Hydrophilic implants generated using a low-cost dielectric barrier discharge plasma device at the time of placement exhibit increased osseointegration in an animal pre-clinical study: An effect that is sex-dependent.

OBJECTIVES: Increased wettability of titanium and titanium alloy surfaces due to processing and storage methods increases osteoprogenitor cell differentiation and osseointegration compared to microroughness alone. Implants that are exposed to air have a hydrophobic surface due to adsorption of atmospheric hydrocarbons, which can limit overall implant success. Dielectric barrier discharge plasma (DBD) is one method to increase surface hydrophilicity. Although current DBD methods yield a hydrophilic surface, adsorbed hydrocarbons rapidly restore hydrophobicity. We demonstrated that application of DBD to implants previously packaged in a vacuum, generates a hydrophilic surface that supports osteoblastic differentiation in vitro and this can be done immediately prior to use. In the present study, we tested the hypothesis that DBD treatment to alter surface wettability at the time of implant placement will improve osseointegration in vivo. MATERIALS AND METHODS: Twenty male and sixteen female rabbits were used in a preclinical trans-axial femur model of osseointegration. Control and DBD treatment implants were inserted randomized per hind limb in each rabbit (1 implant/hind-limb). At 6 weeks post-surgery, bone-to-implant contact, adjacent bone volume, and torque to failure were assessed by micro-CT, calcified histology, and mechanical testing. RESULTS: DBD plasma treatment of vacuum-sealed implants increased surface wettability and did not change surface chemistry or roughness. Peak torque and torsional energy, and bone-to-implant contact increased with DBD treatment in males. In contrast, female rabbits showed increased osseointegration equal to DBD treated male implants regardless of DBD plasma treatment. CONCLUSION: DBD treatment is an effective method to enhance osseointegration by increasing surface wettability; however, this response is sex dependent. In healthy female patients, DBD treatment may not be necessary but in older patients or patients with compromised bone, this treatment could be an effective measure to ensure implant success.

[Appreciating COVID-19 as a child and adolescent psychiatrist on the move]. / Appréhender le COVID-19 au fil de l'eau en tant que psychiatre d'enfant et d'adolescent.

COVID-19 is a multi-organ disease due to an infection with the SARS-CoV2 virus. It has become a pandemic in early 2020. The disease appears less devastating in children and adolescents. However, stress, quarantine and eventually mourning have major impacts on development. It is difficult to describe what this pandemic implies for a child psychiatrist, other than by giving a first-hand account. I propose to go through the main ethical questions that have arisen; to describe how my hospital team has reorganized itself to meet the new demands and questions, in particular by opening a unit dedicated to people with autism and challenging behaviors affected by COVID-19; and to address, in a context of national discussion, how the discipline has sought to understand the conditions of a certain well-being during quarantine. Finally, I will try to conclude with more speculative reflections on re-opening.

Financial Neutrality for Living Organ Donors: Reasoning, Rationale, Definitions, and Implementation Strategies.

In the United States, live organ donation can be a costly and burdensome undertaking for donors. While most donation-related medical expenses are covered, many donors still face lost wages, travel expenses, incidentals, and potential for future insurability problems. Despite widespread consensus that live donors (LD) should not be responsible for the costs associated with donation, little has changed to alleviate financial burdens for LDs in the last decade. To achieve this goal, the transplant community must actively pursue strategies and policies to eliminate unreimbursed out-of-pocket costs to LDs. Costs should be more appropriately distributed across all stakeholders; this will also make live donation possible for people who, in the current system, cannot afford to proceed. We propose the goal of LD "financial neutrality," offer an operational definition to include the coverage/reimbursement of all medical, travel, and lodging costs, along with lost wages, related to the act of donating an organ, and guidance for consideration of medical care coverage, and wage and other expense reimbursement. The intent of this report is to provide a foundation to inform discussion within the transplant community and to advance initiatives for policy and resource allocation.

Comparing Effective Doses During Image-Guided Core Needle Biopsies with Computed Tomography Versus C-Arm Cone Beam CT Using Adult and Pediatric Phantoms.

PURPOSE: To compare the effective doses of needle biopsies based on dose measurements and simulations using adult and pediatric phantoms, between cone beam c-arm CT (CBCT) and CT. METHOD: Effective doses were calculated and compared based on measurements and Monte Carlo simulations of CT- and CBCT-guided biopsy procedures of the lungs, liver, and kidney using pediatric and adult phantoms. RESULTS: The effective doses for pediatric and adult phantoms, using our standard protocols for upper, middle and lower lungs, liver, and kidney biopsies, were significantly lower under CBCT guidance than CT. The average effective dose for a 5-year old for these five biopsies was 0.36 ± 0.05 mSv with the standard CBCT exposure protocols and 2.13 ± 0.26 mSv with CT. The adult average effective dose for the five biopsies was 1.63 ± 0.22 mSv with the standard CBCT protocols and 8.22 ± 1.02 mSv using CT. The CT effective dose was higher than CBCT protocols for child and adult phantoms by 803 and 590% for upper lung, 639 and 525% for mid-lung, and 461 and 251% for lower lung, respectively. Similarly, the effective dose was higher by 691 and 762% for liver and 513 and 608% for kidney biopsies. CONCLUSIONS: Based on measurements and simulations with pediatric and adult phantoms, radiation effective doses during image-guided needle biopsies of the lung, liver, and kidney are significantly lower with CBCT than with CT.

Consensus conference on best practices in live kidney donation: recommendations to optimize education, access, and care.

Live donor kidney transplantation is the best treatment option for most patients with late-stage chronic kidney disease; however, the rate of living kidney donation has declined in the United States. A consensus conference was held June 5-6, 2014 to identify best practices and knowledge gaps pertaining to live donor kidney transplantation and living kidney donation. Transplant professionals, patients, and other key stakeholders discussed processes for educating transplant candidates and potential living donors about living kidney donation; efficiencies in the living donor evaluation process; disparities in living donation; and financial and systemic barriers to living donation. We summarize the consensus recommendations for best practices in these educational and clinical domains, future research priorities, and possible public policy initiatives to remove barriers to living kidney donation.

Cognitive behavioural anger management intervention for people with intellectual disabilities: costs of intervention and impact on health and social care resource use.

BACKGROUND: Anger and aggression among adults with intellectual disability (ID) are associated with a range of adverse consequences for their well-being and that of their family or staff carers. The aims were to evaluate the effectiveness of an anger management intervention for adults with mild to moderate ID and to evaluate the costs of the intervention and its impact on health and social care resource use. This paper is concerned with the latter aim. METHODS: A cluster-randomised controlled trial was conducted involving day services for adults with ID in Scotland, England and Wales. Incremental costs of delivering the intervention and its impact on subsequent total health and social care package costs were calculated. Full data comparing costs between baseline and follow-up 10 months later were collected for 67 participants in the intervention arm and 62 participants in the control arm. Cost differences between the groups at follow-up, adjusted for baseline levels, were calculated using non-parametric bootstrapping controlling for clustering. RESULTS: The mean hourly excess cost of intervention over treatment as usual was £12.34. A mean adjusted cost difference of £22.46 per person per week in favour of the intervention group was found but this was not statistically significant. CONCLUSIONS: The baseline-adjusted cost difference at follow-up would result in a fairly immediate compensation for the excess costs of intervention, provided the difference is not a statistical artefact. Further research is needed to clarify the extent to which it might represent a real saving in service support costs.

A cluster randomised controlled trial of a manualised cognitive behavioural anger management intervention delivered by supervised lay therapists to people with intellectual disabilities.

BACKGROUND: Anger is a frequent problem for many people with intellectual disabilities, and is often expressed as verbal and/or physical aggression. Cognitive-behaviour therapy (CBT) is the treatment of choice for common mental health problems, but CBT has only recently been adapted for people with intellectual disabilities. Anger is the main psychological presentation in which controlled trials have been used to evaluate CBT interventions for people with intellectual disabilities but these do not include rigorous randomised studies. OBJECTIVES: To evaluate (1) the impact of a staff-delivered manualised CBT anger management intervention on (a) reported anger among people with mild to moderate intellectual disabilities, and (b) anger coping skills, aggression, mental health, quality of life and costs of health and social care; (2) factors that influence outcome; and (3) the experience of service users, lay therapists and service managers. DESIGN: A cluster randomised controlled trial based on 30 day centres (15 intervention and 15 control). Intention-to-treat comparisons of outcomes used a two-level linear regression model to allow for clustering within centres with baseline outcome levels as a covariate. Comparison of cost data used non-parametric bootstrapping. Qualitative analysis used interpretative phenomenological analysis and thematic analysis. SETTING: Recruited day centres had four-plus service users with problem anger who were prepared to participate, two-plus staff willing to be lay therapists, a supportive manager and facilities for group work, and no current anger interventions. PARTICIPANTS: A total of 212 service users with problem anger were recruited. Thirty-three were deemed ineligible (30 could not complete assessments and three withdrew before randomisation). Retention at follow-up was 81%, with 17 withdrawals in each arm. Two to four staff per centre were recruited as lay therapists. Eleven service users, nine lay therapists and eight managers were interviewed. INTERVENTIONS: The manualised intervention comprised 12 weekly 2-hour group sessions supplemented by 'homework'. Lay therapists received training and ongoing supervision from a clinical psychologist. Treatment fidelity, group attendance and resources used in intervention delivery were monitored. MAIN OUTCOME MEASURES: The primary outcome was the service user-rated Provocation Index (PI), a measure of response to hypothetical situations that may provoke anger. Secondary trial outcomes were the key worker-rated PI; the service user- and key worker-rated Profile of Anger Coping Skills (PACS); the service user-rated PACS imaginal provocation test (PACS-IPT), a measure of response to actual situations known to provoke anger; aggression; mental health; self-esteem; quality of life; and health and social care resource use. Assessments were administered before randomisation and at 16 weeks and 10 months after randomisation. RESULTS: Fourteen treatment groups were delivered, each with 12 sessions lasting an average of 114 minutes, with a mean of 4.9 service users and 2.0 lay therapists. The mean hourly cost per service user was £ 25.26. The mean hourly excess cost over treatment as usual was £ 12.34. There was no effect of intervention on the primary outcome - self-rated PI. There was a significant impact on the following secondary outcomes at the 10-month follow-up: key worker-rated PI, self-rated PACS-IPT and self- and key worker-rated PACS. Key workers and home carers reported significantly lower aggression at 16 weeks, but not at 10 months. There was no impact on mental health, self-esteem, quality of life or total cost of health and social care. Service users, key workers and service managers were uniformly positive. CONCLUSIONS: The intervention was effective at changing anger coping skills and staff-rated anger. Impact on self-rated anger was equivocal. With hindsight there are reasons, from an analysis of factors influencing outcomes, to think that self-rated PI was not a well-chosen primary outcome. Widespread implementation of manualised lay therapist-led but psychologist-supervised anger management CBT for people with mild to moderate intellectual disabilities is recommended.

Comparison of discrete ordinate and Monte Carlo simulations of polarized radiative transfer in two coupled slabs with different refractive indices.

A comparison is presented of two different methods for polarized radiative transfer in coupled media consisting of two adjacent slabs with different refractive indices, each slab being a stratified medium with no change in optical properties except in the direction of stratification. One of the methods is based on solving the integro-differential radiative transfer equation for the two coupled slabs using the discrete ordinate approximation. The other method is based on probabilistic and statistical concepts and simulates the propagation of polarized light using the Monte Carlo approach. The emphasis is on non-Rayleigh scattering for particles in the Mie regime. Comparisons with benchmark results available for a slab with constant refractive index show that both methods reproduce these benchmark results when the refractive index is set to be the same in the two slabs. Computed results for test cases with coupling (different refractive indices in the two slabs) show that the two methods produce essentially identical results for identical input in terms of absorption and scattering coefficients and scattering phase matrices.

Use of neighbourhood parks: does socio-economic status matter? A four-city study.

OBJECTIVES: To determine if neighbourhood socio-economic status (SES) is associated with park use and park-based physical activity. STUDY DESIGN: Cross-sectional study. METHODS: The use and characteristics of 24 neighbourhood parks in Albuquerque, Chapel Hill/Durham, Columbus and Philadelphia were observed systematically in three seasons (spring, summer and autumn), with nearly 36,000 park users observed. Twelve parks were in high-poverty neighbourhoods and 12 parks were in low-poverty neighbourhoods. In total, 3559 park users and 3815 local residents were surveyed. Park incivilities were assessed and park administrators were interviewed about management practices. RESULTS: The size and number of facilities in parks in high-poverty neighbourhoods were similar to those in parks in low-poverty neighbourhoods, but the former had more hours of programming. Neighbourhood poverty level, perception of safety and the presence of incivilities were not associated with the number of park users observed. However, programmed activities and the number of activity facilities were strongly correlated with park use and energy expended in the park. CONCLUSIONS: The finding that park programming is the most important correlate of park use and park-based physical activity suggests that there are considerable opportunities for facilitating physical activity among populations of both high- and low-poverty areas.

Adults with intellectual disabilities and challenging behaviour: the costs and outcomes of in- and out-of-area placements.

BACKGROUND: People with severe challenging behaviour are vulnerable to exclusion from local services and removal to out-of-area placements if locally available supported accommodation is insufficient to meet their needs. There are concerns about the high costs and potentially poorer outcomes of out-of-area placements but relatively little is known about how costs and outcomes compare with provision for a similar population placed locally. METHODS: Costs, quality of care and a wide range of quality of life outcomes for 38 people with intellectual disabilities and challenging behaviour living in-area and 38 similar people living out-of-area were compared. The two groups were matched as far as possible on risk factors for out-of-area placement. The out-of-area group represented two-thirds of the total number of people who originated from the territory served by the largest specialist health service in Wales and were placed in residential settings at least 10 miles beyond its boundaries. RESULTS: There was a mixed pattern of quality of care and quality of outcome advantages between the two types of setting, although in-area placements had a greater number of advantages than out-of-area placements. Unexpectedly, out-of-area placements had lower total costs, accommodation costs and daytime activity costs. CONCLUSIONS: No overall conclusion could be reached about cost-effectiveness. A number of potential reasons for the differences in cost were identified. Although additional resources may be needed to provide in-area services for those currently placed out-of-area, government policy to provide comprehensively for those who want to live locally, irrespective of their needs, appears to be attainable.

A consolidated biovigilance system for blood, tissue and organs: one size does not fit all.

Biovigilance systems to assess and analyze risks for disease transmission through the transfer of organs, tissue, cells and blood between people is part of administrative oversight and has impact upon clinical practice and policy. In 2009, a formal recommendation by the Public Health Service requested that Health and Human Services fund and support efforts to consolidate national biovigilance efforts. There are differences in the biovigilance issues involved in organ and tissue donation/transplantation. If disease avoidance is made the dominant principle guiding organ donor testing, an unintended consequence may be an increase in deaths on the waiting list. We propose that overall benefit for the organ transplant recipient, tempered by patient informed awareness of limited organ availability and assessment processes, should be the guiding principle of such a system.

Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes: the DEPICTED study.

OBJECTIVE: To develop and evaluate a health-care communication training programme to help diabetes health-care professionals (HCPs) counsel their patients more skilfully, particularly in relation to behaviour change. DESIGN: The HCP training was assessed using a pragmatic, cluster randomised controlled trial. The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster (service) and individual effects, and involved two-level linear models. SETTING: Twenty-six UK paediatric diabetes services. PARTICIPANTS: The training was delivered to HCPs (doctors, nurses, dietitians and psychologists) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4-15 years and families after 1 year (95.3% follow-up). INTERVENTIONS: A blended learning programme was informed by a systematic review of the literature, telephone and questionnaire surveys of professional practice, focus groups with children and parents, experimental consultations and three developmental workshops involving a stakeholder group. The programme focused on agenda-setting, flexible styles of communication (particularly guiding) and a menu of strategies using web-based training and practical workshops. MAIN OUTCOME MEASURES: The primary trial outcome was a change in glycosylated haemoglobin (HbA1c) levels between the start and finish of a 12-month study period. Secondary trial outcomes included change in quality of life, other clinical [including body mass index (BMI)] and psychosocial measures (assessed at participant level as listed above) and cost (assessed at service level). In addition, patient details (HbA1c levels, height, weight, BMI, insulin regimen), health service contacts and patient-borne costs were recorded at each clinic visit, along with details of who patients consulted with, for how long, and whether or not patients consulted on their own at each visit. Patients and carers were also asked to complete an interim questionnaire assessing patient enablement (or feelings towards clinic visit for younger patients aged 7-10 years) at their first clinic visit following the start of the trial. The cost of the intervention included the cost of training intervention teams. RESULTS: Trained staff showed better skills than control subjects in agenda-setting and consultation strategies, which waned from 4 to 12 months. There was no effect on HbA1c levels (p = 0.5). Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes, whereas controls showed surprisingly reduced barriers (p = 0.03) and improved adherence (p = 0.05). Patients in intervention clinics reported short-term increased ability (p = 0.04) to cope with diabetes. Parents in the intervention arm experienced greater excitement (p = 0.03) about clinic visits and improved continuity of care (p = 0.01) without the adverse effects seen in their offspring. The mean cost of training was £13,145 per site or £2163 per trainee. There was no significant difference in total NHS costs (including training) between groups (p = 0.1). CONCLUSIONS: Diabetes HCPs can be trained to improve consultation skills, but these skills need reinforcing. Over 1 year, no benefits were seen in children, unlike parents, who may be better placed to support their offspring. Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 29. See the HTA programme website for further project information.

Assessment of the underestimation of childhood diarrhoeal disease burden in Israel.

We determined the extent by which mandatory reporting on isolates of Shigella and Salmonella underestimates the burden of diarrhoeal diseases in individuals aged <17 years in Israel and examined paediatricians' knowledge, attitudes and practices related to patient visits with diarrhoeal diseases. Sources of data were a nationwide population-based telephone survey for presence of diarrhoeal diseases, Maccabi Healthcare Services databases and a mail survey among its paediatricians. Monte Carlo simulation and rate estimates for all stages, from visit to physician to reporting on a culture-confirmed case of shigellosis or salmonellosis, were used to determine the underestimation factor. Of 1492 children, 5·7% reported a diarrhoeal episode during the 2 weeks prior to interview. The rate of visiting a physician with and without fever was 86% and 16%, respectively. A stool culture was performed for around 20% of patients and the isolation rates were 7·1% for Shigella and 2·1% for Salmonella. Paediatricians (n=214) ranked very young age of patient and the complaint 'bloody diarrhoea' as the most important determinants. We estimated that one reported isolate of Shigella or Salmonella represented 152 diarrhoeal episodes of all aetiologies. This estimate is important for further assessments of the true burden of diarrhoeal diseases.

HIV testing coverage of family members of adult antiretroviral therapy patients in Malawi.

Many children in sub-Saharan Africa die from AIDS, not having accessed HIV testing and care. Children of adult antiretroviral therapy (ART) patients are a target group for HIV testing in order to increase access to care, but the HIV test coverage of this group in Malawi is unknown. In a cross-sectional survey of 832 patients at a large urban ART clinic in Blantyre, we found that 81.2% of 1223 children and 37.7% of 488 spouses of adult ART patients were reportedly not HIV tested. Wives of male patients were significantly less frequently HIV tested than husbands of female patients (53.0% vs. 72.4%, p<0.0001). Children under the age of 8 years (adjusted odds ratios [aOR] 2.76), children of female patients (aOR 2.53) and of patients whose partner had been HIV tested (aOR 2.87) were significantly more likely to have been tested for HIV. More attention needs to be given to provider initiated testing of children and spouses of ART patients.

The potential to forgo social welfare gains through overrelianceon cost effectiveness/cost utility analyses in the evidence base for public health.

Economic evaluations of clinical treatments most commonly take the form of cost effectiveness or cost utility analyses. This is appropriate since the main-sometimes the only-benefit of such interventions is increased health. The majority of economic evaluations in public health, however, have also been assessed using these techniques when arguably cost benefit analyses would in many cases have been more appropriate, given its ability to take account of nonhealth benefits as well. An examination of the nonhealth benefits from a sample of studies featured in a recent review of economic evaluations in public health illustrates how overfocusing on cost effectiveness/cost utility analyses may lead to forgoing potential social welfare gains from programmes in public health. Prior to evaluation, programmes should be considered in terms of the potential importance of nonhealth benefits and where these are considerable would be better evaluated by more inclusive economic evaluation techniques.

Efficacy and safety of enteric-coated mycophenolate sodium in de novo renal transplant recipients: pooled data from three 12-month multicenter, open-label, prospective studies.

BACKGROUND: The myfortic Prospective Multicenter Study (myPROMS) utilizes a core protocol in which renal transplant patients receive enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion. Substudies investigate specific aspects of the immunosuppressive regimen. METHODS: A pooled analysis of three 12-month myPROMS substudies in de novo renal transplant patients was undertaken. Patients in the US01 and DE01 substudies were randomized to higher or lower cyclosporine C(2) target ranges; patients in FR01 were randomized to early or delayed introduction of cyclosporine. All patients received steroids and interleukin-2 receptor antagonist induction. RESULTS: In total, 456 patients were included in the pooled analysis. Treatment failure (biopsy-proven acute rejection, graft loss, or death) occurred in 118 patients (25.9%) by month 12, with biopsy-proven acute rejection reported in 101 patients (22.1%). Fourteen patients (3.1%) lost their graft, and six patients died (1.3%). Median calculated creatinine clearance was 62.9 mL/min at month 12 (median serum creatinine, 138 +/- 51 mumol/L). Gastrointestinal (GI) adverse events were reported in 354 patients (77.6%); these were mild or moderate in 323 patients. Within 12 months, 16.2% of patients required EC-MPS dose changes for GI adverse events. GI disorders led to EC-MPS discontinuation in only 10 patients (2.2%). Over the 12-month study, mean EC-MPS dose was 1352 +/- 230 mg/d (94% of recommended dose). CONCLUSION: Cyclosporine, EC-MPS, and steroids with interleukin-2 antagonist induction offers effective and well-tolerated immunosuppression following renal transplantation. Graft survival was excellent and renal function was stable. High EC-MPS dosing was sustained throughout (>90% recommended dose) and dose modifications due to EC-MPS-related adverse events or infections were infrequent.

Use of rubella seroepidemiological data for assessment of previous vaccination policy and for decision making in response to epidemics in Israel.

We examined the prevalence of rubella antibodies in a representative sample of the Israeli population. Three thousand three hundred and twenty-six sera collected during 1997 and 1998, from an age-stratified general population sample were tested for specific IgG antibodies against rubella. The sero-positivity rates to rubella were higher among females as compared with males (89.1% versus 82.3%, respectively (p < 0.001). This difference was the result of much lower sero-positivity rates among males in the age group 13-17, with the lowest value (56.3%) among subjects aged 16. Male subjects of this age group were in 2000 the target of an outbreak of rubella among 18-19-year old male recruits of the Israel Defense Force. The data of this study served to assess previous exposure to the wild virus or vaccine strains, to identify pockets of low level of immunity and contributed to decision making in response to the onset of a rubella outbreak.

Can randomised trials rely on existing electronic data? A feasibility study to explore the value of routine data in health technology assessment.

OBJECTIVES: To estimate the feasibility, utility and resource implications of electronically captured routine data for health technology assessment by randomised controlled trials (RCTs), and to recommend how routinely collected data could be made more effective for this purpose. DATA SOURCES: Four health technology assessments that involved patients under care at five district general hospitals in the UK using four conditions from distinct classical specialties: inflammatory bowel disease, obstructive sleep apnoea, female urinary incontinence, and total knee replacement. Patient-identifiable, electronically stored routine data were sought from the administration and clinical database to provide the routine data. REVIEW METHODS: Four RCTs were replicated using routine data in place of the data already collected for the specific purpose of the assessments. This was done by modelling the research process from conception to final writing up and substituting routine for designed data activities at appropriate points. This allowed a direct comparison to be made of the costs and outcomes of the two approaches to health technology assessment. The trial designs were a two-centre randomised trial of outpatient follow-up; a single-centre randomised trial of two investigation techniques; a three-centre randomised trial of two surgical operations; and a single-centre randomised trial of perioperative anaesthetic intervention. RESULTS: Generally two-thirds of the research questions posed by health technology assessment through RCTs could be answered using routinely collected data. Where these questions required analysis of NHS resource use, data could usually be identified. Clinical effectiveness could also be judged, using proxy measures for quality of life, provided clinical symptoms and signs were collected in sufficient detail. Patient and professional preferences could not be identified from routine data but could be collected routinely by adapting existing instruments. Routine data were found potentially to be cheaper to extract and analyse than designed data, and they also facilitate recruitment as well as have the potential to identify patient outcomes captured in remote systems that may be missed in designed data collection. The study confirmed previous evidence that the validity of routinely collected data is suspect, particularly in systems that are not under clinical and professional control. Potential difficulties were also found in identifying, accessing and extracting data, as well as in the lack of uniformity in data structures, coding systems and definitions. CONCLUSIONS: Routine data have the potential to support health technology assessment by RCTs. The cost of data collection and analysis is likely to fall, although further work is required to improve the validity of routine data, particularly in central returns. Better knowledge of the capability of local systems and access to the data held on them is also essential. Routinely captured clinical data have real potential to measure patient outcomes, particularly if the detail and precision of the data could be improved.