An Ion-Pair Induced Intermediate Complex Captured in Class D Carbapenemase Reveals Chloride Ion as a Janus Effector Modulating Activity.

Antibiotic-resistant Enterobacterales that produce oxacillinase (OXA)-48-like Class D ß-lactamases are often linked to increased clinical mortality. Though the catalytic mechanism of OXA-48 is known, the molecular origin of its biphasic kinetics has been elusive. We here identify selective chloride binding rather than decarbamylation of the carbamylated lysine as the source of biphasic kinetics, utilizing isothermal titration calorimetry (ITC) to monitor the complete reaction course with the OXA-48 variant having a chemically stable N-acetyl lysine. Further structural investigation enables us to capture an unprecedented inactive acyl intermediate wedged in place by a halide ion paired with a conserved active site arginine. Supported by mutagenesis and mathematical simulation, we identify chloride as a "Janus effector" that operates by allosteric activation of the burst phase and by inhibition of the steady state in kinetic assays of ß-lactams. We show that chloride-induced biphasic kinetics directly affects antibiotic efficacy and facilitates the differentiation of clinical isolates encoding Class D from Class A and B carbapenemases. As chloride is present in laboratory and clinical procedures, our discovery greatly expands the roles of chloride in modulating enzyme catalysis and highlights its potential impact on the pharmacokinetics and efficacy of antibiotics during in vivo treatment.

Head and Neck Ultrasound - EFSUMB Training Recommendations for the Practice of Medical Ultrasound in Europe.

Different surgical and medical specialists increasingly use head and neck ultrasound and ultrasound-guided interventions as part of their clinical practice. We need to ensure high quality and standardized practice across specialties, and this position paper of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) describes the training requirements for head and neck ultrasound. Traditionally, a minimum number of ultrasound examinations indicates competence, but this is unreliable, and a general shift towards competence-based training is ongoing. For each EFSUMB level, we will outline the theoretical knowledge and skills needed for clinical practice. The recommendations follow the three EFSUMB competency levels for medical ultrasound practice. Level 1 describes the skills required to perform essential head and neck ultrasound examinations independently, level 2 includes ultrasound-guided interventions, while level 3 involves the practice of high-level neck ultrasound and use of advanced technologies. Our goal is to ensure high quality and standardized head and neck ultrasound practice performed by different clinical specialists with these recommendations.

Delayed Achilles tendon rupture presentation: Non-operative management may be the SMART choice.

INTRODUCTION: This biomechanical study aims to assess the function of patients who were treated non-operatively for delayed diagnosis Achilles tendon rupture. Patients were treated using the Swansea Morriston Achilles Rupture Treatment protocol (SMART), which is a physiotherapy led non-operative treatment program. METHODS: 19 patients (16M:3F) were enrolled and prospectively assessed using Achilles Repair Scores (ARS)/Achilles Tendon Rupture Scores (ATRS) (PROMS), Ankle ROM and isokinetic peak torque for plantarflexion of the ankle. MRI scans of both the injured and uninjured TA were performed to compare both AP diameter and length. RESULTS: Both ATRS and ARS improved between short- and long-term follow-up. The mean difference in plantar torque between the injured and uninjured leg was 21.9%. There was no significant difference in ankle plantarflexion or dorsiflexion. There was no significant difference in length of the injured and uninjured TA on MRI. Three patients failed the SMART protocol requiring surgical fixation. DISCUSSION: The SMART protocol can be an effective method of treatment even in younger and active patients especially if delay to treatment is less than 12 weeks. It may still be preferable for patients with a large gap size or high functional demand to elect for surgical intervention, but clinicians should consider the SMART protocol as an alternative to surgery and discuss it with some patients as a viable alternative.

Evaluation of diffusion weighted imaging in the context of multi-parametric MRI of the prostate in the assessment of suspected low volume prostatic carcinoma.

Data from a multi-parametric MRI study of patients with possible early-stage prostate cancer was assessed with a view to creating a more efficient clinical protocol. Based on a correlation analysis suggesting that diffusion-weighted imaging (DWI) scores are more strongly correlated with overall PIRADS scores than other modalities such as dynamic contrast enhanced imaging or spectroscopy, we investigate the combination of T2-weighted imaging (T2w) and DWI as a potential diagnostic tool for prostate cancer detection, staging and guided biopsies. Quantification of the noise floor in the DWI images and careful fitting of the data suggests that the mono-exponential model provides a very good fit to the data and there is no evidence of non-Gaussian diffusion for b-values up to 1000s/mm2. This precludes the use of kurtosis or other non-Gaussian measures as a biomarker for prostate cancer in our case. However, the ADC scores for healthy and probably malignant regions are significantly lower for the latter in all 20 but one patient. The results suggest that a simplified mp-MRI protocol combining T2w and DWI may be a good compromise for a cost and time efficient, early-stage prostate cancer diagnostic programme, combining robust MR biomarkers for prostate cancer that can be reliably quantified and appear well-suited for general clinical practice.

Risk-based approach to developing a national residue sampling plan for testing under European Union regulation for veterinary medicinal products and coccidiostat feed additives in domestic animal production.

A ranking system for veterinary medicinal products and coccidiostat feed additives has been developed as a tool to be applied in a risk-based approach to the residue testing programme for foods of animal origin in the Irish National Residue Control Plan (NRCP). Three characteristics of substances that may occur as residues in food are included in the developed risk ranking system: Potency, as measured by the acceptable daily intake assigned by the European Medicines Agency Committee for Medicinal Products for Veterinary Use, to each substance; Usage, as measured by the three factors of Number of Doses, use on Individual animals or for Group treatment, and Withdrawal Period; and Residue Occurrence, as measured by the number of Non-Compliant Samples in the NRCP. For both Number of Doses and Non-Compliant Samples, data for the 5-year period 2008-12 have been used. The risk ranking system for substances was developed for beef cattle, sheep and goats, pigs, chickens and dairy cattle using a scoring system applied to the various parameters described above to give an overall score based on the following equation: Potency × Usage (Number of Doses + Individual/Group Use + Withdrawal Period) × Residue Occurrence. Applying this risk ranking system, the following substances are ranked very highly: antimicrobials such as amoxicillin (for all species except pigs), marbofloxacillin (for beef cattle), oxytetracycline (for all species except chickens), sulfadiazine with trimethoprim (for pigs and chickens) and tilmicosin (for chickens); antiparasitic drugs, such as the benzimidazoles triclabendazole (for beef and dairy cattle), fenbendazole/oxfendazole (for sheep/goats and dairy cattle) and albendazole (for dairy cattle), the avermectin ivermectin (for beef cattle), and anti-fluke drugs closantel and rafoxanide (for sheep/goats); the anticoccidials monensin, narasin, nicarbazin and toltrazuril (for chickens). The risk ranking system described is a relatively simple system designed to provide a reliable basis for selecting the veterinary medicinal products and coccidiostat feed additives that might be prioritised for residue testing.

A rare association of extragonadal seminoma with synchronous papillary carcinoma of the thyroid.

A 45-year-old man presented with a large para-aortic retroperitoneal tumour, a smaller second mediastinal tumour and elevated lactate dehydrogenase (LDH). Biopsy established a diagnosis of extragonadal seminoma. Treatment with cisplatin and etoposide resulted in complete resolution of the mediastinal mass, reduction of the size of the retroperitoneal mass and normalisation of LDH. Postchemotherapy positron emission tomography (PET) scan showed a small residual focus of uptake in the retroperitoneal mass and an unexpected focus in the left side of the neck. This was initially thought to represent residual active disease, but an ultrasound (US) scan and US-guided core biopsy of a cervical lymph node demonstrated metastatic papillary thyroid cancer rather than seminoma. A small (1 cm) primary papillary tumour in the thyroid was identified subsequently. The patient received consolidation radiotherapy to the retroperitoneum and underwent total thyroidectomy and neck dissection followed by radio-iodine treatment. He is currently in complete remission from both cancers.

Brominated and fluorinated organic pollutants in the breast milk of first-time Irish mothers: is there a relationship to levels in food?

Brominated flame retardants - polybrominated diphenyl ethers (PBDEs), polybrominated biphenyls (PBBs), hexabromocyclododecane (HBCD) and others - have been measured in 11 pooled breast milk samples from 109 first-time mothers in Ireland. Additionally, the study has measured levels of polybrominated dibenzo-p-dioxins and furans (PBDD/Fs), mixed halogenated dioxins (PXCC/Fs) and biphenyls (PXBs), polychlorinated naphthalenes (PCNs) and perfluoroalkylated substances (PFAS) in these samples. The mean sum of 19 PBDEs including BDE-209 was 4.85 ng g(-1) fat, which is comparable with that found in other European countries. BDE-47, BDE-153, BDE-209, BDE-99 and BDE-100 were found at the highest concentrations. The only PBBs detected consistently were BB-77, BB-126 and BB-153, with highest concentrations being found for BB-153 (mean = 0.13 ng g(-1) fat). The mean sum of HBCD enantiomers was 3.52 ng g(-1) fat, with α-HBCD representing over 70% of the total. Of the other brominated flame retardants - tetrabromobisphenol-A (TBBP-A), hexabromobenzene (HBB), decabromodiphenylethane (DBDPE) and bis(2,4,6-tribromophenoxyethane) (BTBPE) - examined, only TBBP-A was detected above the limit of detection (LOD), in two of the 11 pools analysed. All measured PBDF congeners were observed (at 0.02-0.91 pg g(-1) fat), but 2,3,7,8-tetrabromo-dibenzodioxin (TeBDD) was the only PBDD detected, with a mean concentration of 0.09 pg g(-1) fat. The occurrence of the mixed chlorinated/brominated dibenzodioxins, dibenzofurans and biphenyls, 2-B-3,7,8-CDD, 2,3-B-7,8-CDF, 4-B-2,3,7,8-CDF, PXB 105, PXB 118, PXB 126 and PCB 156 in breast milk in the current study may indicate that levels of these contaminants are increasing in the environment. Polychlorinated naphthalenes were detected in all samples, but not perfluorooctane sulfonate (PFOS) and other PFAS. The pattern of occurrence of these brominated and fluorinated persistent organic pollutants (POPs) in Irish breast milk shows a general relationship to their occurrence in food, as reported in a number of surveillance studies carried out by the Food Safety Authority of Ireland.

What is the best clinical test for Achilles tendinopathy?

BACKGROUND: Differential diagnosis of Achilles pathology is demanding. This study evaluates the diagnostic accuracy of clinical tests identified for a chronic mid body Achilles tendinopathy. Ultrasound scanning provides the reference standard. METHODS: Twenty-one participants with, and without, an Achilles tendinopathy, had an ultrasound scan followed immediately by the application of ten clinical tests. The accuracy and reproducibility of each test was determined. RESULTS: The most valid tests are; pain on palpation of the tendon (sensitivity 84%, specificity 73%, kappa 0.74-0.96) and the subjective reporting of pain 2-6 cm above the insertion into the calcaneum (sensitivity 78%, specificity 77%, kappa 0.75-0.81). CONCLUSION: Only location of pain and pain on palpation were found to be sufficiently reliable and accurate, to be recommended for use.

Polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) in breast milk of first-time Irish mothers: impact of the 2008 dioxin incident in Ireland.

The 2008 dioxin incident in Ireland resulted in elevated concentrations of polychlorinated dibenzo-p-dioxins (PCDDs), dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) in Irish pork and pork products, due to the consumption of contaminated animal feed by pigs. In order to investigate any resulting impact on the Irish population, these contaminants were measured in pooled breast milk samples from 109 first-time mothers, collected in 2010. A comparison of the results with similar data from 2002 revealed generally lower concentrations of PCDD/Fs and dioxin-like PCBs in the 2010 samples, confirming the declining trend reported by many authors. Contaminant concentration levels for both 2002 and 2010 were generally slightly lower than those reported internationally, with a mean combined PCDD/F and PCB WHO-TEQ of 9.66pgg(-1)fat, for an overall pooled sample of milk from 2010. An apparent slight increase in PCDFs was observed between 2002 and 2010 (from 2.73pg WHO-TEQ g(-1)fat to 3.21pg WHO-TEQ g(-1)fat), with the main contributory congener being 2,3,4,7,8-PentaCDF. While it cannot be totally discounted that the slight increase in 2,3,4,7,8-PentaCDF and in the overall PCDF WHO-TEQ in breast milk could be attributable to consumption of Irish pork during the 2008 incident, we consider that it is more likely that this was due to other factors, including the predominantly urban/industrial sampling locations for the 2010 samples, compared to 2002.

How to develop web-based decision support interventions for patients: a process map.

OBJECTIVE: Significant advances have been made in the development of decision support interventions, also called decision aids, for patients facing difficult or uncertain decisions. However, challenges related to the definition, the theoretical underpinnings, the relative contribution of different components and how to migrate these tools to the Internet, remain unresolved. We propose a systematic process map for others to consider as they develop web-based, perhaps multimedia, decision support interventions and to examine the future challenges faced by developers. METHODS: Based on our experiences of developing and evaluating web-based decision support interventions, we outline a process map to illustrate the general principles of content specification followed by creative design and tailoring to the target audience. RESULTS: Content specification is fundamental and it should go beyond the traditional emphasis on scientific evidence in order to ensure patients' perspectives on the proposed options. The creative design phase aims to develop a medium to achieve three fundamental tasks: present information; achieve accurate affective forecasting; provide a basis for preference construction. This phase should be an open to experimentation and, where empirical work may be difficult or not yet available, guided by consultation with users, using an iterative method of trial and adaptation. CONCLUSION: There is little empirical research on how best to achieve these tasks. The guiding principle needs to be one of customising the delivery, based on close consultation with the target users and an iterative development process until the intervention is deemed accessible and useful. PRACTICE IMPLICATIONS: The process map provides a basis for further developments and outlines areas where remaining challenges need further investigation.

Supporting informed decision making for prostate specific antigen (PSA) testing on the web: an online randomized controlled trial.

BACKGROUND: Men considering the prostate specific antigen (PSA) test for prostate cancer, an increasingly common male cancer, are encouraged to make informed decisions, as the test is limited in its accuracy and the natural history of the condition is poorly understood. The Web-based PSA decision aid, Prosdex, was developed as part of the UK Prostate Cancer Risk Management Programme in order to help men make such informed decisions. OBJECTIVES: The aim of this study was to evaluate the effect of the Web-based PSA decision aid, Prosdex, on informed decision making. METHODS: A Web-based randomized controlled trial was conducted in South Wales, United Kingdom. Men aged 50 to 75 who had not previously had a PSA test were randomly allocated to two intervention and two control groups. Participants in the intervention groups either viewed Prosdex or were given a paper version of the text. The main outcome measures were the three components of informed decision making: (1) knowledge of prostate cancer and PSA, (2) attitude toward PSA testing, (3) behavior using a proxy measure, intention to undergo PSA testing. Decisional conflict and anxiety were also measured as was uptake of the PSA test. Outcomes were measured by means of an online questionnaire for the Prosdex group, the paper version group, and one of two control groups. Six months later, PSA test uptake was ascertained from general practitioners' records, and the online questionnaire was repeated. Results are reported in terms of the Mann-Whitney U-statistic divided by the product of the two sample sizes (U/mm), line of no effect 0.50. RESULTS: Participants were 514 men. Compared with the control group that completed the initial online questionnaire, men in the Prosdex group had increased knowledge about the PSA test and prostate cancer (U/mn 0.70; 95% CI 0.62 - 0.76); less favourable attitudes to PSA testing (U/mn 0.39, 95% CI 0.31 - 0.47); were less likely to undergo PSA testing (U/mn 0.40, 95% CI 0.32 - 0.48); and had less decisional conflict (U/mn 0.32, 95% CI 0.25 - 0.40); while anxiety level did not differ (U/mn 0.50, 95% CI 0.42 - 0.58). For these outcomes there were no significant differences between men in the Prosdex group and the paper version group. However, in the Prosdex group, increased knowledge was associated with a less favourable attitude toward testing (Spearman rank correlation [rho] = -0.49, P < .001) and lower intention to undergo testing (rho = -0.27, P = .02). After six months, PSA test uptake was lower in the Prosdex group than in the paper version and the questionnaire control group (P = .014). Test uptake was also lower in the control group that did not complete a questionnaire than in the control group that did, suggesting a possible Hawthorne effect of the questionnaire in favour of PSA testing. CONCLUSIONS: Exposure to Prosdex was associated with improved knowledge about the PSA test and prostate cancer. Men who had a high level of knowledge had a less favourable attitude toward and were less likely to undergo PSA testing. Prosdex appears to promote informed decision making regarding the PSA test. TRIAL REGISTRATION: ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5r1TLQ5nK).

Supporting informed decision making online in 20 minutes: an observational web-log study of a PSA test decision aid.

BACKGROUND: Web-based decision aids are known to have an effect on knowledge, attitude, and behavior; important components of informed decision making. We know what decision aids achieve in randomized controlled trials (RCTs), but we still know very little about how they are used and how this relates to the informed decision making outcome measures. OBJECTIVE: To examine men's use of an online decision aid for prostate cancer screening using website transaction log files (web-logs), and to examine associations between usage and components of informed decision making. METHODS: We conducted an observational web-log analysis of users of an online decision aid, Prosdex. Men between 50 and 75 years of age were recruited for an associated RCT from 26 general practices across South Wales, United Kingdom. Men allocated to one arm of the RCT were included in the current study. Time and usage data were derived from website log files. Components of informed decision making were measured by an online questionnaire. RESULTS: Available for analysis were 82 web-logs. Overall, there was large variation in the use of Prosdex. The mean total time spent on the site was 20 minutes. The mean number of pages accessed was 32 (SD 21) out of a possible 60 pages. Significant associations were found between increased usage and increased knowledge (Spearman rank correlation [rho] = 0.69, P < .01), between increased usage and less favorable attitude towards PSA testing (rho = -0.52, P < .01), and between increased usage and reduced intention to undergo PSA testing (rho = -0.44, P < .01). A bimodal distribution identified two types of user: low access and high access users. CONCLUSIONS: Increased usage of Prosdex leads to more informed decision making, the key aim of the UK Prostate Cancer Risk Management Programme. However, developers realistically have roughly 20 minutes to provide useful information that will support informed decision making when the patient uses a web-based interface. Future decision aids need to be developed with this limitation in mind. We recommend that web-log analysis should be an integral part of online decision aid development and analysis. TRIAL REGISTRATION: ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5pqeF89tS).

Dietary acrylamide exposure estimates for the United Kingdom and Ireland: comparison between semiprobabilistic and probabilistic exposure models.

Since the discovery of acrylamide in foods, there have been many calculations of dietary exposure. Total diet studies have been commonly used to estimate consumer exposure of acrylamide; however, these often fall short in evaluating true exposure levels because of limitations in small occurrence data sets. Dietary exposure to acrylamide can also be estimated by use of modeling packages. The U.K. Food Standards Agency and the Food Safety Authority of Ireland have prepared estimates for dietary acrylamide exposure using semiprobabilistic and probabilistic modeling. Occurrence data were obtained from the European Union acrylamide monitoring database, whereas consumption data were obtained from the relevant U.K. and Irish National Diet and Nutrition Surveys. The mean adult U.K. consumer exposure was estimated as 0.61 microg/kg of body weight (bw)/day and high-level adult consumer exposure (P97.5) as 1.29 microg/kg of bw/day. The mean adult Irish consumer exposure was estimated as 0.59 microg/kg of bw/day and the high-level adult consumer exposure (P97.5) as 1.75 microg/kg of bw/day. Owing to the wide range of acrylamide levels in foods, semiprobabilistic modeling does not always provide an accurate picture of dietary exposure levels and patterns. Therefore, a comparison of semiprobabilistic assessments to probabilistic assessments of U.K. and Irish dietary exposure estimates of certain food groups is provided.

A randomised controlled trial of the effects of a web-based PSA decision aid, Prosdex. Protocol.

BACKGROUND: Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing. The aim of this study is to evaluate the effect of a web-based PSA decision-aid, Prosdex, on informed decision making in men. The objective is to assess the effect of Prosdex on six specific outcomes: (i) knowledge of PSA and prostate cancer-related issues - the principal outcome of the study; (ii) attitudes to testing; (iii) decision conflict; (iv) anxiety; (v) intention to undergo PSA testing; (vi) uptake of PSA testing. In addition, a mathematical simulation model of the effects of Prosdex will be developed. METHODS: A randomised controlled trial with four groups: two intervention groups, one viewing Prosdex and the other receiving a paper version of the site; two control groups, the second controlling for the potential Hawthorn effect of the questionnaire used with the first control group. Men between the ages of 50 and 75, who have not previously had a PSA test, will be recruited from General Practitioners (GPs) in Wales, UK. The principal outcome, knowledge, and four other outcome measures - attitudes to testing, decision conflict, anxiety and intention to undergo testing - will be measured with an online questionnaire, used by men in three of the study groups. Six months later, PSA test uptake will be ascertained from GP records; the online questionnaire will then be repeated. These outcomes, and particularly PSA test uptake, will be used to develop a mathematical simulation model, specifically to consider the impact on health service resources.

Toward a model for field-testing patient decision-support technologies: a qualitative field-testing study.

BACKGROUND: Field-testing is a quality assurance criterion in the development of patient decision-support technologies (PDSTs), as identified in the consensus statement of the International Patient Decision Aids Standards Collaboration. We incorporated field-testing into the development of a Web-based, prostate-specific antigen PDST called Prosdex, which was commissioned as part of the UK Prostate Cancer Risk Management Programme. OBJECTIVES: The aim of this study was to develop a model for the future field-testing of PDSTs, based on the field-testing of Prosdex. Our objectives were (1) to explore the reactions of men to evolving prototypes of Prosdex, (2) to assess the effect of these responses on the development process, and (3) to develop a model for field-testing PDSTs based on the responses and their effect on the development process. METHODS: Semistructured interviews were conducted with the men after they had viewed evolving prototypes of Prosdex in their homes. The men were grouped according to the prototype viewed. Men between 40 and 75 years of age were recruited from two family practices in different parts of Wales, United Kingdom. In the interviews, the men were asked for their views on Prosdex, both as a whole and in relation to specific sections such as the introduction and video clips. Comments and technical issues that arose during the viewings were noted and fed back to the developers in order to produce subsequent prototypes. RESULTS: A total of 27 men were interviewed, in five groups, according to the five prototypes of Prosdex that were developed. The two main themes from the interviews were the responses to the information provided in Prosdex and the responses to specific features of Prosdex. Within these themes, two of the most frequently encountered categories were detail of the information provided and balance between contrasting viewpoints. Criticisms were encountered, particularly with respect to navigation of the site. In addition, we found that participants made little use of the decision-making scale. The introduction of an interactive contents page to prototype 2 was the main change made to Prosdex as a result of the field-testing. Based on our findings, a model for the field-testing of PDSTs was developed, involving an exploratory field-testing stage between the planning stage and the development of the first prototype, and followed by the prototype field-testing stage, leading to the final PDST. CONCLUSIONS: In the field-testing of Prosdex, a Web-based prostate-specific antigen PDST, the responses of interviewed men were generally favorable. As a consequence of the responses, an interactive contents page was added to the site. We developed a model for the future field-testing of PDSTs, involving two stages: exploratory field-testing and prototype field-testing.

Prominent strategy but rare in practice: shared decision-making and patient decision support technologies in the UK.

In the UK there has recently been considerable financial investment in the publicly funded health service, NHS, but it is unclear whether this has resulted in improvements in patient participation and shared decision-making. There has been encouragement from central government in the form of initiatives such as copying referral letters. Progress, however, has been slow, and the quality of materials, for example, available to patients is highly variable. Nonetheless, there are other organisations, outside of central government, which are active in this field. The Picker Institute, for example, is involved in research, policy and the development of initiatives to improve patient participation. Two of the most important arenas for shared decision-making implementation in the UK are education and the development of patient decision support technologies (PDSTs). In the case of medical education, whilst there has been some recognition at policy level, implementation, to date, has been limited across both undergraduate and postgraduate curricula. Similarly, the development of PDSTs has been unplanned and fragmented, though is gaining momentum in a number of clinical domains. In terms of barriers and support for shared decision-making implementation in the UK, attention has been focused on the role of financial incentives for healthcare organisations, and on the role of Information Technology, specifically the potential benefits to patients of the 3.3 euro National Programme for IT. The legislative framework in the UK is conducive to the implementation of shared decision-making, and there is a growing body of research literature, albeit focused on PDSTs.

"It's a maybe test": men's experiences of prostate specific antigen testing in primary care.

BACKGROUND: Prostate specific antigen (PSA) testing in primary care is an important and contentious issue. Due to concerns about the test and the value of early detection, countries such as the UK advocate 'informed choice' instead of population screening. It is not known whether this policy is actually adhered to in primary care. Furthermore, little is known of the experiences of men who face this decision. AIM: To explore the experiences, understanding, and views of men who considered or undertook PSA testing in UK primary care. DESIGN OF STUDY: Qualitative interview-based study. SETTING: Primary care, Wales, UK. METHOD: Semi-structured one-to-one interviews were conducted with 28 men, representing a range of clinical outcomes. Transcripts were coded and subjected to thematic analysis. RESULTS: Three themes were identified: the decision-making context, the locus of decision making, and uncertainty related to the PSA test. CONCLUSION: The decision to undertake PSA testing was affected by both social and media factors and it did not appear to be a patient-led decision. The decision created considerable uncertainty for men and this uncertainty persisted after the test, even if the result was normal. Raised PSA led to further investigations and this exacerbated the uncertainty. Anxiety and regret were consequences of this uncertainty.

Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested.

OBJECTIVE: To examine the impact of a brief patient decision aid (pDA) on men's knowledge, attitudes and intention to have a prostate specific antigen (PSA) test. To explore the important predictors of intention to be tested in men who received the brief pDA. METHODS: A brief pDA designed to facilitate informed decision-making for men considering PSA testing was developed for the NHS Prostate Cancer Risk Management Programme. Men aged 40-75 years selected from 11 General Practices in England and Wales were randomised to receive either a mailed copy of the brief pDA and a questionnaire (intervention group), or a questionnaire alone (control group). The questionnaire assessed knowledge, attitudes, perceived risk and intention to have a PSA test and, for the intervention group, their perceptions of the brief pDA. RESULTS: Nine hundred and ninety of the men who were eligible for the study returned completed questionnaires (response rate=54%). Men who received the brief pDA had significantly higher knowledge scores (p<0.0001) and less positive attitudes (p<0.0001) regarding PSA testing than men in the control group. There was no significant difference between the two groups in intention to be tested within the next 12 months. 87% of men found the brief pDA was easy to read, 94% considered it contained about the right amount of detail and 94% felt the information was presented in a balanced way. Multivariate analysis identified perceived risk (p<0.0001), perceived benefits of PSA testing (p<0.0001), knowledge (p=0.004), attitude (p=0.007) and age (p=0.01) as the most important independent predictors of intention to be tested amongst men in the intervention group. CONCLUSION: The brief pDA was shown to dramatically increase men's knowledge of the benefits and risks of the PSA test. Men who received the brief pDA were significantly less positive about the PSA test, although there was no difference between the two groups regarding their intention to be tested within the next year. PRACTICE IMPLICATIONS: This brief pDA could serve as an acceptable and low cost adjunct to counselling by the General Practitioner (GP), and should promote informed decision making regarding the PSA test. Further research is required to ascertain the utility of the decision aid during the consultation.