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Biomedical subjects

I Russell

Publications and source records attributed to I Russell.

At least 19 recordsLinked to original sources

Topical treatments for fungal infections of the skin and nails of the foot.

OBJECTIVES: The objective of this review is to identify and evaluate the evidence of efficacy for topical treatments for fungal infections of the skin and nails of the human foot. To establish the effectiveness of topical treatments in achieving a cured condition and in preventing recurrence SEARCH STRATEGY: Randomised controlled trials were identified from the MEDLINE, EMBASE and CINHAL databases, from the beginning of these databases to December 1997. Also we screened the Cochrane Controlled Trials Register, the Science Citation Index BIOSIS, CAB - Health, Healthstar and Economic databases. References and unpublished studies were searched, podiatry journals handsearched and the pharmaceutical industry contacted. SELECTION CRITERIA: Only randomised controlled trials (RCTs) using participants who have mycologically diagnosed fungal infections of the skin and nails of the human foot are included in the analysis. DATA COLLECTION AND ANALYSIS: Two reviewers independently summarised the included trials and appraised their quality of reporting using a structured data extraction tool which assessed 12 quality criteria. MAIN RESULTS: Of 126 trials identified in 121 papers, 72 met the inclusion criteria. Placebo-controlled trials yielded the following pooled relative risks of failure to cure (RRFC) for skin infections: allylamines 0.30 (95% confidence interval 0.23 to 0.37); azoles 0.53 (0.42 to 0.68); undecenoic acid 0.28 (0.11 to 0.74); tolnaftate 0.46 (0.17 to 1.22). Though meta-analysis of 11 trials comparing allylamines and azoles showed an RRFC of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidence of language bias. Seven English language reports favoured allylamines (RRFC = 0.79; 0.68 to 0.93) but four foreign language reports showed no difference between the two drugs (RRFC = 1.00; 0.90 to 1.12). The two trials of nail infections did not provide any evidence of benefit for topical treatments compared with placebo. REVIEWER'S CONCLUSIONS CONCLUSIONS: In placebo-controlled trials allylamines, azoles and undecenoic acid were efficacious. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive. The most cost-effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails.

Administration, Topical↗

Patient-assessed measures of health outcome in asthma: a comparison of four approaches.

The study compares the psychometric properties of four different approaches to patient-assessed health outcomes in asthma, including the Asthma Quality of Life Questionnaire (AQLQ), Newcastle Asthma Symptoms Questionnaire (NASQ), SF-12 and EuroQol. The instruments were administered by means of a self-completed postal questionnaire to 394 patients recruited from general practices in the North East of England. Patients completed a follow-up questionnaire at 6 months. The levels of missing data were assessed and instrument scores compared using correlational analysis. Scores were related to self-reports of smoking behaviour, socioeconomic status and health transition. Responsiveness was assessed using standardized response means. Two hundred and thirty-five patients took part in the study giving a response rate of 59.6%. There was a relatively large amount of missing data for the individualized section of the AQLQ. Correlational analysis provided evidence of convergent validity between the specific instruments; the largest correlation was found between NASQ scores and the asthma symptoms scale of the AQLQ (r = 0.84). The NASQ was found to be the most powerful at discriminating between smokers and non-smokers. All four instruments were linearly related to self-reported asthma transition (P<0.05); the specific instruments having the strongest association. The specific instruments showed good levels of responsiveness with the NASQ producing a large SRM of 0.82. SRMs for the AQLQ were of a moderate to large size (0.32-0.77) and the SRMs for the SF-12 and EuroQol were of a small size. The two specific instruments are capable of greater levels of discrimination between groups of patients and are more responsive to changes in health than the generic SF-12 and EuroQol. The greater responsiveness of the NASQ is probably due to its focus being restricted to symptoms of asthma compared to the broader focus of the AQLQ domains. The NASQ has a strong relationship with the AQLQ and is a more practical instrument that is more acceptable to patients. However, the AQLQ does measure broader patient concerns. The SF-12 and EuroQol have greater potential to capture side-effects and have wider scope for application in economic evaluation.

Asthma↗

Guidelines in gynaecology: evaluation in menorrhagia and in urinary incontinence.

OBJECTIVE: To evaluate the effectiveness of national guidelines and local protocols in improving hospital care (process and outcome) for women with menorrhagia and for women with urinary incontinence. DESIGN: 2 x 2 balanced incomplete block controlled before and after study. SETTING: Gynaecology units in four district general hospitals across Scotland. INTERVENTION: National guidelines were adapted locally to protocols, which were disseminated at specific local educational meetings and implemented by placing a copy of the appropriate protocol in women's hospital casenotes prior to consultation. POPULATION: Four hundred and ninety-seven women with menorrhagia and 449 women with urinary Incontinence. MAIN OUTCOME MEASURES: Process of care within six key areas of clinical practice: initial hospital assessment; appropriate use of hospital investigations; inappropriate use of hospital investigations; appropriate first line treatments; appropriate pre-surgery assessment; and use of surgical treatments. Outcome of care using condition-specific outcome measures and four domains of SF-36 at zero, six and twelve months following intervention. RESULTS: There were significant improvements with the introduction of guidelines and protocols in two (initial hospital assessment and appropriate pre-surgery assessment) of the six key areas of clinical practice assessed. In the other areas there were no significant improvements or deteriorations observed. There was no evidence of effect of guidelines and protocols on the condition-specific outcome measures or on the four domains of the SF-36. CONCLUSIONS: There were only very modest benefits observed from the introduction of guidelines and protocols on the hospital management of the two conditions. The reasons for this lack of impact of the guidelines is unclear. Experience of this study raises important methodological issues for future research in this area.

Adult↗

Donor lymphocyte infusions for relapsed multiple myeloma after allogeneic stem-cell transplantation: predictive factors for response and long-term outcome.

PURPOSE: To determine the efficacy, toxicity, and long-term outcome and prognostic factors of donor lymphocyte infusions (DLI) in patients with relapsed multiple myeloma (MM) after allogeneic stem-cell transplantation (AlloSCT). MATERIALS AND METHODS: Twenty-seven patients received 52 DLI courses at a median of 30 months after the previous AlloSCT. Reinduction therapy was administered to 13 patients before DLI. RESULTS: Reinduction therapy was successful in eight of 13 patients. Fourteen patients (52%) responded to DLI, including six patients (22%) who achieved a complete remission (CR). Five patients responded after T-cell dose escalation in subsequent DLIs. Four patients experienced relapse or disease progression (three from partial response and one from CR). Five patients remain in remission more than 30 months after DLI. Major toxicity was acute and chronic graft-versus-host disease (GVHD), which was present in 55% and 26% of patients, respectively. Two patients died from bone marrow aplasia. Median overall survival of all patients was 18 months. Overall survival was 11 months for DLI-resistant patients and has not been reached for the responding patients. In two patients, sustained molecular remission was observed. The factors that were correlated with response to DLI were a T-cell dose of more than 1.10(8) cells/kg, response to reinduction therapy, and chemotherapy-sensitive disease before AlloSCT. CONCLUSION: These data confirm the potential and durable graft-versus-myeloma effect of DLI in patients with relapsed MM after AlloSCT. Future studies should be aimed at increasing response rates, especially in patients with chemoresistant disease, and reducing toxicity by limiting GVHD. Adjuvant DLI seems an attractive and promising approach for patients who do not achieve a molecular remission after AlloSCT.

Adult↗

Systematic review of topical treatments for fungal infections of the skin and nails of the feet.

OBJECTIVE: To identify and synthesise the evidence for efficacy and cost effectiveness of topical treatments for superficial fungal infections of the skin and nails of the feet. DESIGN: Systematic review. INTERVENTIONS: Topical treatments for superficial fungal infections. MAIN OUTCOME MEASURES: Cure confirmed by culture and microscopy for skin and by culture for nails in patients with clinically diagnosed fungal infections. RESULTS: Of 126 trials identified in 121 papers, 72 (57.1%) met the inclusion criteria. Placebo controlled trials yielded pooled relative risks of failure to cure skin infections: allylamines (0.30, 95% confidence interval 0.24 to 0.38); azoles (0.54, 0.42 to 0.68); undecenoic acid (0.28, 0. 11 to 0.74); and tolnaftate (0.46, 0.17 to 1.22). Although meta-analysis of 11 trials comparing allylamines and azoles showed a relative risk of failure to cure of 0.88 (0.78 to 0.99) in favour of allylamines, there was evidence of language bias. Seven reports in English favoured allylamines (0.79, 0.69 to 0.91), but four reports in foreign languages showed no difference between the two drugs (1. 01, 0.90 to 1.13). Neither trial of nail infections showed significant differences between alternative topical treatments. CONCLUSIONS: Allylamines, azoles, and undecenoic acid were efficacious in placebo controlled trials. There are sufficient comparative trials to judge relative efficacy only between allylamines and azoles. Allylamines cure slightly more infections than azoles but are much more expensive than azoles. The most cost effective strategy is first to treat with azoles or undecenoic acid and to use allylamines only if that fails.

Administration, Topical↗

A randomized trial of Evidence-based OutReach (EBOR): rationale and design.

There is increasing interest in evaluating the methods used to implement the findings from medical research. This paper describes the Evidence-based OutReach (EBOR) trial, which is the first large randomized study in the United Kingdom that will evaluate the effectiveness and efficiency of educational outreach visits by trained pharmacists who are delivering messages derived from four evidence-based clinical practice guidelines. General practices form the unit of allocation and analysis. The study design addresses important factors that may influence the effectiveness of the intervention, such as the pharmacist who delivers the messages, the health authority in which practices are located, and the size of a practice.

Family Practice↗

Barriers to participation in randomised controlled trials: a systematic review.

METHOD: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. RESULTS: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. CONCLUSIONS: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.

Data Collection↗

Efficient literature searching in diffuse topics: lessons from a systematic review of research on communicating risk to patients in primary care.

Using the example of communication about risk in a primary care setting, this paper puts forward a method of developing and evaluating a detailed search strategy for locating the literature for a systematic review of a 'diffuse' subject. The aim of this paper is to show how to develop a search strategy that maximizes both recall and precision while keeping search outputs manageable. Six different databases were used, namely Medline, Embase, PsychLIT, CancerLIT, Cinahl and Social Science Citation Index (SSCI). The searches were augmented by hand-searching, contacting authors, citation searching and reference lists from included papers. Other databases were searched but yielded no extra references for this subject matter. Of the 99 papers included, 80 were indexed on Medline. The Medline search strategy identified 54 of them and the remaining 26 were located on other databases. The 19 further unique references were found using the other databases and methods of retrieval. A combination of several databases must be used to maximize recall and to increase the precision of searches on individual databases, thus improving the overall efficiency of the search.

Databases, Bibliographic↗

Multicycle high-dose chemotherapy and filgrastim-mobilized peripheral-blood progenitor cells in women with high-risk stage II or III breast cancer: five-year follow-up.

PURPOSE: To determine the safety and efficacy of multiple cycles of dose-intensive, nonablative chemotherapy in women with poor-prognosis breast cancer. PATIENTS AND METHODS: Women with stage II breast cancer and 10 or more involved nodes or four or more involved nodes and estrogen receptor-negative tumors and women with stage III disease received three cycles of epirubicin 200 mg/m2 and cyclophosphamide 4 g/m2, with progenitor cell and filgrastim support every 28 days (n = 79) or 21 days (n = 20). Patients were reviewed at least twice yearly thereafter. Twenty-six patients had bone marrow and apheresis collections assessed for the presence of micrometastatic tumor cells. RESULTS: Ninety-nine women (median age, 43 years; range, 24 to 60 years) were treated. Ninety-two completed all three cycles of chemotherapy. The major toxicity was severe, reversible myelosuppression that was more prolonged with successive cycles, and this did not differ between patients given treatment every 28 days and those treated every 21 days. Febrile neutropenia occurred in 176 (61%) of 287 cycles. Severe mucositis (grade 3 or 4) occurred in 23% of cycles but tended to be short-lived and was reversible. The cardiac ejection fraction fell by a median of 4% during treatment, and three patients developed evidence of cardiac failure after chemotherapy. Two patients (2%) died of acute toxicity. Three of 26 patients had evidence of circulating micrometastatic tumor cells. The actuarial distant disease-free and overall survival rates at 60-month follow-up were 64% (95% confidence interval [CI], 53% to 75%) and 67% (95% CI, 56% to 78%), respectively. CONCLUSION: Multiple cycles of dose-intensive, nonablative chemotherapy is a feasible and safe approach. Disease control and survival are similar to those in other studies of myeloablative chemotherapy in poor-prognosis breast cancer. The regimen is being evaluated in a randomized trial of the International Breast Cancer Study Group.

Adult↗

Predictors of returning for second round screening at a population based mammographic screening programme in Melbourne, Australia.

OBJECTIVE: To examine factors associated with returning for second round mammography screening. SETTING: This was a population based mammographic screening programme in Melbourne, Australia. DESIGN: A cohort design was used whereby 668 women were interviewed before the screening programme began and attendance for both first and second round screening was ascertained from programme records. The cohort sample was drawn from two regions of a defined area (close to and distant from the screening centre). MAIN RESULTS: Of the 315 women who attended for first round screening, 75% from the proximal sample and 70% from the distal sample returned for second round screening. Attendance at the second round was predicted by the following: the method of recruitment for first round screening, with women who required a letter of invitation and a reminder being less likely to reattend than those who initially attended in response to a community campaign (OR = 0.34; CI 0.19, 0.61); mammographic history before the initial screen, with women who reported previous diagnostic mammography being more likely to reattend than those who did not (OR = 2.97; CI 1.01, 8.9); stated intention of attending for the initial screen, with those with weakest intention of attending for their first round being less likely to attend for second round (OR = 0.44; CI 0.23, 0.85); and increasing scores on a scale that measured preventive orientation to health (OR = 1.24; CI 1.02, 1.50). CONCLUSION: Our findings corroborate other findings of reduced long term attendance for screening from people who are "reluctant participants" initially.

Aged↗

Developing a condition-specific measure of health for patients with dyspepsia and ulcer-related symptoms.

A patient-administered instrument for dyspepsia and symptoms suggestive of duodenal or gastric ulcer, based on the type of questions asked when taking a patient's history, was developed and tested using the following steps: literature reviews, devising the questions, testing the responses to the questions using factor analysis and internal consistency, assessing test-retest reliability, and validating the questionnaire by comparing patient responses to the SF-36 health survey questionnaire. The main sample consisted of 135 patients referred to an outpatient clinic with dyspepsia, and 152 patients in general practice who were not referred to a specialist. The final instrument produced a Cronbach's alpha of 0.72 and an intraclass correlation coefficient of 0.69. Patient scores on the dyspepsia questionnaire had small to moderate correlations with the SF-36 health survey, the largest correlation being with the SF-36 scale of pain. Patient scores were significantly related to general practitioner perceptions of symptom severity, family history of gastric ulcer disease, and whether the patient was referred. The questions asked in taking a clinical history from a patient with dyspepsia and other symptoms suggestive of ulcer disease can be used to construct a valid and reliable measure of the effect of dyspepsia on health.

Adult↗

Developing clinically valid practice guidelines.

Valid guidelines, when appropriately disseminated and implemented, can lead to changes in clinical practice and improvements in patient outcome. Guidelines are more likely to be valid if they are developed using systematic reviews, national or regional guideline development groups (including representatives of key disciplines) and explicit links between recommendations and scientific evidence. This paper discusses the practical implications of adopting this approach for guideline development and the role of peer review guidelines as another element of the process to ensure validity. Considerable resources are required to develop evidence-linked guidelines, but this investment can be recouped by relatively small changes in the process or outcome of care. Good leadership and technical support are required for the successful development of clinically valid guidelines, which is dependent upon the small-group processes of guideline development panels and the translation of evidence into recommendations. Future guideline developers need to gain expertise in these areas. Research priorities are identified.

Consensus Statements as Topic↗