Adolescent valuation of CARIES-QC-U: a child-centred preference-based measure of dental caries.

OBJECTIVES: This study develops an adolescent value set for a child-centred dental caries-specific measure of oral health-related quality of life (OHRQoL) based upon CARIES-QC (Caries Impacts and Experiences Questionnaire for Children). This study develops a new approach to valuing child health by eliciting adolescent preferences and anchoring these onto the 1-0 full health-dead QALY (quality adjusted life year) scale using ordinal adult preferences. METHODS: Two online surveys were created to elicit preferences for the CARIES-QC classification system. The first comprised best-worst scaling (BWS) tasks for completion by adolescents aged 11-16 years. The second comprised discrete choice experiment tasks with a duration attribute (DCETTO) for completion by adults aged over 18 years. Preferences were modelled using the conditional logit model. Mapping regressions anchored the adolescent BWS data onto the QALY scale using adult DCETTO values, since the BWS survey data alone cannot generate anchored values. RESULTS: 723 adolescents completed the BWS survey and 626 adults completed the DCETTO survey. The samples were representative of UK adolescent and adult populations. Fully consistent and robust models were produced for both BWS and DCETTO data. BWS preferences were mapped onto DCETTO values, resulting utility estimates for each health state defined by the classification system. CONCLUSION: This is the first measure with predetermined scoring based on preferences to be developed specifically for use in child oral health research, and uses a novel technique to generate a value set using adolescent preferences. The estimates can be used to generate QALYs in economic evaluations of interventions to improve children's oral health.

Optical communications downlink from a low-earth orbiting 1.5U CubeSat.

In this article, we present the first demonstration of an optical communications downlink from a low-earth orbiting free-flying CubeSat. Two 1.5U vehicles, AC7-B&C, built under NASA's Optical Communications and Sensors Demonstration (OCSD) program were launched in November 2017 and subsequently placed into a 450-km, 51.6° inc. circular orbit. Pseudorandom data streams using on-off key (OOK) modulation were transmitted from AC-7B to a 40 cm aperture telescope located at sea level in El Segundo, CA. At 200 Mbps, without forward error correction (FEC), we achieved a 115-second link that was ~78% error free, with the remaining portion exhibiting an error rate below 1E-5. At the time of the engagement, the 1064-nm laser transmitter was operating at 2 W (half capacity) with a full width half maximum (FWHM) beam divergence of ~1 mrad, which was approximately double the anticipated pointing accuracy of the vehicle.

Developing a questionnaire to determine the impact of self-management in diabetes: giving people with diabetes a voice.

BACKGROUND: The prevalence of diabetes mellitus (DM) is increasing dramatically, placing considerable financial burden on the healthcare budget of each country. Patient self-management is crucial for the control of blood glucose, which largely determines the chances of developing diabetes-related complications. Self-management interventions vary widely, and a method is required for assessing the impact of self-management. This paper describes the development of a questionnaire intended for use to measure the impact of self-management in diabetes. METHODS: An iterative development process was undertaken to identify the attributes of self-management using 5 steps. First, a literature review was undertaken to identify and understand themes relating to self-management of DM to inform a topic guide. Second, the topic guide was further refined following consultation with a Patient and Public Involvement group. Third, the topic guide was used to inform semi-structured interviews with patients with Type 1 DM (T1DM) and Type 2 DM (T2DM) to identify how self-management of DM affects individuals. Fourth, the research team considered potential attributes alongside health attributes from an existing measure (Diabetes Health Profile, DHP) to produce an instrument reflecting both health and self-management outcomes simultaneously. Finally, a draft instrument was tested in a focus group to determine the wording and acceptability. RESULTS: Semi-structured interviews were carried out with 32 patients with T1DM and T2DM. Eight potential attributes were identified: fear/worry/anxiety, guilt, stress, stigma, hassle, control, freedom, and feeling supported. Four of these self-management attributes were selected with four health attributes (mood, worry about hypos (hypoglycaemic episodes), vitality and social limitations) to produce the Health and Self-Management in Diabetes (HASMIDv1) questionnaire. CONCLUSIONS: HASMIDv1 is a short questionnaire that contains eight items each with four response levels to measure the impact of self-management in diabetes for both T1DM and T2DM. The measure was developed using a mixed-methods approach that involved semi-structured interviews with people with diabetes. The measure has high face validity. Ongoing research is being undertaken to assess the validity of this questionnaire for measuring the impact of self-management interventions in economic evaluation.

Developing preference-based measures for diabetes: DHP-3D and DHP-5D.

AIMS: The aim of this study was to develop two diabetes-specific preference-based measures [the Diabetes Health Profile-3 Dimension (DHP-3D) and the Diabetes Health Profile-5 Dimension (DHP-5D)] for use in the calculation of Quality Adjusted Life Years, a key outcome in economic evaluation. These measures were based on the non-preference-based instrument the Diabetes Health Profile. METHODS: For DHP-3D, psychometric and Rasch analyses were used to develop a health state classification system based on the Diabetes Health Profile-18 (DHP-18). The DHP-5D added two dimensions to the DHP-3D to extend the range of impacts measured. Each classification system was valued by 150 general public respondents in the United Kingdom using Time Trade Off (TTO). Multivariate regression was used to estimate utility value sets. The matched dimensions across each measure were compared using z-score tests. RESULTS: The DHP-3D included three dimensions defined as mood, eating and social limitations, and the DHP-5D added dimensions defined as hypoglycaemic attacks and vitality. For both, the random effects generalized least squares regression model produced consistent value sets, with the DHP-3D and DHP-5D ranging from 0.983 (best state) to 0.717 (worst state), and 0.979 to 0.618 respectively. The addition of the two extra dimensions leads to significant differences for the more severe levels of each matched dimension. CONCLUSIONS: We have developed two diabetes-specific preference-based measures that, subject to psychometric assessment, can be used to provide condition-specific utility values to complement generic utilities from more widely validated measures such as the EuroQol-5 Dimension.

QLU-C10D: a health state classification system for a multi-attribute utility measure based on the EORTC QLQ-C30.

PURPOSE: To derive a health state classification system (HSCS) from the cancer-specific quality of life questionnaire, the EORTC QLQ-C30, as the basis for a multi-attribute utility instrument. METHODS: The conceptual model for the HSCS was based on the established domain structure of the QLQ-C30. Several criteria were considered to select a subset of dimensions and items for the HSCS. Expert opinion and patient input informed a priori selection of key dimensions. Psychometric criteria were assessed via secondary analysis of a pooled dataset comprising HRQOL and clinical data from 2616 patients from eight countries and a range of primary cancer sites, disease stages, and treatments. We used confirmatory factor analysis (CFA) to assess the conceptual model's robustness and generalisability. We assessed item floor effects (>75 % observations at lowest score), disordered item response thresholds, coverage of the latent variable and differential item function using Rasch analysis. We calculated effect sizes for known group comparisons based on disease stage and responsiveness to change. Seventy-nine cancer patients assessed the relative importance of items within dimensions. RESULTS: CFA supported the conceptual model and its generalisability across primary cancer sites. After considering all criteria, 12 items were selected representing 10 dimensions: physical functioning (mobility), role functioning, social functioning, emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems. CONCLUSIONS: The HSCS created from QLQ-C30 items is known as the EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The next phase of the QLU-C10D's development involves valuation studies, currently planned or being conducted across the globe.

Using a discrete choice experiment to value the QLU-C10D: feasibility and sensitivity to presentation format.

PURPOSE: To assess the feasibility of using a discrete choice experiment (DCE) to value health states within the QLU-C10D, a utility instrument derived from the QLQ-C30, and to assess clarity, difficulty, and respondent preference between two presentation formats. METHODS: We ran a DCE valuation task in an online panel (N = 430). Respondents answered 16 choice pairs; in half of these, differences between dimensions were highlighted, and in the remainder, common dimensions were described in text and differing attributes were tabulated. To simplify the cognitive task, only four of the QLU-C10D's ten dimensions differed per choice set. We assessed difficulty and clarity of the valuation task with Likert-type scales, and respondents were asked which format they preferred. We analysed the DCE data by format with a conditional logit model and used Chi-squared tests to compare other responses by format. Semi-structured telephone interviews (N = 8) explored respondents' cognitive approaches to the valuation task. RESULTS: Four hundred and forty-nine individuals were recruited, 430 completed at least one choice set, and 422/449 (94 %) completed all 16 choice sets. Interviews revealed that respondents found ten domains difficult but manageable, many adopting simplifying heuristics. Results for clarity and difficulty were identical between formats, but the "highlight" format was preferred by 68 % of respondents. Conditional logit parameter estimates were monotonic within domains, suggesting respondents were able to complete the DCE sensibly, yielding valid results. CONCLUSION: A DCE valuation task in which only four of the QLU-C10D's ten dimensions differed in any choice set is feasible for deriving utility weights for the QLU-C10D.

Increasing screening frequency in men who have sex with men: impact of guidance on risk profiling on workload and earlier diagnosis of sexually transmitted infection and HIV.

Increasing screening frequency in men who have sex with men (MSM) engaging in high-risk behaviours can reduce prevalence of sexually transmitted infections (STIs). This evaluation investigated the impact of applying stricter screening guidelines for MSM on service workload and earlier STI diagnoses. A validated risk assessment tool (RAT) was distributed to MSM attending a level 3 sexual health service over three months. Australian screening guidelines were applied to the data to identify MSM requiring more frequent screening and data projected to the larger MSM population. The RAT identified a 2-5-fold increase in the number of STI and HIV screenings required based on six- and three-monthly screening intervals, respectively, in the MSM cohort. When screening intervals are reduced from three-monthly to six-monthly there is a potential loss of 66.7% of earlier HIV diagnoses. The use of RATs will increase workload in sexual health services, but potentially diagnose a large proportion of disease earlier.

A glimmer of hope? Evaluation of time for non-genitourinary medicine physicians to diagnose HIV infection in patients presenting with HIV-related illness.

A study conducted in 2002-2003 at three UK south coast hospitals measuring the length of time for non-genitourinary medicine physicians to diagnose HIV when patients presented with an HIV-related illness, found a median time to diagnosis of four days with 70% of diagnoses being made within seven days. This retrospective cohort study of all patients newly diagnosed with HIV between 1 January 2010 and 31 December 2011 was conducted at the same three hospitals. Thirty-seven patients were newly diagnosed with HIV in non-genitourinary (GU) medicine inpatient and outpatient settings (24 men, 13 women), with a mean age of 43 years. The median time to diagnosis was one day (interquartile range of 0-4 days), with 81% of diagnoses made within seven days of first presentation. Late diagnosis of HIV remains a significant challenge, but delayed diagnosis in a patient admitted with an HIV-related illness is reducing in this setting.

Development of DEMQOL-U and DEMQOL-PROXY-U: generation of preference-based indices from DEMQOL and DEMQOL-PROXY for use in economic evaluation.

BACKGROUND: Dementia is one of the most common and serious disorders in later life and the economic and personal cost of caring for people with dementia is immense. There is a need to be able to evaluate interventions in dementia using cost-effectiveness analyses, but the generic preference-based measures typically used to measure effectiveness do not work well in dementia. Existing dementia-specific measures can effectively measure health-related quality of life but in their current form cannot be used directly to inform cost-effectiveness analysis using quality-adjusted life-years as the measure of effectiveness. OBJECTIVES: The aim was to develop two brief health-state classifications, one from DEMQOL and one from DEMQOL-Proxy, to generate health states amenable to valuation. These classification systems consisted of items taken from DEMQOL and DEMQOL-Proxy so they can be derived from any study that has used these instruments. DATA SOURCES: In the first stage of the study we used a large, clinically representative sample aggregated from two sources: a sample of patients and carers attending a memory service in south London and a sample of patients and carers from other community services in south London. This included 644 people with a diagnosis of mild/moderate dementia and 689 carers of those with mild/moderate dementia. For the valuation study, the general population sample of 600 respondents was drawn to be representative of the UK general population. Households were sampled in urban and rural areas in northern England and balanced to the UK population according to geodemographic profiles. In the patient/carer valuation study we interviewed a sample of 71 people with mild dementia and 71 family carers drawn from a memory service in south London. Finally, the instruments derived were applied to data from the HTA-SADD (Study of Antidepressants for Depression in Dementia) trial. REVIEW METHODS: This was a complex multiphase study with four linked phases: phase 1 - derivation of the health-state classification system; phase 2 - general population valuation survey and modelling to produce values for every health state; phase 3 - patient/carer valuation survey; and phase 4 - application of measures to trial data. RESULTS: All four phases were successful and this report details this development process leading to the first condition-specific preference-based measures in dementia, an important new development in this field. LIMITATIONS: The first limitation relates to the lack of an external data set to validate the DEMQOL-U and DEMQOL-Proxy-U classification systems. Throughout the development process we have made decisions about which methodology to use. There are other valid techniques that could be used and it is possible to criticise the choices that we have made. It is also possible that the use of a mild to moderate dementia sample has resulted in classification systems that do not fully reflect the challenges of severe dementia. CONCLUSION: The results presented are sufficiently encouraging to recommend that the DEMQOL instruments be used alongside a generic measure such as the European Quality of Life-5 Dimensions (EQ-5D) in future studies of interventions in dementia as there was evidence that they can be more sensitive for patients at the milder end of disease and some limited evidence that the person with dementia measure may be able to reflect deterioration. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Developing and testing methods for deriving preference-based measures of health from condition-specific measures (and other patient-based measures of outcome).

OBJECTIVES: Generic preference-based measures such as EQ-5D are widely used to estimate quality-adjusted life-years but may not be available or, more importantly, appropriate in some medical conditions. Condition-specific preference-based measures (CSPBMs) provide an alternative to generic measures that may be more relevant in some conditions. This project conducted five studies to examine issues in the development and use of CSPBMS: (1) literature review of measures; (2) deriving health states values for classifications with highly correlated dimensions; (3) impact of condition labelling; (4) impact of add-on dimensions; and (5) comparative performance of measures. DESIGN: (1) Systematic search and literature review; (2) and (5) psychometric analyses on existing data; (2), (3) and (4) valuation surveys and survey analyses. SETTING: Valuation surveys conducted using face-to-face interviews in the respondents' homes. PARTICIPANTS: Valuation surveys conducted using representative samples of the UK general population. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The project developed a CSPBM CORE-6D and analyses AQL-5D, CORE-6D, EORTC-8D, EQ-5D, OAB-5D and SF-6D data. RESULTS: (1) There was substantial variability in methods used to develop CSPBMs. (2) A new method for generating states using Rasch analysis was undertaken, which successfully dealt with the problem of highly correlated domains. (3) Condition labels affected utility values but this was dependent on the condition and severity of the health state. (4) Adding on an extra dimension affected health-state values and preference weights for other dimensions. (5) The performance of CSPBMs was comparable with that of their parent instrument and of generic preference-based measures with better performance for discrimination between severity groups. CONCLUSIONS: CSPBMs have an important role for economic evaluation, for which generic measures are inappropriate. However, their use in economic evaluation may be compromised by naming the condition; the exclusion of side effects and comorbidities; and focusing effects. Whether a reduction in comparability should be accepted depends on the extent of any gain in validity and responsiveness. This will depend on the condition and measure in question. Research agenda: (1) The appropriateness of generic preference-based measures should be examined in more conditions (and compared with CSPBMs). (2) Further quantitative and qualitative work is requested into the impact of, and reasons for labelling effects. (3) Use of add-ons for condition-specific measures (for side effects and comorbidities) and as a solution to the limitation of generic measures should be explored. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Hoarseness of voice in an AIDS patient: a rare presenting feature of disseminated histoplasmosis.

Laryngeal histoplasmosis is very rare among patients with HIV and very few cases have so far been documented. We report a case of laryngeal histoplasmosis in a patient with no prior AIDS defining diagnosis, which mimicked epithelial neoplasia, and was treated successfully with oral fluconazole.

A multicentre, randomised, double-blind, placebo controlled study of cryotherapy versus cryotherapy and podophyllotoxin cream as treatment for external anogenital warts.

OBJECTIVES: To compare the efficacy and safety of combination therapy with cryotherapy and podophyllotoxin 0.15% cream versus cryotherapy alone in the treatment of anogenital warts. METHODS: A randomised, double-blind, multicentre controlled trial. Patients received podophyllotoxin cream or placebo twice daily for 3 days/week for up to 4 weeks, with weekly cryotherapy continued to week 12 if required. Further treatment from week 12 to 24 was discretionary. Patients were stratified by sex and history of warts. HIV positivity, warts treated in the past 4 months, or warts with a combined area of less than 10 mm(2) were exclusion criteria. Primary endpoints were clearance at weeks 4 and 12. RESULTS: 70 patients per group were randomly assigned and started treatment; 101 first-episode warts, 91 male. No treatment-related serious adverse events were reported. Follow-up at week 12 was 85%. By intention-to-treat analysis, clearances at 4 and 12 weeks were higher in the combination group (60.0% and 60.0%, respectively) than with cryotherapy alone (45.7%, 45.7%) although not statistically significant (RR 1.31, 95% CI 0.95 to 1.81). By week 24 there was no difference between the groups (68.6% and 64.3%, respectively; RR 1.07, CI 0.84 to 1.35). At week 4, wart clearance was higher in men (p = 0.001) and those with a past history of warts (p = 0.009), but these differences were not detected at week 12. There was some evidence for a higher relapse rate in the group receiving cryotherapy alone. CONCLUSIONS: Initial combination therapy with podophyllotoxin/cryotherapy was well tolerated and may have resulted in earlier clearance in some patients, compared with cryotherapy alone; however, overall differences in clearance rates were not statistically significant.

Compliance with hand hygiene in a genitourinary medicine department.

The ability to control hospital-acquired infections is highly dependent upon control of cross-contamination from health-care workers to patients, and from one anatomical area of the patient to another anatomical area. Hand hygiene has been demonstrated to be an essential prerequisite in preventing cross-contamination. Wearing gloves does not afford complete protection against cross-contamination. Hand hygiene includes handwashing between patients, the use of alcohol-based skin cleansers and changing or removing gloves between examining different anatomical sites. There are no previously published audits regarding compliance to hand hygiene in genitourinary (GU) medicine clinics. A validated observation tool was employed in this audit. Doctors and nurses were observed in clinical practice. The adherence to hand hygiene protocols was overall poor. Doctors were more likely to adhere to protocols than nurses (83.3% vs. 66%). However, techniques of glove removal were universally satisfactory. Strategies for improvement in hand hygiene are suggested. These include performance feedback and use of posters.

Patient-initiated delay at a genitourinary medicine clinic: are there public health consequences?

OBJECTIVES: To assess the public health consequence of patients electing not to be seen within 48 hours in a genitourinary medicine (GUM) clinic. METHODS: A 3-month retrospective case notes review was carried out for 310 new and re-book patients who chose to wait for more than 48 hours to be seen. RESULTS: Altogether, 10% (310/3110) of patients opted to be seen beyond 48 h. Their median wait was 6 days including weekends and 4 days excluding weekends. Demographic details did not vary except for the male to female ratio of 1:1.7 (1:1 in patients seen within 48 h). We found that no symptomatic patients or asymptomatic contacts of those with known sexually transmitted infections (STIs) reported sex with a new partner after booking their appointment. No patient reported sex with a recently treated partner who consequently required re-treatment and none suffered a complication of a STI. In addition, there were no cases of new HIV infection in this group and the rates of STIs were similar compared with patients seen within 48 hours of contacting the unit. CONCLUSIONS: Despite 10% of patients choosing to delay attendance beyond 48 h, no adverse public health outcomes were demonstrated.

An unusual case of pelvic pain: retention of fetal bone after abortion.

We present a 21-year-old woman with a short history of pelvic pain. The history was unremarkable apart from that of undergoing a surgical termination of pregnancy (TOP) some three-and-half years ago. Examination revealed a foreign body at the cervical os. Subsequent investigations revealed more foreign bodies within the cervical canal and uterine cavity, which were removed. Histologically these were found to be bones. Removal of the bone fragment initially discovered lead to an improvement of symptoms. Although the patient was treated for pelvic-inflammatory disease, no infective cause could be established. The condition of intrauterine retained fetal bones is recognized, but rare. Patients experiencing pelvic pain usually present sooner after TOP than did this patient. Although rare, it is an important condition to diagnose as it represents a treatable cause of infertility.