Improvement of facial skin characteristics using copper oxide containing pillowcases: a double-blind, placebo-controlled, parallel, randomized study.

Copper plays a key role in several processes of skin formation and regeneration. Copper has been shown to be absorbed through intact skin. We hypothesized that sleeping on fabrics containing copper-impregnated fibres would have a positive cosmetic effect on the skin. The aim of this study was to confirm our hypothesis. A 4-week, double blind, parallel, randomized study was carried out in which 57 volunteers aged 40-60 years used either copper oxide containing pillowcases (0.4% weight/weight) or control pillowcases not containing copper. Photographs were taken by a professional photographer of each participant at the beginning of the study and at 2 and 4 weeks after the commencement of the study. Two expert graders (a dermatologist and a cosmetologist) evaluated the pictures for the effect on several cosmetic facial skin characteristics. The copper-containing pillowcases had a positive effect for the following facial characteristics: reduction of wrinkles (P < 0.001) and crow's feet/fine lines (P < 0.001) and improvement of general appearance (P < 0.001) at both 2 and 4 weeks. The differences were statistically significant (Wilcoxon scores and chi-squared tests). Consistent sleeping for 4 weeks on copper oxide containing pillowcases caused a significant reduction in the appearance of facial wrinkles and crow's feet/fine lines and significant improvement in the appearance of facial skin. In most trial participants, this effect was already noticeable within 2 weeks of using the copper oxide containing pillowcases.

Pegylated interferon alpha-2a and -2b in combination with ribavirin in the treatment of chronic hepatitis C: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical-effectiveness and cost-effectiveness of pegylated interferon-alpha combined with ribavirin in the treatment of chronic hepatitis C. DATA SOURCES: Electronic databases, reference lists of retrieved reports, and the industry submissions to the National Institute for Clinical Excellence. REVIEW METHODS: Sources were rigorously searched and studies were selected that met the inclusion criteria of being randomised controlled trials (RCTs) involving comparisons between pegylated interferon-alpha plus ribavirin and non-pegylated interferon plus ribavirin (two trials) or pegylated interferon alone and non-pegylated interferon alone (four trials). The primary outcome in all trials was sustained virological response (SVR) at follow-up. The trials were generally of good quality, although reporting of methodological details could have been more thorough in places. A cost-effectiveness model followed a hypothetical cohort of 1000 individuals with chronic hepatitis C over a 30-year period. RESULTS: In the two trials that tested pegylated interferon plus ribavirin against non-pegylated interferon plus ribavirin the combined percentage of sustained virological response was 55%. The relative risk (RR) for remaining infected was reduced by 17% for pegylated interferon plus ribavirin compared with non-pegylated interferon plus ribavirin. Response to therapy varied according to viral genotype. Patients with genotype 1 had the lowest levels of sustained virological response and patients with genotype 2 or 3 had the highest. In the four trials that evaluated pegylated interferon monotherapy against non-pegylated interferon the combined sustained virological response rates were 31% for pegylated interferon and 14% for non-pegylated interferon. The RR for remaining infected with hepatitis C was reduced by 20% with the use of pegylated interferon. Patients with genotype 1 had the lowest levels of sustained virological response. There were also variations in sustained virological response according to other prognostic variables such as baseline viral load. Regimens involving pegylated interferon appear to be fairly well tolerated. Adverse events were been reported, but they did not differ substantially from levels of adverse events in regimens involving non-pegylated interferon. The incremental discounted cost per QALY for comparing no active treatment to 48 weeks of dual therapy with pegylated interferon and ribavirin (PEG + RBV) was 6045 pounds sterling. When moving from 48 weeks of dual therapy with non-pegylated interferon and ribavirin (IFN + RBV) to 48 weeks of dual therapy with PEG + RBV the figure was 12,123 pounds sterling. Subgroup analyses for dual PEG + RBV therapy demonstrated that the most favourable incremental discounted cost per QALY estimates were for patients infected with genotypes 2 and 3, and with low baseline viral load (3921 pounds sterling) compared with no active treatment. Results of one-way sensitivity analyses showed that the estimates varied according to differences in SVRs, drug costs and discount rates. In general estimates remained under 30,000 pounds sterling per QALY. The incremental discounted cost per QALY when moving from no active treatment to 48 weeks of monotherapy with pegylated interferon was 6484 pounds sterling. When moving from 48 weeks of monotherapy with IFN to 48 weeks of monotherapy with PEG the figure was 8404 pounds sterling. As with dual therapy, the lowest incremental cost per QALY was for patients with genotypes 2 and 3 and low baseline viral load, in the range 2641-4194 pounds sterling. The highest estimates were for patients with genotype 1 and high baseline viral load, around 30,000 pounds sterling. CONCLUSIONS: Well-designed RCTs show that patients treated with pegylated interferon, both as dual therapy and as monotherapy, experience higher sustained viral response rates than those treated with non-pegylated interferon. Patients with genotypes 2 and 3 experience the highest response, with rates in excess of 80%. Patients with the harder to treat genotype 1 nevertheless benefit, with up to 46% of patients experiencing an SVR in one of the trials. Pegylated interferon also appears to be relatively cost-effective in both monotherapy and dual therapy, with cost per QALY estimates remaining generally under 30,000 pounds sterling. The most favourable estimates were for patients with genotypes 2 and 3. Pegylated interferon is a relatively new intervention in the treatment of hepatitis C and therefore there are areas where further research is needed. These include: efficacies of therapy with PEG-alpha-2a vs PEG-alpha-2b; retreatment of previous non-responders using pegylated interferon; efficacy of treatments and long-term outcomes in patients who have other co-morbidities; prospective tests of rules governing stopping treatment; treating patients with acute hepatitis C; problems that may occur in a minority of patients with hepatitis C, such as cryoglobulinaemia and vasculitis; additional psychological effects on quality of life due to hepatitis C and also on the treatment of children and adolescents with hepatitis C.

Involving consumers in research and development agenda setting for the NHS: developing an evidence-based approach.

OBJECTIVES: To look at the processes and outcomes of identification and prioritisation in both national and regional R&D programmes in health and elsewhere, drawing on experiences of success and failure. Also to identify the barriers to, and facilitators of, meaningful participation by consumers in research identification and prioritisation. DATA SOURCES: Electronic databases and interviews with UK consumers and research programme managers. REVIEW METHODS: A framework was devised for examining the diverse ways of involving consumers in research. It identified key distinguishing features as: the types of consumers involved; whether consumers or researchers initiated the involvement; the degree of consumer involvement (consultation, collaboration or consumer control); forums for communication (e.g. committees, surveys, focus groups); methods for decision-making; and the practicalities for implementation. Context (institutional, geographical and historical setting) and underpinning theories were considered as important variables for analysing examples of consumer involvement. This innovative framework was then applied to the review data from reports selected for inclusion and interviews. RESULTS: The study found 286 documents explicitly mentioning consumer involvement in identifying or prioritising research topics. Of these, 91 were general discussions, some of which included a theoretical analysis or a critique of research agendas from a consumer perspective, 160 reported specific efforts to include consumers in identifying or prioritising research topics and a further 51 reported consumers identifying or prioritising research topics in the course of other work. Detailed reports of 87 specific examples were identified. Most of this literature was descriptive reports by researchers who were key actors in involving consumers. A few reports were written by consumer participants. Fewer still were by independent researchers. Our conclusions are therefore not based on rigorous research, but implications for policy are drawn from individual reports and comparative analyses. CONCLUSIONS: Productive methods for involving consumers require appropriate skills, resources and time to develop and follow appropriate working practices. The more that consumers are involved in determining how this is to be done, the more research programmes will learn from consumers and about how to work with them. Further success might be expected if research programmes embarking on collaborations approach well-networked consumers and provide them with information, resources and support to empower them in key roles for consulting their peers and prioritising topics. To be worthwhile, consultations should engage consumer groups directly and repeatedly in facilitated debate; when discussing health services research, more resources and time are required if consumers are drawn from groups whose main focus of interest is not health. These barriers can largely be overcome with good leadership, purposeful outreach to consumers, investing time and effort in good communication, training and support and thereby building good working relationships and building on experience. Organised consumer groups capable of identifying research priorities also need to find ways of introducing their ideas into research programmes. Further research is suggested to develop and evaluate different training methods, information and education and other support for consumers and those wishing to involve them; to address the barriers to consumers' ideas influencing research agendas; and to carry out prospective comparative studies of different methods for involving consumers. Research about collective decision-making would also be further advanced by addressing the processes and outcomes of consensus development that involves consumers.

The role of performance indicators in changing the autonomy of the general practice profession in the UK.

Performance indicators (PIs) are widely used across the UK public sector, but they have only recently been applied to clinical care. In doing so, they challenge a previously guarded aspect of clinical autonomy-the assessment of work performance. This "challenge" is specific to a primary care setting and in the general practice profession. This paper reviews the qualitative findings from an empirical study within one English primary care group on the response to a set of clinical PIs relating to general practitioners (GPs) in terms of the effect upon their clinical autonomy. Prior to interviews with GPs, primary care teams received feedback on their clinical performance as judged by indicators. Five themes were crucial in understanding GPs responses: the credibility of PIs, the growing need to demonstrate competence, perceptions of autonomy, the ulterior purpose of PIs, and the identity of the assessor of their performance. PIs are playing a key role in changing the locus of performance assessment along two dimensions: location and expertise. As the locus helps to determine the nature of clinical autonomy, it is likely to have implications for the nature of the general practice profession.

Understanding the role of opinion leaders in improving clinical effectiveness.

We present findings from evaluations of two government-funded initiatives exploring the transfer of research evidence into clinical practice--the PACE Programme (Promoting Action on Clinical Effectiveness), and the Welsh Clinical Effectiveness Initiative National Demonstration Projects. We situate the findings within the context of available research evidence from healthcare and other settings on the role of opinion leaders or product champions in innovation and change--evidence which leaves a number of problems and unanswered questions. A major concern is the difficulty of achieving a single replicable description of what opinion leaders are and what they do--subjective understandings of their role differ from one setting to another, and we identify a range of very different types of opinion leadership. What makes someone a credible and influential authority is derived not just from their own personality and skills and the dynamic of their relationship with other individuals, but also from other context-specific factors. We examine the question of expert versus peer opinion leaders, and the potential for these different categories to be more or less influential at different stages in the innovation process. An often neglected area is the impact of opinion leaders who are ambivalent or hostile to an innovation. Finally, we note that the interaction between individual opinion leaders and the collective process of negotiating a change and reorienting professional norms remains poorly understood. This raises a number of methodological concerns which need to be considered in further research in this area.

Involving consumers in a needs-led research programme: a pilot project.

OBJECTIVES: To describe the methods used for involving consumers in a needs-led health research programme, and to discuss facilitators, barriers and goals. DESIGN: In a short action research pilot study, we involved consumers in all stages of the Health Technology Assessment (HTA) Programme: identifying and prioritizing research topics; commissioning and reporting research; and communicating openly about the programme. We drew on the experience of campaigning, self-help and patients' representative groups, national charities, health information services, consumer researchers and journalists for various tasks. We explored consumer literature as a potential source for research questions, and as a route for disseminating research findings. These innovations were complemented by training, one-to-one support and discussion. A reflective approach included interviews with consumers, co-ordinating staff, external observers and other programme contributors, document analysis and multidisciplinary discussion (including consumers) amongst programme contributors. RESULTS: When seeking research topics, face-to-face discussion with a consumer group was more productive than scanning consumer research reports or contacting consumer health information services. Consumers were willing and able to play active roles as panel members in refining and prioritizing topics, and in commenting on research plans and reports. Training programmes for consumer involvement in service planning were readily adapted for a research programme. Challenges to be overcome were cultural divides, language barriers and a need for skill development amongst consumers and others. Involving consumers highlighted a need for support and training for all contributors to the programme. CONCLUSIONS: Consumers made unique contributions to the HTA Programme. Their involvement exposed processes which needed further thought and development. Consumer involvement benefited from the National Co-ordinating Centre for Health Technology Assessment (NCCHTA) staff being comfortable with innovation, participative development and team learning. Neither recruitment nor research capacity were insurmountable challenges, but ongoing effort is required if consumer involvement is to be sustained.

Implementation of evidence-based medicine: evaluation of the Promoting Action on Clinical Effectiveness programme.

OBJECTIVES: To evaluate the Promoting Action on Clinical Effectiveness (PACE) programme, which sought to implement clinically effective practice in 16 local sites. METHODS: 182 semi-structured interviews, usually by telephone, with project team members, clinicians, and senior managers and representatives from the Department of Health and the King's Fund. RESULTS: The most influential factors were strong evidence, supportive opinion leaders and integration within a committed organization; without these factors, projects had little chance of success. Other factors (context analysis, professional involvement and good project management) emerged as important, supporting processes; their presence might be an additional help, but on their own they would not be enough to initiate change. A serious problem with any of them could have a strong adverse impact. CONCLUSIONS: Although there is no simple formula for the factors that ensure successful implementation of research-based improvements to clinical practice, certain principles do seem to help. Time and resource need to be devoted to a period of local negotiation and adaptation of good research evidence based on a careful understanding of the local context, in which opinion leader influence is an important component of a well managed and preferably well integrated process of change.

Clinical governance in primary care groups: the feasibility of deriving evidence-based performance indicators.

OBJECTIVES: To test the feasibility of deriving comparative indicators in all the practices within a primary care group. DESIGN: A retrospective audit using practice computer systems and random note review. SETTING: A primary care group in southern England. SUBJECTS: All 18 general practices in a primary care group. MAIN OUTCOME MEASURES: Twenty six evidence-based process indicators including aspirin therapy in high risk patients, detection and control of hypertension, smoking cessation advice, treatment of heart failure, raised cholesterol levels in those with established cardiovascular disease, and the treatment of atrial fibrillation. Feasibility was tested by examining whether it was possible to derive these indicators in all the practices; the problems and constraints incurred when collecting data; the variations in indicator values between practices in both their identification of diseases and in the uptake of various interventions; the possible reasons for these variations; and the cost of generating such indicators. RESULTS: It was possible to derive eight indicators in all practices and in three practices all 26 indicators. The median number of indicators derived was 12 with two practices able to generate eight. There was considerable variation in the use of computers between practices and in the ability and ease of various practice computer systems to generate indicators. Practices varied greatly in the identification of diseases and in the uptake of effective interventions. Variation in identification of ischaemic heart disease could not be explained by a higher prevalence in practices with a more deprived population. The cost of generating these indicators was 5300 Pounds. CONCLUSION: Comparative evidence-based indicators, used as part of clinical governance in primary care groups, could have the potential to turn evidence into everyday practice, to improve the quality of patient care, and to have an impact on the population's health. However, to derive such indicators and to be able to make meaningful comparisons primary care groups need greater conformity and compatibility of computer systems, improved computer skills for practice staff, and appropriate funding.

Treatment of chronic hepatitis C in patients who failed interferon monotherapy: effects of higher doses of interferon and ribavirin combination therapy. The Virginia Cooperative Hepatitis Treatment Group.

OBJECTIVE: The present study was designed to evaluate the effectiveness of interferon-ribavirin combination therapy for treatment of chronic hepatitis C virus (HCV) in patients who failed previous treatment with interferon monotherapy. METHODS: A total of 140 patients with well-documented chronic HCV who failed to achieve a virological (if HCV-RNA was assessed) or biochemical response (if HCV-RNA was not assessed) to interferon monotherapy, 3 mU three times weekly (TIW) for 3-18 months, were randomly assigned to one of three treatment groups. Group A patients were treated with 5 mU interferon TIW for 6 months. Ribavirin (1000-1200 mg daily) was added in those patients HCV-RNA positive at month 3. Group B patients were treated with 3 mU interferon TIW plus ribavirin (1000-1200 mg daily) for 6 months. The dose of interferon was increased to 5 mU TIW in those patients HCV-RNA positive at month 3. Group C patients were treated with 5 mU interferon TIW plus ribavirin (1000-1200 mg daily) for 6 months. Serum ALT and HCV-RNA were monitored during and after treatment for a total of 15 months. RESULTS: Seventeen percent of patients in group A became HCV-RNA negative by treatment month 3. Adding ribavirin resulted in one additional patient becoming HCV-RNA negative. However, none of the patients in this group achieved sustained virological response. Twenty-six percent of patients in group B became HCV-RNA negative by treatment month 3. Increasing the dose of interferon from 3 to 5 mU TIW increased virological response to 30%. However, sustained virological response was observed in only 14%. Thirty percent of patients in group C became HCV-RNA negative, but sustained virological response was observed in only 12%. Sustained virological response was found to be significantly greater in patients with a nontype I HCV genotype (p < 0.002) and in patients who had a decline in HCV-RNA titer to a value < 100,000 copies/ml during their previous course of interferon monotherapy (p < 0.0001). None of the 12 sustained responders were African Americans (p < 0.013). CONCLUSIONS: Retreatment of nonresponders with interferon-ribavirin combination therapy results in limited benefit; only 13% of patients achieved sustained virological response. Response was extremely poor in African Americans and those with HCV genotype 1.

Reactions to the use of evidence-based performance indicators in primary care: a qualitative study.

OBJECTIVES: To investigate reactions to the use of evidence-based cardiovascular and stroke performance indicators within one primary care group. DESIGN: Qualitative analysis of semi-structured interviews. SETTING: Fifteen practices from a primary care group in southern England. PARTICIPANTS: Fifty two primary health care professionals including 29 general practitioners, 11 practice managers, and 12 practice nurses. MAIN OUTCOME MEASURES: Participants' perceptions towards and actions made in response to these indicators. The barriers and facilitators in using these indicators to change practice. RESULTS: Barriers to the use of the indicators were their data quality and their technical specifications, including definitions of diseases such as heart failure and the threshold for interventions such as blood pressure control. Nevertheless, the indicators were sufficiently credible to prompt most of those in primary care teams to reflect on some aspect of their performance. The most common response was to improve data quality through increased or improved accuracy of recording. There was a lack of a coordinated team approach to decision making. Primary care teams placed little importance on the potential for performance indicators to identify and address inequalities in services between practices. The most common barrier to change was a lack of time and resources to act upon indicators. CONCLUSION: For the effective implementation of national performance indicators there are many barriers to overcome at individual, practice, and primary care group levels. Additional training and resources are required for improvements in data quality and collection, further education of all members of primary care teams, and measures to foster organisational development within practices. Unless these barriers are addressed, performance indicators could initially increase apparent variation between practices.

Can dietary assessment in general practice target patients with unhealthy diets?

Diet is important in the aetiology and management of many conditions in primary care. Although valid dietary assessment is required for both clinical work and research, no dietary assessment instruments have been validated among patients seen in primary care. A range of simple self-completion dietary assessment questionnaires and established research instruments were compared with an accepted reference standard, a seven-day weighed record, in 111 subjects assessed in a practice nurse-run treatment room. Simple self-completion tools based on food groups and portion sizes perform as well (likelihood ratios for a positive test = 2 to 3) as much more time-consuming instruments. The error in using such instruments is comparable with the error of the standard itself. There is little justification for using time-consuming dietary assessment questionnaires, since simple tools are accurate enough to be clinically useful--to allow practice nurses to target patients for counselling and waste less time on inappropriate counselling--and also useful for research.

Laparoscopic common bile duct exploration: long-term outcome.

HYPOTHESIS: Transcystic laparoscopic common bile duct exploration (LCBDE) with biliary endoscopy results in excellent long-term clinical outcome and patient satisfaction. DESIGN: Prospective cohort study of unselected patients found to have common bile duct stones during laparoscopic cholecystectomy between October 1989 and April 1998. A mailed survey assessed symptoms, outcome, and satisfaction. SETTING: A large community teaching hospital. PATIENTS: Two hundred seventeen patients with common bile duct stones. INTERVENTION: Transcystic LCBDE with choledochoscopy. MAIN OUTCOME MEASURES: Success of LCBDE, morbidity, postoperative symptoms, and satisfaction. RESULTS: One hundred sixteen surveys (54%) were returned. Mean follow-up was 60 months. The LCBDE procedure failed in 6 patients and endoscopic retrograde cholangiopancreatography was performed in 4 patients (3%). One patient had unsuspected retained stones. No patient had late recognition of retained stones or a bile duct stricture. Abdominal pain was present in 90 patients (89%) preoperatively and in 29 patients (26%) postoperatively (P = .001). The LCBDE procedure reduced 3 specific pain profiles: epigastric, from 47% (n = 54) to 7% (n = 8); back, from 31% (n = 36) to 6% (n = 7); and shoulder, from 18% (n = 21) to 2% (n = 2). When pain persisted, it was different in character in 15%. All nonpain symptoms (such as nausea, bloating, indigestion, and gas) were reduced from 78% (n = 91) to 34% (n = 39) (P = .001) except diarrhea. Diarrhea was present in 24 patients (22%) preoperatively and postoperatively, though it was a new postoperative symptom in 11 patients (11%). One hundred two patients (95%) were satisfied or mostly satisfied with LCBDE. CONCLUSIONS: Pain and nonpain symptoms, while reduced significantly after LCBDE, may persist. The LCBDE procedure does not result in common bile duct strictures or a significant rate of retained stones. This relatively new treatment for common bile duct stones is safe and effective.

The validity of dietary assessment in general practice.

OBJECTIVE: To validate a range of dietary assessment instruments in general practice. METHODS: Using a randomised block design, brief assessment instruments and more complex conventional dietary assessment tools were compared with an accepted "relative" standard--a seven day weighed dietary record. The standard was checked using biomarkers, and by performing test-retest reliability in additional subjects (n = 29). OUTCOMES: Agreement with weighed record. Percentage agreement with weighed record, rank correlation from scatter plot, rank correlation from Bland-Altman plot. Reliability of the weighed record. SETTING: Practice nurse treatment room in a single suburban general practice. SUBJECTS: Patients with risk factors for cardiovascular disease (n = 61) or age/sex stratified general population group (n = 50). RESULTS: Brief self completion dietary assessment tools based on food groups caten during a week show reasonable agreement with the relative standard. For % energy from fat and saturated fat, non-starch polysaccharide, grams of fruit and vegetables and starchy foods consumed the range of agreement with the standard was: median % difference -6% to 12%, rank correlation 0.5 to 0.6. This agreement is of a similar order to the reliability of the weighed record, as good as or better than test standard agreement for more time consuming instruments, and compares favourably with research instruments validated in other settings. Under-reporting of energy intake was common (40%) and more likely if subjects were obese (body mass idex (BMI) > or = 30 60% under-reported; BMI < 30 29%, p < 0.001). CONCLUSION: Under-reporting of absolute energy intake is common, particularly among obese patients. Simple self assessment tools based on food groups, designed for practice nurse dietary assessment, show acceptable agreement with a standard, and suggest such tools are sufficiently accurate for clinical work, research, and possibly population dietary monitoring.

Improving health outcomes--a review of case studies from English health authorities.

We review a series of case studies from English health authorities that have tackled the assessment and improvement of health outcomes. We reflect their concerns and difficulties and the lessons they learnt. We identified case studies from a telephone survey of 91 representatives of the 100 English health authorities (61 were directors of public health). We edited 26 structured case studies which described how they had used population health outcome assessments or indicators. The health outcome assessments included service reviews, needs assessment projects, case-control studies, small area variations analyses, action research, and the use of focus groups. Many case studies highlighted inequalities in health service delivery. Health authorities chose some topics because they were outliers on national indicators, others had found unacceptable inequalities within their district, and others had been concerned that clinicians were not using the most effective interventions. Public health departments played a major role in these population-based health outcome assessments. The case studies highlighted the strengths and weakness of national population-based health outcome indicators, the difficulties of using information on effectiveness, the role of evidence-based process proxies for outcome, the need to extend information sources, the involvement of patients and carers, and the difficulty of changing clinical behaviour. We make recommendations as to how the Department of Health and NHS Executive could help health authorities improve the health outcomes of the populations they serve.