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Caregivers' use of strict criteria for diagnosing active labour in term pregnancy.

BACKGROUND: Application of specific criteria for diagnosis of active labour as part of a labour assessment program aims to differentiate more accurately between latent and active phases of labour. OBJECTIVES: The objective of this review was to assess the effects of the use of specific criteria by caregivers in diagnosing active labour in term pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of last search: January 1998. SELECTION CRITERIA: Randomised trials comparing caregivers' application of strict diagnostic criteria for active labour with routine care. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: One study of 209 women was included. The trial was of excellent quality. Women who experienced early labour assessment were less likely to receive intrapartum oxytocics than women who received standard care (odds ratio 0.45, 95% confidence interval 0.25 to 0.80) and analgesia (odds ratio 0.36, 95% confidence interval 0.16 to 0.78). They reported higher levels of control during labour and birth (weighted mean difference 16.00, 95% confidence interval 7.52 to 24.48). There were no differences detected for rate of caesarean section and other important measures of maternal and neonatal outcome. REVIEWER'S CONCLUSIONS: Early labour assessment (which includes use of specific criteria for diagnosis of active labour) may have some positive outcomes for women at term pregnancy.

Caregivers↗

Mannitol for acute traumatic brain injury.

BACKGROUND: Mannitol is sometimes dramatically effective in reversing acute brain swelling, but its effectiveness in the on-going management of severe head injury remains open to question. There is evidence that in prolonged dosage mannitol may pass from the blood into the brain, where it might cause reverse osmotic shifts that increase intracranial pressure. OBJECTIVES: To assess the effects of different mannitol therapy regimens, of mannitol compared to other intracranial pressure (ICP) lowering agents, and to quantify the effectiveness of mannitol administration given at other stages following acute traumatic brain injury. SEARCH STRATEGY: The review drew on the search strategy for the Injuries Group as a whole. We checked reference lists of trials and review articles, and contacted authors of trials. SELECTION CRITERIA: Randomised trials of mannitol, in patients with acute traumatic brain injury of any severity. The comparison group could be placebo-controlled, no drug, different dose, or different drug. Trials where the intervention was started more than eight weeks after injury, and cross-over trials were excluded. DATA COLLECTION AND ANALYSIS: The reviewers independently rated quality of allocation concealment and extracted the data. Relative risks (RR) and 95% confidence intervals (CI) were calculated for each trial on an intention to treat basis. MAIN RESULTS: Overall there were few eligible trials. There were no trials comparing different doses, or type of administration. One trial compared ICP-directed therapy to 'standard care' (RR for death= 0.83; 95% CI 0.47;1.46). One trial compared mannitol to pentobarbital (RR for death = 0.85; 95% CI 0. 52;1.38). No trials compared mannitol to other ICP lowering agents. One trial tested the effectiveness of pre-hospital administration of mannitol against placebo (RR for death=1.59; 95% CI 0.44;5.79). REVIEWER'S CONCLUSIONS: There are insufficient data to recommend one form of mannitol infusion over another. Mannitol therapy for raised ICP may have a beneficial effect on mortality when compared to pentobarbital treatment. ICP-directed treatment shows a small beneficial effect compared to treatment directed by neurological signs and physiological indicators. There are insufficient data on the effectiveness of pre-hospital administration of mannitol to preclude either a harmful or a beneficial effect on mortality.

Brain Injuries↗

Interventions for early stage Hodgkin's disease in children.

BACKGROUND: Hodgkin's Disease is one of the most curable cancers in children, particularly at the early stages. The debate rests now more with retention of high cures and eliminating treatment sequelae. OBJECTIVES: To assess relapse free survival and overall survival rates in children with Stage l-llA Hodgkin's Disease treated with radiotherapy, chemotherapy or a combination of the two treatments. SEARCH STRATEGY: MEDLINE, EMBASE, CINAHL, Cancer-CD and the Cochrane Library were searched for randomised controlled trials. Key words included 'Hodgkin's Disease', 'Reed-Sternberg cells' and variations of 'child'. SELECTION CRITERIA: Treatments with a combination of the following therapies; involved field radiotherapy, extended field radiotherapy, anthracycline based chemotherapy regimens, or alkylating chemotherapy agents. Patients included children to 19 years of age. DATA COLLECTION AND ANALYSIS: Seven papers were identified as meeting the selection criteria. Of these four were usable, though one only covered a small section of the paper. It was not possible to combine the outcomes as they covered different treatment regimens and the numbers in one study were inaccurate. MAIN RESULTS: The results comparing IF with EF radiotherapy for children are based on one large multi-centred trial. Although the study is substantial and methodologically rigorous, the evidence for efficacy rests simply on this one trial. The results from the other three studies are not generalizable. The outcomes could not be combined as the studies assessed different treatment regimens. In addition there is little evidence to suggest that the methodological quality, particularly in terms of randomisation and simple arithmetic, is of a sufficiently robust nature in two of the studies. REVIEWER'S CONCLUSIONS: The treatment of Hodgkin's Disease Stage l -llA for children has undergone considerable evolution and development in the previous three decades with the introduction and refinement of combined modality treatments. There is now overall consensus that the prognosis for these patients following a short course of chemotherapy and low dose local radiotherapy is very good with a large percentage achieving long-term survival or relapse free survival. The main issues and problems facing practitioners in the field is the reduction and management of late effects and sequelae of treatment. The evidence for this overall agreement is based on a mass of cohort studies that have influenced changes in practice and significantly improved outcomes. However, apart from the collaborative study looking at radiotherapy alone, there is little evidence from randomised controlled trials to support this consensus.

Antineoplastic Agents↗

Local corticosteroid injection for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a clinical syndrome manifested by signs and symptoms of irritation of the median nerve at the level of the carpal tunnel in the wrist. Treatment of CTS can be surgical or non-surgical. Local corticosteroid injection for CTS has been previously studied but most studies have been either retrospective or uncontrolled. The effectiveness and duration of benefit of local corticosteroid injection for CTS remain unknown. OBJECTIVES: To evaluate the effectiveness of local steroid injection for carpal tunnel syndrome versus placebo injection or other non-surgical interventions in improving clinical outcome and to determine the length of symptom relief post injection. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group register, MEDLINE, EMBASE and CINAHL. SELECTION CRITERIA: Studies using either a randomized or quasi-randomized methodology were eligible for inclusion. The studies included participants with the diagnosis of carpal tunnel syndrome and the treatment intervention was local corticosteroid injection. The primary outcome measure was clinical improvement after injection. DATA COLLECTION AND ANALYSIS: Three reviewers independently selected the trials to be included in the study. Studies were rated for their overall quality independently by the reviewers. Studies were compared for heterogeneity using the chi square statistic. Relative risks and 95% confidence intervals were calculated for each trial and summary relative risks and 95% confidence intervals (CI) were also calculated. MAIN RESULTS: We identified four randomized controlled trials studying local corticosteroid injection for the treatment of CTS. Two trials were excluded. One did not include clinical assessment as an outcome and the other did not provide patient outcomes, but only statistical values. Each of the remaining two trials had demonstrated clinical improvement of CTS at one month following local corticosteroid injection compared to placebo injection. The pooled relative risk (RR) favouring treatment was 3.62 (95% CI 1.94 to 6.73). REVIEWER'S CONCLUSIONS: Local corticosteroid injection for CTS provides greater clinical improvement in symptoms one month after injection compared to placebo. Symptom relief beyond one month compared to placebo has not been demonstrated. The effectiveness of local corticosteroid injection has not been compared to other non-surgical or surgical interventions for CTS in randomized controlled trials.

Adrenal Cortex Hormones↗

Compression bandages and stockings for venous leg ulcers.

OBJECTIVES: To assess the effectiveness and cost-effectiveness of compression bandaging and stockings in the treatment of venous leg ulcers. SEARCH STRATEGY: Searches of 19 databases, hand searching of journals, conference proceedings and bibliographies. Manufacturers of compression bandages and stockings and an Advisory Panel were contacted for unpublished studies. SELECTION CRITERIA: Trials that evaluated compression bandaging or stockings, as a treatment for venous leg ulcers. There was no restriction on date or language. Ulcer healing was the primary endpoint. DATA COLLECTION AND ANALYSIS: Details of eligible studies were extracted and summarised using a data extraction sheet. Data extraction was verified by two reviewers independently. MAIN RESULTS: Twenty two trials reporting 24 comparisons were identified. Compression was more effective than no compression (4/6 trials). When multi-layered systems were compared, elastic compression was more effective than non-elastic compression (5 trials). There was no difference in healing rates between 4-layer bandaging and other high compression multi-layered systems (3 trials). There was no difference in healing rates between elastomeric multi-layered systems (4 trials). Multi-layered high compression was more effective than single layer compression (4 trials). Compression stockings were evaluated in two trials. One found a high compression stocking plus a thrombo stocking to be more effective than a short stretch bandage. The second small trial reported no difference between the compression stockings and Unna's boot. There was insufficient data to draw conclusion about the relative cost-effectiveness of different regimens. REVIEWER'S CONCLUSIONS: Compression increases ulcer healing rates compared with no compression. Multi-layered systems are more effective than single-layered systems. High compression is more effective than low compression but there are no clear differences in the effectiveness of different types of high compression.

Bandages↗

Manual versus powered toothbrushes: a summary of the Cochrane Oral Health Group's Systematic Review. Part II.

PURPOSE: A systematic review examining the clinical effectiveness of power versus manual toothbrushes was conducted by the Cochrane Collaborations Oral Health Group. Their review examined clinical trials conducted through 2001 and used international standards to identify, access, evaluate, analyze, and report the data. Part I of this series discussed distinguishing characteristics of evidence-based publications, such as systematic reviews, whereas this report provides a summary of the Cochrane Review, its importance to the profession, and discusses the strengths and limitations of systematic reviews. METHODS: Search strategies to identify published clinical trials on power toothbrushes were developed, and manufacturers were contacted for additional published and unpublished information. Trials were selected based on pre-established criteria; including whether they compared power versus manual toothbrushes used a randomized research design tested products in the general population without disabilities, provided data on plaque and gingivitis, and were at least 28 days in length. Six reviewers independently extracted information in duplicate. Indices for plaque and gingivitis levels were expressed as standardized mean differences for data distillation. Data distillation was accomplished using a meta-analysis, with a mean difference between power and manual toothbrushes as the measure of effectiveness. RESULTS: Searches identified 354 trials, of which 29 met inclusion criteria. These trials involved 2.547 participants who provided data for meta-analysis. Results indicated that for both plaque and gingivitis, all types of power toothbrushes worked as well as manual toothbrushes, however only the rotating oscillating toothbrush consistently provided a statistically significant though modest benefit over manual toothbrushes in reducing plaque (7%) and gingivitis (17%). None of the battery powered toothbrush studies met the inclusion criteria. CONCLUSION: The Cochrane systematic review used international standards to examine more than 30 years of published studies. A concern is that only one type of electric toothbrush, the rotating oscillating toothbrush consistently demonstrated a statistically significant benefit over manual toothbrushes, and the majority of studies did not meet the standards for inclusion in moving forward it will be important to conduct methodologically sound studies demonstrating the ability of power toothbrushes to reduce the incidence and prevalence of caries and periodontal disease.

Decision Making↗

Antibiotics for sore throat.

BACKGROUND: Sore throat is a very common reason for people to attend for medical care. Sore throat is a disease that remits spontaneously, that is, 'cure' is not dependant on treatment. Nonetheless primary care doctors commonly prescribe antibiotics for sore throat and other upper respiratory tract infections. OBJECTIVES: To assess the benefits of antibiotics in the management of sore throat. SEARCH STRATEGY: Systematic search of the literature from 1945 to 1999, using electronic searches of MEDLINE (using the keywords, "pharyngitis", "sore throat" and "tonsillitis") after 1966, the Cochrane Library, the Cochrane collection of hand-searched trials, and the reference sections of the articles identified. Abstracts of identified articles were used to determine which studies were trials. SELECTION CRITERIA: Trials of antibiotic against control with either measures of the typical symptoms (throat soreness, headache or fever), or complications (suppurative and non-suppurative) of sore throat. DATA COLLECTION AND ANALYSIS: RevMan 4.0.3 MAIN RESULTS: A total number of 10,484 cases of sore throat have been studied. 1. Non-suppurative complications There was a trend for protection against acute glomerulonephritis by antibiotics, but insufficient cases were recorded to be sure of this effect. Several studies found benefit from antibiotics for acute rheumatic fever, which reduced this complication to less than one third (OR = 0.30; 95% CI = 0.20-0.45). 2. Suppurative complications Antibiotics reduced the incidence of acute otitis media to about one quarter of that in the placebo group (OR = 0.22; 95% CI = 0.11-0.43) and reduced the incidence of acute sinusitis to about one half of that in the placebo group (OR = 0.46; 95% CI = 0.10-2.05). The incidence of quinsy was also reduced in relation to placebo group (OR = 0.18; 95% CI = 0.08-0.43). 3. Symptoms Symptoms of headache, throat soreness and fever were reduced by antibiotics to about one half. The greatest time for this to be evident was at about three and a half days (when the symptoms of about 50% of untreated patients had settled). About 90% of treated and untreated patients were symptom-free by one week. 4. Subgroup analyses of symptom reduction Subgroup analysis by age; blind vs unblinded; us of antipyretics; or results of swabs for Streptococcus yielded no significant differences. REVIEWER'S CONCLUSIONS: Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in modern Western society can only be achieved by treating many with antibiotics who will derive no benefit. Antibiotics shorten the duration of symptoms, but by a mean of only about half of one day at day 3 (the time of maximal effect), and by about eight hours overall.

Anti-Bacterial Agents↗

Interventions for treating constipation in pregnancy.

BACKGROUND: Circulating progesterone may be the cause of slower gastrointestinal movement in mid and late pregnancy. OBJECTIVES: The objective of this review was to assess the effects of different methods for treating constipation in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and Medline (1987 to 1997). SELECTION CRITERIA: Randomised trials of any treatment for constipation in pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality assessments and data extraction were done independently by two reviewers. MAIN RESULTS: One trial of 40 women was included. Fibre supplements increased the frequency of defaecation (odds ratio 0.18, 95% confidence interval 0.05 to 0.67), and lead to softer stools. REVIEWER'S CONCLUSIONS: Dietary supplements of fibre in the form of bran or wheat fibre are likely to help women experiencing constipation in pregnancy.

Constipation↗

Mucolytic agents for chronic bronchitis or chronic obstructive pulmonary disease.

BACKGROUND: Individuals with chronic bronchitis or chronic obstructive pulmonary disease (COPD) may suffer recurrent exacerbations with an increase in volume and/or purulence of sputum and any therapy that reduced the number of exacerbations would be useful. There is a marked difference between countries in terms of the prescribing of mucolytics depending on whether or not they are perceived to be effective. OBJECTIVES: To assess the effects of oral mucolytics in adults with stable chronic bronchitis or COPD. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register and reference lists of articles. SELECTION CRITERIA: Randomised trials that compared oral mucolytic therapy with placebo for at least two months in adults with chronic bronchitis or COPD. Studies of people with asthma and cystic fibrosis were excluded. DATA COLLECTION AND ANALYSIS: One reviewer extracted data. Study authors and drug companies were contacted for missing information. MAIN RESULTS: Twenty two trials were included. Compared with placebo, there was a significant reduction in the number of exacerbations per patient with oral mucolytics (weighted mean difference (WMD) -0.067 per month, 95% confidence interval -0.079, -0.055, p<0.001) which is a 29% reduction. The annualised rate of exacerbations in the control patients was 2.7 per year. The number of days of disability also fell on mucolytic therapy (WMD -0.56, 95% confidence interval -0.77, -0.35, p<0.001). The number of patients who remained exacerbation-free was greater in the mucolytic group thanin the placebo group (OR 2.22, 95% confidence interval 1.93, 2.54, p<0.001). There was no difference in lung function or in adverse effects reported between treatments. REVIEWER'S CONCLUSIONS: In subjects with chronic bronchitis or COPD, treatment with mucolytics was associated with a small reduction in acute exacerbations and a somewhat greater reduction in total number of days of disability.

Adult↗

Penicillamine for rheumatoid arthritis.

OBJECTIVES: To estimate the short-term effects of D-penicillamine for the treatment of rheumatoid arthritis (RA). SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, Medline up to and including December 1998 and Embase from 1988-1998. We also carried out a handsearch of the reference lists of the trials retrieved from the electronic search. SELECTION CRITERIA: All randomized controlled trials and controlled clinical trials comparing D-penicillamine against placebo in patients with rheumatoid arthritis. DATA COLLECTION AND ANALYSIS: The methodological quality of the trials was assessed independently by two reviewers (CS, EB) and checked by a third (MS) using a validated quality assessment tool. Rheumatoid arthritis outcome measures were extracted from the publications for the six-month endpoint and stratified according to D-penicillamine dosages: low (<500mg/day), moderate (500 to <1000mg/day) and high (1000 mg/day or greater). Data was abstracted by one reviewer and checked by a second (CS, MS). The pooled analysis was performed using the standardized mean difference for joint counts, pain and global assessments. The weighted mean difference was used for erythrocyte sedimentation rate (ESR). Toxicity was evaluated with pooled odds ratios for withdrawals and adverse reactions. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout, since no statistical heterogeneity was found. MAIN RESULTS: Six trials were identified, with 425 patients randomized to D-penacillamine and 258 to placebo. A statistically significant benefit was observed for D-penicillamine when compared to placebo for all three-dose ranges and for most outcome measures including: tender joint counts, pain, physician's global assessments and ESR. The standardized weighted mean differences between treatment and placebo in moderate doses were -0. 51 [95% CI -0.88, -0.14] for tender joint counts, -0.56 (95% CI -0. 87, -0.26) for pain and -0.97 (95% CI -1.25, -0.70) for global assessment. The difference for ESR was -10.6 mm/hr. Similar results were observed for the higher dose group. Total withdrawals were significantly higher in the moderate and high dosage D-penicillamine groups (OR=1.63 and 2.13 respectively), mostly due to increased adverse reactions (OR = 2.60 and 4.95 respectively), including renal and hematological abnormalities. REVIEWER'S CONCLUSIONS: D-penicillamine appears to have a clinically and statistically significant benefit on the disease activity of patients with rheumatoid arthritis. Its efficacy appears to be similar to that of other disease modifying anti-rheumatic drugs (DMARDs), but with a significantly higher toxicity. Its effects on long-term functional status and radiological progression are not clear from this review.

Antirheumatic Agents↗

[Zinc and epilepsy: is there a causal relation between them?].

INTRODUCTION: Zinc is a fundamental trace element for an adequate nervous system function. It has been suggested that in the brain, a zinc homeostasis alteration may be associated with the genesis of epilepsy, although it is not yet determined if concentrations of zinc are a cause or a consequence of seizures. Another poorly studied aspect is the relationship between antiepileptic drugs and the neuronal zinc behaviour. DEVELOPMENT: We perform a systematic review of the literature to evaluate the role that zinc plays in epilepsy as well as the antiepileptic effect of zinc concentrations. Databases such as MEDLINE, EMBASE, SCISEARCH and LILACS were consulted from January 1974 to July 2005. All articles published in English and Spanish were considered. A manual review of the references present in each article was done in order to identify the articles that the electronic search may have not found itself. The title and abstract of the potential articles were analyzed before asking for the complete article. However, articles that seemed ambiguous were completely analyzed later to establish their relevance. CONCLUSIONS: Clinical research in epilepsy presented contradictory results. In fact, the reviewed studies, both animal and human, did not give enough evidence to determine if organic zinc variations are directly related to epilepsy. Most of them gave not statistically significant results.

Animals↗

Danazol for pelvic pain associated with endometriosis.

BACKGROUND: Endometriosis is defined as the presence of endometrial tissue (stromal and glandular) outside the normal uterine cavity. Conventional medical and surgical treatments for endometriosis aim to remove or decrease deposits of ectopic endometrium. The observation that hyperandrogenic states (an excess of male hormone) induce atrophy of the endometrium has led to the use of androgens in the treatment of endometriosis. Danazol is one of these treatments used. The efficacy of danazol is based on its ability to produce a high androgen/low estrogen environment (a pseudo menopause) which results in the atrophy of endometriotic implants and thus an improvement in painful symptoms. OBJECTIVES: To determine the effectiveness of danazol compared to placebo or no treatment in the treatment of the symptoms and signs, other than infertility, of endometriosis in women of reproductive age. SEARCH STRATEGY: The Menstrual Disorders Group search strategy was used to identify randomised controlled trials of the use of danazol in endometriosis. In addition, all reference lists of included trials were searched, and relevant drug companies were contacted for details of unpublished trials SELECTION CRITERIA: Randomised controlled trials in which danazol (alone or as adjunctive therapy) was compared to placebo or no therapy. Trials which only reported infertility outcomes were excluded. DATA COLLECTION AND ANALYSIS: Only four trials met the inclusion criteria and two authors extracted data independently from these trials. All four trials compared danazol to placebo. Two trials used danazol as sole therapy and two trials used danazol as an adjunct to surgery. Although the main outcome was pain improvement other data relating to laparoscopic scores and hormonal parameters were also collected. MAIN RESULTS: Treatment with danazol (including adjunctive surgical therapy) was effective in relieving painful symptoms related to endometriosis when compared to placebo. Laparoscopic scores were improved with danazol treatment (including adjunctive therapy) when compared with either placebo or no treatment. Side effects were more commonly reported in those patients receiving danazol than placebo. REVIEWER'S CONCLUSIONS: Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.

Danazol↗

Interventions for preventing and treating backache in pregnancy.

BACKGROUND: More than a third of women experience back pain during pregnancy. OBJECTIVES: The objective of the review was to assess the effects of preventive interventions and treatments for backache in pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. SELECTION CRITERIA: Randomised trials of any treatment to reduce the incidence or severity of back pain in pregnancy, or to prevent back pain arising in pregnancy. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: One trial of 109 women was included. This cross-over trial compared the use of a special shaped pillow to fit under the woman's abdomen (Ozzlo pillow) with a standard pillow. Women experienced less pain in the week when they used the Ozzlo pillow than in the week with the standard pillow (odds ratio 0.32, 95% confidence interval 0.18 to 0.58). REVIEWER'S CONCLUSIONS: Specially shaped pillows appear to help reduce back pain in late pregnancy and improve sleep.

Back Pain↗

Validation therapy for dementia.

BACKGROUND: Validation therapy is a "therapy for communicating with old-old people who are diagnosed as having Alzheimer's disease and related dementia". The approach was developed by Naomi Feil between 1963 and 1980. She classifies individuals with cognitive impairment as having one of four stages on a continuum of dementia: these stages are Malorientation, Time Confusion, Repetitive Motion and Vegetation. The benefits of Validation therapy for patients are reported by Feil as restoration of self worth, minimisation of the the degree to which patients withdraw from the outside world, promotion of communication and interaction with other people, reduction of stress and anxiety, stimulation of dormant potential, help in resolving unfinished life tasks, facilitation of independent living for as long as possible. These benefits are highly desirable and Validation therapy but there is a need to show them on the basis of substantive research yielding strong evidence across a number of well designed studies. The potential number of people that might benefit from the implementation of Validation therapy is considerable given the increasing incidence of dementia. OBJECTIVES: To evaluate the effectiveness of using validation therapy with people diagnosed as having senile dementia of the Alzheimer's type, other forms of dementia, or cognitive impairment. SEARCH STRATEGY: The Cochrane Controlled Trials Register was searched by the Cochrane Dementia and Cognitive Impairment Group Coordinator and relevant references were forwarded to the primary reviewer. The reviewers carried out independent searches of the following electronic databases - MEDLINE, EMBASE, Eureka, CINAHL, PSYCLIT, RLIN, SIGLE and SOCIOFILE. The following key terms were used in searches; validation-therapy, dementia, cognitive impairmnent, communication, and random*-control*. An author search using Feil and Naomi was also carried out. Personal contact was made with the Validation Institute, Cleveland, Ohio USA and unpublished studies were sought by direct contact with the relevant authors, or institutions. Key individuals who might provide further information regarding validation therapy were contacted. SELECTION CRITERIA: All randomised controlled trials (RCTs) and quasi-randomised controlled trials examining Validation therapy as an intervention for dementia were considered for inclusion in review. The criteria for inclusion/exclusion comprised systematic assessment of the quality of study design and the risk of bias, using a standard data extraction form. Outcome measures of cognitive and/or behavioural change were required. DATA COLLECTION AND ANALYSIS: Data were extracted independently by both reviewers, using a previously tested data extraction form. Authors were contacted for data not provided in the papers. Psychological scales measuring cognitive and behavioural changes were examined. Subcategory analysis was performed due to the diversity of the scales and the inability to combine data across studies. MAIN RESULTS: Only three studies were identifed that potentially met the inclusion criteria and only two small studies were able to be obtained. The Peoples 1982 study was not obtainable through a British Library loan because the cost was prohibitive. Data from 2 studies were entered using MetaView - Robb 1986, Toseland et al 1997, incorporating data on a total of 87 patients (32 in the experimental group, and 55 in the control groups (usual care 34 and social contact 21)). It was not possible to pool the data from the two included studies, and therefore, subcategory analyses were carried out. The analysis of the data failed to reveal statistically significant results although there were trends toward favouring validation therapy for some outcomes. (ABSTRACT TRUNCATED)

Alzheimer Disease↗

Nursing record systems: effects on nursing practice and health care outcomes.

BACKGROUND: A nursing record system is the record of care planned and/or given to individual patients/clients by qualified nurses or other caregivers under the direction of a qualified nurse. Nursing record systems may be an effective way of influencing nurse practice. OBJECTIVES: To assess the effects of nursing record systems on nursing practice and patient outcomes. SEARCH STRATEGY: We searched The Cochrane Library, MEDLINE, Cinahl, Sigle, and databases of the Royal College of Nursing, King's Fund, the NHS Centre for Reviews and Dissemination, and the Institute of Electrical Engineers up to August 1999; and OCLC First Search, Department of Health database, NHS Register of Computer Applications and the Health Visitors' Association database up to the end of 1995. We hand searched the Journal of Nursing Administration (1971-1999), Computers in Nursing (1984-1999), Information Technology in Nursing (1989-1999) and reference lists of articles. We also hand searched the major health informatics conference proceedings. We contacted experts in the field of nursing informatics, suppliers of nursing computer systems, and relevant Internet groups. SELECTION CRITERIA: Randomised trials, controlled before and after studies and interrupted time series comparing one kind of nursing record system with another, in hospital, community or primary care settings. The participants were qualified nurses, students or health care assistants working under the direction of a qualified nurse and patients receiving care recorded and/or planned using nursing record systems. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Six trials involving 1407 people were included. In three studies of client held records, there were no overall positive or negative effects, although some administrative benefits through fewer missing notes were suggested. A paediatric pain management sheet study showed a positive effect on the children's pain intensity. A computerised nursing care planning study showed a negative effect on documented nursing care planning. A controlled before-and-after study of two paper nursing record systems showed improvement in meeting documentation standards. REVIEWER'S CONCLUSIONS: No evidence was found of effects on practice attributable to changes in record systems. Although there is a paucity of studies of sufficient methodological rigour to yield reliable results in this area, it is clear from the literature that it is possible to set up randomised trials or other quasi-experimental designs needed to produce evidence for practice. The research undertaken so far may have suffered both from methodological problems and faulty hypotheses.

Humans↗

Azathioprine for rheumatoid arthritis.

OBJECTIVES: To assess the short-term effects of azathioprine for the treatment of rheumatoid arthritis (RA). SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Group's trials register, the Cochrane Controlled Trials Register, Medline up to and including July 1998 and Embase from 1988-1998. We also carried out a handsearch of the reference lists of the trials retrieved from the electronic search. SELECTION CRITERIA: All randomized controlled trials and controlled clinical trials comparing azathioprine against placebo in patients with rheumatoid arthritis. DATA COLLECTION AND ANALYSIS: Data was extracted independently by two reviewers (CS, EB); disagreements were resolved by discussion or third party adjudication (MS). The same reviewers (CS, EB) assessed the methodological quality of the trials using a validated quality assessment tool. Rheumatoid arthritis outcome measures were extracted from the publications for the six-month endpoint. The pooled analysis was performed using standardized mean differences for joint counts, pain and functional status assessments. Weighted mean differences were used for erythrocyte sedimentation rate (ESR). Toxicity was evaluated with pooled odds ratios for withdrawals and for adverse reactions. The 95% confidence intervals (95% CI) are presented. A chi-square test was used to assess heterogeneity among trials. Fixed effects models were used throughout, since no statistical heterogeneity was found. MAIN RESULTS: Three trials with a total of 81 patients were included in the analysis. Forty patients were randomized to azathioprine and forty-one to placebo. A pooled estimate was calculated for two outcomes. A statistically significant benefit was observed for azathioprine when compared to placebo for tender joint scores. The standardized weighted mean difference between treatment and placebo was -0.98 (95% CI -1.45, -0.50). Withdrawals from adverse reactions were significantly higher in the azathioprine group OR=4.56 (95% CI 1.16, 17.85). REVIEWER'S CONCLUSIONS: Azathioprine appears to have a statistically significant benefit on the disease activity in joints of patients with RA. This evidence however is based on a small number of patients, included in older trials. Its effects on long-term functional status and radiological progression were not assessed due to lack of data. Toxicity is shown to be higher and more serious than that observed with other disease-modifying anti-rheumatic drugs (DMARDs). Given this high risk to benefit ratio, there is no evidence to recommend the use of azathioprine over other DMARDs.

Antirheumatic Agents↗

Does low birthweight increase the risk of caries? A systematic review.

Low birthweight is a major public health and social problem in the United States. While a long list of mortality and morbidity conditions have been associated with low birthweight, dental conditions have not received much attention. This systematic review addresses this question: Do low-birthweight children (birthweight <2500 grams) subsequently develop more caries than do children with normal-to-high birthweight? The MEDLINE and EMBASE databases were searched for English-language papers published between January 1966 and July 2000 using a search expression developed in conjunction with an experienced librarian. There were 198 papers located in the initial search; a title and abstract review to identify clearly irrelevant papers reduced this number to 37. Two readers each read these papers, and application of predetermined inclusion/exclusion criteria reduced this number to only four papers. Quality criteria were established for scoring each of these papers on evidence tables. The maximum score for each paper was 100; the four papers rated scored between 31 and 61. Results showed that no relationship between low birthweight and subsequent development of caries was reported in any of the four papers. However, conclusions must be cautious because of the scarcity of studies on the subject and the limited scope of the four papers judged. The relationship of low birthweight to subsequent development of caries, especially in the permanent dentition, needs further exploration.

Child, Preschool↗