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Pelvic floor muscle training for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training is the most commonly recommended physical therapy treatment for women with stress leakage of urine. It is also used in the treatment of women with mixed incontinence, and less commonly for urge incontinence. Adjuncts, such as biofeedback or electrical stimulation, are also commonly used with pelvic floor muscle training. The content of pelvic floor muscle training programmes is highly variable. OBJECTIVES: To determine the effects of pelvic floor muscle training for women with symptoms or urodynamic diagnoses of stress, urge and mixed incontinence, in comparison to no treatment or other treatment options. SEARCH STRATEGY: Search strategy: We searched the Cochrane Incontinence Group trials register (May 2000), Medline (1980 to 1998), Embase (1980 to 1998), the database of the Dutch National Institute of Allied Health Professions (to 1998), the database of the Cochrane Rehabilitation and Related Therapies Field (to 1998), Physiotherapy Index (to 1998) and the reference lists of relevant articles. We handsearched the proceedings of the International Continence Society (1980 to 2000). We contacted investigators in the field to locate studies. Date of the most recent searches: May 2000. SELECTION CRITERIA: Randomised trials in women with symptoms or urodynamic diagnoses of stress, urge or mixed incontinence that included pelvic floor muscle training in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Sensitivity analysis on the basis of diagnosis was planned and undertaken where appropriate. MAIN RESULTS: Forty-three trials met the inclusion criteria. The primary or only reference for 15 of these was a conference abstract. The pelvic floor muscle training programs, and comparison interventions, varied markedly. Outcome measures differed between trials, and methods of data reporting varied, making the data difficult to combine. Many of the trials were small. Allocation concealment was adequate in five trials, and nine trials used assessors masked to group allocation. Thirteen trials reported that there were no losses to follow up, seven trials had dropout rates of less than 10%, but in the remaining trials the proportion of dropouts ranged from 12% to 41%. Pelvic floor muscle training was better than no treatment or placebo treatments for women with stress or mixed incontinence. 'Intensive' appeared to be better than 'standard' pelvic floor muscle training. PFMT may be more effective than some types of electrical stimulation but there were problems in combining the data from these trials. There is insufficient evidence to determine if pelvic floor muscle training is better or worse than other treatments. The effect of adding pelvic floor muscle training to other treatments (e.g. electrical stimulation, behavioural training) is not clear due to the limited amount of evidence available. Evidence of the effect of adding other adjunctive treatments to PFMT (e.g. vaginal cones, intravaginal resistance) is equally limited. The effectiveness of biofeedback assisted PFMT is not clear, but on the basis of the evidence available there did not appear to be any benefit over PFMT alone at post treatment assessment. Long-term outcomes of pelvic floor muscle training are unclear. Side effects of pelvic floor muscle training were uncommon and reversible. A number of the formal comparisons should be viewed with caution due to statistical heterogeneity, lack of statistical independence, and the possibility of spurious confidence intervals in some instances. REVIEWER'S CONCLUSIONS: Pelvic floor muscle training appeared to be an effective treatment for adult women with stress or mixed incontinence. Pelvic floor muscle training was better than no treatment or placebo treatments. The limitations of the evidence available mean that is difficult to judge if pelvic floor muscle training was better or worse than other treatments. Most trials to date have studied the effect of treatment in younger, premenopausal women. The role of pelvic floor muscle training for women with urge incontinence alone remains unclear. Many of the trials were small with poor reporting of allocation concealment and masking of outcome assessors. In addition there was a lack of consistency in the choice and reporting of outcome measures that made data difficult to combine. Methodological problems limit the confidence that can be placed in the findings of the review. Further, large, high quality trials are necessary.

Female↗

Quality assessment of fetal death records in Georgia: a method for improvement.

OBJECTIVES: Although more fetal deaths than neonatal deaths occur, routinely collected fetal death data are seldom used for perinatal epidemiologic research because of data quality concerns. We developed a strategy for identifying and correcting errors in birthweight and gestational age in fetal death records. METHODS: Using data from Georgia for 1989 and 1990, we detected singleton fetal death records having improbable or missing birthweight or gestational age by comparing these values with referent values. To verify the questionable values, we contacted 100 reporting hospitals in 1992. RESULTS: In 817 of 2226 records, values were either improbable (60.1%) or missing (39.9%). We were able to contact the hospitals to verify data for 716 (88%) of these records. Verification resulted in corrections to 405 (57%) records, and 48% of unreported birthweights were obtained. CONCLUSIONS: Many errors in recorded gestational age and birthweight were identified by this method. Rather than deleting or inputting problem data for analyses, researchers should consider efforts to verify them. Efforts to improve this information should include improved reporting, strict quality assurance, and procedures for routine verification and correction of records.

Birth Weight↗

Coding accuracy for endophthalmitis diagnosis and cataract procedures in Western Australia. The Endophthalmitis Population Study of Western Australia (EPSWA): second report.

As an initial phase of the Endophthalmitis Population Study of Western Australia (EPSWA), this paper reports the results from an intensive comparative validation of all possible surgery-related endophthalmitis cases identified for the period from 1980 to June 1999 from the Hospital Morbidity Data System (HMDS) of the WA Record Linkage Project with external sources. The external sources were the microbiology and anaesthetic databases from Royal Perth Hospital (where most of the cases of endophthalmitis were treated) and surgeon logbooks of two vitreoretinal surgeons treating endophthalmitis in Perth over the study period. As it was discovered that a large proportion of all cases coded with endophthalmitis did not have any ocular surgery, the validation also included a sample from these cases. The purpose of validating these cases was to ensure that our count of post-operative endophthalmitis had not excluded any cases whose surgery might not have been recorded in the HMDS database. It was also intended to provide an estimate of all miscoded endophthalmitis cases as a first step towards future improvement of coding accuracy. Since we suspected that phaco-emulsification was under-coded, we also examined a sample of cataract procedures. Of all surgery-related endophthalmitis cases coded in the HMDS, only 50.9% (274 of 538) were found to be valid cases. External sources identified 83 cases of endophthalmitis, 49 did not have endophthal-mitis codes but were in the HMDS file with an associated code. Of the remaining externally identified cases, 13 were missing altogether from the HMDS file, 7 of which were correctly coded in the notes while the other 6 were coded with associated codes, and 21 were diagnosed after the date the HMDS file was extracted. The validation of a random sample of the non-surgery-related cases coded with endophthalmitis suggested that the vast majority of them were miscoded (88%, 139 of 158 sampled from 1474 cases). The systematic coding errors reported in this paper may be attributed to both the clinical and the coding departments of the hospital. In any case, coding inaccuracy itself is a serious concern for data quality of any linked database systems and for epidemiological researchers using such data. The increased use of aggregated data in epidemiological research further underscores the importance of coding accuracy and thus data validation. The use of external sources for case identification and case validation are two ways of ensuring data completeness/quality and validity of results.

Cataract↗

Quality of life in rectal cancer patients: a four-year prospective study.

OBJECTIVE: To assess long-term quality of life in a population-based sample of rectal cancer patients. SUMMARY BACKGROUND DATA: Quality of life in rectal cancer patients who suffer reduced bowel and sexual function is very important. Few studies, however, have long term follow-up data or sufficient sample sizes for reliable comparisons between operation groups. PATIENTS AND METHODS: A 4-year prospective study of rectal cancer patients' quality of life was assessed by using the European Organization for Research and Treatment of Cancer QLQ-30 and CR38 questionnaires. RESULTS: A total of 329 patients returned questionnaires. Overall, anterior resection patients had better quality of life scores than abdominoperineal extirpation patients. High-anterior resection patients had significantly better scores than both low-anterior resection and abdominoperineal extirpation patients. Low-anterior resection patients, however, overall had a better quality of life than abdominoperineal extirpation patients, especially after 4 years. Abdominoperineal extirpation patients' quality of life scores did not improve over time. Stoma patients had significantly worse quality of life scores than nonstoma patients. Quality of life improved greatly for patients whose stoma was reversed. CONCLUSIONS: Anterior resection and nonstoma patients, despite suffering micturition and defecation problems, had better quality of life scores than abdominoperineal extirpation and stoma patients. Comparisons between abdominoperineal extirpation and anterior resection patients should consider the effect of temporary stomas. Improvements in quality of life scores over time may be explained by reversal of temporary stomas or physiologic adaptation.

Aged↗

Capacities and limitations of information systems as data sources on quality of care at the end of life.

Assessing quality of care at the end of life involves measurements in several domains-use of evidence-based guidelines, patient and family satisfaction, quality of life, and incidence of adverse events, among others. There are several different data sources from which to calculate quality measures. Each data source has a balance of strengths and weaknesses, and not all data sources are available in all possible settings of care. This paper describes how various data sources can be used to obtain the key data elements required for quality of care measures, as well as the challenges to linking data elements across sites and levels of care. There are some important quality domains (e.g., interpersonal and spiritual aspects of care) that are very difficult to assess using readily available data; primary data collection through interview and survey methods will be required to assess quality in these areas.

Data Collection↗

Optimal gene expression analysis by microarrays.

DNA microarrays make possible the rapid and comprehensive assessment of the transcriptional activity of a cell, and as such have proven valuable in assessing the molecular contributors to biological processes and in the classification of human cancers. The major challenge in using this technology is the analysis of its massive data output, which requires computational means for interpretation and a heightened need for quality data. The optimal analysis requires an accounting and control of the many sources of variance within the system, an understanding of the limitations of the statistical approaches, and the ability to make sense of the results through intelligent database interrogation.

Algorithms↗

Managing data for integrity: policies and procedures for ensuring the accuracy and quality of the data in the laboratory.

Management of the research data is an extremely important responsibility of the Principal Investigator (PI) and other members of the research team. Without accurate data, no worthwhile conclusions can be drawn from the research study. Integrity in data management is critical to the success of the research group and to public trust in the research outcomes. One of the primary responsibilities of the PI is to provide proper training to the junior members of the lab. This effort can be buttressed by institutional data policies that are implemented at the group level. Extensive and frequent guidance in good research practices by the PI and other senior research staff is critical to the proper training of new scientists.

Data Collection↗

A spurious correlation between hospital mortality and complication rates: the importance of severity adjustment.

OBJECTIVES: When two outcome measures, such as mortality and complication rates, are intended to measure the same underlying quantity (in this case hospital quality of care), one expects they will be highly correlated. In addition, as data quality improves, one expects the correlation will increase. The authors show that these expectations are, in a significant way, mistaken. METHODS: The authors study two outcomes (hospital mortality and complication rates after surgery) using three predictive models that vary in adjustment for severity of illness. RESULTS: Two hospital rankings, based on each of the two outcomes, are well correlated when not adjusted for severity. However, as clinical data are added to the models, the correlation tends to disappear. The authors explain this based on assumptions regarding the relative size of the partial correlations between mortality, complication rate, and severity covariates. CONCLUSIONS: Before claims of construct validity can be made, investigators must show that correlations between outcomes purporting to measure quality of care are sustained after adequate correction for severity. Most importantly, it should be recognized that inadequately controlled confounding variables may lead to a spurious high correlation between an accepted and a new outcome measure, and a false sense of adequate construct validity.

Adult↗

Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations.

The primary objectives of this research were to translate, validate, and generate normative data on the SF-36 Health Survey for use among Dutch-speaking residents of the Netherlands. Translation of the SF-36 into Dutch followed the stepwise, iterative procedures developed by the IQOLA Project. Following extensive pilot testing, the SF-36 was administered to: (1) a random sample of adult residents of Amsterdam (n = 4172); (2) a random, nationwide sample of adults (n = 1742); (3) a sample of migraine sufferers (n = 423); and (4) a sample of cancer patients undergoing active anti-neoplastic treatment (n = 485). Data quality across the four studies was consistently high. The rates of missing data ranged from 1% to 5% at the item level, and from 1.2% to 2.6% at the scale level. Multitrait scaling analysis confirmed the hypothesized scale structure of the SF-36 and associated scale scoring in all four samples. Cronbach's alpha coefficients surpassed the 0.70 criterion for group comparisons in all but one case (the Social Functioning scale in the cancer sample), with a mean alpha coefficient across all scales and samples of 0.84. Known-group comparisons yielded consistent support for the validity of the SF-36. In the two community samples, statistically significant differences in SF-36 mean scale scores were observed as a function of age, gender, and the prevalence of chronic health conditions. In the migraine and cancer samples, mean SF-36 scale scores varied significantly as a function of various indicators of disease severity. The SF-36 profiles for the two community samples were highly similar. The cancer sample yielded the lowest SF-36 scores, with the migraine sample holding an intermediate position. On-going studies will generate data on the responsiveness of the SF-36 to within-group changes in health over time. Efforts are underway to translate and validate the questionnaire for use among ethnic minority groups in the Netherlands.

Adolescent↗

Linear structural equation model in analyzing quality-of-life-data from clinical trials.

Assessment of quality of life (QOL) in clinical trials becomes a challenging task from the viewpoint of clinical biostatistics. The responses of the items for measuring QOL indices usually vary widely from patient to patient and from time to time. Measurement errors might be present in the responses of the items, and they might be correlated. Hence, in analyzing QOL data, the usual assumption that there are no measurement errors in responses is too liberal. Because the QOL indices are likely to be correlated, separate analysis of each index might not be efficient from the point of view of statistical methodology. We apply linear structural equation modeling (LISREL) in assessing the QOL data obtained from a clinical trial. A basic premise of the LISREL approach is that the abstract concepts (latent constructs) that are not directly measurable can be studied. LISREL is a statistical procedure for conceiving and testing structural hypotheses that cannot be tested adequately with other statistical procedures. It allows us to specify relations between unobserved and observed variables while controlling for measurement errors and correlations among both the measurement errors and the latent constructs.

Arterial Occlusive Diseases↗

Intravenous immunoglobulin in autoimmune neuromuscular diseases.

CONTEXT: Intravenous immunoglobulin (IVIG) enhances immune homeostasis by modulating expression and function of Fc receptors, interfering with activation of complement and production of cytokines, providing anti-idiotypic antibodies, and affecting the activation and effector functions of T and B cells. These mechanisms may explain the effectiveness of IVIG in autoimmune neuromuscular disorders. OBJECTIVE: To systematically review the current status of the treatment of autoimmune neuromuscular diseases with IVIG, with emphasis on controlled trials. DATA SOURCES: Peer-reviewed publications identified through MEDLINE (1966-2003), EMBASE (1974-2003), and references from bibliographies of pertinent articles. Each autoimmune neuromuscular disease term was searched in combination with the term intravenous immunoglobulin. STUDY SELECTION AND DATA EXTRACTION: Criteria for selection of studies included controlled study design, English language, and clinical pertinence. Data quality was based on venue of publication and relevance to clinical care. DATA SYNTHESIS: Outcomes of controlled trials indicate that IVIG at a total dose of 2 g/kg is effective as first-line therapy in Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy and as second-line therapy in stiff-person syndrome, dermatomyositis, myasthenia gravis, and Lambert-Eaton myasthenic syndrome. In other controlled studies, IVIG produced a modest, variable, and transient but not statistically significant benefit in patients with inclusion body myositis and paraproteinemic anti-myelin-associated glycoprotein antibody demyelinating polyneuropathy. Intravenous immunoglobulin is not effective in patients with multiple sclerosis who have established weakness or optic neuritis. In myasthenia gravis, it should be reserved for difficult cases or before thymectomy in lieu of plasma exchange. CONCLUSION: Intravenous immunoglobulin is effective in many autoimmune neurologic diseases, but its spectrum of efficacy, especially as first-line therapy, and the appropriate dose for long-term maintenance therapy are not fully established. Further controlled studies of IVIG, combined with a dose-finding effect, pharmacoeconomics, and quality-of-life assessments, are warranted to improve the evidence base for clinical practice.

Autoimmune Diseases of the Nervous System↗

Big data and psychiatry: advances, constraints and future directions.

Early work in psychiatry research, often involving single sites, small samples, and limited variables, has shifted to contemporary research involving multiple sites, large samples, and many variables. Such research raises important questions, including concerns about data quality and methodological rigor, uncertainty about its key lessons, issues regarding clinical relevance, and questions about how to optimize future advances. Here we consider these questions and concerns against the context of big data work on community and register-based surveys, cohort and biobank studies, electronic health records, digital phenotyping, brain imaging, genomics and other -omics, and randomized controlled trials. The development of large datasets allowing well-powered analyses is a major milestone, but sample size alone does not guarantee more precise estimates, and ongoing attention to the quality and rigor of big data collation and analysis is needed. Big data research has fostered trans-disciplinarity and given insights into mechanisms underlying psychiatric disorders, but also emphasizes the intricacy, heterogeneity and variability of such mechanisms, and the importance of triangulating between large-scale and small-scale research. The complexity of psychiatric phenotypes and psychobiological mechanisms contributes to the difficulty in bridging from big data to clinical application; big data research reinforces the importance of holding our diagnoses of psychiatric disorders lightly and providing explanations of these conditions humbly; and future work needs to be more attentive to clinical issues. There is enormous scope for further building databases relevant to psychiatry, but advances in conceptual models and asking the right questions are equally valuable. The full impact of big data, including artificial intelligence analyses, remains to be seen, but overenthusiastic support should be tempered by a better understanding of its strengths and limitations. At its best, such work will contribute in an iterative and integrative way to advancing our knowledge of psychiatric disorders and mental health.

Big data↗

Application of CCME Water Quality Index to monitor water quality: a case study of the Mackenzie River Basin, Canada.

All six ecosystem initiatives evolved from many years of federal, provincial, First Nation, local government and community attention to the stresses on sensitive habitats and species, air and water quality, and the consequent threats to community livability. This paper assesses water quality aspect for the ecosystem initiatives and employs newly developed Canadian Council of Ministers of the Environment Water Quality Index (CCME WQI) which provides a convenient mean of summarizing complex water quality data that can be easily understood by the public, water distributors, planners, managers and policy makers. The CCME WQI incorporates three elements: Scope - the number of water quality parameters (variables) not meeting water quality objectives (F(1)); Frequency - the number of times the objectives are not met (F(2)); and Amplitude. the extent to which the objectives are not met (F(3)). The index produces a number between 0 (worst) to 100 (best) to reflect the water quality. This study evaluates water quality of the Mackenzie - Great Bear sub-basin by employing two modes of objective functions (threshold values): one based on the CCME water quality guidelines and the other based on site-specific values that were determined by the statistical analysis of the historical data base. Results suggest that the water quality of the Mackenzie-Great Bear sub-basin is impacted by high turbidity and total (mostly particulate) trace metals due to high suspended sediment loads during the open water season. Comments are also provided on water quality and human health issues in the Mackenzie basin based on the findings and the usefulness of CCME water quality guidelines and site specific values.

Arctic Regions↗

The EUROCARE-3 database: methodology of data collection, standardisation, quality control and statistical analysis.

The EUROCARE database contains data on 6.5 million cancer patients diagnosed from 1978 to 1994 in populations covered by 67 cancer registries in 22 European countries. The quality-checked entries specify age, sex, diagnosis date, cancer site, morphology, microscopic confirmation and vital status, as well as containing broad indicators of stage. For EUROCARE-3, which refers to diagnoses from 1990 to 1994, 3389 cases with major data problems and 142,525 second or subsequent cancers were removed, leaving more than 2 million cases for analysis. From these data, observed and relative survival for each cancer site and country were calculated at 1, 3 and 5 years from diagnosis. Overall European survival for each cancer site and for all cancers combined were calculated combining country-specific survival figures. Overall, 1.1% of cases were lost to follow-up, 4.2% were known from death certificates only and 1.2% were known at autopsy only. The percentage of microscopically confirmed cases varied with cancer site and country, and was always higher in northern European countries. Comparison of quality indicators for the EUROCARE-3 database with earlier EUROCARE databases indicates that data quality and standardisation have improved.

Adult↗

Considerations for using a geographic information system to assess environmental supports for physical activity.

The use of a geographic information system (GIS) to study environmental supports for physical activity raises several issues, including acquisition and development, quality, and analysis. We recommend to public health professionals interested in using GIS that they investigate available data, plan for data development where none exists, ensure the availability of trained personnel and sufficient time, and consider issues such as data quality, analyses, and confidentiality. This article shares information about data-related issues that we encountered when using GIS to validate responses to a questionnaire about environmental supports for physical activity.

Crime↗

Cleveland health quality choice: a model for collaborative community-based outcomes assessment.

BACKGROUND: Cleveland Health Quality Choice Coalition was established in 1989 as a voluntary, collaborative effort between hospitals, physicians, and purchasers in the Cleveland metropolitan area to assess the quality and efficiency of care in 31 hospitals. The objective of the project is to produce high-fidelity comparative hospital outcomes data that support market-based health care reform strategies. METHODS: The project reports on a broad spectrum of hospital outcomes, including patient satisfaction, in-hospital mortality, length of stay, hospital-acquired complications, and cesarean section rates for adult medical, surgical, obstetrical, and intensive care patients. Intensive care outcomes and patient satisfaction are assessed using previously validated measurement systems. Outcomes for medical, surgical, and obstetrical patients are examined using a standardized data collection and severity adjustment methodology developed by Cleveland physicians and an independent consultant. RESULTS: The project released its initial report to purchasers in April 1993, with subsequent reports scheduled for release every six months. Several policies, procedures, and programs have been instituted to ensure data quality and participant buy-in. These include initial testing and rigorous validation of all outcomes measurement systems before release of data, a commitment to continuously refine risk-adjustment methodologies, independent auditing of data reliability, and a series of user-training workshops for project participants and local news media. CONCLUSION: The early success of Cleveland Health Quality Choice Coalition demonstrates that it is possible for purchasers and providers to cooperatively assess the quality of health care on a regional basis and to institute a market-based strategy for health care reform. Further evaluation is needed to determine how performance data being reported are used by purchasers in selecting health care and by hospitals for quality improvement.

Adult↗

Draft framework for evaluating syndromic surveillance systems.

Interest in public health surveillance to detect outbreaks from terrorism is driving the exploration of nontraditional data sources and development of new performance priorities for surveillance systems. A draft framework for evaluating syndromic surveillance systems will help researchers and public health practitioners working on nontraditional surveillance to review their work in a systematic way and communicate their efforts. The framework will also guide public health practitioners in their efforts to compare and contrast aspects of syndromic surveillance systems and decide whether and how to develop and maintain such systems. In addition, a common framework will allow the identification and prioritization of research and evaluation needs. The evaluation framework is comprised of five components: a thorough description of the system (e.g., purpose, stakeholders, how the system works); system performance experience (e.g., usefulness, acceptability to stakeholders, generalizability to other settings, operating stability, costs); capacity for outbreak detection (e.g., flexibility to adapt to changing risks and data inputs, sensitivity to detect outbreaks, predictive value of system alarms for true outbreaks, timeliness of detection); assessment of data quality (e.g., representativeness of the population covered by the system, completeness of data capture, reliability of data captured over time); and conclusions and recommendations. The draft framework is intended to evolve into guidance to support public health practice for terrorism preparedness and outbreak detection.

Bioterrorism↗

[Health economic evaluation of disease management programs].

Disease management has become an important element in the improvement of care for people with chronic illnesses and has become embedded in the discussion on health policy in recent years. The approach has been introduced very differently to the health systems worldwide. Since 1 January 2003 accredited disease management programs (DMPs) have been a part of the risk structure compensation scheme of the German statutory health insurance. This is seen as the first step to a morbidity orientation of the risk structure compensation. DMPs have to be evaluated according the German Social Law, especially whether the objectives of the programs and the criteria for inclusion of the patients have been met and the quality of care for the patients is insured. The criteria for evaluation are threefold: medical issues, economic issues and subjective quality of life of the patients. Due to the immense amounts of data which can be expected the evaluation of the German DMPs is a huge logistical challenge. Until now not very much is known about the data quality. The evaluation is focused on the perspective of the sickness funds as e.g. information about indirect cost is not collected. In the article the methods for evaluation are described and critically discussed.

Cost-Benefit Analysis↗