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PubMed2002

Recruiting family physicians and patients for a clinical trial: lessons learned.

BACKGROUND: The randomized controlled trial (RCT) is the most definitive tool for evaluating an intervention. However, methodological deficiencies may limit the internal or external validity of the RCT. OBJECTIVE: Our aim was to describe the tactics used and the resources required randomly to select and recruit family physicians (FPs) and their patients aged 65 and older (seniors) for a community-based cluster RCT in primary care. METHODS: We randomly selected 48 FPs in 24 urban and rural sites in Southern Ontario, and 889 of their community-dwelling seniors (approximately 20 per FP) taking five or more medications daily. To accomplish this, the principal investigator (an FP) contacted the eligible FPs. The participating FPs' office staff then generated and contacted the roster of eligible seniors, with support provided by the research staff. RESULTS: Of the 163 randomly selected FPs telephoned, 94 were ineligible and 48 (69.6%) of the remaining 69 participated. The rosters were generated with the assistance of the research staff (taking 1.5-8.0 hours) in each of the 48 practices, using electronic appointment records (n = 26), electronic billing records (n = 17), electronic medical records (n = 2) or written charts or file cards (n = 3). Of the 2078 seniors approached, 799 were ineligible and 889 (69.5%) of the remaining 1279 participated. Seniors' refusal rates among practices ranged from 4.8 to 62.3%. CONCLUSIONS: Recruitment of a representative sample and generalizability of results are possible in RCTs in primary care. Involvement of an FP in physician recruitment and clinical research nurses who provided assistance to office staff were keys to success.

Aged↗
PubMed2000

Publication bias in reproductive research.

Publication bias is defined as any tendency on the part of investigators or editors to fail to publish study results on the basis of the direction or strength of the findings. This may lead to overestimation of treatment effects in published work. Inappropriate decisions about patient management may result. We investigated what proportion of abstracts at the European Society of Human Reproduction and Embryology (ESHRE) annual meeting eventually reached full publication, what was the time to publication, and which factors might have affected publication. Among the 2691 abstracts of six ESHRE annual meetings, 151 (5.6%) reporting randomized controlled trials (RCT) were identified. Comprehensive searches of electronic databases and handsearching of the two major journals in the field yielded 79 full publications pertaining to these abstracts. Kaplan-Meier analysis estimated 56% of RCT abstracts to be eventually published in full, the median time to publication being 32.5 months. Positive outcome (i.e. significant results) did not affect the publication rate, and neither did sample size, the subject category, or the native language (English/non-English) of the country of origin. Oral presentations resulted in eventual full publication significantly more frequently (69%) than posters (42%). It is concluded that a considerable publication deficit, but not a publication bias, exists for RCT in reproductive research.

Humans↗
PubMed2002

Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review.

BACKGROUND: The effectiveness of human albumin administration in prevention of severe ovarian hyperstimulation syndrome (OHSS) was reviewed using the Cochrane Menstrual Disorders and Subfertility Group literature search strategy. METHODS: Only randomized controlled trials (RCT) comparing the effect of human albumin with placebo or no treatment were included in this review. Seven RCT were identified, five of which met our inclusion criteria and enrolled 378 women (193 in the albumin-treated group and 185 in the control group). Trials under consideration were evaluated for methodological quality and appropriateness for inclusion without consideration of their results. The five included trials were single-centre parallel RCT. Relevant data were extracted independently by two reviewers using the standardized data extraction sheet. Validity was assessed in terms of method of randomization, completeness of follow-up, presence or absence of crossover and co-intervention. RESULTS: There was significant reduction in severe OHSS on administration of human albumin [odds ratio (OR): 0.28; 95% confidence interval (95% CI) 0.11-0.73]. Relative risk was 0.35 (95% CI 0.14-0.87) and absolute risk reduction was 5.5. For every 18 women at risk of severe OHSS, albumin infusion will save one more case. There was no evidence of an increase in the pregnancy rate [OR 1.09 (95% CI 0.65-1.83)]. CONCLUSIONS: This Cochrane review shows a clear benefit from administration of i.v. albumin at the time of oocyte retrieval in prevention of severe OHSS in high-risk cases. Whether the number needed to treat would justify the routine use of albumin infusion in cases at risk of severe OHSS needs to be judged by clinical decision-makers.

Adult↗
PubMed2002

Can we individualize the 'number needed to treat'? An empirical study of summary effect measures in meta-analyses.

BACKGROUND: Meta-analyses summarize the magnitude of treatment effect using a number of measures of association, including the odds ratio (OR), risk ratio (RR), risk difference (RD) and/or number needed to treat (NNT). In applying the results of a meta-analysis to individual patients, some textbooks of evidence-based medicine advocate individualizing NNT, based on the RR and the patient's expected event rate (PEER). This approach assumes constant RR but no empirical study to date has examined the validity of this assumption. METHODS: We randomly selected a subset of meta-analyses from a recent issue of the Cochrane Library (1998, Issue 3). When a meta-analysis pooled more than three randomized controlled trials (RCT) to produce a summary measure for an outcome, we compared the OR, RR and RD of each RCT with the corresponding pooled OR, RR and RD from the meta-analysis of all the other RCT. Using the conventional P-value of 0.05, we calculated the percentage of comparisons in which there were no statistically significant differences in the estimates of OR, RR or RD, and refer to this percentage as the 'concordance rate'. RESULTS: For each effect measure, we made 1843 comparisons, extracted from 55 meta-analyses. The random effects model OR had the highest concordance rate, closely followed by the fixed effects model OR and random effects model RR. The minimum concordance rate for these indices was 82%, even when the baseline risk differed substantially. The concordance rates for RD, either fixed effects or random effects model, were substantially lower (54-65%). CONCLUSIONS: The fixed effects OR, random effects OR and random effects RR appear to be reasonably constant across different baseline risks. Given the interpretational and arithmetic ease of RR, clinicians may wish to rely on the random effects model RR and use the PEER to individualize NNT when they apply the results of a meta-analysis in their practice.

Evidence-Based Medicine↗
PubMed1993

Placebo controls and epistemic control in orthodox medicine.

American orthodox medicine consolidated its professional authority in the early 20th Century on the basis of its unbiased scientific method. The centerpiece of such a method is a strategy for identifying truly effective new therapies, i.e., the randomized clinical trial (RCT). A crucial component of the RCT in illnesses without established treatment is the placebo control. Placebo effects must be identified and distinguished from pharmacological effects because placebos produce actual but unexplained therapeutic successes. The blinding necessary for a proper placebo-controlled RCT therefore introduces an epistemic bias into orthodox medicine: therapeutic successes that rely upon a direct link between knowing and healing, such as placebo effects, are discarded in favor of therapeutic successes that rely upon an indirect link between knowing and healing, such as pharmacological interventions. Where the capacity to produce therapeutic results once validated the method of clinical medical science, now method validates results. The clinical consequences of this method of testing therapies include a diminished vision of the therapeutic potential of the doctor-patient relationship and of the potential human resources available for healing.

Clinical Medicine↗
PubMed2001

A review of studies on the effect of iron deficiency on cognitive development in children.

Studies on the effect of iron deficiency on children's cognition and behavior are selectively reviewed, looking for evidence of a causal relationship. Most correlational studies have found associations between iron-deficiency anemia and poor cognitive and motor development and behavioral problems. Longitudinal studies consistently indicate that children anemic in infancy continue to have poorer cognition, school achievement, and more behavior problems into middle childhood. However, the possible confounding effects of poor socioeconomic backgrounds prevent causal inferences from being made. In anemic children <2 y old, short-term trials of iron treatment have generally failed to benefit development. Most longer trials lacked randomized placebo groups and failed to produce benefits. Only one small randomized controlled trial (RCT) has shown clear benefits. It therefore remains uncertain whether the poor development of iron-deficient infants is due to poor social backgrounds or irreversible damage or is remediable with iron treatment. Similarly, the few preventive trials have had design problems or produced no or questionable benefits only. For children >2 y old, the evidence from RCT is reasonably convincing but not conclusive. RCT of iron treatment are warranted especially in younger children.

Achievement↗
PubMed2002

In-patient interventions supported by results of randomized controlled trials in Japan.

OBJECTIVE: To determine to what extent the results of randomized controlled trials (RCTs) support medical interventions for in-patients at the department of general medicine of a university hospital in Japan. DESIGN: Retrospective analysis. By reviewing discharge summaries, two physicians first independently decided on patients' respective primary problems at admission and up to two secondary problems. Next, up to five interventions for the primary problem and one intervention for each of the secondary problems were selected. Differences of opinion (if any) between the two physicians regarding these selected interventions were resolved by discussion. MEDLINE and/or the Cochrane Library were used as data sources for literature regarding the selected interventions. SETTING: A ward of the department of general medicine of a Japanese university hospital, 1995-1997. MAIN MEASURES: The proportion of therapeutic interventions supported by RCT results and associated meta-analyses. RESULTS: For the primary problems, 103 (48.8%) of the 211 most important interventions were supported by the results of RCTs, as were 47.8% of all the interventions including the most important and the adjunctive ones. Furthermore, 56.2% of the most important interventions for the secondary problems were also supported by the RCT results. CONCLUSIONS: Approximately half of the therapeutic interventions performed at an academic medical in-patient unit in Japan were RCT-supported. This was true not only for the most important interventions for primary problems but also for the adjunct interventions for the primary problems and the interventions for secondary problems.

Adolescent↗
PubMedDate not supplied

Spinal cord stimulation for complex regional pain syndrome: an evidence-based medicine review of the literature.

OBJECTIVES: The purpose of this investigation is to assess the evidence for efficacy of SCS in the management of pain in patients with CRPS. METHODS SEARCH STRATEGY: Electronic databases such as Medline and Cochrane Library were queried using key words such as "spinal cord stimulation," "reflex sympathetic dystrophy (RSD)," and "complex regional pain syndrome (CRPS)." SELECTION CRITERIA: Relevant published randomized controlled trials (RCT), cohort studies, case-control studies, case series, and case reports that described SCS as the primary treatment modality for patients with CRPS were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Data extracted from qualified studies were summarized in sections of methodology, demographics, SCS equipment, primary and secondary outcomes, and complications. RESULTS: Thirteen studies using the primary search strategy and 7 studies from their reference lists were considered. Five of these 20 studies were discarded. One RCT, 2 prospective observational, and 12 retrospective observational studies were eventually considered. The methodological quality of all studies was poor except for the single RCT study. DISCUSSION: Although limited in quality and quantity, available evidence from the examined literature suggests that SCS is effective in the management of pain in patients with CRPS (grade B/C). Clinically useful information extracted from the available studies is very limited in guiding clinicians in the rational use of SCS for pain management in CRPS patients. Future attempts to investigate the efficacy of SCS in CRPS patients should involve methodologically robust designs such as randomized studies that have sufficient power.

Complex Regional Pain Syndromes↗
PubMed2000

Which therapeutic interventions in critical care medicine have been shown to reduce mortality in prospective, randomized, clinical trials? A survey of candidates for the Belgian Board Examination in Intensive Care Medicine.

OBJECTIVE: To highlight the lack of randomized controlled trial (RCT) evidence in support of accepted therapeutic interventions in the intensive care unit by assessing the ability of Intensive Care Board Examination candidates to cite relevant studies. DESIGN: As part of the Board Examination for Intensive Care Medicine in Belgium, candidates were asked to name accepted therapeutic interventions that have been shown to reduce mortality in RCTs. SETTING: Survey of doctors. SUBJECTS: Candidates for the 1998 Board Examination for Intensive Care Medicine in Belgium. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: Of the 46 candidates, 25 (54%) gave no response and 3 (7%) stated that no such study exists; 16 responses from 13 doctors were considered acceptable answers. CONCLUSIONS: Candidates for the Board Examination of Intensive Care in Belgium were unable to list many accepted interventions in critical care medicine that are supported by RCT evidence. The RCT may not be the most appropriate tool for assessing the value of an intervention in the intensive care environment.

Belgium↗
PubMedDate not supplied

Range of normal and abnormal subacromial/subdeltoid bursa fluid.

OBJECTIVE: To determine the range of normal and abnormal subacromial/subdeltoid (SA/SD) bursa fluid. METHODS: Using a 1.5-T magnetic resonance (MR) imaging scanner, 2 observers evaluated coronal oblique T2-weighted, fast spin echo, fat-suppressed images of 71 persons (36 asymptomatic volunteers and 35 patients with full-thickness rotator cuff tears [RCTs]) for the 1) widest thickness of the SA/SD bursa; 2) medial extent of bursa from the acromioclavicular joint (ACJ); and 3) because patients were supine, whether fluid was in the posterior quarter, middle quarter, anterior quarter, or anterior-most quarter of the bursa. RESULTS: The range of bursa thickness was 0 to 7 mm (mean = 1.3 mm, median = 2 mm) in normal bursas and 0 to 8 mm (mean = 3.3 mm, median = 3 mm; P < 0.05, t test) in RCTs. Only 2 volunteers exceeded 3 mm in bursa thickness. In volunteers, 36% had no fluid present, 61% had a small amount of fluid lateral to the ACJ, and 1 had fluid directly beneath the ACJ (P < 0.05). In RCT patients, 37% had fluid directly under the ACJ or medial to the ACJ. Only 1 patient with an RCT had no bursal fluid. In volunteers, most fluid was in the posterior quarter (53%) or middle quarter (22%) of the bursa, whereas in RCT patients, most fluid was located in the anterior quarter of the humerus or anterior to the humerus (89%; P < 0.05). CONCLUSIONS: Normal SA/SD bursa fluid is rarely thicker than 2 mm and tends to be located posteriorly. An abnormal amount of fluid is present when the thickness exceeds 3 mm, fluid is present medial to the ACJ, and fluid is seen in the part of the bursa anterior to the humerus.

Adolescent↗
PubMed2003

Pediatric Crohn Disease Activity Index: responsive to short-term change.

BACKGROUND/AIMS: Despite documented feasibility, reliability, and validity, the Pediatric Crohn's Disease Activity Index (PCDAI) has yet to be demonstrated to be sensitive to change in the time frame of acute treatment trials. We evaluated short-term responsiveness and determined the minimal change in PCDAI score associated with a clinically meaningful improvement in disease activity. METHODS: Standardized effect size (SES) and standardized response mean (SRM) were calculated as measures of responsiveness among pediatric patients being treated for acute exacerbations of Crohn disease 1) in a regular clinical practice setting and 2) as part of a multicenter, randomized controlled trial (RCT). Receiver operating characteristic (ROC) curves were constructed to determine the minimal PCDAI score change associated with significant clinical improvement used as the gold standard in 1) physician global assessment of change and in 2) change in adult Crohn disease activity index (CDAI). RESULTS: Among responders, the SES and SRM of the PCDAI were 1.78 and 1.41 (95% CI: 0.89-1.92) and 2.10 and 1.95 (95% CI: 1.70-2.20) in the clinical practice setting and RCT setting, respectively. The optimal minimal PCDAI change score associated with clinically significant change in physician global assessment was determined to be -12.5 (sensitivity 83.3%, specificity 92.3%). In the RCT setting a change in PCDAI of -10 corresponded to a change in CDAI of not greater-than-or-equal 70 points. CONCLUSIONS: The PCDAI is responsive to improvement in disease activity in Crohn disease patients over a short interval. As such, the PCDAI is an appropriate instrument to use in pediatric acute treatment trials.

Adolescent↗
PubMed1999

Neuromuscular characteristics and muscle power as determinants of 5-km running performance.

PURPOSE: The purpose of this study was to investigate neuromuscular characteristics and muscle power as determinants of distance running performance. METHODS: Seventeen male endurance athletes performed a 5-km time trial (5K) that included three separate constant-velocity 200-m laps during the course and a maximal 20-m speed (V20m) test on an indoor track, and running economy (RE) tests on a treadmill and on the track. Maximal anaerobic (MART) and aerobic running tests on the treadmill were used to determine maximal velocity in the MART (VMART), maximal oxygen uptake (VO2max), peak treadmill performance (VO2max demand), and respiratory compensation threshold (RCT). RESULTS: Velocity in the 5K (V5K) correlated positively (P < 0.05) with VO2max, VO2max demand, RCT, and RE, as well as with V20m and VMART. Regression analysis showed that RCT, track RE, and VMART were the most important determinants of V5K. V5K also correlated (P < 0.05) with contact times (CT) and stride rates in the maximal 20-m run (r = -0.49 and 0.58, respectively), as well as with the mean CT of the constant velocity laps during the 5K (r = -0.50). VMART correlated significantly with peak blood lactate concentration in MART (r = 0.59, P < 0.05), V20m (r = 0.87, P < 0.001), and CT in the maximal 20-m run (r = -0.61, P < 0.01). CONCLUSIONS: We conclude that neuromuscular characteristics and VMART were related to 5-km running performance in well trained endurance athletes. Relationships between VMART and neuromuscular and anaerobic characteristics suggest that VMART can be used as a measure of muscle power in endurance athletes.

Adult↗
PubMed1999

Physical activity and weight gain and fat distribution changes with menopause: current evidence and research issues.

PURPOSE: At the onset of menopause a woman's body weight reaches its maximum. For any given subsequent body weight there is an increase in relative body fat and abdominal fatness with advancing age. The increased body fatness and abdominal fat distribution are associated with a high incidence of cardiovascular disease and certain cancers, particularly breast cancer. The aim of this analysis was to assess the role of physical activity for weight gain and changes in fat distribution occurring with menopause. METHODS: A systematic review based on a Medline search was conducted. RESULTS: According to cross-sectional observational studies postmenopausal women with high levels of physical activity have lower body fat and abdominal fat. Longitudinal studies show that physically active women are less likely to gain body fat and abdominal fat after menopause than sedentary women (Evidence category C). There are very few randomized controlled trials (RCT) comparing exercise with no intervention, and diet with diet plus exercise, and the results do not allow a firm conclusion as to whether physical activity may prevent or limit the gain of total fat and abdominal fat after menopause, or whether it may be effective as part of an obesity treatment program. CONCLUSIONS: There is a need for RCT to evaluate the effect of increased physical activity and fitness as a tool for prevention of the changes in body composition associated with menopause and aging in normal weight women. The efficiency of different programs of exercise training as a treatment option in postmenopausal women with existing overweight and obesity should be investigated. RCT should have the appropriate design and size and use accurate methods to assess exercise compliance, body composition, and intra-abdominal adipose tissue.

Abdomen↗
PubMed1999

Is abdominal fat preferentially reduced in response to exercise-induced weight loss?

PURPOSE: It is known that a preferential deposition of fat in the abdominal region is the obesity phenotype that conveys the greatest health risk. Although physical activity is commonly prescribed to reduce obesity, the influence of exercise-induced weight loss on abdominal fat is unclear. This review was undertaken to clarify whether abdominal fat is preferentially reduced consequent to weight loss induced by regular exercise. METHODS: A literature search (Medline, 1966-1998) was performed using appropriate keywords to identify studies reporting changes in both whole body and abdominal fat in response to exercise. RESULTS: At present there are no randomized controlled trails (RCT) wherein it was clear that exercise alone induced weight loss. For the four RCT within which regular exercise was not associated with weight loss, abdominal fat measured by waist circumference was unchanged. A similar trend is observed for the nonrandomized studies. Abdominal obesity as measured by waist circumference is unchanged for those studies reporting no loss in weight or fat; however, a modest reduction (approximately 3 cm) is observed in response to exercise-induced weight loss of about 3 kg. Without exception, these studies were not designed to determine whether abdominal obesity was preferentially reduced. Absent from the literature are RCT that employ imaging techniques (e.g., computerized tomography or magnetic resonance imaging) to determine whether exercise-induced weight loss is associated with reductions in either visceral or abdominal subcutaneous fat. However, the findings from four nonrandomized or controlled studies report that exercise with or without weight loss is associated with reductions in both visceral and subcutaneous fat. CONCLUSION: There is insufficient evidence to determine whether exercise-induced weight loss is associated with reductions in abdominal fat. Clearly there is a need for carefully controlled studies wherein the primary aim is to determine the influence of regular exercise on total and abdominal adiposity.

Abdomen↗
PubMed1999

Physical activity for preventing and treating obesity-related dyslipoproteinemias.

PURPOSE: The clinical trial data were reviewed on effects of physical activity on obesity-related dyslipoproteinemias (specifically low HDL-cholesterol (HDL-C), elevated triglycerides (TG), and high total and LDL-cholesterol (TC and LDL-C)) in adult men and women. METHODS: Effort was made to identify all randomized clinical trials (RCT), with exercise intervention programs of at least 4 months' duration, which had lipoprotein outcomes. Those that had both an exercise only intervention and control groups or both a diet plus exercise and identical diet only intervention groups were reviewed. Tables were developed of baseline characteristics and weight and lipoprotein changes for aerobic exercise trials by body mass index: 1) < 25.0 kg x m(-2), 2) 25.0-29.9 kg x m(2), and 3) > or = 30.0 kg x m(-2)and for studies involving resistance exercise or increased energy expenditure from daily activities versus structured exercise programs. RESULTS: Very few RCT were found that specifically addressed the role of physical activity in preventing or treating obesity-related adverse lipoprotein levels. There was essentially no evidence found in lean or overweight men or women to support a specific role for exercise in improving undesirable lipoprotein levels; however, trial data strongly suggest that the addition of exercise to a hypocaloric, reduced-fat diet improves HDL-C and TG in men and women with generally desirable initial levels and reduces LDL-C in men and women with initially elevated LDL-C levels. The evidence is also reasonably strong that weight loss, including that achieved solely by exercise, improves HDL-C and TG in obese men, without reducing LDL-C, whereas it remains weak for women. There are also virtually no trial data to support a role for resistance exercise or an increase in daily living activities for improving obesity-related lipoproteins. CONCLUSIONS: Current evidence from RCT is too limited to determine whether physical activity can raise low HDL-C or lower high TG or LDL-C levels in overweight and obese individuals.

Adult↗
PubMedDate not supplied

Retention control training in the treatment of younger versus older enuretic children.

This study compared the efficacy of retention control training (RCT) in two groups of children suffering from nocturnal enuresis: a younger group of 15 children aged 4 to 5 years and an older group of 15 children aged 7 to 8 years. To control for family history, frequency, and type of enuresis, only children with primary nocturnal enuresis who had a family history of enuresis and who wet the bed 4 to 7 nights per week were included. RCT was found to be an effective treatment for young children who were closer to the final stage of bladder development, but not for older children. RCT may be used for older children as a preliminary treatment to increase functional bladder capacity, after which treatment of enuresis should be continued by other methods, such as bell-and-pad reinforcement programs.

Age Factors↗
PubMed2002

Treatment of unresectable, locally advanced pancreatic adenocarcinoma with combined radiochemotherapy with 5-fluorouracil and cisplatin.

INTRODUCTION: Adenocarcinoma of the pancreas remains one of the most difficult malignancies to treat. Its incidence has steadily increased over the past four decades, and its prognosis is still dismal. AIM To assess tumor control and the palliative benefit of 5-fluorouracil (5-FU), cisplatin (CDDP), and radiotherapy in patients with advanced pancreatic cancer. METHODOLOGY: Systemic chemotherapy consisted of 5-FU (600 mg/m ), given as a 22-hour infusion on days 1 to 5, and CDDP (100 mg/m ), given as a 90-minute infusion on day 2. Treatment courses were repeated identically on day 21. Radiotherapy was delivered using megavolt irradiation of 25-MV photons with a two- or four-field isocentric technique. RESULTS: Twenty-seven patients were treated with this radiochemotherapy (RCT). Twenty-one patients (78%) completed initial treatment. The median dose of radiation therapy delivered was 42.5 Gy. At the time of evaluation (1 month after the end of the RCT), no grade 4 (WHO) toxicity was observed; 12 patients had improved or stable body weight; pain was improved for 20 patients, with 11 experiencing no pain; and analgesic consumption decreased for 18 patients, of whom 11 stopped intake. The clinical benefit response was 7/27 (26%). Median survival and time to progression were, respectively, 9 and 4.4 months. CONCLUSION: This RCT regimen had a good impact on clinical benefit in locally advanced pancreatic carcinoma, without severe side effects.

Adenocarcinoma↗
PubMed2003

Management of glomerular proteinuria: a commentary.

It is widely accepted that proteinuria reduction is an appropriate therapeutic goal in chronic proteinuric kidney disease. Based on large randomized controlled clinical trials (RCT), ACE inhibitor (ACEI) and angiotensin receptor blocker (ARB) therapy have emerged as the most important antiproteinuric and renal protective interventions. However, there are numerous other interventions that have been shown to be antiproteinuric and, therefore, likely to be renoprotective. Unfortunately testing each of these antiproteinuric therapies in RCT is not feasible. The nephrologist has two choices: restrict antiproteinuric therapies to those shown to be effective in RCT or expand the use of antiproteinuric therapies to include those that, although unproven, are plausibly effective and prudent to use. The goal of this work is to provide the documentation needed for the nephrologist to choose between these strategies. This work describes 25 separate interventions that are either antiproteinuric or may block injurious mechanisms of proteinuria. Each intervention is assigned a level of recommendation (Level 1 is the highest; Level 3 is the lowest) according to the strength of the evidence supporting its antiproteinuric and renoprotective efficacy. Pathophysiologic mechanisms possibly involved are also discussed. The number of interventions at each level of recommendation are: Level 1, n = 7; Level 2, n = 9; Level 3, n = 9. Our experience indicates that we can achieve in most patients the majority of Level 1 and many of the Level 2 and 3 recommendations. We suggest that, until better information becomes available, a broad-based, multiple-risk factor intervention to reduce proteinuria can be justified in those with progressive nephropathies. This work is intended primarily for clinical nephrologists; therefore, each antiproteinuria intervention is described in practical detail.

Disease Progression↗