What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey.

OBJECTIVES: The public and patients are primary contributors and beneficiaries of pandemic-relevant clinical research. However, their views on research participation during a pandemic have not been systematically studied. We aimed to understand public views regarding participation in clinical research during a hypothetical influenza pandemic. STUDY DESIGN: This is an international cross-sectional survey. METHODS: We surveyed the views of nationally representative samples of people in Belgium, Poland, Spain, Ireland, the United Kingdom, Canada, Australia and New Zealand, using a scenario-based instrument during the 2017 regional influenza season. Descriptive and regression analyses were conducted. RESULTS: Of the 6804 respondents, 5572 (81.8%) thought pandemic-relevant research was important, and 5089 (74.8%) thought 'special rules' should be applied to make this research feasible. The respondents indicated willingness to take part in lower risk (4715, 69.3%) and higher risk (3585, 52.7%) primary care and lower risk (4780, 70.3%) and higher risk (4113, 60.4%) intensive care unit (ICU) study scenarios. For primary care studies, most (3972, 58.4%) participants preferred standard enrolment procedures such as prospective written informed consent, but 2327 (34.2%) thought simplified procedures would be acceptable. For ICU studies, 2800 (41.2%) preferred deferred consent, and 2623 (38.6%) preferred prospective third-party consent. Greater knowledge about pandemics, trust in a health professional, trust in the government, therapeutic misconception and having had ICU experience as a patient or carer predicted increased willingness to participate in pandemic-relevant research. CONCLUSIONS: Our study indicates current public support for pandemic-relevant clinical research. Tailored information and initiatives to advance research literacy and maintain trust are required to support pandemic-relevant research participation and engagement.

A pragmatic RCT of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos.

BACKGROUND: Intact frozen-thawed embryos have a greater potential than damaged embryos to establish successful pregnancies. This study aimed to determine whether elevated concentrations of sucrose during freezing would increase the proportion of patients with ≥ 50% of embryos intact after thawing (primary outcome), and improve clinical outcome. METHODS: In a two arm, parallel group, pragmatic trial, IVF/ICSI couples were randomized prospectively to have their supernumerary embryos frozen in a medium containing 0.1 M sucrose (control; n = 99) or 0.3 M sucrose (intervention; n = 102). RESULTS: More control (74/99) than intervention (63/102) couples had at least one embryo thawed (P = 0.07). Significantly more (P = 0.005) intervention (53/63) than control (45/74) couples had ≥ 50% of embryos intact. Freezing in a medium containing 0.3 M sucrose increased by 3.4-fold [95% confidence interval (CI) (1.45, 7.82)] the likelihood of a couple having ≥ 50% of their embryos intact. In the fresh cycle, live birth rate per transfer was similar in the control (35/95) and intervention (36/93) groups (P = 0.91). More control (19/63) than intervention (9/59) couples had a live birth after frozen embryo transfer (P = 0.08). When fresh and frozen cycles were combined, fewer intervention (n = 102) than control (n = 99) couples had at least one live birth (42 versus 53%). The difference in cumulative live birth rate was not significant [hazard ratio = 0.75, 95% CI (0.49, 1.13); P = 0.17]. CONCLUSIONS: Increasing the concentration of sucrose in the freezing medium improves embryo survival, but this is not reflected by increased cumulative birth rates. CLINICAL TRIALS REGISTRATION NUMBER: ISRCTN93314892.

Clomifene citrate and intrauterine insemination as first-line treatments for unexplained infertility: are they cost-effective?

BACKGROUND: First-line treatments for unexplained infertility traditionally include clomifene citrate (CC) or unstimulated intrauterine insemination (IUI). A recently published randomized controlled trial considered the effectiveness of CC and IUI in patients with unexplained infertility and found that neither treatment offered a superior live birth rate when compared with expectant management (EM). This paper reports the economic evaluation conducted alongside this trial in order to assess whether health care providers are gaining value for money in this clinical area. METHODS: Five hundred and eighty women across five Scottish hospitals were randomized to either EM, CC or IUI for 6 months. The primary outcome measure was live births. Resource-use data were collected during the trial and costs were calculated from a UK National Health Service (NHS) perspective. Incremental cost-effectiveness ratios were calculated, expressed as cost per live birth, in order to compare the cost-effectiveness of CC and IUI with that of EM to treat unexplained infertility. RESULTS: Live birth rates in the three randomized groups were: EM = 32/193 (17%), CC = 26/194 (13%) and IUI = 43/193 (22%). The mean (standard deviation) costs per treatment cycle were £0 for EM, £83 (£17) for CC and £98 (£31) for IUI. The mean treatment costs per patient for EM, CC and IUI were £12 (£117), £350 (£220) and £331 (£222), respectively. The cost per live birth for EM, CC and IUI was £72 (95% confidence interval £0-£206), £2611 (£1870-£4166) and £1487 (£1116-£2155), respectively. The incremental cost-effectiveness ratio for IUI versus EM was £5604 (-£12204 to £2227), with CC dominated by IUI. CONCLUSIONS: Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples. ISRCT Number: 71762042.

Acupuncture for pain relief during induced labour in nulliparae: a randomised controlled study.

OBJECTIVE: To assess the role of acupuncture for analgesia during labour. DESIGN: Double-blind study of manual, electro and sham acupuncture, and single-blind study comparing acupuncture with a control group for analgesia for labour induction. SETTING: A major obstetric unit in the UK. POPULATION: A cohort of 105 nulliparae undergoing labour induction at term. METHODS: Twenty-three subjects needed to be randomised to each group to have an 80% power of detecting a 50% relative reduction in epidural rate with an alpha value of 0.05. MAIN OUTCOME MEASURES: The primary end point was the rate of intrapartum epidural analgesia, and the secondary end points were parenteral analgesia requirement, labour length, delivery mode, neonatal condition and postpartum haemorrhage. RESULTS: There was no difference in epidural analgesia between acupuncture and sham acupuncture, relative risk 1.18 (95% CI 0.8-1.74), or between acupuncture and control, relative risk 0.88 (95% CI 0.66-1.19). There were no significant differences in the secondary end points between the acupuncture groups and the control group. Side effects or complications of acupuncture were not identified. CONCLUSIONS: Using the protocols studied, there was no analgesic benefit with acupuncture for pain relief during induced labour in nulliparae.

Antimicrobial drug use and infection control practices associated with the prevalence of methicillin-resistant Staphylococcus aureus in European hospitals.

Major regional variations in the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) are observed across Europe. This study investigated hospital MRSA prevalence in relation to patterns of antimicrobial use and infection control policies in an observational, cross-sectional study that used retrospective data from 2001 and linear regression to model relationships. MRSA prevalence (median 20.8%, n = 173 hospitals) and antimicrobial consumption (median 55.2 defined daily doses/100 bed-days, n = 140 hospitals) both varied significantly according to geographical region (p <0.001). MRSA prevalence and antimicrobial consumption data were provided by 128 hospitals, and showed a strong statistical relationship between macrolide use and MRSA prevalence. Use of (i) third-generation cephalosporins, (ii) all antimicrobial agents, and (iii) all antimicrobial agents except glycopeptides was also associated with MRSA prevalence. Up to 146 hospitals provided data on MRSA prevalence and key infection control parameters. Adjusted linear regression modelling provided strong evidence that infection control policy recommendations associated with lower MRSA prevalence rates were (i) use of alcohol-based solutions for hand hygiene (mean difference 10.3%, 99% CI 1.2-10.3), and (ii) placement of MRSA patients in single rooms (mean difference 11.2%, 99% CI 1.4-20.9). Hospitals with problems in implementing isolation policies had higher resistance levels (mean difference 12%, 99% CI 3.8-20.1). Additional recommendations showed less evidence of association with a low MRSA prevalence. Overall, this study highlighted significant associations between MRSA prevalence, antimicrobial use and various key infection control parameters, all of which showed significant individual variations according to geographical region.

Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis (thrush). OBJECTIVES: The primary objective of this review was to assess the relative effectiveness of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. The secondary objectives of the review were to assess the cost-effectiveness, safety and patient preference of oral versus intra-vaginal anti-fungals. SEARCH STRATEGY: The following sources were searched for the original review: The Cochrane Library (Issue 4, 1999), MEDLINE (January 1985 to May 2000), EMBASE (January 1980 to January 2000) and the Cochrane Sexually Transmitted Disease (STD) Group Specialised Register of Controlled Trials. The manufacturers of anti-fungals available in the UK were contacted. For the update, CENTRAL (January 2000 to August 2006), PUBMED (January 2000 to August 2006), EMBASE (January 2000 to August 2006) and the Cochrane STD Group Specialised Register were searched in August 2006. The reference lists of retrieved articles were reviewed manually. SELECTION CRITERIA: Randomised controlled trials published in any language. Trials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. Women (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. The diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). Trials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breast feeding or diabetic. The primary outcome measure was clinical cure. DATA COLLECTION AND ANALYSIS: Two reviewers screened titles and abstracts of the electronic search results and full text of potentially relevant papers. Independent duplicate abstraction was performed by two reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the fixed effects models (except for two analyses when random effects models were used because of potentially important heterogeneity). MAIN RESULTS: Two new trials reporting three comparisons were found in the update. Nineteen trials are included in the review, reporting 22 oral versus intra-vaginal anti-fungal comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short term (OR 0.94, 95% CI, 0.75 to 1.17) and long term (OR 1.07, 95% CI, 0.82 to 1.41) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.15, 95% CI, 0.94 to 1.42). There was a statistically significant difference for long term follow-up (OR 1.29, 95% CI, 1.05 to 1.60) in favour of oral treatment, however the clinical significance of this result is uncertain. Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported. AUTHORS' CONCLUSIONS: No statistically significant differences were observed in clinical cure rates of anti-fungals administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal candidiasis. No definitive conclusion can be made regarding the relative safety of oral and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis. The decision to prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal administration should take into consideration: safety, cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of some oral anti-fungals is worth the gain in convenience, if this is the patient's preference.

Improving the referral process for familial breast cancer genetic counselling: findings of three randomised controlled trials of two interventions.

OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of two complementary interventions, using familial breast cancer as a model condition. The primary care intervention consisted of providing computerised referral guidelines and related education to GPs. The nurse counsellor intervention evaluated genetic nurses as substitutes for specialist geneticists in the initial assessment and management of referred patients. DESIGN: The computerised referral guidelines study was a pragmatic, cluster randomised controlled trial (RCT) with general practices randomised to intervention or control groups. The nurse counsellor intervention was tested in two concurrent RCTs conducted in separate UK health service locations, using predetermined definitions of equivalence. SETTING: The computerised referral guidelines trial took place in general practices in Scotland from November 2000 to June 2001. The nurse counsellor intervention took place in a regional genetics clinic in Scotland, and in two health authorities in Wales served by a single genetics service during 2001. PARTICIPANTS: The computerised referral guidelines study involved GPs and referred patients. Both nurse counsellor intervention trials included women referred for the first time, aged 18 years or over and whose main concern was family history of breast cancer. INTERVENTIONS: The software system was developed with GPs, presenting cancer genetic referral guidelines in a checklist approach. Intervention GPs were invited to postgraduate update education sessions, and both intervention and control practices received paper-based guidelines. The intervention period was November 2000 to June 2001. For the nurse counsellor trial, trial 1 ran outpatient sessions with the same appointment length as the standard service offered by geneticists, but the nurse counsellor saw new patients at the first appointment and referred back to the GP or on to a clinical geneticist according to locally developed protocol, under the supervision of a consultant geneticist. The control intervention was the current service, which comprised an initial and a follow-up appointment with a clinical geneticist. In trial 2, a nurse counsellor ran outpatient sessions with the same appointment length as the new consultant-based cancer genetics service and new patients were seen at the first appointment and referred as in trial 1. The control intervention was a new service, and comprised collection of family history by telephone followed by a consultation with a clinical assistant or a specialist registrar, supervised by a consultant. The intervention was implemented between 1998 and 2001. MAIN OUTCOME MEASURES: In the software system trial, the primary outcome was GPs' confidence in their management of patients with concerns about family history of breast cancer. For the nurse counsellor trial, the primary outcome was patient anxiety, measured using standard scales. RESULTS: In the software system trial, 57 practices (230 GPs) were randomised to the intervention group and 29 (116 GPs) to the control group. No statistically significant differences were detected in GPs' confidence or any other outcomes. Fewer than half of the intervention GPs were aware of the software, and only 22 reported using it in practice. The estimated total cost was GBP3.12 per CD-ROM distributed (2001 prices). For the two arms of the nurse counsellor trial, 289 patients (193 intervention, 96 control) and 297 patients (197 intervention and 100 control) consented, were randomised, returned a baseline questionnaire and attended the clinic for trials 1 and 2 respectively. The analysis in both cases suggested equivalence in all anxiety scores, and no statistically significant differences were detected in other outcomes in either trial. A cost-minimisation analysis suggested that the cost per counselling episode was GBP10.23 lower in intervention arm than in the control arm and GBP10.89 higher in the intervention arm than in the control arm (2001 prices) for trials 1 and 2, respectively. Taking the trials together, the costs were sensitive to the grades of doctors and the time spent in consultant supervision of the nurse counsellor, but they were only slightly affected by the grade of nurse counsellor, the selected discount rate and the lifespan of equipment. CONCLUSIONS: Computer-based systems in the primary care intervention cannot be recommended for widespread use without further evaluation and testing in real practice settings. Genetic nurse counsellors may be a cost-effective alternative to assessment by doctors. This trial does not provide definitive evidence that the general policy of employing genetics nurse counsellors is sound, as it was based on only three individuals. Future evaluations of computer-based decision support systems for primary care must first address their efficacy under ideal conditions, identify barriers to the use of such systems in practice, and provide evidence of the impact of the policy of such systems in routine practice. The nurse counsellor trial should be replicated in other settings to provide reassurance of the generalisability of the intervention and other models of nurse-based assessment, such as in outreach clinics, should be developed and evaluated. The design of future evaluations of professional substitution should also address issues such as the effect of different levels of training and experience of nurse counsellors, and learning effects.

Teaching undergraduates about familial breast cancer: comparison of a computer assisted learning (CAL) package with a traditional tutorial approach.

We have developed a computer assisted learning package for teaching clinical medical students about familial breast cancer. It explains the principles of genetic predisposition to breast cancer, the association with other cancers, the principles of family history taking and confirmation, risk assessment and possible interventions. Clinical medical students were randomised to either conventional teaching or CAL, 48 students attended the evaluation session. Students randomised to conventional teaching received a 20 min mini-lecture, those randomised to CAL completed the package with technical, but not academic support available. At the end of the intervention both groups of students completed a short written assessment of acceptability and knowledge and understanding of breast cancer genetics. There was no significant difference between the CAL and mini-lecture groups in terms of marks or acceptability. Thus CAL appears to be an acceptable and effective method of teaching clinical medical students about familial breast cancer. Although time consuming to develop, CAL can be used in a variety of settings to increase curriculum flexibility. Methods of motivating students to complete the CAL, and of providing educational support are being explored.

The measurement and monitoring of surgical adverse events.

BACKGROUND: Surgical adverse events contribute significantly to postoperative morbidity, yet the measurement and monitoring of events is often imprecise and of uncertain validity. Given the trend of decreasing length of hospital stay and the increase in use of innovative surgical techniques--particularly minimally invasive and endoscopic procedures--accurate measurement and monitoring of adverse events is crucial. OBJECTIVES: The aim of this methodological review was to identify a selection of common and potentially avoidable surgical adverse events and to assess whether they could be reliably and validly measured, to review methods for monitoring their occurrence and to identify examples of effective monitoring systems for selected events. This review is a comprehensive attempt to examine the quality of the definition, measurement, reporting and monitoring of selected events that are known to cause significant postoperative morbidity and mortality. METHODS - SELECTION OF SURGICAL ADVERSE EVENTS: Four adverse events were selected on the basis of their frequency of occurrence and likelihood of evidence of measurement and monitoring: (1) surgical wound infection; (2) anastomotic leak; (3) deep vein thrombosis (DVT); (4) surgical mortality. Surgical wound infection and DVT are common events that cause significant postoperative morbidity. Anastomotic leak is a less common event, but risk of fatality is associated with delay in recognition, detection and investigation. Surgical mortality was selected because of the effort known to have been invested in developing systems for monitoring surgical death, both in the UK and internationally. Systems for monitoring surgical wound infection were also included in the review. METHODS - LITERATURE SEARCH: Thirty separate, systematic literature searches of core health and biomedical bibliographic databases (MEDLINE, EMBASE, CINAHL, HealthSTAR and the Cochrane Library) were conducted. The reference lists of retrieved articles were reviewed to locate additional articles. A matrix was developed whereby different literature and study designs were reviewed for each of the surgical adverse events. Each article eligible for inclusion was independently reviewed by two assessors. METHODS - CRITICAL APPRAISAL: Studies were appraised according to predetermined assessment criteria. Definitions and grading scales were assessed for: content, criterion and construct validity; repeatability; reproducibility; and practicality (surgical wound infection and anastomotic leak). Monitoring systems for surgical wound infection and surgical mortality were assessed on the following criteria: (1) coverage of the system; (2) whether or not denominator data were collected; (3) whether standard and agreed definitions were used; (4) inclusion of risk adjustment; (5) issues related to data collection; (6) postdischarge surveillance; (7) output in terms of feedback and wider dissemination. RESULTS - SURGICAL WOUND INFECTION: A total of 41 different definitions and 13 grading scales of surgical wound infection were identified from 82 studies. Definitions of surgical wound infection varied from presence of pus to complex definitions such as those proposed by the Centres for Disease Control in the USA. A small body of literature has been published on the content, criterion and construct validity of different definitions, and comparisons have been made against wound assessment scales and multidimensional indices. There are examples of comprehensive hospital-based monitoring systems of surgical wound infection, mainly under the auspices of nosocomial surveillance. To date, however, there is little evidence of systematic measurement and monitoring of surgical wound infection after hospital discharge. RESULTS - ANASTOMOTIC LEAK: Over 40 definitions of anastomotic leak were extracted from 107 studies of upper gastrointestinal, hepatopancreaticobiliary and lower gastrointestinal surgery. No formal evaluations were found that assessed the validity or reliability of definitions or severity scales of anastomotic leak. One definition was proposed during a national consensus workshop, but no evidence of its use was found in the surgical literature. The lack of a single definition or gold standard hampers comparison of postoperative anastomotic leak rates between studies and institutions. RESULTS - DEEP VEIN THROMBOSIS: Although a critical review of the DVT literature could not be completed within the realms of this review, it was evident that a number of new techniques for the detection and diagnosis of DVT have emerged in the last 20 years. The group recommends a separate review be undertaken of the different diagnostic tests to detect DVT. RESULTS - SURGICAL MORTALITY MONITORING SYSTEMS: The definition of surgical mortality is relatively consistent between monitoring systems, but duration of follow-up of death postdischarge varies considerably. The majority of systems report in-hospital mortality rates; only some have the potential to link deaths to national death registers. Risk assessment is an important factor and there should be a distinction between recording pre-intervention factors and postoperative complications. A variety of risk scoring systems was identified in the review. Factors associated with accurate and complete data collection include the employment of local, dedicated personnel, simple and structured prompts to ensure that clinical input is complete, and accurate and automated data capture and transfer. CONCLUSIONS: The use of standardised, valid and reliable definitions is fundamental to the accurate measurement and monitoring of surgical adverse events. This review found inconsistency in the quality of reporting of postoperative adverse events, limiting accurate comparison of rates over time and between institutions. The duration of follow-up for individual events will vary according to their natural history and epidemiology. Although risk-adjusted aggregated rates can act as screening or warning systems for adverse events, attribution of whether events are avoidable or preventable will invariably require further investigation at the level of the individual, unit or department. CONCLUSIONS - RECOMMENDATIONS FOR RESEARCH: (1) A single, standard definition of surgical wound infection is needed so that comparisons over time and between departments and institutions are valid, accurate and useful. Surgeons and other healthcare professionals should consider adopting the 1992 Centers for Disease Control (CDC) definition for superficial incisional, deep incisional and organ/space surgical site infection for hospital monitoring programmes and surgical audits. There is a need for further methodological research into the performance of the CDC definition in the UK setting. (2) There is a need to formally assess the reliability of self-diagnosis of surgical wound infection by patients. (3) There is a need to assess formally the reliability of case ascertainment by infection control staff. (4) Work is needed to create and agree a standard, valid and reliable definition of anastomotic leak which is acceptable to surgeons. (5) A systematic review is needed of the different diagnostic tests for the diagnosis of DVT. (6) The following variables should be considered in any future DVT review: anatomical region (lower limb, upper limb, pelvis); patient presentation (symptomatic, asymptomatic); outcome of diagnostic test (successfully completed, inconclusive, technically inadequate, negative); length of follow-up; cost of test; whether or not serial screening was conducted; and recording of laboratory cut-off values for fibrinogen equivalent units. (7) A critical review is needed of the surgical risk scoring used in monitoring systems. (8) In the absence of automated linkage there is a need to explore the benefits and costs of monitoring in primary care. (9) The growing potential for automated linkage of data from different sources (including primary care, the private sector and death registers) needs to be explored as a means of improving the ascertainment of surgical complications, including death. This linkage needs to be within the terms of data protection, privacy and human rights legislation. (10) A review is needed of the extent of the use and efficiency of routine hospital data versus special collections or voluntary reporting.

The quality of measurement of surgical wound infection as the basis for monitoring: a systematic review.

Comparison of postoperative surgical wound infection rates between institutions and over time is only valid if standard, valid and reliable definitions are used. The aim of this review was to assess evidence of validity and reliability of the definition and measurement of surgical wound infection. A systematic review was undertaken of prospective studies of surgical wound infection published over a seven-year period; 1993-1999. The information extracted from individual studies included: definition of surgical wound infection; details of wound assessment scale, scoring or grading scale systems; and evidence of assessment of validity, reliability and feasibility of identified definitions and grading systems. Two independent reviewers appraised 112 prospective studies, 90 of which were eligible for inclusion; eight studies assessed validity and/or reliability. Forty-one different definitions of surgical wound infection were identified, five of which were 'standard' definitions proposed by multi-disciplinary groups. Presence of pus was the most frequently used single component of any definition; the CDC definitions of 1988 and 1992 were the most widely implemented standard definitions; and the ASEPSIS wound assessment scale was the most frequently used quantitative grading tool. Only two formal validations of a definition were found, and six studies of reliability. This review highlights the extent of variation in definition of surgical wound infection used in clinical practice, and the need for validation of both content and organization of a surveillance system. However, realistically, there will have to be a balance between the quality of the measurement and the practicality of surveillance.

Attitudinal factors associated with community pharmacists' involvement in services for drug misusers.

AIM: To assess the relationship between pharmacists' attitudes towards drug misusers and the availability and provision of services for drug misusers. DESIGN: A cross-sectional postal questionnaire survey. SETTING: All community pharmacies in Scotland (n = 1142). PARTICIPANTS: A total of 864 pharmacists managing community pharmacies on a day-to-day basis (response rate 79%). MEASUREMENTS: Descriptive data were collected on demography, drug misuse services provided and training in drug misuse. Attitude statements were used to measure attitudes to drug misusers, the role of the pharmacist in dispensing controlled drugs and providing injecting equipment, providing advice on drug misuse and financial aspects of service provision. Statements were incorporated into a scale which was correlated with behavioural data on whether and how services were provided. RESULTS: The attitude scale had good internal reliability and was unidimensional. Pharmacists that provided needle/syringe exchanges, sold needles/syringes, dispensed methadone, supervised the consumption of methadone and provided health promotion services to drug misusers had significantly more positive attitudes towards drug misusers. Attitudes were associated with health board area, sex and number of years registered as a pharmacist. After controlling for these characteristics, attitude was an independent predictor of whether needles/syringes were sold, methadone was dispensed and methadone consumption supervised. CONCLUSIONS: Addressing negative attitudes could encourage more pharmacists to provide services and enhance the process of service delivery.

Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of uncomplicated vulvovaginal candidiasis (thrush). OBJECTIVES: The primary objective of this review was to assess the relative effectiveness of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. The secondary objectives of the review were to assess the cost-effectiveness, safety and patient preference of oral versus intra-vaginal anti-fungals. SEARCH STRATEGY: The following sources were searched: The Cochrane Library (Issue 4, 1999), MEDLINE (January 1985 to May 2000), EMBASE (January 1980 to January 2000) and the Cochrane Collaboration Sexually Transmitted Disease Group Specialised Register of Controlled Trials. The reference lists of retrieved articles were reviewed manually. The manufacturers of anti-fungals available in the UK were contacted. SELECTION CRITERIA: ~bullet~Randomised controlled trials published in any language. ~bullet~Trials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. ~bullet~Women (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. ~bullet~The diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). ~bullet~Trials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breastfeeding or diabetic. ~bullet~The primary outcome measure was clinical cure. DATA COLLECTION AND ANALYSIS: Duplicate scrutiny was performed of the titles and abstracts of the electronic search results. Full article formats of all selected abstracts were retrieved and independently assessed by two reviewers. Independent duplicate abstraction was performed by four reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the random effects model. Chi-squared tests with a p-value of less than 0.1 indicated heterogeneity in the results. MAIN RESULTS: Seventeen trials are included in the review, reporting 19 oral versus intra-vaginal anti-fungal comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short term (OR 1.00 (95% CI, 0.72 to 1.40)) and long term (OR 1.03 (95% CI, 0.72 to 1.49)) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.20 (95% CI, 0.87 to 1.65)) or long term follow-up (OR 1.30 (95% CI, 0.99 to 1.71)). Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported. REVIEWER'S CONCLUSIONS: No differences exist in terms of the relative effectiveness (measured as clinical and mycological cure) of anti-fungals administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal candidiasis. No definitive conclusion can be made regarding the relative safety of oral and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis. The oral route of administration is the preferred route for anti-fungals for the treatment of vulvovaginal candidiasis. The decision to prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal administration should take into consideration: safety, cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications, women who are purchasing their own treatment should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of oral anti-fungal administration is worth the gain in convenience, if this is the patient's preference.

Oral versus intra-vaginal imidazole and triazole anti-fungal treatment of uncomplicated vulvovaginal candidiasis (thrush).

BACKGROUND: Anti-fungals are available for oral and intra-vaginal treatment of vulvovaginal candidiasis (thrush). OBJECTIVES: The primary objective of this review was to assess the relative effectiveness of oral versus intra-vaginal anti-fungals for the treatment of uncomplicated vulvovaginal candidiasis. The secondary objectives of the review were to assess the cost-effectiveness, safety and patient preference of oral versus intra-vaginal anti-fungals. SEARCH STRATEGY: The following sources were searched: The Cochrane Library (Issue 4, 1999), MEDLINE (January 1985 to May 2000), EMBASE (January 1980 to January 2000) and the Cochrane Collaboration Sexually Transmitted Disease Group Specialised Register of Controlled Trials. The reference lists of retrieved articles were reviewed manually. The manufacturers of anti-fungals available in the UK were contacted. SELECTION CRITERIA: ~Bullet~Randomised controlled trials published in any language. ~Bullet~Trials had to compare at least one oral anti-fungal with one intra-vaginal anti-fungal. ~Bullet~Women (aged 16 years or over) with uncomplicated vulvovaginal candidiasis. ~Bullet~The diagnosis of vulvovaginal candidiasis to be made mycologically (i.e. a positive culture and / or microscopy for yeast). ~Bullet~Trials were excluded if they solely involved subjects who were HIV positive, immunocompromised, pregnant, breastfeeding or diabetic. ~Bullet~The primary outcome measure was clinical cure. DATA COLLECTION AND ANALYSIS: Duplicate scrutiny was performed of the titles and abstracts of the electronic search results. Full article formats of all selected abstracts were retrieved and independently assessed by two reviewers. Independent duplicate abstraction was performed by four reviewers. Disagreements regarding trial inclusion or data abstraction were resolved by discussion between the reviewers. Odds ratios were pooled using the random effects model. Chi-squared tests with a p-value of less than 0.1 indicated heterogeneity in the results. MAIN RESULTS: Seventeen trials are included in the review, reporting 19 oral versus intra-vaginal anti-fungal comparisons. No statistically significant differences were shown between oral and intra-vaginal anti-fungal treatment for clinical cure at short term (OR 1.00 (95% CI, 0.72 to 1.40)) and long term (OR 1.03 (95% CI, 0.72 to 1.49)) follow-up. No statistically significant differences for mycological cure were observed between oral and intra-vaginal treatment at short term (OR 1.20(95% CI, 0.87 to 1.65)) or long term follow-up (OR 1.30 (95% CI, 0.99 to 1.71)). Two trials each reported one withdrawal from treatment due to an adverse reaction. Treatment preference data were poorly reported. REVIEWER'S CONCLUSIONS: No differences exist in terms of the relative effectiveness (measured as clinical and mycological cure) of anti-fungals administered by the oral and intra-vaginal routes for the treatment of uncomplicated vaginal candidiasis. No definitive conclusion can be made regarding the relative safety of oral and intra-vaginal anti-fungals for uncomplicated vaginal candidiasis. The oral route of administration is the preferred route for anti-fungals for the treatment of vulvovaginal candidiasis. The decision to prescribe or recommend the purchase of an anti-fungal for oral or intra-vaginal administration should take into consideration: safety, cost and treatment preference. Unless there is a previous history of adverse reaction to one route of administration or contraindications: if women are purchasing their own treatment, they should be given full information about the characteristics and costs of treatment to make their own decision. If health services are paying the treatment cost, decision-makers should consider whether the higher cost of oral anti-fungal administration is worth the gain in convenience, if this is the patient's preference.

A prospective randomised study of the effects of prophylactic antibiotics on the incidence of bacteraemia following hysteroscopic surgery.

OBJECTIVE: To study the effect of prophylactic antibiotics on the incidence of bacteraemia following hysteroscopic surgery. DESIGN: Prospective randomized study. SETTING: Aberdeen Royal Infirmary. SUBJECTS: One hundred and sixteen women about to undergo either endometrial laser ablation (ELA) or transcervical resection of the endometrium (TCRE). INTERVENTION: Fifty-five women were randomised to receive 1.2 g of Augmentin (co-amoxiclav) i.v. at induction of anaesthesia. Sixty-one women received no antibiotic prophylaxis. Blood cultures were obtained at the end of the surgical procedure. RESULTS: Incidence of bacteraemia in the non-antibiotic group (16%) was significantly higher than that in the antibiotic group (2%) (95% confidence interval for difference from 5% to 25%). The majority of organisms were of dubious clinical significance and contamination could not be excluded in 7 cases out of 10. CONCLUSION: There is no convincing evidence that antibiotics are of value in this clinical setting.

Admission-discharge policies for hysteroscopic surgery: a randomised comparison of day case with in-patient admission.

OBJECTIVE: To study the effectiveness and acceptability of day case hysteroscopic surgery. DESIGN: Prospective randomised controlled trial. SETTING: Aberdeen Royal Infirmary. SUBJECTS: One hundred and ninety four consecutive women who underwent hysteroscopic endometrial ablation. INTERVENTION: Seventy three women were allocated to day case surgery and 37 to inpatient admission; 84 women though otherwise fit for day case surgery were scheduled for in-patient admission as they lived more than 20 miles away. All women completed a questionnaire 24 h after their operations. Readmission rates were obtained from case notes. Satisfaction rates 12 months after the operation were recorded by means of a follow-up questionnaire. RESULTS: Post-operative pain was absent or slight in 48 (75%) of the women in the day case group 27 (84%) of women in the in-patient group, and 55 (82%) in the non-randomised in-patient group. Post-operative analgesia was necessary in 34 (52%) women in the day case group, 24 (75%) women in the in-patient group and 36 (53%) women in the non-randomised in-patient group. Hospital costs were significantly less in the day case group. Satisfaction with stay 92% in the day case group, and 100% in the other two groups. CONCLUSION: In this setting, day care is a safe acceptable and less expensive alternative to in-patient care for hysteroscopic endometrial ablation.

A cost comparison of hysterectomy and hysteroscopic surgery for the treatment of menorrhagia.

OBJECTIVES: To estimate and compare the costs of treating women with menorrhagia by hysterectomy or hysteroscopic surgery, in the form of transcervical resection of the endometrium (TCRE) or endometrial laser ablation (ELA). STUDY DESIGN: Randomised controlled trial set in the gynaecological department of a large British teaching hospital. Under usual circumstances, 204 women who would have undergone hysterectomy for menorrhagia were randomly allocated to either hysterectomy (n = 99) or hysteroscopic surgery in the form of TCRE (n = 52) or ELA (n = 53). National Health Service (NHS) costs and costs to patients per patient occurring up to 1 year following surgery were estimated. Theatre times and length of hospital stay were recorded during the trial. Costs were obtained from the health board finance department and relevant suppliers of technical equipment. One year after treatment patients completed questionnaires on personal costs incurred. RESULTS: The NHS costs of treating women with hysteroscopic surgery were 24% (TCRE) or 20% (ELA) less than treating women by hysterectomy (1001 pounds/1046 pounds vs. 1315 pounds). On average, women undergoing hysteroscopic surgery incurred 71% less costs to themselves than those who underwent hysterectomy (21 pounds vs. 73.40 pounds). CONCLUSIONS: Hysteroscopic endometrial ablation incurs less costs than hysterectomy both to the National Health Service and to women alike, up to 1 year after surgery.

Costs of intrapartum care in a midwife-managed delivery unit and a consultant-led labour ward.

OBJECTIVE: to investigate whether there are differences between the cost of intrapartum care for women at low obstetric risk in a midwife-managed labour and delivery unit and that in a consultant-led labour and delivery ward. DESIGN: cost analysis based on the findings of a randomised controlled trial comparing two alternative types of intrapartum care. SETTING: Aberdeen Maternity Hospital, Grampian. SUBJECTS: the number of women 'booked' for care in the Midwives' Unit in a standard year and a comparable group of women cared for in the consultant-led labour ward. PRIMARY OUTCOME MEASURE: the cost 'outcome' is the extra (or reduced) cost per woman resulting from the introduction of a midwife-managed delivery unit. FINDINGS: the baseline extra cost of the introduction of the Midwives' Unit was found to be 40.71 pounds per woman. Depending on the scenario used, this ranged from a cost saving of 9.74 pounds per woman to an additional cost of 44.23 pounds per woman. CONCLUSIONS: this study has shown that, in terms of costs incurred during the intrapartum period, the marginal cost of caring for women at low obstetric risk alongside women at high obstetric risk in a standard labour ward is small. However, the impact of establishing a separate midwife-managed delivery unit, requiring an increase in midwifery staffing levels, can be significant.

Satisfaction and continuity of care: staff views of care in a midwife-managed delivery unit.

OBJECTIVE: to examine whether there are differences in the midwife's role in, and satisfaction with, intrapartum care and delivery of women at low obstetric risk in a midwife-managed delivery unit compared to a consultant-led labour ward. DESIGN: a pragmatic randomised controlled trial. Subjects were randomised in a 2:1 ratio between the midwives' unit and the labour ward. SETTING: Aberdeen Maternity Hospital, Grampian, UK. SUBJECTS: midwives within the delivery suite who cared for the 2844 women at low obstetric risk receiving care in a pragmatic randomised controlled trial of the two delivery areas. PRIMARY OUTCOME MEASURES: continuity of carer and midwife satisfaction. FINDINGS: midwives looking after women in the midwives' unit group were significantly more likely to be of a higher grade, more qualified and have a longer length of experience than those in the labour ward group. There was greater continuity of carer both during labour and after delivery in the midwives' unit group. Despite a small but statistically significant difference in overall satisfaction between the groups, area of 'booking' or area of delivery were not important in predicting midwife satisfaction. Autonomy and continuity of carer were the best predictors of midwife satisfaction. CONCLUSIONS: midwife-managed intrapartum care increases continuity of carer and, therefore, midwife satisfaction. Extending this outside the delivery suite requires a system of care that is acceptable to midwives as well as women. Such systems will depend to a large extent on geography, consumer demand and availability of resources. However, midwife satisfaction should also be considered. In order to do this further research is required to fully evaluate the effect these systems have on the midwives working in them.

A randomised controlled trial of two pressure-reducing surfaces.

This randomised controlled trial of two dry-flotation pressure-reducing surfaces evaluates pressure sore incidence, patient comfort and the appropriate use of equipment in 100 orthopaedic patients. The trial involved five full Roho mattresses, five Sofflex mattresses and 10 Roho Quatro cushions to be used to complement the beds. Given the low rate of pressure sore incidence in this high-risk group it is not possible to determine whether there is any difference in effectiveness between the two mattresses. Both appear to provide similar levels of comfort, with the majority of patients finding them either comfortable or very comfortable. The initial setting of the equipment was, however, unsatisfactory.

Midwife managed delivery unit: a randomised controlled comparison with consultant led care.

OBJECTIVE: To examine whether intrapartum care and delivery of low risk women in a midwife managed delivery unit differs from that in a consultant led labour ward. DESIGN: Pragmatic randomised controlled trial. Subjects were randomised in a 2:1 ratio between the midwives unit and the labour ward. SETTING: Aberdeen Maternity Hospital, Grampian. SUBJECTS: 2844 low risk women, as defined by existing booking criteria for general practitioner units in Grampian. 1900 women were randomised to the midwives unit and 944 to the labour ward. MAIN OUTCOME MEASURES: Maternal and perinatal morbidity. RESULTS: Of the women randomised to the midwives unit, 647 (34%) were transferred to the labour ward antepartum, 303 (16%) were transferred intrapartum, and 80 (4%) were lost to follow up. 870 women (46%) were delivered in the midwives unit. Primigravid women (255/596, 43%) were significantly more likely to be transferred intrapartum than multi-gravid women (48/577, 8%). Significant differences between the midwives unit and labour ward were found in monitoring, fetal distress, analgesia, mobility, and use of episiotomy. There were no significant differences in mode of delivery or fetal outcome. CONCLUSIONS: Midwife managed intrapartum care for low risk women results in more mobility and less intervention with no increase in neonatal morbidity. However, the high rate of transfer shows that antenatal criteria are unable to determine who will remain at low risk throughout pregnancy and labour.