Point-of-care hemoglobin A1c margin of error alters resident management of Type 2 diabetes when near glycemic target.

AIMS: Point-of-care (POC) HbA1c is frequently used as a surrogate for serum HbA1c. We aimed to determine if resident management of type 2 diabetes changed after accounting for the + 0.5% margin of error associated with POC HbA1c devices. METHODS: Residents were surveyed in an outpatient clinic regarding two of their patients with type 2 diabetes for which they had obtained a POC HbA1c. For one patient, the resident was asked if management would change if the POC HbA1c were 0.5% higher (called the positive case), and for another if management would change if POC HbA1c were 0.5% lower (negative case). RESULTS: Twelve of 58 (21%) cases had a change in management. Of the 27 cases where POC HbA1c was near the glycemic target (defined as POC HbA1c ≥6.0% and <8.0%), 11 (41%) resulted in a change in management while one (3%) of the 31 cases outside that interval had a change in management. CONCLUSION: POC HbA1c testing is well-suited for patients with poorly controlled type 2 diabetes while serum HbA1c testing may be more appropriate when near a patient's personalized HbA1c target since small changes in HbA1c can lead to differences in medical management.

'It's helped me to learn to deal with it': a mixed methods service evaluation of a multicomponent fibromyalgia service.

OBJECTIVES: To evaluate the Royal London Hospital for Integrated Medicine (RLHIM) multicomponent fibromyalgia service. METHODS: Mixed methods approach consisting of the completion of validated quantitative outcome measures (Patient Health Questionnaire-9; Generalised Anxiety Disorder-7; Pain Catastrophising Scale; Patient Self-Efficacy Questionnaire) pre- and post-treatment to explore the impact of treatment; and qualitative focus groups with patients at their follow-up appointments to explore patients' experiences and perspectives on the service. RESULTS: 138 fibromyalgia patients attended the RLHIM group fibromyalgia service during the period of the evaluation. Baseline scores demonstrate that patients were significantly impaired pre-treatment according to all outcome measures. At the end of the course of treatment, scores for all outcome measures showed clinically and statistically significant improvements. These improvements were maintained at both 6- and 9-month follow-up appointments. Qualitative analysis indicated that those participating valued the multicomponent treatment approach, and perceived the service as having a positive impact on their fibromyalgia and overall quality of life, enabling patients to effectively manage their condition. CONCLUSIONS: Patients attending the RLHIM multicomponent fibromyalgia service appear to have demonstrable improvements in presenting symptoms, and quality of life. The findings support a multicomponent approach to the treatment of fibromyalgia.

A feasibility study of a psycho-educational support intervention for men with prostate cancer on active surveillance.

BACKGROUND: PROACTIVE is a psycho-educational support intervention for prostate cancer patients managed on Active Surveillance. PROACTIVE is composed of two interdependent components: group workshops and internet-delivered information modules. AIMS: We conducted a feasibility study to determine the practicality of delivering PROACTIVE at two prostate cancer centres. METHODS AND RESULTS: The feasibility study was a mixed-methods randomized parallel-group exploratory trial. Participants were randomised using a ratio of 3:1 PROACTIVE group to treatment as usual. Qualitative semi-structured interviews and quantitative measures were completed at baseline, intervention completion (week 6), and at 6-month follow-up. Interview transcripts were analysed thematically using Framework analysis. Descriptive statistics were used to examine recruitment and retention rates and changing trends in outcome measures. Most aspects of the research design and PROACTIVE intervention were acceptable to those participating in the study. In particular, participants valued the opportunity to share and discuss experiences with other prostate cancer patients on Active Surveillance and receive detailed authoritative information. However, three issues were identified: (a) a low response rate (13 participants recruited, response rate 16%), (b) low utilisation of internet delivered information modules, (c) self-perceived low levels of anxiety amongst participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety. CONCLUSIONS: Due to these significant research design issues, it is not recommended PROACTIVE be evaluated in a large-scale randomised controlled trial. Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.

Assessment of the quality of reporting in studies of acupuncture for patients with cancer using the STRICTA guidelines.

INTRODUCTION: There has been a burgeoning of research evaluating acupuncture for various symptoms of cancer and the side-effects associated with its treatment. A systematic review was conducted to examine the quality of reporting in published studies of acupuncture in cancer according to the STRICTA (STandards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. METHODS: Systematic review of published research of acupuncture for symptoms of cancer and the side-effects associated with its treatment. Databases searched were: Medline, CINAHL, Cochrane (all databases), Scopus, and PubMed from their inception to December 2014. Clinical trials, pilot/feasibility studies, observational studies, and case studies were included. Only full journal papers published in English were included. The quality of reporting was evaluated using STRICTA guidelines. Each included paper was assessed by two independent reviewers, with disagreements adjudicated by a third reviewer. RESULTS: 88 papers were identified which met the inclusion criteria. The median number of STRICTA items reported in trials with a control or comparator arm (n=47) was 14 out of 17 (range 8 to 17, IQR 4). For studies without a control or comparator arm the median was 11 out of a possible 15 (range 5 to 15, IQR 3). Key weaknesses in reporting included details of other components of treatments, and details of the acupuncturist administering treatments. CONCLUSIONS: Despite the widespread use of the STRICTA guidelines in acupuncture research, adherence remains poor for a few specific items. Further research is required to explore the reasons why authors fail to report those items, and to develop strategies to improve the adherence to the guidelines.

Laboratory Workflow Analysis of Culture of Periprosthetic Tissues in Blood Culture Bottles.

Culture of periprosthetic tissue specimens in blood culture bottles is more sensitive than conventional techniques, but the impact on laboratory workflow has yet to be addressed. Herein, we examined the impact of culture of periprosthetic tissues in blood culture bottles on laboratory workflow and cost. The workflow was process mapped, decision tree models were constructed using probabilities of positive and negative cultures drawn from our published study (T. N. Peel, B. L. Dylla, J. G. Hughes, D. T. Lynch, K. E. Greenwood-Quaintance, A. C. Cheng, J. N. Mandrekar, and R. Patel, mBio 7:e01776-15, 2016, https://doi.org/10.1128/mBio.01776-15), and the processing times and resource costs from the laboratory staff time viewpoint were used to compare periprosthetic tissues culture processes using conventional techniques with culture in blood culture bottles. Sensitivity analysis was performed using various rates of positive cultures. Annualized labor savings were estimated based on salary costs from the U.S. Labor Bureau for Laboratory staff. The model demonstrated a 60.1% reduction in mean total staff time with the adoption of tissue inoculation into blood culture bottles compared to conventional techniques (mean ± standard deviation, 30.7 ± 27.6 versus 77.0 ± 35.3 h per month, respectively; P < 0.001). The estimated annualized labor cost savings of culture using blood culture bottles was $10,876.83 (±$337.16). Sensitivity analysis was performed using various rates of culture positivity (5 to 50%). Culture in blood culture bottles was cost-effective, based on the estimated labor cost savings of $2,132.71 for each percent increase in test accuracy. In conclusion, culture of periprosthetic tissue in blood culture bottles is not only more accurate than but is also cost-saving compared to conventional culture methods.

Optimal Periprosthetic Tissue Specimen Number for Diagnosis of Prosthetic Joint Infection.

We recently demonstrated improved sensitivity of prosthetic joint infection (PJI) diagnosis using an automated blood culture bottle system for periprosthetic tissue culture [T. N. Peel et al., mBio 7(1):e01776-15, 2016, https://doi.org/10.1128/mBio.01776-15]. This study builds on the prior research by examining the optimal number of periprosthetic tissue specimens required for accurate PJI diagnosis. Current guidelines recommend five to six, which is impractical. We applied Bayesian latent class modeling techniques for estimating diagnostic test properties of conventional culture techniques (aerobic and anaerobic agars and thioglycolate broth) compared to inoculation into blood culture bottles. Conventional, frequentist receiver operating characteristic curve analysis was conducted as a sensitivity analysis. The study was conducted at Mayo Clinic, Rochester, MN, from August 2013 through April 2014 and included 499 consecutive patients undergoing revision arthroplasty from whom 1,437 periprosthetic tissue samples were collected and processed. For conventional periprosthetic tissue culture techniques, the greatest accuracy was observed when four specimens were obtained (91%; 95% credible interval, 77 to 100%), whereas when using inoculation of periprosthetic tissues into blood culture bottles, the greatest accuracy of diagnosis was observed when three specimens were cultured (92%; 95% credible intervals, 79 to 100%). Results of this study show that the greatest accuracy of PJI diagnosis is obtained when three periprosthetic tissue specimens are obtained and inoculated into blood culture bottles or four periprosthetic tissue specimens are obtained and cultured using standard plate and broth cultures. Increasing the number of specimens to five or more, per current recommendations, does not improve accuracy of PJI diagnosis.

Improved Diagnosis of Prosthetic Joint Infection by Culturing Periprosthetic Tissue Specimens in Blood Culture Bottles.

UNLABELLED: Despite known low sensitivity, culture of periprosthetic tissue specimens on agars and in broths is routine. Culture of periprosthetic tissue samples in blood culture bottles (BCBs) is potentially more convenient, but it has been evaluated in a limited way and has not been widely adopted. The aim of this study was to compare the sensitivity and specificity of inoculation of periprosthetic tissue specimens into blood culture bottles with standard agar and thioglycolate broth culture, applying Bayesian latent class modeling (LCM) in addition to applying the Infectious Diseases Society of America (IDSA) criteria for prosthetic joint infection. This prospective cohort study was conducted over a 9-month period (August 2013 to April 2014) at the Mayo Clinic, Rochester, MN, and included all consecutive patients undergoing revision arthroplasty. Overall, 369 subjects were studied; 117 (32%) met IDSA criteria for prosthetic joint infection, and 82% had late chronic infection. Applying LCM, inoculation of tissues into BCBs was associated with a 47% improvement in sensitivity compared to the sensitivity of conventional agar and broth cultures (92.1 versus 62.6%, respectively); this magnitude of change was similar when IDSA criteria were applied (60.7 versus 44.4%, respectively; P = 0.003). The time to microorganism detection was shorter with BCBs than with standard media (P < 0.0001), with aerobic and anaerobic BCBs yielding positive results within a median of 21 and 23 h, respectively. Results of our study demonstrate that the semiautomated method of periprosthetic tissue culture in blood culture bottles is more sensitive than and as specific as agar and thioglycolate broth cultures and yields results faster. IMPORTANCE: Prosthetic joint infections are a devastating complication of arthroplasty surgery. Despite this, current microbiological techniques to detect and diagnose infections are imperfect. This study examined a new approach to diagnosing infections, through the inoculation of tissue samples from around the prosthetic joint into blood culture bottles. This study demonstrated that, compared to current laboratory practices, this new technique increased the detection of infection. These findings are important for patient care to allow timely and accurate diagnosis of infection.

Helicobacter canis bacteremia in a patient with fever of unknown origin.

A 57-year-old woman with common variable immune deficiency and liver failure of unknown etiology presented with recurrent fevers over a 5-month period. She was found to have Helicobacter canis bacteremia. Immunocompromised hosts with exposure to cats or dogs may be at risk for infection with this organism, which may be challenging to diagnose.

General practitioners' views on reattribution for patients with medically unexplained symptoms: a questionnaire and qualitative study.

BACKGROUND: The successful introduction of new methods for managing medically unexplained symptoms in primary care is dependent to a large degree on the attitudes, experiences and expectations of practitioners. As part of an exploratory randomised controlled trial of reattribution training, we sought the views of participating practitioners on patients with medically unexplained symptoms, and on the value of and barriers to the implementation of reattribution in practice. METHODS: A nested attitudinal survey and qualitative study in sixteen primary care teams in north-west England. All practitioners participating in the trial (n = 74) were invited to complete a structured survey. Semi-structured interviews were undertaken with a purposive sub-sample of survey respondents, using a structured topic guide. Interview transcripts were used to identify key issues, concepts and themes, which were grouped to construct a conceptual framework: this framework was applied systematically to the data. RESULTS: Seventy (95%) of study participants responded to the survey. Survey respondents often found it stressful to work with patients with medically unexplained symptoms, though those who had received reattribution training were more optimistic about their ability to help them. Interview participants trained in reattribution (n = 12) reported that reattribution increased their confidence to practice in a difficult area, with heightened awareness, altered perceptions of these patients, improved opportunities for team-building and transferable skills. However general practitioners also reported potential barriers to the implementation of reattribution in routine clinical practice, at the level of the patient, the doctor, the consultation, diagnosis and the healthcare context. CONCLUSION: Reattribution training increases practitioners' sense of competence in managing patients with medically unexplained symptoms. However, barriers to its implementation are considerable, and frequently lie outside the control of a group of practitioners generally sympathetic to patients with medically unexplained symptoms and the purpose of reattribution. These findings add further to the evidence of the difficulty of implementing reattribution in routine general practice.

Considering the case for an antidepressant drug trial involving temporary deception: a qualitative enquiry of potential participants.

BACKGROUND: Systematic reviews of randomised placebo controlled trials of antidepressant medication show small and decreasing differences between pharmacological and placebo arms. In part this finding may relate to methodological problems with conventional trial designs, including their assumption of additivity between drug and placebo trial arms. Balanced placebo designs, which include elements of deception, may address the additivity question, but pose substantial ethical and pragmatic problems. This study aimed to ascertain views of potential study participants of the ethics and pragmatics of various balanced placebo designs, in order to inform the design of future antidepressant drug trials. METHODS: A qualitative approach was employed to explore the perspectives of general practitioners, psychiatrists, and patients with experience of depression. The doctors were chosen via purposive sampling, while patients were recruited through participating general practitioners. Three focus groups and 12 in-depth interviews were conducted. A vignette-based topic guide invited views on three deceptive strategies: post hoc, authorised and minimised deception. The focus groups and interviews were tape-recorded and transcribed. Transcripts were analysed thematically using Framework. RESULTS: Deception in non-research situations was typically perceived as acceptable within specific parameters. All participants could see the potential utility of introducing deception into trial designs, however views on the acceptability of deception within antidepressant drug trials varied substantially. Authorized deception was the most commonly accepted strategy, though some thought this would reduce the effectiveness of the design because participants would correctly guess the deceptive element. The major issues that affected views about the acceptability of deception studies were the welfare and capacity of patients, practicalities of trial design, and the question of trust. CONCLUSION: There is a trade-off between pragmatic and ethical responses to the question of whether, and under what circumstances, elements of deception could be introduced into antidepressant drug trials. Ensuring adequate ethical safeguards within balanced placebo designs is likely to diminish their ability to address the crucial issue of additivity. The balanced placebo designs considered in this study are unlikely to be feasible in future trials of antidepressant medication. However there remains an urgent need to improve the quality of antidepressant drug trials.

A computational approach for peptidomic analysis in taxonomic study of amphibian species.

Peptides in the skin secretion of frogs have been studied for some time now because they frequently possess important biological activity such as antibiotic, antimicrobial, or anticancer properties. In this paper, we present a computational approach for measuring the degree of similarity between the entire peptide complement of the skin secretion of specimens from the same or different species. The first step in the analysis is the generation of a mass spectral profile from an experimental high-performance liquid chromatography/electrosparay ionization analysis of the sample. An "overlap" between the mass spectral profiles of different specimens is then proposed as a measure of their similarity. Analysis of specimens from three species of the genus Litoria, viz., L. Aurea, L. Caerulea, and L. Infrafrenata, and Rana Capito of genus Rana shows that the degree of similarity is highest between specimens from the same species, lower for specimens from different species of the same genus, and lowest between specimens from different genera. This indicates that comparison of skin peptide profiles (i.e., mass spectral profiles of skin secretion) is potentially a useful aid in the taxonomic study of amphibian species.

Heuristic charge assignment for deconvolution of electrospray ionization mass spectra.

We propose a new algorithm for deconvolution of electrospray ionization mass spectra based on direct assignment of charge to the measured signal at each mass-to-charge ratio (m/z). We investigate two heuristics for charge assignment: the entropy-based heuristic is adapted from a deconvolution algorithm by Reinhold and Reinhold;10 the multiplicative-correlation heuristic is adapted from the multiplicative-correlation deconvolution algorithm of Hagen and Monnig.6 The entropy-based heuristic is insensitive to overestimates of z(max), the maximum ion charge. We test the deconvolution algorithm on two single-component samples: the measured spectrum of human beta-endorphin has two prominent and one very weak line whereas myoglobin has a well-developed quasi-gaussian envelope of 17 peaks. In both cases, the deconvolution algorithm gives a clean deconvoluted spectrum with one dominant peak and very few artefacts. The relative heights of the peaks due to the parent molecules in the deconvoluted spectrum of a mixture of two peptides, which are expected to ionize with equal efficiency, give an accurate measure of their relative concentration in the sample.