Joana Vasconcelos

Patterns of complementary and alternative medicine use amongst outpatients in Tokyo, Japan

BackgroundThe use of complementary and alternative medicine (CAM) has been increasing rapidly throughout the world during the past decade. The use of CAM in the general Japanese population has been previously reported to be as high as 76%. This study aims to investigate the patterns of CAM use, perceived effectiveness and disclosure of CAM use to orthodox medical practitioners amongst patients attending typical primary and secondary care clinics in a busy district general hospital in Tokyo, Japan.MethodsThe authors analysed data collected during March 2002 on patients attending general outpatient clinics held at Shiseikai Daini Hospital in Tokyo, Japan. Data was collected by use of self-completed questionnaires distributed to patients in the outpatient clinics waiting area. Statistical analysis was performed using chi-square tests of independence.Results515 adults were approached to participate in this study and the overall response rate was 96% (n = 496). 50% of the patients were using or have used at least 1 CAM therapy within the last 12 months. The 5 most commonly used therapies were massage (n = 106, 43%), vitamins (n = 85, 35%), health foods including dietary supplements (n = 56, 23%), acupressure (n = 51, 21%) and kampo (n = 46, 19%). The majority of CAM users (75%, n = 145) found their CAM treatment to be effective (95% CI = 68–81%). Patients who were more likely to use CAM were females (p = 0.003) and those with a high number of medical conditions (p = < 0.0001). Only a small proportion of patients reported their CAM use to their physician (42%, n = 74). There was no significant difference in CAM use for the different age groups (p = 0.85), education level (p = 0.30) and financial status (p = 0.82).ConclusionPatterns of CAM usage in the sample surveyed was high (50%). Despite this high prevalence rate and presumed acceptance of CAM in Japan, the reporting of CAM use by patients to their physicians was low (42%). It is therefore important that physicians are aware of the possibility that their patients may be using CAM and also increase their knowledge and understanding of these treatments.

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial.

Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Design Randomised controlled trial. Setting Four English general practices. Participants 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening. Intervention Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem. Main outcome measures The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders. Results The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference −1.8%, 95% confidence interval −7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type. Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services. Trial registration Current Controlled Trials ISRCTN 73125647.

Are people with negative diabetes screening tests falsely reassured? Parallel group cohort study embedded in the ADDITION (Cambridge) randomised controlled trial

Objective To assess whether receiving a negative test result at primary care based stepwise diabetes screening results in false reassurance. Design Parallel group cohort study embedded in a randomised controlled trial. Setting 15 practices (10 screening, 5 control) in the ADDITION (Cambridge) trial. Participants 5334 adults (aged 40-69) in the top quarter for risk of having undiagnosed type 2 diabetes (964 controls and 4370 screening attenders). Main outcome measures Perceived personal and comparative risk of diabetes, intentions for behavioural change, and self rated health measured after an initial random blood glucose test and at 3-6 and 12-15 months later (equivalent time points for controls). Results A linear mixed effects model with control for clustering by practice found no significant differences between controls and people who screened negative for diabetes in perceived personal risk, behavioural intentions, or self rated health after the first appointment or at 3-6 months or 12-15 months later. After the initial test, people who screened negative reported significantly (but slightly) lower perceived comparative risk (mean difference −0.16, 95% confidence interval −0.30 to −0.02; P=0.04) than the control group at the equivalent time point; no differences were evident at 3-6 and 12-15 months. Conclusions A negative test result at diabetes screening does not seem to promote false reassurance, whether this is expressed as lower perceived risk, lower intentions for health related behavioural change, or higher self rated health. Implementing a widespread programme of primary care based stepwise screening for type 2 diabetes is unlikely to cause an adverse shift in the population distribution of plasma glucose and cardiovascular risk resulting from an increase in unhealthy behaviours arising from false reassurance among people who screen negative. Trial registration Current controlled trials ISRCTN99175498.

Patients’ perspective of botulinum toxin‐A as a long‐term treatment option for neurogenic detrusor overactivity secondary to spinal cord injury

To evaluate patients’ perspective on whether they would consider botulinum toxin‐A (BTX‐A) injections as a long‐term treatment option for managing their neurogenic detrusor overactivity (NDO) secondary to spinal cord injury (SCI).

Using the 7-point checklist as a diagnostic aid for pigmented skin lesions in general practice: A diagnostic validation study

BACKGROUND GPs need to recognise significant pigmented skin lesions, given rising UK incidence rates for malignant melanoma. The 7-point checklist (7PCL) has been recommended by NICE (2005) for routine use in UK general practice to identify clinically significant lesions which require urgent referral. AIM To validate the Original and Weighted versions of the 7PCL in the primary care setting. DESIGN AND SETTING Diagnostic validation study, using data from a SIAscopic diagnostic aid randomised controlled trial in eastern England. METHOD Adults presenting in general practice with a pigmented skin lesion that could not be immediately diagnosed as benign were recruited into the trial. Reference standard diagnoses were histology or dermatology expert opinion; 7PCL scores were calculated blinded to the reference diagnosis. A case was defined as a clinically significant lesion for primary care referral to secondary care (total 1436 lesions: 225 cases, 1211 controls); or melanoma (36). RESULTS For diagnosing clinically significant lesions there was a difference between the performance of the Original and Weighted 7PCLs (respectively, area under curve: 0.66, 0.69, difference = 0.03, P<0.001). For the identification of melanoma, similar differences were found. Increasing the Weighted 7PCLs cut-off score from recommended 3 to 4 improved detection of clinically significant lesions in primary care: sensitivity 73.3%, specificity 57.1%, positive predictive value 24.1%, negative predictive value 92.0%, while maintaining high sensitivity of 91.7% and moderate specificity of 53.4% for melanoma. CONCLUSION The Original and Weighted 7PCLs both performed well in a primary care setting to identify clinically significant lesions as well as melanoma. The Weighted 7PCL, with a revised cut-off score of 4 from 3, performs slightly better and could be applied in general practice to support the recognition of clinically significant lesions and therefore the early identification of melanoma.

A comparison of technologies used for estimation of body temperature

Body temperature measurement is an important clinical parameter. The performance of a number of non-invasive thermometers was measured by comparing intra- and inter-operator variability (n = 100) and clinical accuracy (n = 61). Variability was elevated in febrile compared to normothermic subjects for axillary and oral electronic contact thermometer measures and a temporal artery thermometer (p < 0.001 for both). Temporal artery thermometry and one mode of an infrared tympanic thermometer demonstrated significant clinical inaccuracy (p < 0.001 for both). Electronic contact thermometer repeatability and reproducibility are highly variable in febrile adults both in the axilla and oral cavity. Infrared thermometry of the skin over the superficial temporal artery is unreliable for measuring core body temperature, particularly in febrile subjects and patients in theatre. The infrared tympanic thermometers tested are acceptable for clinical practice; however, care should be exercised with the different modes of operation offered.

Bladder Cancer Diagnosis and Identification of Clinically Significant Disease by Combined Urinary Detection of Mcm5 and Nuclear Matrix Protein 22

Background Urinary biomarkers for bladder cancer detection are constrained by inadequate sensitivity or specificity. Here we evaluate the diagnostic accuracy of Mcm5, a novel cell cycle biomarker of aberrant growth, alone and in combination with NMP22. Methods 1677 consecutive patients under investigation for urinary tract malignancy were recruited to a prospective blinded observational study. All patients underwent ultrasound, intravenous urography, cystoscopy, urine culture and cytologic analysis. An immunofluorometric assay was used to measure Mcm5 levels in urine cell sediments. NMP22 urinary levels were determined with the FDA-approved NMP22® Test Kit. Results Genito-urinary tract cancers were identified in 210/1564 (13%) patients with an Mcm5 result and in 195/1396 (14%) patients with an NMP22 result. At the assay cut-point where sensitivity and specificity were equal, the Mcm5 test detected primary and recurrent bladder cancers with 69% sensitivity (95% confidence interval = 62–75%) and 93% negative predictive value (95% CI = 92–95%). The area under the receiver operating characteristic curve for Mcm5 was 0.75 (95% CI = 0.71–0.79) and 0.72 (95% CI = 0.67–0.77) for NMP22. Importantly, Mcm5 combined with NMP22 identified 95% (79/83; 95% CI = 88–99%) of potentially life threatening diagnoses (i.e. grade 3 or carcinoma in situ or stage ≥pT1) with high specificity (72%, 95% CI = 69–74%). Conclusions The Mcm5 immunoassay is a non-invasive test for identifying patients with urothelial cancers with similar accuracy to the FDA-approved NMP22 ELISA Test Kit. The combination of Mcm5 plus NMP22 improves the detection of UCC and identifies 95% of clinically significant disease. Trials of a commercially developed Mcm5 assay suitable for an end-user laboratory alongside NMP22 are required to assess their potential clinical utility in improving diagnostic and surveillance care pathways.

Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial

Introduction Proliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. Methods and analysis This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. Ethics and dissemination The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects’ regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. Trial registration number ISRCTN 32207582.

Visceral abdominal obesity - is there an increased prevalence in men presenting with testicular teratoma?

Background: There is evidence to suggest a link between the accumulation of visceral abdominal adipose tissue and an increased incidence of prostate, endometrial, breast, and colonic cancer. Purpose: To investigate whether an increase in ratio of visceral to subcutaneous abdominal adipose tissue is demonstrated in patients with testicular teratoma. Material and Methods: Following ethical approval, 22 male patients who had undergone staging computed tomography (CT) between 2004 and 2007 for testicular teratoma were identified from our database. Abdominal adipose tissue distribution for these 22 patients was compared with that of 22 control patients, standardized for age, sex, and body mass index. Visceral and subcutaneous adipose tissue volumes were calculated from a single axial CT slice at the level of the umbilicus. A two-sample t test for the difference in volume ratio between the two groups was used. A P value of < 0.05 was considered statistically significant. Results: There was a statistically significant difference in the mean ratio of visceral to subcutaneous volumes between the teratoma patients and controls (P=0.02). The ratio in teratoma patients was 1.56 times greater than seen in control patients. Conclusion: Patients with testicular teratoma have a relatively greater proportion of abdominal visceral adipose tissue compared with controls. This is concordant with published literature for other malignancies.