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Biomedical subjects

A Edwards

Publications and source records attributed to A Edwards.

At least 19 recordsLinked to original sources

Development and first validation of the shared decision-making questionnaire (SDM-Q).

OBJECTIVE: Due to a lack of valid German instruments measuring shared decision-making (SDM), a theory-driven questionnaire (SDM-Q) to measure the process of SDM was developed and validated. METHODS: As a theoretical basis steps of the SDM process were defined in an expert panel. Item formulation was then conducted according to the Delphi method. For the first validation on a mixed sample Rasch analysis was used to eliminate items not fitting the construct thus receiving a unidimensional scale. RESULTS: After eliminating 4 items the remaining 11 form a unidimensional scale with an acceptable reliability for person measures (0.77) and very good reliability for item difficulties (0.95). Analysis of subgroups revealed a different use of items in different conditions. Furthermore the scale showed high ceiling effects. CONCLUSION: A new theory-driven instrument to measure the process of SDM has been developed and validated by use of a rigorous method revealing first promising results. Yet the ceiling effects require the addition of more discriminating items, and the different use of items in different conditions demands an in depth analysis. PRACTICE IMPLICATIONS: While the concept of SDM is constantly receiving more attention in medical practice, its valid and reliable measurement remains challenging.

Decision Making↗

Chromatid damage in human lymphocytes is not affected by 50 Hz electromagnetic fields.

Cultured human blood lymphocytes were exposed during the S/G(2) phases of the cell cycle to continuous extremely low frequency (50 Hz) electromagnetic fields of 0.23, 0.47 or 0.7 mT either alone or immediately after an acute exposure to 1.0 Gy of gamma rays. The ionising radiation, as expected, induced chromosomal aberrations of the chromatid-type observed at the next metaphase. The field applied alone did not induce chromosomal damage nor did it modify the frequency of aberrations caused by the gamma rays.

Cell Division↗

935 MHz cellular phone radiation. An in vitro study of genotoxicity in human lymphocytes.

PURPOSE: The possibility of genotoxicity of radiofrequency radiation (RFR) applied alone or in combination with x-rays was investigated in vitro using several assays on human lymphocytes. The chosen specific absorption rate (SAR) values are near the upper limit of actual energy absorption in localized tissue when persons use some cellular telephones. The purpose of the combined exposures was to examine whether RFR might act epigenetically by reducing the fidelity of repair of DNA damage caused by a well-characterized and established mutagen. METHODS: Blood specimens from 14 donors were exposed continuously for 24 h to a Global System for Mobile Communications (GSM) basic 935 MHz signal. The signal was applied at two SAR; 1 and 2 W/Kg, alone or combined with a 1-min exposure to 1.0 Gy of 250 kVp x-rays given immediately before or after the RFR. The assays employed were the alkaline comet technique to detect DNA strand breakage, metaphase analyses to detect unstable chromosomal aberrations and sister chromatid exchanges, micronuclei in cytokinesis-blocked binucleate lymphocytes and the nuclear division index to detect alterations in the speed of in vitro cell cycling. RESULTS: By comparison with appropriate sham-exposed and control samples, no effect of RFR alone could be found for any of the assay endpoints. In addition RFR did not modify any measured effects of the x-radiation. CONCLUSIONS: This study has used several standard in vitro tests for chromosomal and DNA damage in Go human lymphocytes exposed in vitro to a combination of x-rays and RFR. It has comprehensively examined whether a 24-h continuous exposure to a 935 MHz GSM basic signal delivering SAR of 1 or 2 W/Kg is genotoxic per se or whether, it can influence the genotoxicity of the well-established clastogenic agent; x-radiation. Within the experimental parameters of the study in all instances no effect from the RFR signal was observed.

Adult↗

Self-monitoring in Type 2 diabetes: a randomized trial of reimbursement policy.

AIM: Self-monitoring of blood glucose is often considered a cornerstone of self-care for patients with diabetes. We assessed whether provision of free testing strips would improve glycaemic control in non-insulin-treated Type 2 diabetic patients. METHODS: Adults with Type 2 diabetes, excluding those with private insurance or using insulin, were recruited through community pharmacies and randomized to receive free testing strips for 6 months or not; all patients received similar baseline education and a glucose meter. Primary outcome was change in HbA(1c) over 6 months. RESULTS: We randomized 262 patients (131 intervention and 131 control subjects). Mean age was 68.4 years (sd 10.9), 48% were male, mean duration of diabetes was 8.2 years (sd 7.2), 97% used oral glucose-lowering agents and mean baseline HbA(1c) was 7.4% (sd 1.2). After 6 months, we observed no difference in HbA(1c) between intervention and control patients, after adjusting for baseline HbA(1c)[adjusted difference 0.03, 95% confidence interval (CI) -0.16, 0.22; P = 0.78]. A per protocol analysis of study completers (152/262; 60%) yielded similar results. Intervention patients reported testing 0.64 days per week more often than control subjects (95% CI 0.18, 1.10; P = 0.007), although testing was not associated with better glycaemic control (Pearson r = -0.10, P = 0.12). CONCLUSIONS: Reducing financial barriers by providing free testing strips did not improve glycaemic control in patients with Type 2 diabetes not using insulin. Our results question the value of policies that reduce financial barriers to testing supplies in this population.

Aged↗

Audit of hepatitis C antibody requests made by a genito-urinary department.

Requests for hepatitis C antibodies (HCV Ab) made by the Oxford Department of Genito-urinary (GU) Medicine were audited against national guidelines to determine how the service performed and to develop locally applicable standards. This resulted in more effective screening and cost savings.

Female Urogenital Diseases↗

Anatomy of the posterior cruciate ligament and the meniscofemoral ligaments.

This paper describes the anatomy of the posterior cruciate ligament (PCL) and the meniscofemoral ligaments (MFLs). The fibres of the PCL may be split into two functional bundles; the anterolateral bundle (ALB) and the posteromedial bundle (PMB), relating to their femoral attachments. The tibial attachment is relatively compact, with the ALB anterior to the PLB. These bundles are not isometric: the ALB is tightest in the mid-arc of knee flexion, the PMB is tight at both extension and deep flexion. At least one MFL is present in 93% of knees. On the femur, the anterior MFL attaches distal to the PCL, close to the articular cartilage; the posterior MFL attaches proximal to the PCL. They both attach distally to the posterior horn of the lateral meniscus. Their slanting orientation allows the MFLs to resist tibial posterior drawer.

Femur↗

Prospective evaluation of 6895 groin hernia repairs in women.

BACKGROUND: Although 8 per cent of groin hernia repairs are performed in women, there is little published literature relating specifically to women. This study compared differences in outcome between women and men after groin hernia repair. METHODS: Data collected prospectively in the Swedish Hernia Register between 1992 and 2003 were analysed, including 6895 groin hernia repairs in women and 83 753 in men. RESULTS: A higher proportion of emergency operations was carried out in women (16.9 per cent) than men (5.0 per cent), leading to bowel resection in 16.6 and 5.6 per cent respectively. During reoperation femoral hernias were found in 41.6 per cent of the women who were diagnosed with a direct or indirect inguinal hernia at the primary operation. The corresponding proportion for men was 4.6 per cent. The hernia repair was not classified as a standard operation (e.g. Shouldice, Lichtenstein, Plug/Mesh, TAPP/TEP) in 38.2 per cent of women and 11.2 per cent of men. Women had a significantly higher risk of reoperation for recurrence than men, and techniques associated with the lowest risk for reoperation in men had the highest risk in women. CONCLUSION: A greater proportion of women than men require emergency groin hernia repair, with consequently higher rates of bowel resection, complications and death. Surgical techniques developed for use in men may put women at unnecessary risk.

Adolescent↗

Effectiveness of whole brain radiotherapy in the treatment of brain metastases: a systematic review.

BACKGROUND: Brain metastases are the most common intracranial tumour in adults, estimated to occur in up to 40% of patients with cancer. Despite being used in clinical practice for 50 years, the effectiveness of whole brain radiotherapy for the treatment of brain metastases remains uncertain. OBJECTIVES: To assess the effectiveness of whole brain radiotherapy (WBRT) on survival and quality of life. To identify whether patient performance status, number of brain metastases, extent of extracranial disease and primary site of cancer are important effect modifiers. DESIGN: Systematic literature review. METHODS: Electronic searches of four databases, augmented by hand searches of the most frequently encountered journal and assessment of the reference lists of consensus statements and all retrieved papers. Included papers underwent structured data extraction, assessment and qualitative synthesis. RESULTS: Thirty-two primary studies were included, with a range of study designs, methodological quality, pre-treatment variables, interventions and outcome measures. From the limited evidence available, survival appeared to increase when patients were selected by performance status (survival increasing from approximately three to seven months in high performance status groups, as defined by Karnofsky performance status or Recursive Partitioning Analysis classification). The evidence suggests no survival benefit when patients with poor performance status were treated with whole brain radiotherapy. No studies undertook direct measurement of patients' quality of life. Surrogate measures of patients' quality of life, such as improvement in neurological function or improvement/maintenance of KPS > or =70, produced response rates ranging from 7 to 90%. CONCLUSION: The heterogeneity of study designs, quality and outcomes necessitates caution in interpreting the review findings. WBRT appears to be of benefit in higher performance status patients but not in low performance status patients. This suggests a basis for current practice, however further robust trial evidence is required.

Brain Neoplasms↗

The effect of nitrogen loading on on-site system design: a model for determining land application area size.

Designers of on-site wastewater management systems have six opportunities to remove pollutants of concern from the aqueous waste stream before it reaches ground or surface waters. These opportunities occur at source, at point of collection (primary treatment), secondary treatment, tertiary treatment, land application and buffers. This paper presents a computer based model for the sizing of on-site system land application areas applicable to the Lismore area in Northern New South Wales, a region of high rainfall. Inputs to the model include daily climatic data, soil type, number of people loading the system and size of housing allotment. Constraints include allowable phosphorus export, nitrogen export and hydraulic percolation. In the Lismore area nitrogen is the nutrient of most concern. In areas close to environmentally sensitive waterways, and in dense developments, the allowable annual nitrogen export becomes the main factor determining the land application area size. The model offers system designers the opportunity to test various combinations of nitrogen attenuation strategies (source control, secondary treatment) in order to create a solution which offers an acceptable nitrogen export rate while meeting the client's household and financial needs. The model runs on an Excel spreadsheet and has been developed by Lismore City Council.

Filtration↗

Biological estimates of dose to inhabitants of Belarus and Ukraine following the Chernobyl accident.

The purpose of this paper is to investigate how well various assays on blood can detect radiation dose to people exposed many years previously and, if possible, to estimate that dose. The assays were applied to persons resident close to Chernobyl in 1986. Blood samples were taken 13-15 years after the reactor accident. The assays used were the frequencies of lymphocyte chromosomal translocations, micronuclei, HPRT mutations and apoptotic cells. Translocation yields in the exposed groups were marginally higher than in their respective controls, leading to dose estimates of about 0.2 Gy but with large uncertainties. All other assays showed inconsistency from person to person or other variations apparently not related to dose. The measurement of translocations, it is concluded, is the biological method of choice for retrospective dosimetry.

Adult↗

HIV evolution: CTL escape mutation and reversion after transmission.

Within-patient HIV evolution reflects the strong selection pressure driving viral escape from cytotoxic T-lymphocyte (CTL) recognition. Whether this intrapatient accumulation of escape mutations translates into HIV evolution at the population level has not been evaluated. We studied over 300 patients drawn from the B- and C-clade epidemics, focusing on human leukocyte antigen (HLA) alleles HLA-B57 and HLA-B5801, which are associated with long-term HIV control and are therefore likely to exert strong selection pressure on the virus. The CTL response dominating acute infection in HLA-B57/5801-positive subjects drove positive selection of an escape mutation that reverted to wild-type after transmission to HLA-B57/5801-negative individuals. A second escape mutation within the epitope, by contrast, was maintained after transmission. These data show that the process of accumulation of escape mutations within HIV is not inevitable. Complex epitope- and residue-specific selection forces, including CTL-mediated positive selection pressure and virus-mediated purifying selection, operate in tandem to shape HIV evolution at the population level.

Adult↗

Long-term persistence of translocations in stable lymphocytes from victims of a radiological accident.

PURPOSE: To investigate whether translocations in 'stable' lymphocytes, i.e. those not containing unstable aberrations in any chromosome including counterstained ones, would have a longer persistence with time compared with those measured in all cells. MATERIALS AND METHODS: The time-course of chromosomal aberrations in the three most highly exposed radiation victims of an Estonian accident in November 1994 was followed for 7 post-accident years encompassing 15 samples. Chromosome painting was performed using probes for chromosomes 1, 2 and 4 with a pan-centromeric probe, and chromosomal aberrations involving the painted chromosomes were scored using a developed version of the Protocol for Aberration Identification and Nomenclature Terminology (PAINT) nomenclature. Metaphases containing aberrations were captured with an image analyser and stored on a computer. An earlier analysis of aberrations in the painted portion of the genome was performed in all cells, irrespective of the possible aberrations in the unpainted part of the genome. The present analysis has taken into account the 'stable/unstable' nature of the complete cell. Evaluation was performed on images, counting all chromosomes and checking the counterstained chromosomes for unstable aberrations, i.e. dicentrics, acentrics or ring chromosomes. RESULTS: In the original analyses of all cells, a decrease in translocation frequency in the early samples was observed. In the present study of stable cells, the results showed that the yield of translocations is constant with time. CONCLUSIONS: The results show that translocations observed in stable cells are persistent with time. This implies that retrospective dosimetry and calibration should be performed using stable cells. To obtain more information on this issue, the stability status of all cells in any future fluorescence in situ hybridization follow-up of a radiation accident should be noted.

Humans↗

Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

BACKGROUND: A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients. OBJECTIVE: The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations. METHODS: A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. After baseline, participating doctors were randomized to receive training in (i) SDM skills or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician. RESULTS: Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops. CONCLUSIONS: These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes.

Adult↗

Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

BACKGROUND: Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies. OBJECTIVE: Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes. METHODS: A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables. RESULTS: No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects. CONCLUSION: Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time.

Adult↗

An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction.

OBJECTIVE: To compare the efficacy and safety of sildenafil and apomorphine in the treatment of men with erectile dysfunction (ED). PATIENTS AND METHODS: In all, 139 men with ED who were naïve to treatment were entered into an open-label crossover trial with two treatment periods, each of 8 weeks, separated by a 2-week washout period. Men were randomized to receive either sildenafil then apomorphine or apomorphine then sildenafil, and were allowed to titrate the dose on both drugs. The primary endpoint was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and other endpoints included diary data, the other domains of the IIEF, overall assessment questions and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire. RESULTS: The EF domain score after treatment was 25.2 for sildenafil and 15.9 for apomorphine. The treatment difference of the adjusted means was 9.3 points (95% confidence interval 7.6-11.1; P < 0.001). After sildenafil the successful intercourse rate was 75%, vs 35% for apomorphine (P < 0.001), and the EDITS scores were 82.5 for sildenafil and 46.8 for apomorphine (P < 0.001). Of the men, 96% expressed a preference for sildenafil as a treatment for their ED. The side-effect profiles for both drugs were in keeping with published data. CONCLUSION: By all measurable endpoints sildenafil was superior to apomorphine in this open-label crossover study of men with ED who were naïve to therapy

Adult↗