Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

BACKGROUND: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS: In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

A national Health and Work Strategy: a search for evidence.

BACKGROUND: The Health and Safety Executive's new Health and Work Strategy is based on an up-to-date assessment of workplace health priorities. Rather than replicating traditional prioritization approaches, a broader assessment of health and work priorities was carried out using a range of stakeholders. AIMS: To develop a set of health priorities for further research and intervention activity. METHODS: Four exercises were carried out, including internal prioritization, two external web-hosted questionnaire studies of younger workers and occupational health professionals, focus groups and tele-depth interviews with workplace health and safety professionals. RESULTS: The highest rated internal priorities (weighted priority scores) were identified as mesothelioma (70), lung cancer (69.25), chronic obstructive pulmonary disease (COPD; 69), musculoskeletal disorders (MSDs; 66.25), hearing loss (65.75), stress (65.5), asthma (64.5) and hand-arm vibration syndrome (61.5). Using the three highest ranked criteria developed by occupational health professionals ((i) the preventability of the condition, (ii) the impact of the condition and (iii) the number of workers affected), mesothelioma, lung cancer, COPD, MSDs, hearing loss, stress and asthma were identified as the top seven priorities. Generic issues identified included ageing and work, obesity, newer technologies, and ethnicity and cultures of workforces. Apprentices identified stress, depression, anxiety, musculoskeletal and respiratory disorders, fatigue and workload as important workplace health considerations. CONCLUSIONS: This process identified a number of expected and new areas of health research interest. We believe the findings reflect the real world requirements of work as assessed by occupational health and safety practitioners and workers.

How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods.

BACKGROUND: The Patient-Oriented Eczema Measure (POEM), scored 0-28, is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To date, two published studies have broadly concurred that the minimally important change (MIC) of the POEM is three points. Further assessment of the MIC of POEM in different populations, and using a variety of methods, will improve interpretability of the POEM in research and clinical practice. OBJECTIVES: To calculate the smallest detectable change in the POEM and estimate the MIC of the POEM using a variety of methods in a trial dataset of children with moderate-to-severe atopic eczema. METHODS: This study used distribution-based and anchor-based methods to calculate the MIC of the POEM in children with moderate-to-severe eczema. RESULTS: Data were collected from 300 children. The smallest detectable change was 2·13. The MIC estimates were 1·07 (using 0·2 SD of baseline POEM scores) and 2·68 (using 0·5 SD of baseline POEM scores) based on distribution-based methods; were 3·09-6·13 based on patient-/parent-reported anchor-based methods; and were 3·23-5·38 based on investigator-reported anchor-based methods. CONCLUSIONS: We recommend the following thresholds be used to interpret changes in POEM scores: ≤ 2, unlikely to be a change beyond measurement error; 2·1-2·9, a small change detected that is likely to be beyond measurement error but may not be clinically important; 3-3·9, probably a clinically important change; ≥ 4, very likely to be a clinically important change.

Underestimation of spirometry if recommended testing guidance is not followed.

Background: Lung function measured at work is used to make important employment decisions. Improving its quality will reduce misclassification and allow more accurate longitudinal interpretation over time. Aims: To assess the amount by which lung function (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]) values will be underestimated if recommended spirometry testing guidance is not followed. Methods: Lung function was measured in a population of workers. Knowledge of the final reproducible FEV1 and FVC for each worker allowed estimation of the underestimates that would have occurred if less forced manoeuvres than recommended had been performed. Results: A total of 667 workers (661 males, mean age 43 years, range 18-66) participated. Among them, 560 (84%) achieved reproducible results for both FEV1 and FVC; 470 (84%) of these did so after three technically acceptable forced expiratory manoeuvres, a cumulative total of 533 after four, 548 after five, 557 after six, 559 after seven and 560 after eight blows. If only one (or first two) technically acceptable blow(s) had been performed, mean underestimates were calculated for FEV1 of 115.1 ml (35.4 ml) and for FVC of 143.4 ml (42.3 ml). Conclusions: In this study, reproducible spirometry was achievable in most workers. Not adhering to standards underestimates lung function by clinically significant amounts.

Labour induction near term for women aged 35 or over: an economic evaluation.

OBJECTIVE: Induction of labour at 39 weeks for nulliparous women aged 35 years and over may prevent stillbirths and does not increase caesarean births, so it may be popular. But the overall costs and benefits of such a policy have not been compared. DESIGN: A cost-utility analysis alongside a randomised controlled trial (the 35/39 trial). SETTING: Obstetric departments of 38 UK National Health Service hospitals and one UK primary-care trust. POPULATION: Nulliparous women aged 35 years or over on their expected due date, with a singleton live fetus in a cephalic presentation. METHODS: Costs were estimated from the National Health Service and Personal Social Services perspective and quality-adjusted life-years (QALYs) were calculated based on patient responses to the EQ-5D at baseline and 4 weeks. MAIN OUTCOME MEASURES: Data on antenatal care, mode of delivery, analgesia in labour, method of induction, EQ-5D (baseline and 4 weeks postnatal) and participant-administered postnatal health resource use data were collected. RESULTS: The intervention was associated with a mean cost saving of £263 and a small additional gain in QALYs (though this was not statistically significant), even without considering any possible QALY gains from stillbirth prevention. CONCLUSION: A policy of induction of labour at 39 weeks for women of advanced maternal age would save money. TWEETABLE ABSTRACT: A policy of induction of labour at 39 weeks of gestation for women of advanced maternal age would save money.

Noninvasive biomagnetic detection of intestinal slow wave dysrhythmias in chronic mesenteric ischemia.

Chronic mesenteric ischemia (CMI) is a challenging clinical problem that is difficult to diagnose noninvasively. Diagnosis early in the disease process would enable life-saving early surgical intervention. Previous studies established that superconducting quantum interference device (SQUID) magnetometers detect the slow wave changes in the magnetoenterogram (MENG) noninvasively following induction of mesenteric ischemia in animal models. The purpose of this study was to assess functional physiological changes in the intestinal slow wave MENG of patients with chronic mesenteric ischemia. Pre- and postoperative studies were conducted on CMI patients using MENG and intraoperative recordings using invasive serosal electromyograms (EMG). Our preoperative MENG recordings showed that patients with CMI exhibited a significant decrease in intestinal slow wave frequency from 8.9 ± 0.3 cpm preprandial to 7.4 ± 0.1 cpm postprandial (P < 0.01) that was not observed in postoperative recordings (9.3 ± 0.2 cpm preprandial and 9.4 ± 0.4 cpm postprandial, P = 0.86). Intraoperative recording detected multiple frequencies from the ischemic portion of jejunum before revascularization, whereas normal serosal intestinal slow wave frequencies were observed after revascularization. The preoperative MENG data also showed signals with multiple frequencies suggestive of uncoupling and intestinal ischemia similar to intraoperative serosal EMG. Our results showed that multichannel MENG can identify intestinal slow wave dysrhythmias in CMI patients.

Occupational chronic obstructive pulmonary disease: a standard of care.

BACKGROUND: Consistent evidence from population studies report that 10-15% of the total burden of chronic obstructive pulmonary disease (COPD) is associated with workplace exposures. This proportion of COPD could be eliminated if harmful workplace exposures were controlled adequately. AIMS: To produce a standard of care for clinicians, occupational health professionals, employers and employees on the identification and management of occupational COPD. METHODS: A systematic literature review was used to identify published data on the prevention, identification and management of occupational COPD. Scottish Intercollegiate Guidance Network grading and the Royal College of General Practitioner three star grading system were used to grade the evidence. RESULTS: There are a number of specific workplace exposures that are established causes of COPD. Taking an occupational history in patients or workers with possible or established COPD will identify these. Reduction in exposure to vapours, gases, dusts and fumes at work is likely to be the most effective method for reducing occupational COPD. Identification of workers with rapidly declining lung function, irrespective of their specific exposure, is important. Individuals can be identified at work by accurate annual measures of lung function. CONCLUSIONS: Early identification of cases with COPD is important so that causality can be considered and action taken to reduce causative exposures thereby preventing further harm to the individual and other workers who may be similarly exposed. This can be achieved using a combination of a respiratory questionnaire, accurate lung function measurements and control of exposures in the workplace.

The effects of homelessness on Veterans' health care service use: an evaluation of independence from comorbidities.

OBJECTIVES: This study evaluates the prevalence of Multiple Comorbid Chronic Disease (MCCD) within homeless and non-homeless Veterans and the association between MCCD and inpatient medical care. METHODS: All individuals seen in the VA North Texas Health Care System between October 1, 2009 and September 30, 2010 (n = 102,034) were evaluated. Homelessness during the year and the number of common chronic diseases were evaluated for an association with likelihood of medical and psychiatric hospitalizations, bed days of care, inpatient substance treatment, rehabilitation admissions, and emergency department visits. RESULTS: Homeless Veterans had higher all-cause mortality rates and rates of use of almost all resources after controlling for chronic disease burden using the Charlson Comorbidity Index, psychiatric illnesses, substance use disorders, and demographic variables. CONCLUSIONS: Homelessness Veterans are vulnerable to a high use of resources and mortality, independent of medical and psychiatric conditions. This finding should focus additional attention on reducing homelessness.

Smoking cessation in the workplace.

BACKGROUND: The workplace is an important setting for reaching potentially large numbers of smokers. AIMS: To review the evidence about smoking cessation in the workplace. METHODS: Literature review including a synthesis of findings from recent systematic reviews and meta-analyses of workplace smoking cessation programmes, a separate review of the qualitative evidence, case studies and an expert panel assessment. RESULTS: We found advantages, identified or confirmed from the mixed methods used in this work to holding smoking cessation programmes in the workplace. These included: (i) easy access to large numbers of worker populations for large workplaces, (ii) the potential improved recruitment to such programmes given this, (iii) the opportunity to access young men, traditionally difficult to achieve, (iv) access to occupational health and other staff who can assist with support and delivery and (v) ability for workers to attend relatively easily. Evidence on the importance of developing peer support at work was mixed. The simple provision or availability of programmes and interventions was unlikely to provide any beneficial behaviour change. Interventions should target workers that actively want to stop smoking, use elements that workers have identified as useful or focus on altering beliefs about smoking and the need to stop. CONCLUSIONS: Smoking cessation programmes at work can provide useful support for workers wishing to stop smoking. They are only likely to be effective if participants have moved beyond the contemplation stage regarding smoking cessation, so that stopping smoking is a personal priority.

Principles and clinical methods of body surface gastric mapping: Technical review.

BACKGROUND AND PURPOSE: Chronic gastric symptoms are common, however differentiating specific contributing mechanisms in individual patients remains challenging. Abnormal gastric motility is present in a significant subgroup, but reliable methods for assessing gastric motor function in clinical practice are lacking. Body surface gastric mapping (BSGM) is a new diagnostic aid, employs multi-electrode arrays to measure and map gastric myoelectrical activity non-invasively in high resolution. Clinical adoption of BSGM is currently expanding following studies demonstrating the ability to achieve specific patient subgrouping, and subsequent regulatory clearances. An international working group was formed in order to standardize clinical BSGM methods, encompassing a technical group developing BSGM methods and a clinical advisory group. The working group performed a technical literature review and synthesis focusing on the rationale, principles, methods, and clinical applications of BSGM, with secondary review by the clinical group. The principles and validation of BSGM were evaluated, including key advances achieved over legacy electrogastrography (EGG). Methods for BSGM were reviewed, including device design considerations, patient preparation, test conduct, and data processing steps. Recent advances in BSGM test metrics and reference intervals are discussed, including four novel metrics, being the 'principal gastric frequency', BMI-adjusted amplitude, Gastric Alimetry Rhythm Index™, and fed: fasted amplitude ratio. An additional essential element of BSGM has been the introduction of validated digital tools for standardized symptom profiling, performed simultaneously during testing. Specific phenotypes identifiable by BSGM and the associated symptom profiles were codified with reference to pathophysiology. Finally, knowledge gaps and priority areas for future BSGM research were also identified by the working group.

Clinical implications of machine-probe combinations on obstetric ultrasound measurements used in pregnancy dating.

OBJECTIVE: To investigate the effect of use of different machine-probe combinations on measurement variability and to assess how this variability impacts on accuracy of pregnancy dating. METHODS: Sixteen different ultrasound machine-probe combinations were used for lateral measurement of targets spaced 10 and 40 mm apart and axial measurement of targets spaced 10 and 50 mm apart in an ultrasound phantom, and differences between the measured and true values were determined. The mean of the 40-mm lateral measurements was used to estimate gestational age using standard obstetric dating tables for crown-rump length (CRL) and femur length (FL) and the mean of the 50-mm axial measurements was used to estimate gestational age using the obstetric dating tables for biparietal diameter (BPD). RESULTS: As absolute measurements became larger, differences observed using different machine-probe combinations exceeded those due to intraobserver variability. Maximum dating differences for first-trimester CRL of 2 days (based on a measured CRL range of 39-42 mm), second-trimester BPD of 4 days (based on a measured BPD range of 49-52 mm) and FL of 9 days (based on a measured FL range of 39-42 mm) were observed when measurements were transposed to the equivalent gestational age using standard charts. CONCLUSION: Differences between measured and true values of biometric measurements reflect both machine-probe and intraobserver variability. Incremental first-trimester CRL growth with time is rapid, but second-trimester FL growth is much less so, leaving this lateral measurement more prone to both observer and machine-probe errors. The only axial growth measurement commonly performed is BPD where the measurement differences were intermediate between those of CRL and FL. The differences that can be ascribed to different equipment combinations are in many cases greater than those expected in clinical practice and are of potential importance in determining how fetal biometry is used for dating pregnancies.

Self-reported work-related symptoms in hairdressers.

BACKGROUND: Detailed studies of current symptoms reported by hairdressers and of the training received to reduce the health risks associated with this work are uncommon. AIMS: To document current levels of self-reported health problems in hairdressers, compared to non-hairdressing controls. METHODS: An interviewer-led questionnaire recording demographic information, work history, health training levels and the presence of self-reported respiratory, skin, musculoskeletal and non-specific symptoms was administered. RESULTS: In total, 147 hairdressers, 86% of whom were female (median age 27 years) and 67 non-hairdressing controls, all female (median age 38 years) were recruited. Following adjustment for age, smoking and years worked, hairdressers reported significantly higher levels of musculoskeletal problems, including work-related shoulder pain (OR 11.6, 95% CI 2.4-55.4), work-related wrist and hand pain (2.8, 1.1-7.6), work-related upper back pain (3.8, 1.0-14.9), work-related lower back pain (4.9, 1.5-15.9) and work-related leg/foot pain (31.0, 3.8-267.4). The frequency of self-reported asthma was similar in both groups (hairdressers 16%, controls 17%) as was chest tightness and wheeze. Work-related cough was significantly more frequently reported in hairdressers than in controls (13.2, 1.3-131.5). While hairdresser training was commonplace, such training did not always appear to have resulted in awareness of potential workplace health risks. CONCLUSIONS: This study identified frequently reported musculoskeletal, skin and respiratory symptoms in hairdressers. This points to a need to develop training that not only deals with risk assessment but also informs hairdressers about the health risks of their work.

Medium-density fibreboard and occupational asthma. A case series.

BACKGROUND: Medium-density fibreboard (MDF) is a wood composite material, composed primarily of softwood, bonded with a synthetic formaldehyde-based resin. It is increasingly used, as it has various advantages over natural woods. METHODS: Enquiry of the national reporting scheme data and three case reports were used to further the evidence base linking this exposure to occupational asthma (OA). RESULTS: From 1991 to 2007, 21 cases of occupational sensitization to MDF were reported to the UK voluntary reporting scheme, Surveillance of Work Related Occupational Respiratory Disease (SWORD): 18 reported as occupational asthma (OA) and 3 as occupational rhinitis. All workers were male, with a mean age of 48 years, working in education, furniture manufacturing or joinery among other employments. CONCLUSIONS: Whilst reporting scheme data identified relatively small numbers of cases of OA likely to be due to MDF, the evidence base supporting this link is generally lacking. The three cases presented, where OA was attributed to MDF exposure, add to this evidence.

Work-related symptoms in nail salon technicians.

BACKGROUND: Nail salons are a rapidly expanding small business sector. Environmental health practitioners have raised concerns about potential health and safety issues. AIMS: To establish the extent of work-related health issues reported by nail salon technicians, their knowledge of health and safety regulations and of the products used. METHODS: Nail technicians completed a researcher-administered questionnaire, and responses were compared to those of non-exposed office-based control subjects. RESULTS: In all, 39 of 588 nail salons approached agreed to participate (7%), with all 71 (100%) of the available nail technicians within these salons completing study questionnaires. The majority of the nail technicians (99%) had received training that had included aspects of health and safety and most reported being aware of the Control of Substances Hazardous to Health regulations (59/70, 84%) and risk assessments (65/70, 93%). Compared to the control group, the nail technicians reported statistically significant increased levels of work-related neck (OR 5.0, 95% CI 1.6-15.6), shoulder (15.0, 3.1-71.8), wrist/hand (3.6, 1.2-10.7) and lower back problems (3.5, 1.0-12.5). Work-related nasal symptoms were also significantly more common in nail technicians (6.2, 1.3-30.7). CONCLUSIONS: This study demonstrated a higher prevalence of a range of musculoskeletal problems and respiratory symptoms reported by nail technicians compared to office-based controls. An ergonomic and exposure assessment of work practices in this industry is warranted to identify the working practices associated with these symptoms, in order to inform best practice, supplement industry and regulatory guidance and develop appropriate practical work-based training.

Do patient characteristics matter when calculating sample size for eczema clinical trials?

Background: The Patient-Oriented Eczema Measure (POEM) is the core outcome instrument recommended for measuring patient-reported atopic eczema symptoms in clinical trials. To ensure that the statistical significance of clinical trial results is meaningful, trials are often designed by specifying the target difference in the primary outcome as part of the sample size calculation. One method used to specify the target difference is a score that corresponds to a standardized effect size. Objectives: to assess how the standardized effect size of POEM scores vary across age, gender, ethnicity and disease severity. Methods: This study combined data from five UK-based randomized clinical trials of eczema treatments in order to assess differences in self-reported eczema symptoms (POEM) corresponding to a standardized effect size (0.5 SD of baseline POEM scores) across age, gender, ethnicity and disease severity. Results: POEM scores corresponding to 0.5 SD(baseline) were remarkably consistent across participants of varying ages, gender, ethnicity and disease severity from datasets of five UK trials in children (range 2.99-3.45). Conclusions: This study provides information that can support those designing clinical trials to determine their sample size and can aid individuals interpreting trial results. Further exploration of differences in populations beyond the United Kingdom is needed.

Approaches to the diagnosis and management of occupational asthma amongst UK respiratory physicians.

This study aimed to assess the approach to the diagnosis and management of occupational asthma amongst general (non-specialist) respiratory consultants in the UK. A random sample of 100 UK general respiratory physicians were invited to participate, and asked to provide information on their diagnostic approach to a case scenario of a patient with possible occupational asthma relating to flour exposure. Participation rates were 42% for the main part of the study. Less than half of consultants specifically reported they would ask whether symptoms improved away from work, and just over a third mentioned examining the patient. All of those interviewed recommended a chest X-ray, and 98% simple spirometry. Eighty-six per cent suggested measurement of serial peak flows, recorded for between 2 and 8 weeks, with measurements taken half-twelve hourly. Less than half advocated a specific flour allergy test, and almost one-quarter (23%) would not perform any immunological test at all. Once a diagnosis of occupational asthma was confirmed, less than two-thirds of those interviewed commented they would recommend some form of exposure reduction, and only 28% specifically stated they would offer compensation advice. The diagnosis of occupational asthma by general respiratory physicians within the UK lacks standardisation, and in some cases falls short of evidence-based best practise.

Defining and investigating occupational asthma: a consensus approach.

BACKGROUND: At present there is no internationally agreed definition of occupational asthma and there is a lack of guidance regarding the resources that should be readily available to physicians running specialist occupational asthma services. AIMS: To agree a working definition of occupational asthma and to develop a framework of resources necessary to run a specialist occupational asthma clinic. METHOD: A modified RAND appropriateness method was used to gain a consensus of opinion from an expert panel of clinicians running specialist occupational asthma clinics in the UK. RESULTS: Consensus was reached over 10 terms defining occupational asthma including: occupational asthma is defined as asthma induced by exposure in the working environment to airborne dusts vapours or fumes, with or without pre-existing asthma; occupational asthma encompasses the terms "sensitiser-induced asthma" and "acute irritant-induced asthma" (reactive airways dysfunction syndrome (RADS)); acute irritant-induced asthma is a type of occupational asthma where there is no latency and no immunological sensitisation and should only be used when a single high exposure has occurred; and the term "work-related asthma" can be used to include occupational asthma, acute irritant-induced asthma (RADS) and aggravation of pre-existing asthma. Disagreement arose on whether low dose irritant-induced asthma existed, but the panel agreed that if it did exist they would include it in the definition of "work-related asthma". The panel agreed on a set of 18 resources which should be available to a specialist occupational asthma service. These included pre-bronchodilator FEV1 and FVC (% predicted); peak flow monitoring (and plotting of results, OASYS II analysis); non-specific provocation challenge in the laboratory and specific IgE to a wide variety of occupational agents. CONCLUSION: It is hoped that the outcome of this process will improve uniformity of definition and investigation of occupational asthma across the UK.

Biomagnetic characterization of spatiotemporal parameters of the gastric slow wave.

Certain gastric disorders affect spatiotemporal parameters of the gastric slow wave. Whereas the electrogastrogram (EGG) evaluates electric potentials to determine primarily temporal parameters, fundamental physical limitations imposed by the volume conduction properties of the abdomen suggest the evaluation of gastric magnetic fields. We used a multichannel superconducting quantum interference device magnetometer to study the magnetogastrogram (MGG) in 20 normal human subjects before and after a test meal. We computed the frequency and amplitude parameters of the gastric slow wave from MGG. We identified normal gastric slow wave activity with a frequency of 2.6 +/- 0.5 cycles per minute (cpm) preprandial and 2.8 +/- 0.3 cpm postprandial. In addition to frequency and amplitude, the use of surface current density mapping applied to the multichannel MGG allowed us to visualize the propagating slow wave and compute its propagation velocity (6.6 +/- 1.0 mm s(-1) preprandial and 7.4 +/- 0.4 mm s(-1) postprandial). Whereas MGG and EGG signals exhibited strong correlation, there was very little correlation between the MGG and manometry. The MGG not only records frequency dynamics of the gastric slow wave, but also characterizes gastric propagation. The MGG primarily reflects the underlying gastric electrical activity, but not its mechanical activity.