Do Surgical Trials Meet the Scientific Standards for Clinical Trials?

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials that use bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions toward the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based on adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999 through 2008, which reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials that appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This article reports our results and raises concerns about the methodologic, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice

Are Surgical Trials with Negative Results Being Interpreted Correctly?

BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (b 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated

A quasi-experimental test of an intervention to increase the use of thiazide-based treatment regimens for people with hypertension

BACKGROUND: Despite recent high-quality evidence for their cost-effectiveness, thiazides are underused for controlling hypertension. The goal of this study was to design and test a practice-based intervention aimed at increasing the use of thiazide-based antihypertensive regimens. METHODS: This quasi-experimental study was carried out in general medicine ambulatory practices of a large, academically-affiliated Veterans Affairs hospital. The intervention group consisted of the practitioners (13 staff and 215 trainees), nurses, and patients (3,502) of the teaching practice; non-randomized concurrent controls were the practitioners (31 providers) and patients (18,292) of the non-teaching practices. Design of the implementation intervention was based on Rogers' Diffusion of Innovations model. Over 10.5 months, intervention teams met weekly or biweekly and developed and disseminated informational materials among themselves and to trainees, patients, and administrators. These teams also reviewed summary electronic-medical-record data on thiazide use and blood pressure (BP) goal attainment. Outcome measures were the proportion of hypertensive patients prescribed a thiazide-based regimen, and the proportion of hypertensive patients attaining BP goals regardless of regimen. Thirty-three months of time-series data were available; statistical process control charts, change point analyses, and before-after analyses were used to estimate the intervention's effects. RESULTS: Baseline use of thiazides and rates of BP control were higher in the intervention group than controls. During the intervention, thiazide use and BP control increased in both groups, but changes occurred earlier in the intervention group, and primary change points were observed only in the intervention group. Overall, the pre-post intervention difference in proportion of patients prescribed thiazides was greater in intervention patients (0.091 vs. 0.058; p = 0.0092), as was the proportion achieving BP goals (0.092 vs. 0.044; p = 0.0005). At the end of the implementation period, 41.4% of intervention patients were prescribed thiazides vs. 30.6% of controls (p < 0.001); 51.6% of intervention patients had achieved BP goals vs. 44.3% of controls (p < 0.001). CONCLUSION: This multi-faceted intervention appears to have resulted in modest improvements in thiazide prescribing and BP control. The study also demonstrates the value of electronic medical records for implementation research, how Rogers' model can be used to design and launch an implementation strategy, and how all members of a clinical microsystem can be involved in an implementation effort

A conceptual framework for the study of early readmission as an indicator of quality of care

Despite the perennial popularity of readmission as an indicator of the quality of hospital care, the empiric evidence linking it to process-of-care problems during the prior hospitalization is inconsistent. We devised a conceptual model for the use of unscheduled readmission within 31 days as an indicator of the quality of medical-surgical inpatient care for adults, and then conducted a systematic review of the readmission literature to determine the extent to which the evidence supports the proposed relationships. A fairly complex web of relationships influences the association between the process of inpatient care and early readmission. From the evidence to date, it is impossible to say with confidence that early readmission is or is not a valid and useful quality indicator. In most negative studies, the absence of an association appears to be explainable on the basis of improper study design, omission of important variables, or mis-specification of variables. Variables intervening between or confounding the relationship of the process of inpatient care to early readmission have received inadequate attention in past work. Investigators can use the proposed model and literature review to ensure their work advances the field and puts the hypothesis that early readmission is a valid quality indicator to a rigorous test. This matter has a certain urgency in view of the vast amount of resources that providers and payers devote to monitoring readmission rates and reviewing readmissions.readmission quality of care process-outcome studies evaluation

Variation in hemodialysis patient compliance according to demographic characteristics

Patient noncompliance with treatment regime undermines the effectiveness of medical care, resulting in an unpredictable progression of the primary disease and a greater likelihood of complications. Hemodialysis patients are well suited for studying noncompliance because their treatment is prolonged and intensive, and medical regimens are clear cut and easily determined with objective measures. Moreover, noncompliant behavior by these patients not only endangers their life in the long run, but also results in negative effects within a day or two. Despite severe consequences, noncompliance with their medical regimen is the norm for dialysis patients rather than the exception. A large-scale study of chronic, outpatient hemodialysis patients (N = 1230 patients, response RATE = 96%) treated in a variety of facility types (N = 29 facilities) was conducted to investigate prevalence and associated demographic characteristics of noncompliance with four treatment regimens--protein and potassium restrictions in the diet, medication regimen, and fluid restrictions. Few patients were noncompliant with diet regimens (9% with protein and 2% with potassium restrictions) but half were noncompliant with medication taking (50.2%) and fluid restrictions (49.5%). The prevalence of noncompliance with medication and fluid regimens was consistent with previous studies of dialysis patients but the prevalence of noncompliance with diet was much lower than that reported elsewhere. Prevalence of noncompliant patients varied between studies according to the cut-point used to establish compliance criteria, where more stringent cut-points inflated the percentage and more lenient cut-points reduced the percentage. Thus, there is a need to establish uniform criteria in order to test real differences in compliance between patient groups vs simply differences in measurement. In this study, younger patients were uniformly more likely to be noncompliant, otherwise demographic characteristics differed with each treatment regimen: more single patients were noncompliant with protein restrictions; more low income patients were noncompliant with medication regimen; and more low income, white, and male patients were noncompliant with fluid restrictions. Thus, in order for clinical interventions to be successful, they need to be tailored to differences in compliance behavior according to each specific treatment regimen. Demographic profiles can be an efficient way to identify subgroups of patients at high risk.compliance patient demographics hemodialysis end stage renal disease

Using administrative databases to evaluate the quality of medical care: A conceptual framework

Health care is consuming an ever larger share of national resources in the United States. Measures to contain costs and evidence of unexplained variation in patient outcomes have led to concern about inadequacy in the quality of health care. As a measure of quality, the evaluation of hospitals through analysis of their discharge databases has been suggested because of the scope and economy offered by this methodology. However, the value of the information obtained through these analyses has been questioned because of the inadequacy of the clinical data contained in administrative databases and the resultant inability to control accurately for patient variation. We suggest, however, that the major shortcoming of prior attempts to use large databases to perform across-facility evaluation has resulted from the lack of a conceptual framework to guide the analysis. We propose a framework which identifies component areas and clarifies the underlying assumptions of the analytic process. For each area, criteria are identified which will maximize the validity of the results. Hospitals identified as having unexpectedly high unfavorable outcomes when our framework is applied will be those where poor quality will most likely be found by primary review of the process of care. We outline the following criteria for the selection of disease-outcome pairs to be studied in large administrative database analysis: (1) disease entities or clinical states selected should be well defined and easily diagnosed; (2) if diagnostic classification systems are used, disease groups should be homogeneous as to the clinical states they contain; (3) the disease entities should be prevalent; (4) a plausible link should exist between the quality (process) of care and the frequency of the outcome; (5) types of care which conform to acceptable practice standards but still lead to variation in the outcome of interest should be excluded from the analysis; (6) the outcomes should be prevalent; (7) constraints of the ICD-9 coding system should be understood such that only those disease-outcome pairs least affected by these limitations are selected for analysis; (8) constraints of the structure of the database should be considered when the analysis is performed; and (9) disease-outcome pairs should be chosen where there is agreement on the processes of care that affect the outcome of interest, either favorably or unfavorably.quality of care database analysis evaluation conceptual framework