Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project.

BACKGROUND: Data collection consumes a large proportion of clinical trial resources. Each data item requires time and effort for collection, processing and quality control procedures. In general, more data equals a heavier burden for trial staff and participants. It is also likely to increase costs. Knowing the types of data being collected, and in what proportion, will be helpful to ensure that limited trial resources and participant goodwill are used wisely. AIM: The aim of this study is to categorise the types of data collected across a broad range of trials and assess what proportion of collected data each category represents. METHODS: We developed a standard operating procedure to categorise data into primary outcome, secondary outcome and 15 other categories. We categorised all variables collected on trial data collection forms from 18, mainly publicly funded, randomised superiority trials, including trials of an investigational medicinal product and complex interventions. Categorisation was done independently in pairs: one person having in-depth knowledge of the trial, the other independent of the trial. Disagreement was resolved through reference to the trial protocol and discussion, with the project team being consulted if necessary. KEY RESULTS: Primary outcome data accounted for 5.0% (median)/11.2% (mean) of all data items collected. Secondary outcomes accounted for 39.9% (median)/42.5% (mean) of all data items. Non-outcome data such as participant identifiers and demographic data represented 32.4% (median)/36.5% (mean) of all data items collected. CONCLUSION: A small proportion of the data collected in our sample of 18 trials was related to the primary outcome. Secondary outcomes accounted for eight times the volume of data as the primary outcome. A substantial amount of data collection is not related to trial outcomes. Trialists should work to make sure that the data they collect are only those essential to support the health and treatment decisions of those whom the trial is designed to inform.

Motivational interviewing for dental clinicians.

Motivational interviewing (MI) is a patient-centred, directive, therapeutic approach that supports patients' readiness to change by exploring their ambivalence about doing so. This increases the patients' motivation and helps them to commit to the process of change. In relation to dentistry, MI has been effectively used to: promote oral health behaviour; facilitate smoking cessation; and, alter health behaviours.

Validation of a modified National Institutes of Health chronic prostatitis symptom index to assess genitourinary pain in both men and women.

OBJECTIVES: To date, separate condition-specific instruments have been used to assess severity of symptoms, in men and women with urological pain conditions. We developed a single instrument that can be used to assess treatment response in clinical trials and cohort studies that involve both genders. METHODS: We developed the Genitourinary Pain Index (GUPI) by modifying and adding questions to the National Institutes of Health-Chronic Prostatitis Symptom Index. To assess discriminant validity, concurrent validity, and reliability, we administered the GUPI to 1653 men and 1403 women in a large managed care population. To assess responsiveness, we administered the GUPI to 47 men and women who completed a National Institutes of Health-sponsored trial of pelvic floor physical therapy. RESULTS: The GUPI discriminated between men with chronic prostatitis or interstitial cystitis, those with other symptomatic conditions (dysuria, frequency, chronic cystitis), and those with none of these diagnoses (P <.05). It also discriminated between women with interstitial cystitis, those with incontinence, and those with none of these diagnoses (P <.05). The GUPI demonstrated good internal consistency within subscale domains, and GUPI scores correlated highly with scores on the Interstitial Cystitis Symptom Index and Problem Index. The GUPI was highly responsive to change, and the change in score was similar in both male and female responders. A reduction of 7 points robustly predicted being a treatment responder (sensitivity 100%, specificity 76%). CONCLUSIONS: The GUPI is a valid, reliable, and responsive instrument that can be used to assess the degree of symptoms in both men and women with genitourinary pain complaints.

Lesbians' disclosure of sexual orientation and satisfaction with care.

The overarching aim of this study was to explore demographic variables and their association with a woman's disclosure of sexual orientation to a health care provider (HCP). This descriptive correlation study used a convenience sample of 96 women recruited at gay and lesbian community events held in Delaware. A self-report survey of 35 questions was used to obtain the data. None of the women identified themselves as exclusively heterosexual. The results indicate that a woman's self-identified sexual orientation is significant in predicting whether she has shared her orientation with her HCP. The more a woman's self-reported orientation moves toward the heterosexual end of the preference scale, the less likely she is to share her orientation with her HCP. Culturally competent care and a nondiscriminatory atmosphere will provide this population with the trust needed to enable open rapport with their HCPs.

Prevalence of overweight and obesity on the island of Ireland: results from the North South Survey of Children's Height, Weight and Body Mass Index, 2002.

BACKGROUND: Childhood obesity is emerging as a major public health problem in developed and developing countries worldwide. The aim of this survey was to establish baseline data on the prevalence and correlates of overweight and obesity among children and adolescents in the Republic of Ireland (RoI) and Northern Ireland (NI). METHODS: The heights and weights of 19,617 school-going children and adolescents aged between 4 and 16 years in NI and RoI were measured using standardised and calibrated scales and measures. The participants were a representative cross-sectional sample of children randomly selected on the basis of age, gender and geographical location of the school attended. Overweight and obesity were classified according to standard IOTF criteria. RESULTS: Males were taller than females, children in RoI were taller than those in NI and the more affluent were taller than the less well off. The overall prevalence of overweight and obesity was higher among females than males in both jurisdictions. Overall, almost one in four boys (23% RoI and NI) and over one in four girls (28% RoI, 25% NI) were either overweight or obese. In RoI, the highest prevalence of overweight was among 13 year old girls (32%) and obesity among 7 year old girls (11%). In NI the highest prevalence of overweight and obesity were found among 11 and 8 year old girls respectively (33% and 13%). CONCLUSION: These figures confirm the emergence of the obesity epidemic among children in Ireland, a wealthy country with the European Union. The results serve to underpin the urgency of implementing broad intersectoral measures to reduce calorie intake and increase levels of physical activity, particularly among children.

Association of parental smoking behaviors and absences in school-age children: implications for the nurse practitioner.

PURPOSE: To examine the association between reported absences and parental smoking in school-age children, aged 6-17, and to specifically explore the impact of maternal smoking on the health and attendance of school-age children. DATA SOURCES: The sample of 7488 parent-child dyads was randomly selected from the 2002 National Health Interview Survey, a multipurpose cross-sectional household interview survey conducted by the Centers for Disease Control and Prevention. The parent sample included 2673 men and 4375 women. Children's ages ranged from 6 to 17 with a mean of 11.7 years. CONCLUSIONS: Maternal, but not paternal, present and past smoking behavior significantly impacts the child's wellness and school attendance. The reasons for this disparity are unclear but may relate to synergistic effects of pre- and postnatal nicotine exposure, the traditional role of mother as caregiver, or specific smoking habits that increase environmental tobacco exposure. IMPLICATIONS FOR PRACTICE: Assessment and educational strategies for families regarding the hazards of childhood exposure to environmental tobacco smoke are indicated. Specific implications for the role of the nurse practitioner across diverse specialties are addressed with emphasis on the need for development of gender, age, and culturally sensitive smoking cessation programs and support networks.

Predictors of alcohol and crack cocaine use outcomes over a 3-year follow-up in treatment seekers.

This study identified predictors of long-term alcohol and crack cocaine use outcomes in individuals participating in the Persistent Effects of Treatment Study. The domains that were assessed included motivation, self-efficacy, social support, psychiatric severity, employment, housing status, and self-help group attendance at baseline and 6, 12, 24, and 30 month follow-ups. In alcohol users, higher perceived seriousness of substance use problems, self-efficacy, and self-help group attendance, as well as lower social support for substance use, consistently predicted better alcohol use outcomes in the subsequent assessment period. In crack cocaine users, only self-efficacy consistently predicted cocaine use outcomes. Higher self-efficacy during follow-up was predicted by lower perceived seriousness of substance use and lower alcohol use frequency in the prior assessment period, whereas greater self-help group attendance was predicted by greater perceived seriousness of substance use, and lower substance use frequency.

School league tables: a new population based predictor of dental restorative treatment need.

AIM: To test whether dental restorative treatment need was related to the school league tables and level of social deprivation of the school ward. DESIGN: An ecological study using clinical data aggregated at school level, collected in the school dental screening examinations (1996-97), National Census (1991) and the results of the UK school league tables--Key Stage 2 SATs (1996-97). SETTING: State primary schools in the Greenwich District of SE London, UK (1996-97). SUBJECTS: 12,854 pupils (6-11 years of age) in 62 schools. OUTCOME MEASURE: The percentage of 6 to 11 year old pupils per school requiring dental restorative treatment. RESULTS: Deprivation as measured by the overall Jarman Under Privileged Area Index (UPA) of the school ward was not associated with dental restorative treatment need (p > 0.05). Only two components of the Jarman Index, level of unemployment and the number of lone parent families in the school ward were found to be significantly associated with dental restorative treatment need (p < 0.05). Results of stepwise multiple linear regression analysis showed that the association with the school league table results in all three subjects, English, Mathematics and Science remained statistically significant after adjusting for levels of unemployment and single parents. Results of multiple linear regression analysis showed that a high level of dental restorative treatment need was significantly associated with poor school league table results in English, Mathematics and Science (p < 0.05) after adjusting for the overall Jarman score of the school ward. A separate analysis for the 11-year-old pupils aggregated by school (n = 46 schools) gave similar results. CONCLUSIONS: Aggregate measures of academic achievement may be a potential indicator of dental restorative treatment need.

Prostate cryoablation: a scientific rationale for future modifications.

This investigation was designed to identify potential directions for future modification of the percutaneous prostate cryoablation procedure. An analysis of prostate cancer location and volume in radical prostatectomy specimens was performed to evaluate the potential clinical consequences of these proposed modifications. A list of recommendations for improvements in the prostate cryoablation procedure was compiled from informal discussions held with participants in 9 training courses and conferences on prostate cryoablation over 18 months. Subsequently, a population of 112 consecutive, sagittally sectioned whole-mount radical prostatectomy samples was evaluated for prostate cancer volume, number of individual foci, and location to examine the disease-specific outcomes of these proposed modifications. The most common areas for potential alterations in the current cryoablation technique include modifications that would further simplify the procedure, continue to reduce real and perceived toxicity, and augment efficacy. Importantly, modifications designed to reduce treatment side effects could conflict with efforts designed to improve eradication of prostate cancer. Pathologic analysis revealed multifocal cancer in 79.5% of the samples, with 66% of cases exhibiting cancer within 5 mm of the urethra. The median volume of the index cancer was 1.6 cm3, whereas the median volume of the smaller ancillary lesions was 0.3 cm3. Prostate parenchymal-sparing alterations, proposed to reduce incontinence and erectile dysfunction by targeting the index cancer, would likely eradicate clinically significant cancer in 79% of men. The recent enthusiasm for prostate cryoablation as a reasonable minimally invasive treatment option for men with clinically localized cancer is likely to result in modifications of the established surgical technique. Knowledge of the anatomic location and cancer volume within the prostate gland is an important adjunct to planning such alterations. It is possible that parenchymal-sparing modifications to total gland prostate cryoablation can eradicate clinically significant cancer in most men, with a reduction in toxicity and cost.