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Biomedical subjects

Paul Shekelle

Publications and source records attributed to Paul Shekelle.

17 recordsLinked to original sources
PubMed2005

Meta-analysis: chronic disease self-management programs for older adults.

BACKGROUND: Although enthusiasm is growing for self-management programs for chronic conditions, there are conflicting data regarding their effectiveness and no agreement on their essential components. PURPOSE: To assess the effectiveness and essential components of self-management programs for hypertension, osteoarthritis, and diabetes mellitus. DATA SOURCES: The authors searched multiple sources dated through September 2004, including the Cochrane Library, MEDLINE, PsycINFO, and Nursing and Allied Health databases, and bibliographies of 87 previous reviews. STUDY SELECTION: Randomized trials that compared outcomes of self-management interventions with a control or with usual care for diabetes mellitus, osteoarthritis, or hypertension; outcomes included hemoglobin A1c level, fasting blood glucose level, weight, blood pressure, pain, or function. DATA EXTRACTION: Two reviewers independently identified trials and extracted data regarding whether the intervention used tailored adjustments to meet individual patient needs, a group setting, feedback, and psychological services, and whether the intervention was provided by the patient's usual physician. DATA SYNTHESIS: Of 780 studies screened, 53 studies contributed data to the random-effects meta-analysis (26 diabetes studies, 14 osteoarthritis studies, and 13 hypertension studies). Self-management interventions led to a statistically and clinically significant pooled effect size of -0.36 (95% CI, -0.52 to -0.21) for hemoglobin A1c, equivalent to a reduction in hemoglobin A1c level of about 0.81%. Self-management interventions decreased systolic blood pressure by 5 mm Hg (effect size, -0.39 [CI, -0.51 to -0.28]) and decreased diastolic blood pressure by 4.3 mm Hg (effect size, -0.51 [CI, -0.73 to -0.30]). Pooled effects of self-management interventions were statistically significant but clinically trivial for pain and function outcomes for osteoarthritis. No consistent results supported any of the 5 characteristics examined as essential for program success. LIMITATIONS: Studies had variable quality, and possible publication bias was evident. CONCLUSIONS: Self-management programs for diabetes mellitus and hypertension probably produce clinically important benefits. The elements of the programs most responsible for benefits cannot be determined from existing data, and this inhibits specification of optimally effective or cost-effective programs. Osteoarthritis self-management programs do not appear to have clinically beneficial effects on pain or function.

Adult↗
PubMed2005

Psychiatric symptoms associated with ephedra use.

The objective of this review is to describe psychiatric adverse events occurring after ingestion of dietary supplements containing herbal ephedra and to assess the possible relationship between supplement use and the events. The authors reviewed all adverse event reports related to dietary supplements containing herbal ephedra from US FDA MedWatch files as of 30 September, 2001. Psychosis, mania or severe agitation, severe depression, hallucinations, delusions, suicide attempts, paranoia and violent behaviour were classified as serious psychiatric events. Events were categorised based on the amount of information supporting a causal relationship. Out of almost 1800 total adverse events, 57 were classified as both psychiatric in nature and serious. Two-thirds of these psychiatric cases involved patients with pre-existing psychological/psychiatric conditions and/or use of other mood-altering medications or illicit substances. The majority of case reports were insufficiently documented to make an informed judgment about a relationship between the use of ephedra and the adverse event in question. The case reports evaluated do not prove a definitive causal link between ephedra and psychiatric complications. However, they do raise concern that such a relationship may exist.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Comparison of quality of care for patients in the Veterans Health Administration and patients in a national sample.

BACKGROUND: The Veterans Health Administration (VHA) has introduced an integrated electronic medical record, performance measurement, and other system changes directed at improving care. Recent comparisons with other delivery systems have been limited to a small set of indicators. OBJECTIVE: To compare the quality of VHA care with that of care in a national sample by using a comprehensive quality-of-care measure. DESIGN: Cross-sectional comparison. SETTING: 12 VHA health care systems and 12 communities. PATIENTS: 596 VHA patients and 992 patients identified through random-digit dialing. All were men older than 35 years of age. MEASUREMENTS: Between 1997 and 2000, quality was measured by using a chart-based quality instrument consisting of 348 indicators targeting 26 conditions. Results were adjusted for clustering, age, number of visits, and medical conditions. RESULTS: Patients from the VHA scored significantly higher for adjusted overall quality (67% vs. 51%; difference, 16 percentage points [95% CI, 14 to 18 percentage points]), chronic disease care (72% vs. 59%; difference, 13 percentage points [CI, 10 to 17 percentage points]), and preventive care (64% vs. 44%; difference, 20 percentage points [CI, 12 to 28 percentage points]), but not for acute care. The VHA advantage was most prominent in processes targeted by VHA performance measurement (66% vs. 43%; difference, 23 percentage points [CI, 21 to 26 percentage points]) and least prominent in areas unrelated to VHA performance measurement (55% vs. 50%; difference, 5 percentage points [CI, 0 to 10 percentage points]). LIMITATIONS: Unmeasured residual differences in patient characteristics, a lower response rate in the national sample, and differences in documentation practices could have contributed to some of the observed differences. CONCLUSIONS: Patients from the VHA received higher-quality care according to a broad measure. Differences were greatest in areas where the VHA has established performance measures and actively monitors performance.

Cross-Sectional Studies↗
PubMed2004

Increased Medicare expenditures for physicians' services: what are the causes?

In light of rising expenditures for physicians' services and the scheduled decreases in the amounts Medicare pays for such services, we identified the sources of change in the volume and intensity of Medicare physicians' services. We found that the per capita volume and intensity of physicians services used by Medicare beneficiaries increased more than 30% between 1993 and 1998. Our analyses indicated that, at most, half of this increase was due to measurable changes in the demographic composition, places of residence, prevalence of health conditions, and managed care enrollment of beneficiaries. The other half was due to a general increase in the use of care across beneficiary categories.

Aged↗
PubMed2003

Standardized reporting of clinical practice guidelines: a proposal from the Conference on Guideline Standardization.

Despite enormous energies invested in authoring clinical practice guidelines, the quality of individual guidelines varies considerably. The Conference on Guideline Standardization (COGS) was convened in April 2002 to define a standard for guideline reporting that would promote guideline quality and facilitate implementation. Twenty-three people with expertise and experience in guideline development, dissemination, and implementation participated. A list of candidate guideline components was assembled from the Institute of Medicine Provisional Instrument for Assessing Clinical Guidelines, the National Guideline Clearinghouse, the Guideline Elements Model, and other published guideline models. In a 2-stage modified Delphi process, panelists first rated their agreement with the statement that "[Item name] is a necessary component of practice guidelines" on a 9-point scale. An individualized report was prepared for each panelist; the report summarized the panelist's rating for each item and the median and dispersion of rankings of all the panelists. In a second round, panelists separately rated necessity for validity and necessity for practical application. Items achieving a median rank of 7 or higher on either scale, with low disagreement index, were retained as necessary guideline components. Representatives of 22 organizations active in guideline development reviewed the proposed items and commented favorably. Closely related items were consolidated into 18 topics to create the COGS checklist. This checklist provides a framework to support more comprehensive documentation of practice guidelines. Most organizations that are active in guideline development found the component items to be comprehensive and to fit within their existing development methods.

Documentation↗
PubMed2003

Evidence assessment of the accuracy of methods of diagnosing middle ear effusion in children with otitis media with effusion.

OBJECTIVES: We report the findings of an evidence assessment on the accuracy of methods of diagnosing middle ear effusion in children with otitis media with effusion (OME). METHODS: We searched Medline (1966-January 2000), the Cochrane Library (through January 2000), and Embase (1980-January 2000) and identified additional articles from reference lists in proceedings, published articles, reports, and guidelines. Excluded were nonhuman studies; case reports; editorials; letters; reviews; practice guidelines; non-English-language publications; and studies on patients with immunodeficiencies, craniofacial anomalies (including cleft palate), primary mucosal disorders, or genetic conditions. From each eligible study, we calculated the sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and prevalence of OME in the cohort. We determined the number of studies for each comparison of a diagnostic method and a reference standard listed within the scope of our assessment. For comparisons with 3 or more studies, we derived random effects estimates of sensitivity, specificity, and prevalence rate. Using the pooled estimates, we plotted the performance of each diagnostic test in terms of sensitivity and (1 - specificity) and identified the best performer among the tests included in the comparison. RESULTS: Among 8 diagnostic methods, pneumatic otoscopy had the best apparent performance with a sensitivity of 94% (95% confidence interval: 92%-96%) and a specificity of 80% (95% confidence interval: 75%-86%). However, examiner qualifications were reported inconsistently, and training was not specified. CONCLUSIONS: The finding that pneumatic otoscopy can do as well as or better than tympanometry and acoustic reflectometry has significant practical implications. For the typical clinician, pneumatic otoscopy should be easier to use than other diagnostic methods. The important question may be what degree of training will be needed for the clinician to be as effective with pneumatic otoscopy as were the examiners in the studies reviewed in this report.

Acoustic Impedance Tests↗
PubMed2002

Use of complementary/alternative therapies by women with advanced-stage breast cancer.

BACKGROUND: This study sought to describe the pattern of complementary/alternative medicine (CAM) use among a group of patients with advanced breast cancer, to examine the main reasons for their CAM use, to identify patient's information sources and their communication pattern with their physicians. METHODS: Face-to-face structured interviews of patients with advanced-stage breast cancer at a comprehensive oncology center. RESULTS: Seventy three percent of patients used CAM; relaxation/meditative techniques and herbal medicine were the most common. The most commonly cited primary reason for CAM use was to boost the immune system, the second, to treat cancer; however these reasons varied depending on specific CAM therapy. Friends or family members and mass media were common primary information source's about CAM. CONCLUSIONS: A high proportion of advanced-stage breast cancer patients used CAM. Discussion with doctors was high for ingested products. Mass media was a prominent source of patient information. Credible sources of CAM information for patients and physicians are needed.

Adult↗
PubMed2002

Do NSAIDs cause dyspepsia? A meta-analysis evaluating alternative dyspepsia definitions.

OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with dyspepsia, but the relationship is obscured by variations in the terminology used to report GI symptoms. Using alternative definitions, we assessed the relationship between NSAID use and dyspepsia. METHODS: We searched MEDLINE, EMBASE, HEALTHSTAR, and BIOSIS databases (1966-1997) and New Drug Application reviews, identifying randomized, placebo-controlled trials (5 days or more duration) of any NSAID, reporting original data on GI complications. Based upon reported terms describing upper GI symptoms, we derived three definitions: strict, using terms synonymous with epigastric pain/discomfort; loose, (containing the strict definition plus terms for heartburn, nausea, bloating, anorexia, and vomiting); and a loose definition without heartburn terms (the loose-less-heartburn definition). Using each definition, we performed a random-effects model meta-analysis of the relationship between NSAID exposure and dyspepsia. RESULTS: Fifty-five published and 37 unpublished controlled NSAID trials met our inclusion criteria. The mean duration of the trials was 33.2 days (SD 40 days). Application of the strict definition resulted in a pooled risk ratio of dyspepsia for NSAIDs compared with placebo of 1.36 (95% CI = 1.11-1.67). For the loose definition, the pooled risk ratio was 1.13 (95% CI = 0.98-1.32). The loose-less-heartburn definition yielded a pooled risk ratio of 1.19 (95% CI = 1.03-1.39). In the placebo-treated control groups, the percent of patients reporting dyspepsia ranged from 2.3% (strict definition) to 4.2% (loose and loose-less-heartburn definitions). CONCLUSIONS: Using the strict definition, based solely on epigastric pain-related symptoms, NSAIDs increased the risk of dyspepsia by 36% (p < 0.05). These findings may be useful in creating a standardized definition of NSAID-related dyspepsia.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

A metaanalysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs.

OBJECTIVE: Prior metaanalyses of the risk of upper gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAID) have focused on the published English language epidemiologic literature and/or only a portion of the relevant evidence, restrictions that are now known to be associated with bias in metaanalysis. We synthesized the published and unpublished evidence to determine the least biased estimates of the risks of perforations, ulcers, and bleeds (PUB) associated with NSAID use from all study designs and all languages. METHODS DATA SOURCES: Using MEDLINE, EMBASE, HEALTHSTAR, and BIOSIS, we searched for English and non-English language studies of NSAID from 1966-1998 reporting primary data on GI complications. We obtained unpublished data from the US Food and Drug Administration (FDA) new drug application (NDA) reviews. NDA were hand searched to identify unpublished studies with inclusion criteria identical to those used for published reports. STUDY SELECTION: Studies had to assess the use of oral NSAID for more than 4 days duration in subjects > 18 years of age and report on the clinically relevant upper GI outcomes of PUB. RESULTS: Two reviewers evaluated 4881 published titles and identified 13 NSAID versus placebo randomized clinical trials and 3 previously unpublished FDA placebo controlled randomized controlled trials, 9 cohort studies, and 23 case control studies sufficiently clinically homogeneous to pool. Two reviewers extracted data about study characteristics and study quality. DATA SYNTHESIS: The majority of clinical trials were of good quality, but observational studies had methodologic limitations. The pooled odds ratio (OR) from 16 NSAID versus placebo clinical trials, comprising 4431 patients, was 5.36 (95% CI: 1.79, 16.1). The pooled relative risk of PUB from 9 cohort studies comprising over 750,000 person-years of exposure was 2.7 (95% CI: 2.1, 3.5). The pooled OR of PUB from 23 case control studies using age and sex matching, representing 25,732 patients, was 3.0 (95% CI: 2.5, 3.7). Data were insufficient to justify subgroup analyses stratified by age, comorbid conditions, drug, or dose. CONCLUSION: These data support an association between the use of NSAID and serious upper GI complications, including estimates from different study designs. Prior pooled estimates about the effect of patient and drug variables on increased risk must be viewed with caution.

Administration, Oral↗
PubMedDate not supplied

Biofeedback interventions for gastrointestinal conditions: a systematic review.

OBJECTIVE: To review evidence for the efficacy of biofeedback in the treatment of gastrointestinal problems. DATA SOURCES: Studies were identified through a search of MEDLINE, HealthSTAR, EMBASE, Allied and Complementary Medicine, MANTIS, PsycINFO, Social Science Citation Index, Science Citation Index, and CINAHL. STUDY SELECTION: Studies were selected if they used biofeedback as the intervention, addressed the treatment of a gastrointestinal condition, and included a control group. DATA EXTRACTION: All titles (4397), articles, and/or abstracts (1362) were evaluated by 2 independent reviewers who extracted data on study design and quality, sample size, type of intervention, and outcomes. DATA SYNTHESIS: We found 16 controlled trials of biofeedback for gastrointestinal problems. Ten studies had a comparison group that did not receive biofeedback (5 studies on constipation and/or encopresis, 3 on fecal incontinence, 1 on constipation, and 1 on abdominal pain). Of the 10 studies that had a "no biofeedback" control arm, 7 provided sufficient data to calculate an effect size. Of these 7 studies, 2 favored biofeedback: 1 study revealed a reduction in fecal incontinence among adults, and the other study showed an improvement in constipation with fecal incontinence (encopresis) among children. The other 5 had nonsignificant results. Three studies had a "no biofeedback" comparison arm but insufficient data to calculate an effect size. One of these studies in adult fecal incontinence reported statistically significant improvement. CONCLUSIONS: The evidence is insufficient to support the efficacy of biofeedback for these gastrointestinal conditions.

Adult↗