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PubMed2006

Smallpox vaccine injury compensation program: Smallpox (Vaccinia) Vaccine Injury Table. Adoption of interim final rule as final rule with an amendment.

This document adopts the Smallpox (Vaccinia) Vaccine Injury Table (the Table) Interim Final Rule as the Final Rule with an amendment, as follows: the Final Rule clarifies that, in order for the presumption of causation to apply, the time intervals listed on the Table refer specifically to the period in which the first symptom or manifestation of onset of injury must appear following administration of the smallpox vaccine or exposure to vaccinia, and that the time intervals listed have no relevance to time of diagnosis of the injury.

Compensation and Redress↗
PubMed1994

Worker exposure studies.

The first federal pesticide law was enacted in 1910 and was replaced by a more expansive Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) in 1947. In 1972 the Federal Environmental Pesticide Control Act amended the FIFRA from primarily a consumer protection law to a risk/benefit regulation with primary emphases on human and environmental health. "Modern" pesticides were beginning to be developed during World War II. Early attempts to assess human exposure to pesticides seemed to coincide with the development of the organophosphate pesticides in the early to mid 1950s. A continually expanding base of toxicological knowledge has forced increased efforts to refine exposure assessments. Early "patch" dosimeters have evolved to numerous and more refined methods of dosimetry. In addition to studying worker exposure, modern students of pesticide application must also deal with a myriad of situations ranging from field or site reentry to bystander and/or residential exposures. Efforts to standardize pesticide exposure assessments resulted in the 1987 issuance of U.S. EPA Pesticide Assessment Guidelines--Subdivision U--Applicator Exposure Monitoring. In October, 1989 (40 CFR Part 160), the Agency directed that studies initiated on or after that date and submitted in support of pesticide regulation must be conducted under the standards of Good Laboratory Practices. All of these and related factors culminate in the continued development and refinement of methodologies for pesticide exposure assessment.

Agriculture↗
PubMed2004

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

Animal Testing Alternatives↗
PubMed1997

Outcome of renal transplantation in systemic lupus erythematosus.

OBJECTIVES: (1) To provide an overview of the world's experience with renal transplantation in systemic lupus erythematosus (SLE), and to consider the most important studies in detail. (2) To examine four specific questions raised by the review, including (a) the frequency of recurrent lupus glomerulonephritis (GN); (b) the effect of pretransplantation dialysis on transplantation outcome; (c) the method of monitoring lupus activity in transplant patients; and (d) the frequency of early graft loss among lupus patients. METHODS: We performed a MEDLINE search of the world's literature from 1975 to 1997 on the subject of renal transplantation in SLE, using the search terms "lupus," "SLE," "kidney," "renal transplantation," and "outcome." We included in this review 20 original reports that devoted significant attention to the outcome of renal transplantation among patients with lupus. RESULTS: Of the nine studies that compared the transplantation outcomes of lupus patients with those of transplant patients with other causes of end-stage renal disease, the allograft survival rates were superior in the comparison groups in six, and approximately equivalent in three. The 1-year allograft survival rate of lupus patients with cadaveric renal transplants (CRTs) was 67% in the largest multicenter study, significantly lower than the rate for the other 14 diseases examined (77%; P = .009). In most studies, the lupus groups were significantly younger than their comparison groups, but they frequently included larger percentages of black patients. Lupus patients who received living-related renal transplants (LRRTs) generally had superior graft survival rates compared with those who received CRTs. In the largest single-center report, the 5-year graft survival rate in the cyclosporine era was 89% for LRRTs, compared with 41% for CRTs. Recurrence of lupus nephritis in the allograft is relatively rare, approximately 2%; this estimate is probably low. However, recurrent lupus glomerular nephritis (GN) did not invariably result in allograft failure. Short length of pretransplantation dialysis (i.e., less than 6 months) had no adverse effect on transplantation outcome in 10 of 11 studies that examined the relationship. Pretransplantation serological parameters, such as complement and anti-double-stranded DNA antibody levels, appear to be unreliable predictors of the likelihood of recurrence, and also may be inaccurate measures of disease activity in the posttransplantation period. Finally, 9 of the 20 studies reviewed noted an increased risk of early graft loss among lupus transplant patients, possibly because of an increased frequency of acute injection reactions and thrombotic events associated with antiphospholipid antibodies. CONCLUSIONS: Despite the fact that many lupus patients have excellent renal transplantation outcomes, substantial evidence indicates that renal transplant patients with lupus do not fare as well as patients with other causes of end-stage renal disease. Lupus patients may be particularly susceptible to adverse events occurring in the first year after transplantation. Further investigation is needed to improve renal transplantation outcomes for patients with lupus.

Humans↗
PubMed2005

Influence of phosphate and copper on reductive dechlorination of thiobencarb in California rice field soils.

The potential for reductive dechlorination of the herbicide thiobencarb (TB) by microbes and its prevention in saturated anaerobic rice field soils was examined in laboratory microcosms. TB is effective in controlling both annual grasses and broadleaf weeds. In anoxic microcosms, TB was effectively degraded within 30 days to its dechlorinated product, deschlorothiobencarb (DTB), in two Sacramento Valley rice field soils. TB dechlorination, and subsequent degradation, followed pseudo-zero- (lag phase) and first-order (degradation phase) kinetics. Logistic regression analysis (r2 > 0.841) produced a half-life (t(1/2)) in nonsterile soils ranging from 10 to 15 days, which was also observed when microcosms were amended with low concentrations (<3 mg L(-1)) of copper (Cu2+; as the fungicides Cu(OH)2 and CuSO4.5H2O). High Cu2+ concentrations (>40 mg L(-1)) were added to the microcosms to determine if copper toxicity to dechlorinating microbes is concentration dependent within the range used. After 30 days, the low-copper-amended soils closely resembled the nonsterile experiments to which no Cu2+ was added while the high-copper-amended microcosms were similar to the sterile experiment. Microcosms were also separately amended with 5.7 g L(-1) phosphate (PO4(2-); as KH2PO4), a nutrient regularly applied to rice fields. Phosphate-amended experiments also showed TB degradation, but no DTB formation, indicating the phosphate played a role, possibly as a microbial inhibitor or an alternative electron acceptor, in limiting the dechlorination of TB. In summary, TB dechlorination was inhibited at high Cu(OH)2, CuSO4.5H2O, and KH2PO4 concentrations.

Anaerobiosis↗
PubMed2000

Assessment of psychiatric patients' competency to give informed consent: legal safeguard of civil right to autonomous decision-making.

Amendment of the Mental Health and Welfare Law in Japan will limit admission for medical care and protection only for those individuals who are incapable of giving consent to admission. This is a first in the history of the Japanese mental health legislation. By reviewing the law and psychiatric literature, it is argued that: (i) informed consent is a legal transaction that embodies the idea of an individual's right to autonomous decision-making in medical settings; (ii) health professionals have a duty to protect those individuals who cannot decide medical matters because of lack of capacity to do so; (iii) some patients are marginally incompetent so assessment of their competency is essential in protecting patients' civil rights; (iv) in order for a competency assessment to be reliable (and hence fair) the method should be psychometrically sound; (v) at the same time, in order for a competency assessment to be valid, the structure of a competency assessment should match the patient's psychological, cultural, and social background; and (vi) because informed consent is a process rather than a cross-sectional event, a competency assessment should be performed in everyday practice. The use of a brief and semistructured interview to assess patients' competency to give informed consent may meet all of the requirements described.

Decision Making↗
PubMedDate not supplied

Mechanisms of nutrient attenuation in a subsurface flow riparian wetland.

Riparian wetlands are transition zones between terrestrial and aquatic environments that have the potential to serve as nutrient filters for surface and ground water due to their topographic location. We investigated a riparian wetland that had been receiving intermittent inputs of NO3- and PO4(3-) during storm runoff events to determine the mechanisms of nutrient attenuation in the wetland soils. Few studies have shown whether infrequent pulses of NO3- are sufficient to maintain substantial denitrifying communities. Denitrification rates were highest at the upstream side of the wetland where nutrient-rich runoff first enters the wetland (17-58 microg N2O-N kg soil(-1) h(-1)) and decreased further into the wetland. Carbon limitation for denitrification was minor in the wetland soils. Samples not amended with dextrose had 75% of the denitrification rate of samples with excess dextrose C. Phosphate sorption isotherms suggested that the wetland soils had a high capacity for P retention. The calculated soil PO4(3-) concentration that would yield an equilibrium aqueous P04(3-) concentration of 0.05 mg P L(-1) was found to be 100 times greater than the soil PO4(3-) concentration at the time of sampling. This indicated that the wetland could retain a large additional mass of PO4(3-) without increasing the dissolved P04(3-) concentrations above USEPA recommended levels for lentic waters. These results demonstrated that denitrification can be substantial in systems receiving pulsed NO3- inputs and that sorption could account for extensive PO4(3-) attenuation observed at this site.

Adsorption↗
PubMed1981

Additional standards for human blood and blood products; source plasma (human)--Food and Drug Administration. Final rule.

The Food and Drug Administration [FDA] is amending the biologics regulations to make clear that an active plasmapheresis donor, who is to be immunized for the production of high-titer plasma, does not need to be reexamined before the first immunization injection if the same donor has previously received a physical examination for plasmapheresis in accordance with section 640.63(b)(1). This rule eliminates a burden on the individual plasmapheresis donor and the plasmapheresis center.

Blood Donors↗
PubMed2003

Phase II multicentre trial of ZD9331 monotherapy as first-line treatment for gastric cancer.

BACKGROUND: ZD9331 is a novel, direct-acting and specific inhibitor of thymidylate synthase that has shown clinical activity and manageable tolerability in solid tumours. This phase II trial was designed to determine the antitumour activity and tolerability of ZD9331 given as a first-line therapy to patients with advanced gastric cancer. PATIENTS AND METHODS: Eligible patients who were chemonaïve with histologically or cytologically proven gastric cancer entered an open-label, multicentre, two-stage trial. Initially, patients were dosed at 130 mg/m2 (Regimen 1); however, following a protocol amendment, the starting dose was reduced to 65 mg/m2 (Regimen 2). Patients received ZD9331 as a 30-min i.v. infusion once weekly for 2 weeks followed by 1 week without treatment (3-week cycle). RESULTS: Twenty-nine patients with advanced, relapsed or inoperable gastric cancer were recruited from 11 centres across Europe. Five patients (17.2%), all from Regimen 2, showed a partial response and 16 patients (55.2%) had a best response of disease stabilisation. Most patients (72.4%) had a best response of disease control with median time to progression being 98 days. ZD9331 had manageable toxicity with the most frequently reported adverse events being neutropenia (62%) and diarrhoea (38%). CONCLUSIONS: ZD9331, as a first-line treatment for patients with advanced gastric cancer, demonstrated clinical activity and manageable toxicity.

Abdominal Pain↗
PubMed1998

Medical devices; performance standards for dental and mammographic X-ray devices; amendment--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to exempt panoramic dental x-ray units from the requirement that they be manufactured with exposure timers which automatically reset to zero upon premature termination of an exposure. Removing the automatic timer reset requirement will not compromise the quality of the radiographic image and will protect patients from being subjected to unnecessary radiation due to repeat radiographs. FDA also proposes five changes to align the performance standard with the equipment requirements issued under the Mammography Quality Standards Act of 1992 (MQSA). First, the agency proposes to remove any reference to the use of equipment not specifically designed for mammography from the performance requirements for mammography equipment. Second, FDA proposes that the mammographic field alignment requirements restrict the irradiation beam to less than 2 percent of the source-image receptor distance (SID) beyond the image receptor edges. Third, it is proposed that the definition of an image receptor support device be amended to specify that it must provide a primary protective barrier for any orientation of the x-ray tube and image receptor support device assembly. Fourth, it is proposed that the useful beam must be confined to the dimensions of the primary barrier provided by the image receptor support device (except on the chest wall side). Fifth, it is proposed that exposures not be permitted without the primary barrier in place.

Equipment Safety↗
PubMed2004

Development of a terrestrial vertebrate model for assessing bioavailability of cadmium in the fence lizard (Sceloporus undulatus) and in ovo effects on hatchling size and thyroid function.

In the terrestrial environment, standardized protocols are available for measuring the exposure and effects of contaminants to invertebrates, but none currently exist for vertebrates. In an effort to address this, we proposed that developing lizard embryos may be used as a terrestrial vertebrate model. Lizard eggs may be particularly susceptible to soil contamination and in ovo exposure may affect hatchling size, mortality, as well as thyroid function. Toxicant-induced perturbations of thyroid function resulting from in ovo chemical exposure may result in toxicity during the critical perinatal period in reptiles. Fertilized Eastern fence lizard (Sceloporus undulatus) eggs were placed in cadmium (Cd)-spiked expanded perlite (0, 1.48, 14.8, 148, 1480, 14,800 microg Cd/g, nominal concentrations), artificially incubated at 28 degrees C, and examined daily for mortality. Whole lizard hatchlings as well as failed hatches were homogenized in ethanol and the homogenate was divided for Cd body residue analysis and thyroid hormone (triiodothyronine (T3) and thyroxine (T4)) analyses. Acute mortality was observed in the two highest doses (1480 and 14800 microg Cd/g). Cadmium body residues showed a higher internal concentration with increasing exposure concentration indicating uptake of Cd. There was a decrease in T3:T4 ratio at the highest surviving dose (148 microg Cd/g), however, there were no differences observed in hatchling size measured as weight and snout-vent length, or in whole body thyroid hormone levels. In summary, this study has shown Cd amended to a solid phase representing soil (perlite) can traverse the thin, parchment-like shell membrane of the fence lizard egg and bioaccumulate in lizard embryos. We believe this study is a good first step in investigating and evaluating this species for use as a model.

Animals↗
PubMed1998

The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group.

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Study Group has adopted a modular approach to quality of life (QoL) assessment in cancer clinical trials. The core instrument (the EORTC QLQ-C30) covers a range of QoL issues relevant to a broad spectrum of patients with cancer. The QLQ-C30 is designed to be supplemented by more specific subscales ('modules') to assess aspects of QoL of particular importance to specific subgroups of patients. Since individual members of the study group were to be involved in module development, guidelines were established. The primary aim of these guidelines was to standardize the module development process in order to ensure uniformly high quality across modules. This paper gives an update of the work completed to date. First, while the guidelines proved practical for module development, producing modules that exhibit adequate levels of psychometric and cross-cultural validity, experience pointed to three areas where the guidelines required more precision. These amendments will be provided and include (1) stricter monitoring of the developmental process from within the study group, (2) the explicit requirement of involvement of the study group and (3) a more precise definition of the criteria to be fulfilled before modules are allowed to be called 'EORTC modules'. Second, an overview of the modules currently under development or available for general use is provided. These modules include those for body image, high-dose chemotherapy, leukaemia, myeloma, palliative care and the following cancers: bladder, brain, breast, colorectal, head and neck, lung, oesophageal, ophthalmic, ovarian, pancreas and prostate. Finally, the need for the coordination of efforts in module development, both from within and outside the EORTC, is discussed.

Algorithms↗
PubMed2003

OraSure begins shipping rapid HIV test to hospitals. CLIA waiver could come in several months.

Long desired and long delayed, the first truly rapid HIV test is now available in many U.S. hospitals. The simple, 20-minute test, which uses fingerstick whole blood, was categorized as one of moderate complexity under the Clinical Laboratory Improvement Amendment. However, the tests aren't approved for use in the field where they are needed most. That soon may change if the FDA adopts a waiver requested by the manufacturer.

AIDS Serodiagnosis↗
PubMed2001

Detection of the cyclic nitramine explosives hexahydro-1,3,5-trinitro- 1,3,5-triazine (RDX) and octahydro- 1,3,5,7-tetranitro- 1,3,5,7-tetrazine (HMX) and their degradation products in soil environments.

The cyclic nitramine explosives hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX) and octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazine (HMX) were examined in field and microcosm soil samples to determine their patterns of degradation and environmental fates. A number of analytical techniques, including solid-phase microextraction with on-fiber derivatization, gas chromatography-mass spectrometry, gas chromatography with electron-capture detection, liquid chromatography-mass spectrometry, and micellar electrokinetic chromatography were required for the analyses. Two different classes of intermediates were detected, both of which lead ultimately to the formation of nitrous oxide (N2O) and carbon dioxide (CO2). The first class was identified as the nitroso derivatives formed by the sequential reduction of -NO2 functional groups. The second class of intermediates, which was favored at higher humidities and in the presence of anaerobic sludge amendments, consisted of ring cleavage products including bis-(hydroxymethyl)-nitramine and methylenedinitramine. Rye-grass (Lolium perenne) present in field samples was found to extract and accumulate HMX from soil without further degradation. In all cases (excepting the plant samples), the indigenous microbes or amended domestic anaerobic sludge consortia degraded the cyclic nitramine explosives eventually to produce N2O and CO2.

Azocines↗
PubMed2002

The effect of polymer addition on granulation in an anaerobic baffled reactor (ABR). Part I: process performance.

The stability and performance of an anaerobic baffled reactor (ABR) treating an ice-cream wastewater at several organic loading rates have been investigated. Specifically, it was determined whether an ABR would promote phase separation and if a polymer additive was capable of enhancing granule formation in an ABR. In order to achieve these goals, two ABRs, having identical dimensions and configurations, were used to study the above objectives using a synthetic ice-cream wastewater. The ABR proved to be an efficient reactor configuration for the treatment of a high-strength synthetic ice-cream wastewater. An organic loading rate of around 15 kg CODm(-3) d(-1) was treated with a 99% COD removal efficiency. From the jar test and inhibition assay, it was concluded that Kymene SLX-2 was the most effective and least inhibitory polymer tested. The methane yield was higher in the polymer-amended reactor compared to the control reactor. In addition, polymer addition resulted in a considerably higher degree of biomass retention and lower solids washout from the ABR. Consequently, it demonstrated that there was a considerable potential for sludge conditioning in ABRs by facilitating better biomass retention within the reactor which in turn led to better process performance. Granulation was achieved in both ABRs within 3 months. However, the granules from the polymer-amended reactor appeared earlier and were generally larger and more compact, although this was not quantified in detail during the present study. The main advantage of using an ABR comes from its compartmentalised structure. The first compartment of an ABR may act as a buffer zone to all toxic and inhibitory material in the feed thus allowing the later compartments to be loaded with a relatively harmless, balanced and mostly acidified influent. In this respect, the latter compartments would be more likely to support active populations of the relatively sensitive methanogenic bacteria and partly explains why the best granules and the highest methane yield were obtained in Compartment 2. It is unlikely that a complete separation of phases (acidogenic and methanogenic) occurred within the ABRs since methane production was observed in all compartments, although this was low (approximately 40% of all gas composition) in Compartment 1, becoming higher (approximately 70%) in the following compartments.

Bacteria, Anaerobic↗
PubMed1990

Dimethyl sulfide production from dimethylsulfoniopropionate in coastal seawater samples and bacterial cultures.

Dimethyl sulfide (DMS) was produced immediately after the addition of 0.1 to 2 muM beta-dimethylsulfonio-propionate (DMSP) to coastal seawater samples. Azide had little effect on the initial rate of DMS production from 0.5 muM added DMSP, but decreased the rate of production after 6 h. Filtration of water samples through membrane filters (pore size, 0.2 mum) greatly reduced DMS production for approximately 10 h, after which time DMS production resumed at a high rate. Autoclaving completely eliminated the production of DMS. The antibiotics chloramphenicol, tetracycline, kanamycin, and vancomycin all had little effect on the accumulation of DMS over the first few hours of incubation, but produced significant inhibition thereafter. The effects of individual antibiotics were additive. Chloroform over a range of concentrations (0.25 to 1.25 mM) had no effects on DMS production. Similarly, organic amendments, including acrylate, glucose, protein, and starch, did not affect DMS accumulation from DMSP. Acrylate, a product of the enzymatic cleavage of DMSP, was metabolized in seawater samples, and two strains of bacteria were isolated with this compound as the growth substrate. These bacteria produced DMS from DMSP. The sensitivity to inhibitors with respect to growth and DMSP-lyase activity varied from strain to strain. These results illustrate the significant potential for microbial conversion of dissolved DMSP to DMS in coastal seawater.

Journal Article↗
PubMed2006

Development and testing of a questionnaire to measure patient satisfaction with intermediate care.

BACKGROUND: Individual trials have suggested high levels of general patient satisfaction with intermediate care, but this topic has not been examined in detail. AIMS: To identify the key elements of patient satisfaction with intermediate care, and to see whether these can be validly measured using a questionnaire. METHOD: A questionnaire was developed on the basis of a literature review and piloting with patients and staff on participating schemes (phase I). In phase II, the questionnaire was tested for validity and reliability in a group of patients recently discharged from two "hospital-at-home" intermediate-care schemes. In phase III, a shortened version of the questionnaire was psychometrically tested in five sites taking part in a national evaluation of intermediate care. RESULTS: 96 patients with an average age of 76.5 years took part in phase II. Test-retest reliability was evaluated by repeating the questionnaire 2 weeks later in a subsample of 42 patients. This was "moderate" (kappa 0.4-0.6) for 12 questions, "fair" (kappa 0.2-0.4) for 6 questions and "poor" (kappa 0.1-0.2) for 5 questions. Scores correlated well with the Client Satisfaction Questionnaire (Spearman's r = 0.75, p<0.001). 843 patients (57% of those eligible) from five intermediate-care schemes took part in phase III. Principal components analysis suggested six factors or subscales: general satisfaction, affective response, cognitive response, timing of discharge, coordination after discharge, and access to pain relief, although the last three factors comprised only one question each. The intraclass correlation coefficients in the first three subscales varied from 0.82 to 0.89. Scores for all subscales differed by scheme, suggesting construct validity. Only one question (on general satisfaction) was found to be redundant. CONCLUSION: The questionnaire, with some minor amendments to improve performance, could be used as a validated tool for audit and research in intermediate care. An amended version and scoring programme is available from us on request.

Aged↗
PubMed2004

Proposed methods for reviewing the outcomes of health research: the impact of funding by the UK's 'Arthritis Research Campaign'

BACKGROUND: External and internal factors are increasingly encouraging research funding bodies to demonstrate the outcomes of their research. Traditional methods of assessing research are still important, but can be merged into broader multi-dimensional categorisations of research benefits. The onus has hitherto been on public sector funding bodies, but in the UK the role of medical charities in funding research is particularly important and the Arthritis Research Campaign, the leading medical charity in its field in the UK, commissioned a study to identify the outcomes from research that it funds. This article describes the methods to be used. METHODS: A case study approach will enable narratives to be told, illuminating how research funded in the early 1990s was (or was not) translated into practice. Each study will be organised using a common structure, which, with careful selection of cases, should enable cross-case analysis to illustrate the strengths of different modes and categories of research. Three main interdependent methods will be used: documentary and literature review; semi-structured interviews; and bibliometric analysis. The evaluative framework for organising the studies was previously used for assessing the benefits from health services research. Here, it has been specifically amended for a medical charity that funds a wide range of research and is concerned to develop the careers of researchers. It was further refined in three pilot studies. The framework has two main elements. First, a multi-dimensional categorisation of benefits going from the knowledge produced in peer reviewed journal articles through to the health and potential economic gain. The second element is a logic model, which, with various stages, should provide a way of organising the studies. The stock of knowledge is important: much research, especially basic, will feed into it and influence further research rather than directly lead to health gains. The cross-case analysis will look for factors associated with outcomes. CONCLUSIONS: The pilots confirmed the applicability of the methods for a full study which should assist the Arthritis Research Campaign to demonstrate the outcomes from its funding, and provide it with evidence to inform its own policies.

Journal Article↗