Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 13 de 13
Filter
1.
Cochrane Database Syst Rev ; (9): CD001735, 2015 Sep 03.
Article in English | MEDLINE | ID: mdl-26333288

ABSTRACT

BACKGROUND: Pressure ulcers (i.e. bedsores, pressure sores, pressure injuries, decubitus ulcers) are areas of localised damage to the skin and underlying tissue. They are common in the elderly and immobile, and costly in financial and human terms. Pressure-relieving support surfaces (i.e. beds, mattresses, seat cushions etc) are used to help prevent ulcer development. OBJECTIVES: This systematic review seeks to establish:(1) the extent to which pressure-relieving support surfaces reduce the incidence of pressure ulcers compared with standard support surfaces, and,(2) their comparative effectiveness in ulcer prevention. SEARCH METHODS: In April 2015, for this fourth update we searched The Cochrane Wounds Group Specialised Register (searched 15 April 2015) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL and The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 3). SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised trials, published or unpublished, that assessed the effects of any support surface for prevention of pressure ulcers, in any patient group or setting which measured pressure ulcer incidence. Trials reporting only proxy outcomes (e.g. interface pressure) were excluded. Two review authors independently selected trials. DATA COLLECTION AND ANALYSIS: Data were extracted by one review author and checked by another. Where appropriate, estimates from similar trials were pooled for meta-analysis. MAIN RESULTS: For this fourth update six new trials were included, bringing the total of included trials to 59.Foam alternatives to standard hospital foam mattresses reduce the incidence of pressure ulcers in people at risk (RR 0.40 95% CI 0.21 to 0.74). The relative merits of alternating- and constant low-pressure devices are unclear. One high-quality trial suggested that alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context.Pressure-relieving overlays on the operating table reduce postoperative pressure ulcer incidence, although two trials indicated that foam overlays caused adverse skin changes. Meta-analysis of three trials suggest that Australian standard medical sheepskins prevent pressure ulcers (RR 0.56 95% CI 0.32 to 0.97).  AUTHORS' CONCLUSIONS: People at high risk of developing pressure ulcers should use higher-specification foam mattresses rather than standard hospital foam mattresses. The relative merits of higher-specification constant low-pressure and alternating-pressure support surfaces for preventing pressure ulcers are unclear, but alternating-pressure mattresses may be more cost effective than alternating-pressure overlays in a UK context. Medical grade sheepskins are associated with a decrease in pressure ulcer development. Organisations might consider the use of some forms of pressure relief for high risk patients in the operating theatre.


Subject(s)
Bedding and Linens , Beds , Pressure Ulcer/prevention & control , Beds/standards , Humans , Pressure Ulcer/therapy , Randomized Controlled Trials as Topic
2.
Cochrane Database Syst Rev ; (9): CD002930, 2015 Sep 03.
Article in English | MEDLINE | ID: mdl-26334539

ABSTRACT

BACKGROUND: Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". Electromagnetic therapy (EMT), in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers. OBJECTIVES: To assess the effects of EMT on the healing of pressure ulcers. SEARCH METHODS: For this update we searched the Cochrane Wounds Group Specialised Register (searched 10 June 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 6); Ovid MEDLINE (2014 to 10 June 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 10 June 2015); Ovid EMBASE (2014 to 10 June 2015); and EBSCO CINAHL (2014 to 6 July 2012). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham EMT or other (standard) treatment. DATA COLLECTION AND ANALYSIS: For this update two review authors independently scrutinised the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. In previous versions of the review we made attempts to obtain missing data by contacting study authors. A second review author checked data extraction and disagreements were resolved after discussion between review authors. MAIN RESULTS: We identified no new trials for this update.Two randomised controlled trials (RCTs), involving 60 participants, at unclear risk of bias were included in the original review. Both trials compared the use of EMT with sham EMT, although one of the trials included a third arm in which only standard therapy was applied. Neither study found a statistically significant difference in complete healing in people treated with EMT compared with those in the control group. In one trial that assessed percentage reduction in wound surface area, the difference between the two groups was reported to be statistically significant in favour of EMT. However, this result should be interpreted with caution as this is a small study and this finding may be due to chance. Additionally, the outcome, percentage reduction in wound area, is less clinically meaningful than complete healing. AUTHORS' CONCLUSIONS: The results provide no strong evidence of benefit in using EMT to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out because there were only two included trials, both with methodological limitations and small numbers of participants. Further research is recommended.


Subject(s)
Magnetic Field Therapy/methods , Pressure Ulcer/therapy , Female , Humans , Male , Randomized Controlled Trials as Topic , Wound Healing
3.
Cochrane Database Syst Rev ; (7): CD010471, 2015 Jul 14.
Article in English | MEDLINE | ID: mdl-26171906

ABSTRACT

BACKGROUND: Foot ulcers in people with diabetes mellitus are a common and serious global health issue. Dressings form a key part of ulcer treatment, with clinicians and patients having many different types to choose from. A clear and current overview of current evidence is required to facilitate decision-making regarding dressing use. OBJECTIVES: To summarize data from systematic reviews of randomised controlled trial evidence on the effectiveness of dressings for healing foot ulcers in people with diabetes mellitus (DM). METHODS: We searched the following databases for relevant systematic reviews and associated analyses: the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2015, Issue 2); Database of Abstracts of Reviews of Effects (DARE; The Cochrane Library 2015, Issue 1); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 14 April 2015); Ovid EMBASE (1980 to 14 April 2015). We also handsearched the Cochrane Wounds Group list of reviews. Two review authors independently performed study selection, risk of bias assessment and data extraction. Complete wound healing was the primary outcome assessed; secondary outcomes included health-related quality of life, adverse events, resource use and dressing performance. MAIN RESULTS: We found 13 eligible systematic reviews relevant to this overview that contained a total of 17 relevant RCTs. One review reported the results of a network meta-analysis and so presented information on indirect, as well as direct, treatment effects. Collectively the reviews reported findings for 11 different comparisons supported by direct data and 26 comparisons supported by indirect data only. Only four comparisons informed by direct data found evidence of a difference in wound healing between dressing types, but the evidence was assessed as being of low or very low quality (in one case data could not be located and checked). There was also no robust evidence of a difference between dressing types for any secondary outcomes assessed. AUTHORS' CONCLUSIONS: There is currently no robust evidence for differences between wound dressings for any outcome in foot ulcers in people with diabetes (treated in any setting). Practitioners may want to consider the unit cost of dressings, their management properties and patient preference when choosing dressings.


Subject(s)
Bandages , Diabetic Foot/therapy , Review Literature as Topic , Humans , Randomized Controlled Trials as Topic
4.
Cochrane Database Syst Rev ; (2): CD007948, 2015 Feb 12.
Article in English | MEDLINE | ID: mdl-25674776

ABSTRACT

BACKGROUND: Blood for transfusion may become contaminated at any point between collection and transfusion and may result in bacteraemia (the presence of bacteria in the blood), severe illness or even death for the blood recipient. Donor arm skin is one potential source of blood contamination, so it is usual to cleanse the skin with an antiseptic before blood donation. One-step and two-step alcohol based antiseptic regimens are both commonly advocated but there is uncertainty as to which is most effective. OBJECTIVES: To assess the effects of cleansing the skin of blood donors with alcohol in a one-step compared with alcohol in a two-step procedure to prevent contamination of collected blood or bacteraemia in the recipient. SEARCH METHODS: In December 2014, for this third update, we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. SELECTION CRITERIA: All randomised trials (RCTs) comparing alcohol based donor skin cleansing in a one-step versus a two-step process that includes alcohol and any other antiseptic for pre-venepuncture skin cleansing were considered. Quasi randomised trials were to have been considered in the absence of RCTs. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. MAIN RESULTS: No studies (RCTs or quasi RCTs) met the inclusion criteria. AUTHORS' CONCLUSIONS: We did not identify any eligible studies for inclusion in this review. It is therefore unclear whether a two-step, alcohol followed by antiseptic skin cleansing process prior to blood donation confers any reduction in the risk of blood contamination or bacteraemia in blood recipients, or conversely whether a one-step process increases risk above that associated with a two-step process.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Bacteremia/prevention & control , Blood Donors , Disinfection/methods , Ethanol/administration & dosage , Skin/microbiology , Blood Transfusion , Humans
5.
Cochrane Database Syst Rev ; (9): CD002303, 2014 Sep 09.
Article in English | MEDLINE | ID: mdl-25203307

ABSTRACT

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing/repairing the veins, or by applying compression bandages/stockings to reduce the pressure in the veins.The majority of venous ulcers heal with compression bandages, however ulcers frequently recur. Clinical guidelines therefore recommend that people continue to wear compression, usually in the form of hosiery (tights, stockings, socks) after their ulcer heals, to prevent recurrence. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) in preventing the recurrence of venous ulcers. If compression does prevent ulceration compared with no compression, then to identify whether there is evidence to recommend particular levels of compression (high, medium or low, for example), types of compression, or brands of compression to prevent ulcer recurrence after healing. SEARCH METHODS: For this second update we searched The Cochrane Wounds Group Specialised Register (searched 4 September 2014) which includes the results of regular searches of MEDLINE, EMBASE and CINAHL; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 8). SELECTION CRITERIA: Randomised controlled trials (RCTs)evaluating compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: Two review authors undertook data extraction and risk of bias assessment independently. MAIN RESULTS: Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76).Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second.A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2).No trials of compression bandages for preventing ulcer recurrence were identified. AUTHORS' CONCLUSIONS: There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.


Subject(s)
Stockings, Compression , Varicose Ulcer/prevention & control , Adult , Compression Bandages , Humans , Randomized Controlled Trials as Topic , Risk , Secondary Prevention , Time Factors
6.
Cochrane Database Syst Rev ; (5): CD006477, 2013 May 31.
Article in English | MEDLINE | ID: mdl-23728661

ABSTRACT

BACKGROUND: Venous leg ulcers are a major health burden: annually, in the UK alone, they contribute an estimated cost to the NHS of GBP 400 million. Flavonoids are a diverse group of naturally-occurring venotonic compounds that address certain microcirculatory parameters involved in venous leg ulcer pathophysiology. OBJECTIVES: To evaluate the clinical effects of flavonoids on the healing of venous leg ulcers. SEARCH METHODS: In February 2013 we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 1); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. No date or language restrictions were applied. We checked reference lists of included trials, and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised controlled trials (RCTs) that investigated the efficacy of any flavonoid-containing compound on venous leg ulcer healing in adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for the review and disagreements were referred to a third author. All rejected articles were double-checked by a third author. Assessment of risk of bias and data extraction were performed independently by two authors, discrepancies were resolved by referring to the third author. MAIN RESULTS: Of the nine studies (1075 participants): five investigated Micronised Purified Flavonoid Fraction (MPFF), and four investigated hydroxyethylrutosides (HR).Meta-analysis involving 723 participants from five trials - four of which were characterised by poor reporting - showed more venous leg ulcers were healed in the MPFF groups than in the control groups (RR 1.36; 95% CI 1.07 to 1.74). However, the most rigorously conducted trial, which was at low risk of bias, did not show any additional benefit of MPFF (RR 0.94; 95% CI 0.73 to 1.22). Since this trial was unpublished, the possibility of publication bias in trials involving flavonoids must be acknowledged. Overall, the quality of reporting of trials on HR was also poor. Pooling three trials, all at unclear risk of bias, involving 279 participants showed a statistically significant effect in favour of HR with respect to number of ulcers healed (RR 1.70; 95% CI 1.24 to 2.34). AUTHORS' CONCLUSIONS: Although the overall estimate of the number of healed ulcers appeared to show a significant effect in favour of flavonoids (both MPFF and HR), this result needs to be interpreted cautiously, as most of these trials were poorly reported, and so had an unclear risk of bias for randomisation, allocation concealment, blinding and methods for addressing incomplete outcome data. There was also a possibility of publication bias.


Subject(s)
Flavonoids/therapeutic use , Varicose Ulcer/drug therapy , Adult , Humans , Hydroxyethylrutoside/therapeutic use , Randomized Controlled Trials as Topic
7.
Cochrane Database Syst Rev ; (1): CD007948, 2013 Jan 31.
Article in English | MEDLINE | ID: mdl-23440821

ABSTRACT

BACKGROUND: Blood for transfusion may become contaminated at any point between collection and transfusion and may result in bacteraemia (the presence of bacteria in the blood), severe illness or even death for the blood recipient. Donor arm skin is one potential source of blood contamination, so it is usual to cleanse the skin with an antiseptic before blood donation. One-step and two-step alcohol based antiseptic regimens are both commonly advocated but there is uncertainty as to which is most effective. OBJECTIVES: To assess the effects of cleansing the skin of blood donors with alcohol in a one-step compared with alcohol in a two-step procedure to prevent contamination of collected blood or bacteraemia in the recipient. SEARCH METHODS: For this second update we searched the Cochrane Wounds Group Specialised Register (searched 20 November 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) The Cochrane Library 2012, Issue 11; Ovid MEDLINE (20011 to November Week 2 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations November 20, 2012); Ovid EMBASE ( 20011 to 2012 Week 46); and EBSCO CINAHL ( 2008 to 15 November 2012). SELECTION CRITERIA: All randomised trials (RCTs) comparing alcohol based donor skin cleansing in a one-step versus a two-step process that includes alcohol and any other antiseptic for pre-venepuncture skin cleansing were considered. Quasi randomised trials were to have been considered in the absence of RCTs. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion. MAIN RESULTS: No studies (RCTs or quasi RCTs) met the inclusion criteria. AUTHORS' CONCLUSIONS: We did not identify any eligible studies for inclusion in this review. It is therefore unclear whether a two-step, alcohol followed by antiseptic skin cleansing process prior to blood donation confers any reduction in the risk of blood contamination or bacteraemia in blood recipients, or conversely whether a one-step process increases risk above that associated with a two-step process.


Subject(s)
Anti-Infective Agents, Local/administration & dosage , Bacteremia/prevention & control , Blood Donors , Disinfection/methods , Ethanol/administration & dosage , Skin/microbiology , Blood Transfusion , Humans
8.
Cochrane Database Syst Rev ; 10: CD003584, 2012 Oct 17.
Article in English | MEDLINE | ID: mdl-23076898

ABSTRACT

BACKGROUND: About 15% of the world population have fungal infections of the feet (tinea pedis or athlete's foot). There are many clinical presentations of tinea pedis, and most commonly, tinea pedis is seen between the toes (interdigital) and on the soles, heels, and sides of the foot (plantar). Plantar tinea pedis is known as moccasin foot. Once acquired, the infection can spread to other sites including the nails, which can be a source of re-infection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. OBJECTIVES: To assess the effects of oral treatments for fungal infections of the skin of the foot (tinea pedis). SEARCH METHODS: For this update we searched the following databases to July 2012: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 1946), EMBASE (from 1974), and CINAHL (from 1981). We checked the bibliographies of retrieved trials for further references to relevant trials, and we searched online trials registers. SELECTION CRITERIA: Randomised controlled trials of oral treatments in participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes (fungi) in culture. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook study selection, 'Risk of bias' assessment, and data extraction. MAIN RESULTS: We included 15 trials, involving 1438 participants. The 2 trials (71 participants) comparing terbinafine and griseofulvin produced a pooled risk ratio (RR) of 2.26 (95% confidence interval (CI) 1.49 to 3.44) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole, fluconazole and itraconazole, fluconazole and ketoconazole, or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo: terbinafine (31 participants, RR 24.54, 95% CI 1.57 to 384.32) and itraconazole (72 participants, RR 6.67, 95% CI 2.17 to 20.48). All drugs reported adverse effects, with gastrointestinal effects most commonly reported. Ten of the trials were published over 15 years ago, and this is reflected by the poor reporting of information from which to make a clear 'Risk of bias' assessment. Only one trial was at low risk of bias overall. The majority of the remaining trials were judged as 'unclear' risk of bias because of the lack of clear statements with respect to methods of generating the randomisation sequence and allocation concealment. More trials achieved blinding of participants and personnel than blinding of the outcome assessors, which was again poorly reported. AUTHORS' CONCLUSIONS: The evidence suggests that terbinafine is more effective than griseofulvin, and terbinafine and itraconazole are more effective than no treatment. In order to produce more reliable data, a rigorous evaluation of different drug therapies needs to be undertaken with larger sample sizes to ensure they are large enough to show any real difference when two treatments are being compared. It is also important to continue to follow up and collect data, preferably for six months after the end of the intervention period, to establish whether or not the infection recurred.


Subject(s)
Antifungal Agents/administration & dosage , Tinea Pedis/drug therapy , Administration, Oral , Antifungal Agents/adverse effects , Chronic Disease , Humans , Randomized Controlled Trials as Topic
9.
Cochrane Database Syst Rev ; (8): CD002303, 2012 Aug 15.
Article in English | MEDLINE | ID: mdl-22895929

ABSTRACT

BACKGROUND: Up to 1% of adults will have a leg ulcer at some time. The majority of leg ulcers are venous in origin and are caused by high pressure in the veins due to blockage or weakness of the valves in the veins of the leg. Prevention and treatment of venous ulcers is aimed at reducing the pressure either by removing/repairing the veins, or by applying compression bandages/stockings to reduce the pressure in the veins.The majority of venous ulcers heal with compression bandages, however ulcers frequently recur. Clinical guidelines therefore recommend that people continue to wear compression, usually in the form of hosiery (tights, stockings, socks) after their ulcer heals, to prevent recurrence. OBJECTIVES: To assess the effects of compression (socks, stockings, tights, bandages) in preventing the recurrence of venous ulcers. If compression does prevent ulceration compared with no compression, then to identify whether there is evidence to recommend particular levels of compression (high, medium or low, for example), types of compression, or brands of compression to prevent ulcer recurrence after healing. SEARCH METHODS: For this update we searched The Cochrane Wounds Group Specialised Register (searched 1 March 2012); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 2); Ovid MEDLINE (1950 to February Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, February 29, 2012); Ovid EMBASE (1980 to 2012 Week 08); and EBSCO CINAHL (1982 to 1 March 2012). SELECTION CRITERIA: Randomised controlled trials evaluating compression bandages or hosiery for preventing the recurrence of venous ulcers. DATA COLLECTION AND ANALYSIS: Two review authors undertook data extraction and risk of bias assessment independently. MAIN RESULTS: Four trials (979 participants) were eligible for inclusion in this review. One trial in patients with recently healed venous ulcers (n = 153) compared recurrence rates with and without compression and found that compression significantly reduced ulcer recurrence at six months (Risk ratio (RR) 0.46, 95% CI 0.27 to 0.76).Two trials compared high-compression hosiery (equivalent to UK class 3) with moderate-compression hosiery (equivalent to UK class 2). The first study (n=300) found no significant reduction in recurrence at five years follow up with high-compression hosiery compared with moderate-compression (RR 0.82, 95% CI 0.61 to 1.12). The second study (n = 338) assessed ulcer recurrence at three years follow up and found that high-compression hosiery reduced recurrence compared with moderate-compression (RR 0.57, 95% CI 0.39 to 0.81). Statistically significant heterogeneity precluded meta-analysis of the results from these studies. Patient-reported compliance rates were reported in both trials;,there was significantly higher compliance with medium-compression than with high-compression hosiery in one and no significant difference in the second.A fourth trial (166 patients) found no statistically significant difference in recurrence between two types of medium (UK class 2) compression hosiery (Medi versus Scholl: RR 0.74, 95% CI 0.45 to 1.2).No trials of compression bandages for preventing ulcer recurrence were identified. AUTHORS' CONCLUSIONS: There is evidence from one trial that compression hosiery reduces rates of reulceration of venous ulcers compared with no compression. Results from one trial suggest that recurrence is lower in high-compression hosiery than in medium-compression hosiery at three years whilst another trial found no difference at 5 years. Rates of patient intolerance of compression hosiery were high. There is insufficient evidence to aid selection of different types, brands, or lengths of compression hosiery.


Subject(s)
Stockings, Compression , Varicose Ulcer/prevention & control , Adult , Compression Bandages , Humans , Randomized Controlled Trials as Topic , Risk , Secondary Prevention
10.
Article in English | MEDLINE | ID: mdl-18955352

ABSTRACT

The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested individual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment.

13.
Arch Dermatol ; 138(6): 811-6, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12056964

ABSTRACT

OBJECTIVE: To identify and synthesize the evidence for the efficacy of oral treatments for fungal infections of the toenails. DESIGN: Systematic review of randomized controlled trials. INTERVENTIONS: Oral treatments for dermatophyte infections of the toenails. MAIN OUTCOME MEASURES: Cure confirmed by microscopy and culture results in patients with clinically diagnosed fungal infections. Data relating to the clinical cure rates were also extracted from the trials. RESULTS: A pooled analysis of 2 trials comparing mycological cure rates from continuous treatment with terbinafine (250 mg/d for 12 weeks) and continuous treatment with itraconazole (200 mg/d for 12 weeks) found a statistically significant difference in 11- and 12-month outcomes in favor of terbinafine (risk difference, -0.23 [95% confidence interval, -0.32 to -0.15]; number needed to treat, 5 [95% confidence interval, 4 to 8]). An analysis of clinical cure rates was not possible because of the diversity of definitions used in researching the effectiveness of oral antifungal drugs for onychomycosis. Only 3 trials gave a clear definition of clinical cure and presented data for these outcomes. CONCLUSIONS: There is good evidence that a continuous regimen of terbinafine (250 mg/d) for 3 months is the most effective oral treatment for fungally infected toenails. Consensus among researchers evaluating oral antifungal drugs for onychomycosis is needed to establish meaningful definitions of clinical cure. Most trials were funded by the pharmaceutical industry; we found little independent research, and this may have introduced bias to the review.


Subject(s)
Antifungal Agents/administration & dosage , Onychomycosis/drug therapy , Administration, Oral , Dose-Response Relationship, Drug , Drug Administration Schedule , Evidence-Based Medicine , Female , Foot Dermatoses/diagnosis , Foot Dermatoses/drug therapy , Griseofulvin/administration & dosage , Humans , Itraconazole/administration & dosage , Ketoconazole/administration & dosage , Male , Naphthalenes/administration & dosage , Onychomycosis/diagnosis , Prognosis , Randomized Controlled Trials as Topic , Sensitivity and Specificity , Terbinafine , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...