS) for faecal incontinence and constipation. Electronic databases and selected websites were searched for studies evaluating SNS in the treatment of faecal incontinence or constipation. Primary outcome measures included episodes of faecal incontinence per week (faecal incontinence studies) and number of evacuations per week (constipation studies).
From 106 potentially relevant reports, six patient series and one crossover study of SNS for faecal incontinence, and four patient series and one crossover study of SNS for constipation, were included. After implantation, 41-75 per cent of patients achieved complete faecal continence and 75-100 per cent experienced improvement in episodes of incontinence. There were 19 adverse events among 149 patients. The small crossover study reported increased episodes of faecal incontinence when the implanted pulse generator was switched off. Case series of SNS for constipation reported an increased frequency of evacuation. There were four adverse events among the 20 patients with a permanent implant. The small crossover study reported a reduced number of evacuations when the pulse generator was switched off.
SNS results in significant improvement in faecal incontinence in patients resistant to conservative treatment. Early data also suggest benefit in the treatment of constipation.
British Journal of Surgery 01/2005; 91(12):1559-69. · 4.61 Impact Factor
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ABSTRACT: Claims that laparoscopic groin hernia repair is followed by less persisting pain and numbness than open mesh repair were tested by follow-up within a multicentre randomized clinical trial.
Participants in the UK Medical Research Council Laparoscopic Groin Hernia Trial were followed up by means of self-completed postal questionnaires from 2 to 5 years after trial entry. The principal measures were pain (groin and testicular) and numbness (groin and thigh).
Seven hundred and fifty (80.8 per cent) of the original 928 participants returned at least one questionnaire between 2 and 5 years; respondents were similar to the baseline randomized groups. Fewer respondents in the laparoscopic group had groin pain (absolute differences varied between 7.9 and 2.0 per cent, but were of marginal statistical significance); rates of testicular pain were similar in the two groups. Groin numbness was reported about half as commonly at all time points in the laparoscopic group (P < 0.001); there were no significant differences in thigh numbness.
Laparoscopic surgery was associated with less long-term numbness and probably less pain in the groin.
British Journal of Surgery 01/2005; 91(12):1570-4. · 4.61 Impact Factor
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ABSTRACT: Evidence is needed for the effectiveness of interventions given with reducing diets for obese adults: drug therapy, exercise, or behaviour therapy.
We systematically reviewed randomized controlled trials in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted data and a second checked data extraction. Trial quality was assessed.
Adding orlistat to diet was associated with weight change for up to 24 months (-3.26 kg, 95% CI, -4.15 to -2.37 kg), and statistically significant beneficial changes were found for total and LDL cholesterol, blood pressure and glycaemic control. Adding sibutramine to diet was associated with a 12 month weight change of -4.18 kg (95% CI, -5.14 to -3.21 kg), and statistically significant beneficial effects on high density lipoprotein cholesterol (HDL) and triglycerides (TGs), but an increase in diastolic blood pressure. Adding exercise to diet, or to diet and behaviour therapy, was associated with improved weight loss for up to 36 months and improvements in HDL, TGs and blood pressure. Adding behaviour therapy to diet, or to diet and sibutramine together, was associated with improved weight loss for up to 18 months. Adding drugs, exercise or behaviour therapy to dietary advice was each associated with similar weight change.
Adding orlistat, sibutramine, exercise, or behaviour modification to dietary advice can improve long-term weight loss.
Journal of Human Nutrition and Dietetics 09/2004; 17(4):293-316. · 1.74 Impact Factor
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ABSTRACT: Evidence is needed for the best long-term diet for weight loss, and improvement in cardiac risk and disease in obese adults.
We systematically reviewed randomized controlled trials (RCTs) in any language. We searched 13 databases and handsearched journals. Trials lasted 1 year or more. One investigator extracted the data and a second checked data extraction. Trial quality was assessed.
Low fat diets (LFDs) produced significant weight losses up to 36 months (-3.55 kg; 95% CI, -4.54 to -2.55 kg). Blood pressure, lipids and fasting plasma glucose improved with these diets after 12 months. Four studies found that LFDs may prevent type 2 diabetes and reduce antihypertensive medication for up to 3 years. A very low calorie diet (VLCD, < 4.2 MJ day(-1)) was associated with the most weight loss after 12 months (-13.40 kg; 95% CI, -18.43 to -8.37 kg) in one small study with beneficial effects on asthma. There was no evidence that low carbohydrate protein sparing modified fasts (PSMFs) were associated with greater long-term weight loss than low calorie diets (LCDs, 4.2-6.7 MJ day(-1)) or VLCDs. PSMFs were, however, associated with greater lowering of fasting plasma glucose and HbA1c than LCDs.
Little evidence supports the use of diets other than LFDs for weight reduction. With the increasing prevalence of morbid obesity, long-term follow-up in RCTs is needed to evaluate the effect of LCDs, VLCDs and PSMFs more fully.
Journal of Human Nutrition and Dietetics 08/2004; 17(4):317-35. · 1.74 Impact Factor
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ABSTRACT: To undertake a systematic review of the long-term effects of obesity treatments on body weight, risk factors for disease, and disease.
The study encompassed three systematic reviews that examined different aspects of obesity treatments. (1) A systematic review of obesity treatments in adults where the methods of the Cochrane Collaboration were applied and randomised controlled trials (RCTs) with a follow-up of at least 1 year were evaluated. (2) A systematic epidemiological review, where studies were sought on long-term effects of weight loss on morbidity and/or mortality, and examined through epidemiological modelling. (3) A systematic economic review that sought reports with both costs and outcomes of treatment, including recent reports that assessed the cost-effectiveness of pharmaceutical and surgical interventions. A Markov model was also adopted to examine the cost-effectiveness of a low-fat diet and exercise intervention in adults with obesity and impaired glucose tolerance.
The addition of the drugs orlistat or sibutramine was associated with weight loss and generally improved risk factors, apart from diastolic blood pressure for sibutramine. Metformin was associated with decreased mortality after 10 years in obese people with type 2 diabetes. Low-fat diets were associated with continuing weight loss for 3 years and improvements in risk factors, as well as prevention of type 2 diabetes and improved control of hypertension. Insufficient evidence was available to demonstrate the benefits of low calorie or very low calorie diets. The addition of an exercise or behaviour programme to diet was associated with improved weight loss and risk factors for at least 1 year. Studies combining low-fat diets, exercise and behaviour therapy suggested improved hypertension and cardiovascular disease. Family therapy was associated with improved weight loss for 2 years compared to individual therapy. There was insufficient evidence to conclude that individual therapy was more beneficial than group therapy. Weight lost more quickly (within 1 year), from the epidemiology review, may be more beneficial with respect to the risk of mortality. The effects of intentional weight loss need further investigation. Weight loss from surgical and non-surgical interventions for people suffering from obesity was associated with decreased risk of development of diabetes, and a reduction in low-density lipoprotein cholesterol, total cholesterol and blood pressure, in the long term. Targeting high-risk individuals with drugs or surgery was likely to result in a cost per additional life-year or quality-adjusted life-year (QALY) of no more than 13,000 British pounds. There was also suggestive evidence of cost saving from treatment of people with type 2 diabetes with metformin. Targeting surgery on people with severe obesity and impaired glucose tolerance was likely to be more cost-effective at 2329 British pounds per additional life-year. Economic modelling over 6 years for diet and exercise for people with impaired glucose tolerance was associated with a high initial cost per additional QALY, but by the sixth year the cost per QALY was 13,389 British pounds. Results did not include cost savings from diseases other than diabetes, and therefore may be conservative.
The drugs orlistat and sibutramine appear beneficial for the treatment of adults with obesity, and metformin for obese patients with type 2 diabetes. Exercise and/or behaviour therapy appear to improve weight loss when added to diet. Low-fat diets with exercise, or with exercise and behaviour therapy are associated with the prevention of type 2 diabetes and hypertension. Long-term weight loss in epidemiological studies was associated with reduced risk of type 2 diabetes, and may be beneficial for cardiovascular disease. Low-fat diets and exercise interventions in individuals at risk of obesity-related illness are of comparable cost to drug treatments. Long-term pragmatic RCTs of obesity treatments in populations with obesity-related illness or at high risk of developing such illness are needed (to include an evaluation of risk factors, morbidity, quality of life and economic evaluations). Drug trials that include dietary advice, plus exercise and/or behaviour therapy are also needed. Research exploring effective types of exercise, diet or behaviour and also interventions to prevent obesity in adults is required.
Health technology assessment (Winchester, England) 06/2004; 8(21):iii-iv, 1-182. · 4.26 Impact Factor
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ABSTRACT: To establish whether the early use of sophisticated imaging techniques influences the clinical management and outcome of patients with low back pain (LBP) and whether it is cost-effective.
A pragmatic multicentre randomised controlled trial using a standard two parallel group approach incorporating an economic evaluation. For a subgroup of trial participants, a controlled 'before and after' approach was used to assess the impact of 'early imaging' on clinicians' diagnostic and therapeutic confidence.
A total of 782 participants who had been referred by their general practitioner to a consultant orthopaedic specialist or neurosurgeon because of symptomatic lumbar spine disorders. The study included 14 hospitals in Scotland and one in England over a 24-month period.
Participants in both groups reported an improvement in health status at 8 and 24 months with the 'early imaging' group having statistically significantly better outcome. Other than the proportion of participants receiving imaging (90% versus 30%), there were few differences between the groups in the management received throughout the 24-month follow-up. The total number of outpatient consultations in the two groups was similar although more people in the 'early imaging' group had return outpatient appointments during the 8-month follow-up. Clinicians' diagnostic confidence, between trial entry and follow-up, increased significantly for both groups with a greater increase in the 'early imaging' group. The cost of imaging was the main determinant of the difference in total costs between the groups and it was estimated that 'early imaging' could provide an additional 0.07 quality-adjusted life-years (QALYs), at an additional average cost of 61 British pounds over the 24-month follow-up. Using non-imputed costs and QALYs but adjusted for baseline differences in EQ-5D score, the mean incremental cost per QALY of 'early imaging' was 870 British pounds. The results were sensitive to the costs of imaging and the confidence intervals surrounding estimates of average costs and QALYs.
The early use of sophisticated imaging does not appear to affect management overall but does result in a slight improvement in clinical outcome at an estimated cost of 870 British pounds per QALY. Imaging was associated with an increase in clinicians' diagnostic confidence, particularly for non-specialists. Further research is required to determine if more rapid referral to sophisticated imaging and secondary care is important in the acute episode and whether the use of imaging would be more beneficial for particular categories of LBP.
Health technology assessment (Winchester, England) 06/2004; 8(17):iii, 1-131. · 4.26 Impact Factor
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ABSTRACT: The aim was to review the evidence for the long-term effects of weight loss on diabetes outcomes in obese people or for those at risk of developing type 2 diabetes. Current evidence is mostly based on short-term studies. This is a systematic review of long-term outcomes of weight loss in studies published between 1966 and 2001. Eleven long-term studies with a follow up of more than 2 years were included. Results show that those with diabetes who lost weight intentionally significantly reduced their mortality risks by 25%. Additionally, weight loss of 9-13 kg was most protective. Patients with the risk of developing diabetes due to either family history of diabetes or impaired glucose tolerance, saw a reduction in this risk. Those with large weight losses achievable with surgical interventions reduced their risk by at least 63%. Metabolic handling of glucose improved in 80% of those already with type 2 diabetes who lost weight. Based on one large study, intentional weight loss in obese patients appears to have a beneficial effect on mortality risk for those with type 2 diabetes. Clearly, further studies are needed to endorse this. The risk of developing diabetes being reduced by weight loss was shown in seven studies. However, the results were from studies with different analytical adjustments and outcome indices, making it difficult to make direct comparisons and should be viewed with caution. More long-term prospective studies need to be conducted with commitment to improving the methodological quality and standardization, in order to accurately assess the long-term effects of weight loss for obese diabetic and non-diabetic individuals.
Diabetes Obesity and Metabolism 04/2004; 6(2):85-94. · 3.38 Impact Factor
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ABSTRACT: This paper aims to review the evidence for long-term effectiveness of weight loss on cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides in overweight/obese people. Current evidence is mostly based on short-term studies. A systematic review of long-term lipid outcomes of weight loss in studies published between 1966 and 2001, was conducted. Inclusion criteria included all cohort studies and trials carried out on participants with body mass index of greater than or equal to 28 kg m(-2). Studies had at least two weight change measurements and follow-up of more than 2 years. Thirteen long-term studies with a follow-up of more than 2 years were included. Cholesterol has a significant positive linear relationship with weight change (r = 0.89) where change in weight explains about 80% of the cholesterol difference variation (Adj R2 = 0.80). For every 10 kg weight loss a drop of 0.23 mmol L(-1) in cholesterol may be expected for a person suffering from obesity or are grossly overweight. Weight loss has long-term beneficial effects especially on LDL and cholesterol. Weight loss in obese patients should be encouraged and sustained.
Obesity Reviews 03/2004; 5(1):43-50. · 7.04 Impact Factor
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ABSTRACT: Inguinal hernia repair is the most frequently performed operation in general surgery. The standard method for inguinal hernia repair had changed little over a hundred years until the introduction of synthetic mesh. This mesh can be placed by either using an open approach or by using a minimal access laparoscopic technique. Although many studies have explored the relative merits and potential risks of laparoscopic surgery for the repair of inguinal hernia, most individual trials have been too small to show clear benefits of one type of surgical repair over another.
The objective of this review was to compare minimal access laparoscopic mesh techniques with open techniques. Comparisons of open mesh techniques versus open non-mesh techniques have been considered in a separate Cochrane review.
We searched MEDLINE, EMBASE, and The Cochrane Central Controlled Trials Registry for relevant randomised controlled trials. The reference list of identified trials, journal supplements, relevant book chapters and conference proceedings were searched for further relevant trials. Through the EU Hernia Trialists Collaboration (EUHTC) communication took place with authors of identified randomised controlled trials to ask for information on any other recent and ongoing trials known to them. Specialists involved in research on the repair of inguinal hernia were contacted to ask for information about any further completed and ongoing trials. The world wide web was also searched.
All published and unpublished randomised controlled trials and quasi-randomised controlled trials comparing laparoscopic groin hernia repair with open groin hernia repair were eligible for inclusion. Trials were included irrespective of the language in which they were reported.
Individual patient data were obtained, where possible, from the responsible trialist for all eligible studies. All reanalyses were cross-checked by the reviewers and verified by the trialists before inclusion. Where IPD were unavailable additional aggregate data were sought from trialists and published aggregate data checked and verified by the trialists. IPD were available for 25 trials, additional aggregated data for seven and published data only for nine. Where possible, time to event analysis for hernia recurrence and return to usual activities were performed on an intention to treat principle. The main analyses were based on all trials. Sensitivity analyses based on the data source and trial quality were also performed. Pre-defined subgroup analyses based on recurrent hernias, bilateral hernias and femoral hernias were also carried out.
41 published reports of eligible trials were included involving 7161 participants. Sample sizes ranged from 38 to 994, with follow-up from 6 weeks to 36 months. Duration of operation was longer in the laparoscopic groups (WMD 14.81 minutes, 95% CI 13.98 to 15.64; p<0001). Operative complications were uncommon for both methods but more frequent in the laparoscopic group for visceral (Overall 8/2315 versus 1/2599) and vascular (Overall 7/2498 versus 5/2758) injuries. Length of hospital stay did not differ between groups (WMD -0.04 days, 95% CI -0.08 to 0.00; p=0.05, but return to usual activity was earlier for laparoscopic groups (HR 0.56, 95%CI 0.51 to 0.61; p<0.0001 - equivalent to 7 days). The data available showed less persisting pain (Overall 290/2101 versus 459/2399; Peto OR 0.54, 95% CI 0.46 to 0.64; p<0.0001), and less persisting numbness (Overall 102/1419 versus 217/1624; Peto OR 0.38, 95% CI 0.4286 to 0.49; p<0.0001) in the laparoscopic groups. In total, 86 recurrences were reported amongst 3138 allocated laparoscopic repair and 109 amongst 3504 allocated to open repair (Peto OR 0.81, 95% CI 0.61 to 1.08; p = 0.16). The use of mesh during laparoscopic hernia repair is associated with a reduction in the risk of hernia recurrence, significantly so for the transabdominal preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus preperitoneal repair (TAPP) versus open non-mesh repair (overall 26/1440 versus 47/1119; Peto OR 0.45, 95% CI 0.28 to 0.72; p=0.0009). However, no difference was detected when comparing laparoscopic methods with open mesh methods of hernia repair.
The use of mesh during laparoscopic hernia repair is associated with a relative reduction in the risk of hernia recurrence of around 30-50%. However, there is no apparent difference in recurrence between laparoscopic and open mesh methods of hernia repair. The data suggests less persisting pain and numbness following laparoscopic repair. Return to usual activities is faster. However, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries.
Cochrane database of systematic reviews (Online) 01/2003; · 5.72 Impact Factor
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ABSTRACT: Inguinal hernia repair is the most frequent operation in general surgery. Until recently the standard procedure has been open musculo-aponeurotic repair using sutures under tension to close the defect but 'tension-free' repair using prosthetic mesh is becoming increasingly common in many countries.
The purpose of this review is to evaluate open mesh techniques in comparison with open non-mesh techniques for the surgical repair of groin hernia.
Electronic databases were searched and further trials were sought from the reference lists of reports of known trials. Through the EU Hernia Trialists Collaboration authors of identified randomised controlled trials were asked for information on any other trials known to them. There was no language restriction.
Studies were eligible for inclusion if they were randomised or quasi-randomised trials comparing either a) open mesh with open non-mesh repair of groin hernia or b) open flat mesh repair with plug and mesh repair of groin hernia.
For each outcome the results were derived using data from the best available source. The majority of data for this review came from individual patient data (IPD) supplied by the trialists. When these were unavailable data came from additional aggregated information or from published trial reports. All trials were analysed using the 'intention to treat' principle.
Twenty trials comparing open mesh with open non-mesh repair were identified. Open mesh methods, on average, took 7-10 minutes less to perform than Shouldice procedures, but took 1-4 minutes longer than other non-mesh methods. There were no clear differences between mesh and non-mesh groups for haematomas, seromas or wound/superficial infections. Three serious operative complications were reported after open mesh repair and three following non-mesh repair. Overall, those in the mesh groups had a shorter length of hospital stay and quicker return to usual activities, but this pattern was not observed for all trials. There was a suggestion that persisting pain was less frequent after mesh repair than after non-mesh repair but this result was dependent on one trial and data were not available for 11 trials. There was no evidence of a difference between the groups with respect to persisting numbness. Fewer hernia recurrences were reported after mesh repair (Peto OR: 0.37, 95% CI: 0.26 to 0.51). There were too few data to reliably address differential effects for patients with recurrent, bilateral or femoral hernias. Two trials comparing flat mesh with plug and mesh were identified. There was no clear evidence of differences between the groups.
There is evidence that the use of open mesh repair is associated with a reduction in the risk of recurrence of between 50% and 75%. Although the trials were heterogeneous there is also some evidence of quicker return to work and of lower rates of persisting pain following mesh repair.
Cochrane database of systematic reviews (Online) 02/2002; · 5.72 Impact Factor
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ABSTRACT: To assess clinical status, changes in health related quality of life, and subsequent management five years after medical management or transcervical resection of the endometrium for treatment of heavy menstrual loss.
Five year follow up using postal questionnaires and operative databank review.
Gynaecology department of a large UK teaching hospital.
Women referred to the gynaecologist for treatment of heavy menstrual loss.
Eligible women, without a treatment preference, were randomised equally to either medical treatment or transcervical resection of the endometrium.
Women's satisfaction with treatment, menstrual status, changes in health related quality of life, and additional treatments received at five years.
One hundred and forty-four patients completed questionnaires, achieving 77% follow up (medical n = 71/94; transcervical resection of the endometrium n = 73/93). At five-year follow up, 7/71 (10%) of those randomised to the medical arm still used medical treatment, while 72/94 (77%) had undergone surgical treatment and 17/94 (18%) a hysterectomy. Twenty-five (27%) women allocated to transcervical resection of the endometrium had undergone further surgery, 18/93 (19%) a hysterectomy. At five years women initially randomised to medical treatment were significantly less likely to be totally satisfied (P < 0.01, difference 21%, 95% CI -37% to -4%), or to recommend their allocated treatment to a friend (P < 0.001, difference 59%, 95% CI -73% to -45%). Bleeding and pain scores were similar in both groups and highly significantly reduced. Significantly more women in the transcervical resection of the endometrium arm had no bleeding or very light bleeding (P < 0.02, difference -22%, CI -31% to -4%), and they had significantly less days heavy bleeding (P < 0.02). Short Form 36 health survey scores were significantly improved from baseline for all eight health scales in the transcervical resection of the endometrium arm, and four in the medical arm.
A policy of immediate transcervical resection of the endometrium for women referred to a gynaecologist for treatment of heavy menstrual loss achieves higher levels of satisfaction, better menstrual status, and greater improvements in health related quality of life than medical treatment. In addition, transcervical resection of the endometrium is safe and does not lead to an increase in the number of hysterectomies. An effective endometrial ablative technique should be offered to all eligible women seeking treatment of their heavy menses from a gynaecologist.
BJOG An International Journal of Obstetrics & Gynaecology 01/2002; 108(12):1222-8. · 3.41 Impact Factor
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ABSTRACT: To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with standard management among women with persistent incontinence three months postnatally.
Randomised controlled trial with nine months' follow up.
Community intervention in three centres (Dunedin, New Zealand; Birmingham; Aberdeen).
747 women with urinary incontinence three months postnatally, allocated at random to intervention (371) or control (376) groups.
Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five, seven, and nine months after delivery supplemented with bladder training if appropriate at seven and nine months.
Primary: persistence and severity of urinary incontinence 12 months after delivery. Secondary: performance of pelvic floor exercises, change in coexisting faecal incontinence, wellbeing, anxiety, and depression.
Women in the intervention group had significantly less urinary incontinence: 167/279 (59.9%) v 169/245 (69.0%), difference 9.1% (95% confidence interval 1.0% to 17.3%, P=0.037) for any incontinence and 55/279 (19.7%) v 78/245 (31.8%), difference 12.1% (4.7% to 19.6%, P=0.002) for severe incontinence. Faecal incontinence was also less common: 12/273 (4.4%) v 25/237 (10.5%), difference 6.1% (1.6% to 10.8%, P=0.012). At 12 months women in the intervention group were more likely to be performing pelvic floor exercises (218/278 (79%) v 118/244 (48%), P<0.001).
A third of women may have some urinary incontinence three months after childbirth. Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum. Further trials for faecal incontinence are needed.
BMJ 09/2001; 323(7313):593-6. · 14.09 Impact Factor
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ABSTRACT: To assess the impact of cross-sectional imaging with magnetic resonance (MR) imaging or computed tomography (CT) on clinical decision making for patients with lower back pain (LBP).
A randomized controlled before-and-after study was performed in 145 patients who had symptomatic lumbar spinal disorders and had been referred to orthopedists or neurosurgeons. Participants were a subgroup within a multicenter pragmatic randomized comparison of two imaging policies on LBP treatment: "imaging" versus "no imaging," unless a clear indication developed. Paired assessments were made of diagnosis, diagnostic confidence, proposed treatment, treatment confidence at trial entry and follow-up, and expectations of imaging. Data were analyzed according to the groups as randomized.
At follow-up, there were no statistically significant differences between the groups with respect to diagnosis or treatment plans. Significant increases in diagnostic and therapeutic confidence between trial entry and follow-up were observed for both groups, with a significantly greater increase in diagnostic confidence (P =.01) in the imaging group.
Imaging may increase diagnostic confidence but has minimal influence on diagnostic or therapeutic decisions for patients with LBP. The results highlight the need for evidence-based guidelines for imaging in LBP treatment.
Radiology 09/2001; 220(2):393-9. · 5.73 Impact Factor
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ABSTRACT: For orthopaedic outpatients judged as unlikely to require surgery, how does the cost-effectiveness of treatment from a musculo-skeletal medicine physician compare with that of a conventional orthopaedic surgeon-led service?
Partially randomised, pragmatic trial comparing management from a single musculo-skeletal medicine physician with orthopaedic surgeon-led management, with the timing and nature of treatments at the discretion of individual clinicians. Main outcomes were: change in patient reported health (SF-36 and EuroQol), and marginal health service costs.
Outpatient department of an Edinburgh orthopaedic hospital.
One thousand three hundred and twenty six people; aged over 18, referred to and later attending the outpatient department with a 'non-surgical' musculo-skeletal condition, who provided baseline information. Eight hundred and twenty nine were randomly allocated to management by either the musculo-skeletal medicine physician (medical group) or a conventional orthopaedic surgeon-led service (surgical group); 497 were assigned to the treatment groups according to their general practitioner's preference.
There are aspects of the study design concerning statistical power, potential selection bias and generalisability, which mean that any results must be treated with caution. Although there was no statistically significant difference in health gain between the randomly allocated groups (with similar findings in the non-randomised medical and surgical groups), the patient groups were heterogeneous and the confidence intervals did not rule out clinically important differences. The medical group received more outpatient treatment, 20% vs. 10% (difference 95% CI 5% to 15%) with a higher rate of physiotherapy referral, 45% vs. 30% (15%, 9% to 22%). The surgical group received more inpatient surgical care 6% vs. 17% (-11%, -15% to -7%). Mean healthcare costs in the medical group were 179 Pounds per patient compared with 287 Pounds in the surgical group (-108 Pounds, -25 Pounds to -191 Pounds).
Interpretation should take into account the practical difficulties and circumstances of the study. Although no differences in health gain were found between these two management policies for 'non-surgical' orthopaedic outpatients, the trial was less statistically powerful than planned and the confidence intervals included clinically important differences. Differences in treatment emphasis gave estimated costs savings to the Health Service of 108 Pounds per patient treated by the musculo-skeletal medicine service.
Health bulletin 06/2001; 59(3):198-210.
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ABSTRACT: A key aim when conducting systematic reviews of randomized controlled trials (RCTs) is to include all of the evidence, if possible. Serious bias may result if trials are missed through inadequate search strategies.
The objective was to evaluate the search plan for identifying RCTs in nutrition as part of a systematic review, in The Cochrane Library, of nutritional supplementation trials in patients after hip fracture.
We identified potential studies by searching the electronic databases BIOSIS, CABNAR, CINAHL, EMBASE, HEALTHSTAR, and MEDLINE; reference lists in trial reports; and other relevant articles. We also contacted investigators and other experts for information and searched 4 nutrition journals by hand.
We identified 15 RCTs that met the predefined inclusion criteria. The search plan identified 8 trials each in EMBASE, HEALTHSTAR, and MEDLINE and 7 in BIOSIS and CABNAR. BIOSIS was the only electronic database source of 2 trials. Eleven trials were identified by searching electronic databases and 2 unpublished trials were identified via experts in the field. We found one trial, published only as a conference abstract, by searching nutrition journals by hand. After publication of the protocol for the review in The Cochrane Library, we were informed of another unpublished trial.
We found that a limited search plan based on only MEDLINE or one of the other commonly available databases would have failed to locate nearly one-half of the studies. To protect against bias, the search plan for a systematic review of nutritional interventions should be comprehensive.
American Journal of Clinical Nutrition 04/2001; 73(3):505-10. · 6.67 Impact Factor
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ABSTRACT: Peritonitis is the most frequent serious complication of continuous ambulatory peritoneal dialysis (CAPD). It has a major influence on the number of patients switching from CAPD to haemodialysis and has probably restricted the wider acceptance and uptake of CAPD as an alternative mode of dialysis. This systematic review sought to determine if modifications of the transfer set (Y-set or double-bag systems) used in CAPD exchanges are associated with a reduction in peritonitis and an improvement in other relevant outcomes.
Based on a comprehensive search strategy, we undertook a systematic review of randomized or quasi-randomized controlled trials comparing double-bag and/or Y-set CAPD exchange systems with standard systems, or comparing double-bag with Y-set systems, in patients with end-stage renal disease (ESRD) treated with CAPD. Only published data were used. Data were abstracted by a single investigator onto a standard form and subsequently entered into Review Manager 4.0.4. Its statistical package, Metaview 3.1, calculated an odds ratio (OR) for dichotomous data and a (weighted) mean difference for continuous data with 95% confidence intervals.
Twelve eligible trials with a total of 991 randomized patients were identified. In trials comparing either the Y-set or double-bag systems with the standard systems, significantly fewer patients (133/363 vs 158/263; OR 0.33, 95% CI 0.24-0.46) experienced peritonitis and the number of patient-months on CAPD per episode of peritonitis was consistently greater. When the double-bag systems were compared with the Y-set systems significantly fewer patients experienced peritonitis (44/154 vs 66/138; OR 0.44, 95% CI 0.27-0.71) and the number of patient-months on CAPD per episode of peritonitis was also greater.
Double-bag systems should be the preferred exchange systems in CAPD.
Nephrology Dialysis Transplantation 03/2001; 16(2):341-7. · 3.40 Impact Factor
