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PubMed2006

Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults.

BACKGROUND: Displaced intracapsular fractures may be treated by either reduction and internal fixation, which preserves the femoral head, or by replacement of the femoral head with an arthroplasty. OBJECTIVES: To review all randomised controlled trials that have compared internal fixation with arthroplasty for intracapsular femoral fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 4), MEDLINE, EMBASE, the UK National Research Register, several orthopaedic journals, conference proceedings and reference lists of articles. We contacted trialists where possible. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing internal fixation with arthroplasty for intracapsular hip fractures in adults. DATA COLLECTION AND ANALYSIS: Trial quality was assessed by use of a 10 item scale. At least two review authors independently assessed trial quality and extracted data. Additional information was sought from trialists. After grouping into three broad categories, comparable groups of trials were subgrouped and where appropriate, data were pooled using the fixed-effect model. MAIN RESULTS: Seventeen trials involving 2694 participants were included. Length of surgery, operative blood loss, need for blood transfusion and risk of deep wound infection were significantly less for internal fixation compared with arthroplasty. Arthroplasty had a significantly lower re-operation rate in comparison with fixation. No definite differences for hospital stay, mortality, or regain of same residential state were found. Limited information from some studies suggested pain was less and function was better for a cemented arthroplasty in comparison to fixation. AUTHORS' CONCLUSIONS: Internal fixation is associated with less initial operative trauma but has an increased risk of re-operation on the hip. Definite conclusions cannot be made for differences in pain and residual disability between the two groups. Future studies should concentrate on better reporting of final outcome measures and there is still a need for studies to define which patient groups are better served by the different treatment methods.

Adult↗
PubMed2004

Depot bromperidol decanoate for schizophrenia.

BACKGROUND: Antipsychotic drugs are the mainstay treatment for schizophrenia. Long-acting depot injections of drugs such as bromperidol decanoate are extensively used as a means of long-term maintenance treatment. OBJECTIVES: To assess the effects of depot bromperidol versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes. SEARCH STRATEGY: Relevant trials were identified by searching Biological Abstracts (1982-1999), Cochrane Library (Issue 2, 1999), Cochrane Schizophrenia Group's Register (May 1999), EMBASE (1980-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). References of all identified trials were inspected and Janssen-Cilag was contacted in order to identify more trials. An update search was undertaken in October 2003. The Schizophrenia Groups trials register is based on regular searches of BIOSIS Inside; CENTRAL; CINAHL; EMBASE; MEDLINE and PsycINFO; the hand searching of relevant journals and conference proceedings, and searches of several key grey literature sources. A full description is given in the Group's module. SELECTION CRITERIA: All randomised trials focusing on people with schizophrenia where depot bromperidol, oral antipsychotics or other depot preparations were sought. Primary outcomes were death, clinically significant change in global function, mental state, relapse, hospital admission, adverse effects and acceptability of treatment. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers and cross-checked. Fixed effects relative risks (RR) and 95% confidence intervals (CI) were calculated for dichotomous data. Weighted or standardised means were calculated for continuous data. Where possible, the number needed to treat statistic (NNT) was calculated. Analysis was by intention-to-treat. MAIN RESULTS: Four controlled clinical trials were included (total n=117). We identified a single small study of six months duration comparing bromperidol decanoate with placebo injection. Similar numbers left the study before completion (n=20, 1 RCT, RR 0.4 CI 0.1 to 1.6) and there was no clear differences between bromperidol decanoate and placebo for a list of adverse effects (n=20, 1 RCT, RR akathisia 2.0 CI 0.21 to 18.69, RR increased weight 3.0 CI 0.14 to 65.9, RR tremor 0.33 CI 0.04 to 2.69). When bromperidol decanoate was compared with fluphenazine depot we found no important change on global outcome (n=30, RR no clinical important improvement 1.50 CI 0.29 to 7.73). People allocated to fluphenazine decanoate and haloperidol decanoate had less relapses than those given bromperidol decanoate (n=77, RR 3.92 Cl 1.05 to 14.60, NNH 6 CI 2 to 341). People allocated bromperidol decanoate required additional antipsychotic medication somewhat more frequently than those taking fluphenazine decanoate and haloperidol decanoate but the results did not reach conventional levels of statistical significance (n=77, 2 RCTs, RR 1.72 CI 0.7 to 4.2). The use of benzodiazepine drugs was very similar in both groups (n=77, 2 RCTs, RR 1.08 CI 0.68 to 1.70). People left the bromperidol decanoate group with the same frequency as those allocated other depots (n=97, 3 RCTs, RR 1.92 CI 0.8 to 4.6). Anticholinergic adverse effects were equally common between bromperidol and other depots (n=47, RR 3.13 CI 0.7 to 14.0) and additional anticholinergic medication was needed with equal frequency in both depot groups, although results did tend to favour the bromperidol decanoate group (n=97, 3 RCTs, RR 0.80 CI 0.64 to 1.01). The incidence of movement disorders was similar in both depot groups (n=77, 2 RCTs, RR 0.74 CI 0.47 to 1.17). REVIEWERS' CONCLUSIONS: Currently, minimal poorly reported trial data suggests that bromperidol decanoate may be better than placebo injection but less valuable than fluphenazine or haloperidol decanoate. If bromperidol decanoate is available it may be a viable choice, especially when there are reasons not to use fluphenazine or haloperidol decanoate. Well-conducted and reported randomised trials are needed to inform practice in Belgium, Germany, Italy and the Netherlands.

Antipsychotic Agents↗
PubMed2001

Beta2-agonists for acute bronchitis.

BACKGROUND: The optimal treatment for acute bronchitis is not clear. Because many patients with acute bronchitis have airflow limitation as well as cough, beta2-agonists may be useful. OBJECTIVES: To determine whether beta2-agonists improve the symptoms of acute bronchitis in patients who do not have underlying pulmonary disease. SEARCH STRATEGY: Cochrane Library, MEDLINE, EMBASE, and Conference Proceedings using "bronchodilator (exp)", "adrenergic beta-agonist (exp)", or "sympathomimetics (exp)" and "bronchitis" or "cough"; Science Citation Index for referenced publications; and letters to manufacturers of beta2-agonists. SELECTION CRITERIA: Trials in which patients (adults or children age > 2 years) without known pulmonary disease who were diagnosed with acute bronchitis or acute cough without other cause were randomized to beta2-agonist vs. placebo, no treatment, or alternative treatment. DATA COLLECTION AND ANALYSIS: Three reviewers independently first selected outcomes and evaluated trial quality while blinded to study results, and then extracted data. Trials in children and in adults were analyzed separately. MAIN RESULTS: Two trials in children with acute cough and no evidence of airway obstruction did not find any benefits from beta2-agonists. Five trials in adults with acute cough or acute bronchitis had mixed results, but overall summary statistics did not reveal any significant benefits from beta2-agonists. Subgroups of patients with evidence of airflow limitation had lower symptom scores if given beta2-agonists in one trial; and the trials that did note quicker resolution of cough in patients given beta2-agonists were those that had a higher proportion of patients with wheezing at baseline. Patients given beta2-agonists (whether oral or inhaled) were more likely to report tremor, shakiness, or nervousness than patients in the control groups (NNH for children 9, 95% CI 5 to 100; NNH for adults 2.3, 95% CI 2 to 3). REVIEWER'S CONCLUSIONS: There is no evidence to support using beta2-agonists in children with acute cough who do not have evidence of airflow obstruction. There is also little evidence that the routine use of beta2-agonists for adults with acute cough is helpful. These agents may reduce symptoms, including cough, in patients with evidence of airflow obstruction; but this potential benefit is not well-supported by the available data and must be weighed against the adverse effects associated with beta2-agonists.

Acute Disease↗
PubMed2004

Beta2-agonists for acute bronchitis.

BACKGROUND: The optimal treatment for acute bronchitis is not clear. Because many patients with acute bronchitis have airflow limitation as well as cough, beta2-agonists may be useful. OBJECTIVES: To determine whether beta2-agonists improve the symptoms of acute bronchitis in patients who do not have underlying pulmonary disease. SEARCH STRATEGY: The Cochrane Library (through August 2000), MEDLINE (1966 to 2000), EMBASE (1974 to 2000), and Conference Proceedings using "bronchodilator (exp)", "adrenergic beta-agonist (exp)", or "sympathomimetics (exp)" and "bronchitis" or "cough"; Science Citation Index for referenced publications; and letters to manufacturers of beta2-agonists. An updated search of the Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2003); MEDLINE (January 2000 to July 2003); EMBASE (January 2000 to July 2003) was run in July 2003. SELECTION CRITERIA: Trials in which patients (adults or children over two years of age) without known pulmonary disease who were diagnosed with acute bronchitis or acute cough without other cause were randomized to beta2-agonist versus placebo, no treatment, or alternative treatment. DATA COLLECTION AND ANALYSIS: Three reviewers independently first selected outcomes and evaluated trial quality while blinded to study results, and then extracted data. Trials in children and in adults were analyzed separately. MAIN RESULTS: Two trials in children (n = 109) with acute cough and no evidence of airway obstruction did not find any benefits from beta2-agonists. Combined data did not show a significant difference in daily cough scores between patients given oral beta2-agonists and those in the control groups. Five trials in adults (n = 418) with acute cough or acute bronchitis had mixed results, but overall summary statistics did not reveal any significant benefits from oral (three trials) nor inhaled (two trials) beta2-agonists. There were no significant differences in daily cough scores nor in the number of patients still coughing after seven days (control rate 73%; RR = 0.77, 95% CI 0.54-1.09). Subgroups of patients with evidence of airflow limitation had lower symptom scores if given beta2-agonists in one trial; and the trials that did note quicker resolution of cough in patients given beta2-agonists were those that had a higher proportion of patients with wheezing at baseline. Patients given beta2-agonists were more likely to report tremor, shakiness, or nervousness than patients in the control groups (for trials in children control rate 0%; RR 6.76, 95% CI 0.86 to 53.12, NNH 9, 95% CI 5 to 100; for trials in adults, control rate 11%; RR 7.94, 95% CI 1.17 to 53.94, NNH 2.3, 95% CI 2 to 3). REVIEWER'S CONCLUSIONS: There is no evidence to support using beta2-agonists in children with acute cough who do not have evidence of airflow obstruction. There is also little evidence that the routine use of beta2-agonists for adults with acute cough is helpful. These agents may reduce symptoms, including cough, in patients with evidence of airflow obstruction; but this potential benefit is not well-supported by the available data and must be weighed against the adverse effects associated with beta2-agonists.

Acute Disease↗
PubMed2000

Beds, mattresses and cushions for pressure sore prevention and treatment.

OBJECTIVES: To assess the effectiveness of pressure relieving beds, mattresses and cushions (support surfaces) in the prevention and treatment of pressure sores. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals, conference proceedings, and bibliographies. SELECTION CRITERIA: Randomised controlled trials evaluating support surfaces for the prevention or treatment of pressure sores. There was no restriction on articles based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality was undertaken by two reviewers independently. Trials with similar patients, comparisons, and outcomes were pooled. Where pooling was inappropriate, trials are discussed in a narrative review. MAIN RESULTS PREVENTION: 29 RCTs of support surfaces for pressure sore prevention were identified. Some high specification foam mattresses were more effective than 'standard' hospital foam mattresses in moderate-high risk patients. Pressure relieving mattresses in the operating theatre reduced the incidence of pressure sores post-operatively. The relative merits of alternating and constant low pressure, and of the different alternating pressure devices are unclear. Seat cushions and simple, constant low-pressure devices have not been adequately evaluated. Limited evidence suggests that low air loss beds reduce the incidence of pressure sores in intensive care. TREATMENT: 6 RCTs of support surfaces for pressure sore treatment were identified. There is good evidence that air-fluidised and low air loss beds improve healing rates. Seat cushions have not been adequately evaluated. 2 RCTs evaluated surfaces for both prevention and treatment in the same trial. REVIEWER'S CONCLUSIONS: PREVENTION - There is good evidence of the effectiveness of high specification foam over standard hospital foam, and pressure relief in the operating theatre. Treatment - There is good evidence of the effectiveness of air-fluidised and low air loss devices as treatments. Overall, however, it is impossible to determine the most effective surface for either prevention or treatment.

Beds↗
PubMed2004

Support surfaces for pressure ulcer prevention.

BACKGROUND: Pressure ulcers (also known as bedsores, pressure sores, decubitus ulcers) are areas of localised damage to the skin and underlying tissue due to pressure, shear or friction. They are common in the elderly and immobile and costly in financial and human terms. Pressure-relieving beds, mattresses and seat cushions are widely used as aids to prevention in both institutional and non-institutional settings. OBJECTIVES: This systematic review seeks to answer the following questions: to what extent do pressure-relieving cushions, beds, mattress overlays and mattress replacements reduce the incidence of pressure ulcers compared with standard support surfaces? how effective are different pressure-relieving surfaces in preventing pressure ulcers, compared to one another? SEARCH STRATEGY: The Specialised Trials Register of the Cochrane Wounds Group (compiled from regular searches of many electronic databases including MEDLINE, CINAHL and EMBASE plus handsearching of specialist journals and conference proceedings) was searched up to January 2004, Issue 3, 2004 of the Cochrane Central Register of Controlled Trials was also searched. The reference sections of included studies were searched for further trials. SELECTION CRITERIA: Randomised controlled trials (RCTs), published or unpublished, which assessed the effectiveness of beds, mattresses, mattress overlays, and seating cushions for the prevention of pressure ulcers, in any patient group, in any setting. RCTs were eligible for inclusion if they reported an objective, clinical outcome measure such as incidence and severity of new of pressure ulcers developed. Studies which only reported proxy outcome measures such as interface pressure were excluded. DATA COLLECTION AND ANALYSIS: Trial data were extracted by one researcher and checked by a second. The results from each study are presented as relative risk for dichotomous variables. Where deemed appropriate, similar studies were pooled in a meta analysis. MAIN RESULTS: 41 RCTs were included in the review. Foam alternatives to the standard hospital foam mattress can reduce the incidence of pressure ulcers in people at risk. The relative merits of alternating and constant low pressure devices, and of the different alternating pressure devices for pressure ulcer prevention are unclear.Pressure-relieving overlays on the operating table have been shown to reduce postoperative pressure ulcer incidence, although one study indicated that an overlay resulted in adverse skin changes. One trial indicated that Australian standard medical sheepskins prevented pressure ulcers. There is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices as pressure ulcer prevention strategies.A study of Accident & Emergency trolley overlays did not identify a reduction in pressure ulcer incidence. There are tentative indications that foot waffle heel elevators, a particular low air loss hydrotherapy mattress and an operating theatre overlay are harmful. REVIEWERS' CONCLUSIONS: In people at high risk of pressure ulcer development, consideration should be given to the use of higher specification foam mattresses rather than standard hospital foam mattresses. The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear. Organisations might consider the use of pressure relief for high risk patients in the operating theatre, as this is associated with a reduction in post-operative incidence of pressure ulcers. Seat cushions and overlays designed for use in Accident & Emergency settings have not been adequately evaluated.

Beds↗
PubMed2000

Skin grafting for venous leg ulcers.

BACKGROUND: Venous leg ulceration is a common, recurring, disabling condition affecting up to 1% of adults. Treatment is aimed at healing with simple dressings and compression bandages / stockings. Unfortunately in some cases this treatment is unsuccessful with ulcers remaining open for months or years. In order to stimulate healing, some clinicians use skin grafts. These skin grafts may be taken from the patients own uninjured skin (e.g. thigh), may be grown from the patient's skin cells into a dressing, (both known as autografts) or applied as a sheet of bioengineered skin grown from a donor cells (known as an allograft). Preserved skin from other animals, e.g. pigs, have also been used and these are known as xerografts. OBJECTIVES: To assess the effectiveness of skin grafts in the treatment of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Groups specialised register (date of search October 1999), and reference lists of relevant articles. We hand searched relevant journals and conference proceedings, and contacted experts in the field. SELECTION CRITERIA: Randomised controlled trials evaluating skin grafts in the treatment of venous leg ulcers. There was no restriction on articles based on language or publication status. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality was undertaken by two reviewers independently. Trials with similar patients, comparisons, and outcomes were pooled. MAIN RESULTS: Seven RCTs of skin grafts for venous leg ulcers were identified. In 6 trials patients also received compression bandaging. Two trials (98 patients) evaluated split thickness autografts, three trials (92 patients) evaluated cultured keratinocyte allografts, one compared tissue engineered skin (artificial skin) with a dressing (309 patients) and one compared it with a split thickness skin graft (7 patients, 13 ulcers). The trials comparing artificial skin with a dressing reported a significantly higher proportion of ulcers healing with artificial skin. There was insufficient evidence from the remaining trials to determine whether other types of skin grafting increased the healing of venous ulcers. REVIEWER'S CONCLUSIONS: There is limited evidence that artificial skin used in conjunction with compression bandaging, increases the chance of healing a venous ulcer compared to compression alone. Further research is needed to assess whether other forms of skin grafts increase ulcer healing.

Adult↗
PubMed2000

Vaccines for preventing influenza in people with cystic fibrosis.

BACKGROUND: Viral respiratory tract infections in patients with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for patients with cystic fibrosis. OBJECTIVES: To assess the effectiveness of influenza vaccination for patients with cystic fibrosis. SEARCH STRATEGY: We have used the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and abstract books of conference proceedings and communication to the drug companies marketing influenza vaccines. SELECTION CRITERIA: All randomised and pseudorandomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted data. Additional information were obtained by contacting the investigators when it was indicated. MAIN RESULTS: Three trials enrolling a total of 115 patients with cystic fibrosis (76 (66%) were children aged one to 13 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a sub unit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and one study compared a split virus to a sub unit vaccine (both intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48/201 (24%) for the intranasal live vaccine to 13/30 (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No trial reported other clinically important benefits. REVIEWER'S CONCLUSIONS: There is currently no evidence from randomised studies that influenza vaccine given to patients with cystic fibrosis is of benefit to them. There is a need for a well constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

Cystic Fibrosis↗
PubMed2006

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Female↗
PubMed2006

Mechanical devices for urinary incontinence in women.

BACKGROUND: Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management. The latter more so when a person did not want surgery or when considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment. OBJECTIVES: To determine the effects of mechanical devices in the management of adult female urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (7 December 2005). The register contains trials identified from MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL and handsearching of journals and conference proceedings. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined either by symptom classification or by urodynamic diagnosis. DATA COLLECTION AND ANALYSIS: Three reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2). MAIN RESULTS: There were six trials involving a total of 286 women. Two small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Five trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. There were no trials comparing a mechanical device with another type of treatment. AUTHORS' CONCLUSIONS: The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and a large well-conducted trial is required for clarification. There was also insufficient evidence in favour of one device over another and no evidence to compare mechanical devices with other forms of treatment.

Female↗
PubMed2003

Laparoscopic techniques versus open techniques for inguinal hernia repair.

BACKGROUND: 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. OBJECTIVES: 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. SEARCH STRATEGY: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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. REVIEWER'S CONCLUSIONS: 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.

Hernia, Inguinal↗
PubMed2001

Antenatal day care units versus hospital admission for women with complicated pregnancy.

BACKGROUND: The use of antenatal day care units is widely recognized as an alternative for inpatient care for women with complicated pregnancy. OBJECTIVES: The objective of this review was to assess the clinical safety, plus maternal, perinatal and psychosocial consequences for the women and cost effectiveness of this type of care. SEARCH STRATEGY: The Group's Specialised Register of Controlled Trials was searched in May 2001 as well as the Cochrane Controlled Trials Register (CENTRAL/CCTR), CINAHL (1982-04 to 1998-10) and Current Contents (Life Sciences/Clinical Medicine 1995-05 to 1999). Conference proceedings of PSANZ (Perinatal Society of Australia and New Zealand) and FIGO (Fédération Internationale de Gynécologie et d'Obstétrie) (1997) were searched. SELECTION CRITERIA: Randomized trial comparing day care with inpatient care for women with complicated pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed by two reviewers independently. The author of the study was contacted for additional information. Data were extracted by the same two reviewers independently. MAIN RESULTS: One trial involving 54 women was included. This trial was of average quality. It was found that day care assessment for non-proteinuric hypertension can reduce inpatient stay (difference in mean stay: 4.0 days; 95% confidence interval (CI): 2.1 to 5.9 days). Also a significant increase in the rate of induction of labour in the control group was found (4.9 times more likely: 95% CI: 1.6 to 13.8). The other clinical outcomes did not show a statistically significant difference between the control and intervention group. No other significant differences were observed. REVIEWER'S CONCLUSIONS: Admission to day care for non-proteinuric hypertension reduces the amount of time spent in the hospital and proportion of women induced for labour. However, one trial of 54 women is not sufficient to draw sound conclusions. Additional studies are needed to give more solid evidence to confirm the advantages of antenatal day care units.

Cost-Benefit Analysis↗
PubMed2000

Surgery for small asymptomatic abdominal aortic aneurysms.

BACKGROUND: An aneurysm is an abnormal ballooning of an artery. One site in which this occurs is in the abdominal aorta, which is the major artery running through the abdomen. Some abdominal aortic aneurysms (AAA) present as an emergency and require surgery; others remain asymptomatic. Treatment of asymptomatic aneurysms depends on a number of factors, one of which is size. The risk of rupture increases with aneurysm size. Large asymptomatic aneurysms (>6 cm diameter) are operated on; small aneurysms (<4 cm diameter) have regular ultrasound to monitor growth. OBJECTIVES: The objective of this review was to compare the mortality, quality of life and cost effectiveness of early surgical repair with routine ultrasound surveillance in patients with an AAA of between 4-6 cm diameter. SEARCH STRATEGY: Trials were identified through searching the Cochrane Peripheral Vascular Diseases Group trials register and the reference lists of relevant articles. The reviewers also contacted investigators in the field and hand searched recent conference proceedings. SELECTION CRITERIA: Randomised controlled trials in which men and women with asymptomatic AAA of diameter 4-6 cm were randomly allocated to early surgery, or ultrasound surveillance at least once every 12 months. Outcome measures had to include mortality, quality of life or financial costs. DATA COLLECTION AND ANALYSIS: Data were abstracted by one reviewer and checked by others. Due to the small number of trials at present no tests of heterogeneity or sensitivity analyses were performed. MAIN RESULTS: Only one trial, the UK Small Aneurysm Trial, fulfilled the criteria for inclusion. This trial found no differences in mortality between the early surgery and surveillance groups at two, four and six years following randomisation (six years Peto OR 1.01 [95% CI 0.77-1.31]). Mean health service costs were higher in the surgery than the surveillance group, difference 1,064 pounds per patient [95% CI 796-1332]. Quality of life remained similar in the two groups but early surgery patients thought they were healthier and had less pain one year after randomisation. There were not enough patients in the trial to allow analysis of subgroups by, for example, age or aneurysm size. REVIEWER'S CONCLUSIONS: The results from the one trial to date indicate that patients with asymptomatic AAA of 4-5.5 cm should normally have regular ultrasound surveillance accompanied by surgical intervention for aneurysms which grow rapidly (>1 cm per year) or reach 5.5 cm. The results are awaited of a major trial in progress in the USA.

Aortic Aneurysm, Abdominal↗
PubMed2004

Conservative management for postprostatectomy urinary incontinence.

BACKGROUND: Urinary incontinence is common after both radical prostatectomy and transurethral resection. Conservative management includes pelvic floor muscle training, biofeedback, electrical stimulation, compression devices (penile clamps), lifestyle changes, extra-corporeal magnetic innervation or a combination of methods. OBJECTIVES: To assess the effects of conservative managements for urinary incontinence prostatectomy. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (searched 2 July 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1988 to January 2004), CINAHL (January 1982 to January 2004), PsycLIT (January 1984 to January 2004), ERIC (January 1984 to January 2004), the reference lists of relevant articles, handsearched conference proceedings and contacted investigators to locate studies. SELECTION CRITERIA: Randomised controlled trials evaluating conservative interventions for urinary continence after prostatectomy. DATA COLLECTION AND ANALYSIS: At least two reviewers assessed the methodological quality of trials and abstracted data. MAIN RESULTS: Ten trials met the inclusion criteria, eight trials amongst men after radical prostatectomy, one trial after transurethral resection of prostate and one after either operation. There was considerable variation in the interventions, populations and outcome measures. The trials were of moderate quality and data were not available for many of the pre-stated outcomes. Confidence intervals were wide: it was not possible to reliably identify or rule out a useful effect. There was some support from five trials for pelvic floor muscle training with biofeedback being better than no treatment or sham treatment in the short term for men after radical prostatectomy: relative risk for incontinence with pelvic floor muscle training and biofeedback versus no treatment: 0.74 (95% confidence interval 0.60 to 0.93). Analysis of other conservative interventions such as pelvic floor muscle training alone, transcutaneous electrical nerve stimulation and rectal electrical stimulation, or combinations of these interventions were inconclusive. There were too few data to determine effects on incontinence after transurethral resection of the prostate. The findings should be treated with caution as there were few studies, all of moderate quality. Men in one trial reported a preference for one type of external compression device compared to two others or no treatment. The effect of other conservative interventions such as lifestyle changes remains undetermined as no trials involving these interventions were identified. Men's symptoms tended to improve over time, irrespective of management. REVIEWERS' CONCLUSIONS: The value of the various approaches to conservative management of postprostatectomy incontinence remains uncertain. There may be some benefit of offering pelvic floor muscle training with biofeedback early in the postoperative period immediately following removal of the catheter as it may promote an earlier return to continence. Long-term incontinence may be managed by external penile clamp, but there are safety problems.

Biofeedback, Psychology↗
PubMed2001

Intermittent pneumatic compression for treating venous leg ulcers.

BACKGROUND: Intermittent pneumatic compression (IPC) is a mechanical method of delivering compression to swollen limbs. This technique has been used to treat venous leg ulcers and limb swelling due to lymphoedema. The effectiveness of IPC, and the appropriate duration and frequency of IPC therapy are unknown as are the differences between various types of IPC. This review analyses the evidence for the effectiveness of IPC as a treatment for venous leg ulcers. OBJECTIVES: To determine whether IPC increases the healing of venous leg ulcers. To determine the effects of IPC on health related quality of life of venous leg ulcer patients. SEARCH STRATEGY: The Cochrane Wound Group Trials Register was searched for RCTs of intermittent pneumatic compression in February 2001. Journals and relevant conference proceedings were searched by hand. Companies were also contacted for relevant unpublished data or ongoing studies. SELECTION CRITERIA: Randomised controlled studies either comparing IPC with control (sham IPC or no IPC) or comparisons between IPC treatment regimens, in venous ulcer management were included. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of study quality were undertaken by two reviewers independently. MAIN RESULTS: Four randomised controlled trials were identified. One small trial (45 people) found increased ulcer healing with IPC plus compression than with compression alone (relative risk for healing 11.4, 95% Confidence Interval 1.6 to 82). Two small trials with a total of 75 people found no evidence of a benefit for IPC plus compression compared with compression alone. One small trial (16 people) found no difference between IPC (without additional compression) and compression bandages alone. REVIEWER'S CONCLUSIONS: Further trials are required to determine whether IPC increases the healing of venous leg ulcers.

Air↗
PubMed2000

Prophylactic antibiotics for cystic fibrosis.

BACKGROUND: Patients with cystic fibrosis are sometimes prescribed antibiotics to take continuously on a prophylactic (preventative) basis. This approach is most commonly used in infants where the objective is to reduce pulmonary infection with Staphylococcus aureus and prevent lung damage. This approach may also be used in older patients. This review evaluates the evidence for the effectiveness of this approach and considers potential adverse effects. OBJECTIVES: To compare continuous oral antibiotic prophylaxis with no prophylaxis (short courses of oral antibiotics given as clinically indicated) in patients with cystic fibrosis. This review considers both the effectiveness of prophylaxis (bacteria isolated from the respiratory tract, requirement for additional antibiotic treatment, lung function, survival) and the adverse effects. SEARCH STRATEGY: The Cochrane Cystic Fibrosis and Genetic Disorders Group clinical trials register was used. This comprises references identified from a comprehensive search of electronic databases, as well as hand searching relevant journals and conference abstracts. Companies manufacturing anti-staphylococcal antibiotics were also approached for unpublished data. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All randomised or pseudo-randomised trials where continuous oral prophylactic antibiotics, given for a period of at least one year, were compared to intermittent antibiotic therapy given "as required." Cystic fibrosis patients of any disease severity were considered. DATA COLLECTION AND ANALYSIS: Trials were assessed for eligibility, methodological quality and data extraction by two reviewers (AS & SW). The following outcomes were assessed: lung function; nutrition (weight standard deviation score); survival; requirement for additional antibiotic treatment; isolates of pathogens from the respiratory tract; occurrence of adverse reactions to prophylactic antibiotics. MAIN RESULTS: Only two studies, totalling 66 patients (over half of whom were infants), were suitable for inclusion in the review. A reduced prevalence of Staphylococcus aureus in the respiratory secretions was seen in children receiving anti-staphylococcal antibiotic prophylaxis, although no effect was seen on other common pathogens. This is associated with a reduced requirement for additional courses of oral antibiotics and fewer hospital admissions in the first two years of life in patients receiving prophylaxis. No effect on infant lung function has been shown after one year of prophylactic treatment. Data are not available on adverse effects of the interventions. As the duration of the studies reviewed has been of two years or less, conclusions cannot be drawn about the long term effects of prophylaxis on acquisition of Pseudomonas aeruginosa and survival. REVIEWER'S CONCLUSIONS: Anti-staphylococcal antibiotic prophylaxis may be of benefit when commenced early in infancy and continued up to two years of age. There is insufficient evidence from this review to say whether use in older children, or adults, or for periods of over two year is beneficial.

Adult↗
PubMed2000

Oral protein calorie supplementation for children with chronic disease.

BACKGROUND: Growth failure and poor nutritional status are common features in children with chronic diseases due to reduced appetite, malabsorption and increased nutritional requirements associated with some diseases. The provision of oral protein calorie supplements is one of a number of interventions used to improve nutritional status in these children. The use of these products, which are expensive, may be associated with a number of adverse effects, for example, they may effect development of normal eating behaviour patterns or lead to unpleasant symptoms such as vomiting and diarrhoea. OBJECTIVES: To examine the evidence that in children with chronic disease, oral protein calorie supplements alter daily nutrient intake, nutritional indices, survival and quality of life and are associated with adverse effects, for example diarrhoea, vomiting, reduced appetite, glucose intolerance, bloating and eating behaviour problems. SEARCH STRATEGY: All publications describing RCTs of the use of oral protein calorie supplements in children with chronic diseases were identified through comprehensive electronic database searches, handsearching relevant journals and handsearching abstract books of conference proceedings. The companies which market oral protein calorie supplements were also contacted. SELECTION CRITERIA: All randomised or quasi-randomised controlled trials comparing use of oral protein calorie supplements for at least one month to increase calorie intake with existing conventional therapy, which may include nutritional advice on how to improve nutritional intake from food or no specific intervention, in children with chronic disease. DATA COLLECTION AND ANALYSIS: The following outcomes were assessed: indices of nutrition and growth, anthropometric measures of body composition, calorie and nutrient intake (total, from oral protein calorie supplements and from food), eating behaviour, compliance, quality of life, specific adverse effects and disease severity scores, and mortality. MAIN RESULTS: Three trials have been identified as being suitable for inclusion in the review and we are awaiting further data from one of these trials. All of these trials were carried out in children with cystic fibrosis. Few statistical differences could be found between the treatment and control groups apart from change in total fat intake at three months (weighted mean difference 69.20 [95% CI 11.05, 127.35]). However, this was based on the results of only one, small study. No trials have been identified which assess the effectiveness of oral protein calorie supplements in children with other chronic diseases. REVIEWER'S CONCLUSIONS: Oral protein calorie supplements are widely used to improve the nutritional status of children with a number of chronic diseases. We have only been able to identify a small number of trials assessing these products in children with cystic fibrosis and have been unable to draw any conclusions based on the limited data extracted from these. We therefore recommend that a series of large, randomised controlled trials are undertaken investigating the use of these products in children with different chronic diseases. Until further data are available, we would suggest that these products are only used with caution.

Adolescent↗
PubMed2000

Inhaled corticosteroids for cystic fibrosis.

BACKGROUND: Maintenance of optimal lung function is an important therapeutic goal in cystic fibrosis as it is lung damage that, in the long term, is responsible for most premature death among affected people. Inhaled corticosteroids are being increasingly used to treat children and adults with cystic fibrosis. The rationale for their use is that they have the potential to reduce lung damage arising from inflammation. However chronic use of inhaled steroids may also have adverse effects. It is thus important to establish the current level of evidence about the potential benefits and harms of this practice. OBJECTIVES: The objective of this review is to assess the effectiveness of regular use of inhaled corticosteroids when compared to no inhaled corticosteroids, in the management of patients with cystic fibrosis. SEARCH STRATEGY: Trials were ascertained from the Cochrane Cystic Fibrosis and Genetic Disorders Specialised Register of Controlled Trials which includes published and unpublished trials identified through electronic databases such as Medline and Embase as well as those identified from handsearching of journals and conference proceedings. Pharmaceutical companies manufacturing inhaled corticosteroids were also contacted to identify any trials of inhaled corticosteroids in cystic fibrosis. Date of the most recent search of the Group's specialised register: November 1999. SELECTION CRITERIA: All trials, both published and unpublished, in which inhaled corticosteroids were compared to either placebo or standard treatment in patients with cystic fibrosis. Trials employing random treatment allocation and those using quasi-random allocation methods such as alternate allocation to treatment and control group were included. DATA COLLECTION AND ANALYSIS: The following outcomes were assessed: objective measures of lung function, respiratory exacerbations, use of intravenous antibiotics, hospital admissions, nutritional status, symptoms, quality of life, survival and frequency of adverse effects. Methodological quality of trials was assessed independently using established criteria by two reviewers, who also extracted relevant data independently using standard proformas. Differences were resolved by discussion. MAIN RESULTS: Nine trials were identified reporting the use of inhaled steroids in 266 subjects aged between seven and 45 years with cystic fibrosis. Methodological quality was difficult to assess from published information, specifically with respect to concealment of allocation and method used to generate random sequence. Trials were heterogeneous with respect to inclusion criteria, specifically age, severity of pulmonary involvement, clinical diagnosis of asthma and pulmonary colonisation with Pseudomonas aeruginosa. Trials also differed in type and duration of treatment. Beclomethasone was given for periods of between four and 22 weeks in four trials, budesonide for six weeks and six months respectively in two, and fluticasone for periods of between six weeks and two years in the remaining three. Measures of the volume of air breathed out on a forcible expiration (forced expiratory volumes) were reported in most trials but these data could not be combined for this review partly because reports differed in the way data were summarised and partly because some data were not included in published reports. Outcomes of potentially greater relevance to affected individuals such as nutritional status or quality of life were not reported in any trial. Survival was not reported in any trial, but this may reflect the fact that maximum duration of follow up was too short to allow this outcome to be meaningfully assessed. Adverse effects were systematically documented in only two trials. Although one trial was halted prematurely because a proportion of all those taking part had acquired chronic lung infections with Pseudomonas aeruginosa, no conclusions can be reached from this one small trial as to whether this risk is increased as

Administration, Inhalation↗