Prospective trial

Moore, M.M., Nguyen, D.H.D. and Spotnitz, W.D., Fibrin sealant reduces serous drainage and allows earlier drain removal after axillary dissection a randomized prospective trial. Am. Surg., 63, 97-102 (1997). 

To be useful to those concerned with choices in the allocation of health and social care resources, the data for economic evaluations need to be timely, relevant, credible and accurate (Davies, 1998). As a minimum, the costs associated with the interventions should be estimated from activity data, which quantify resources used, and price or unit cost data. Often evidence from well-controlled prospective trials with high internal validity is required to establish whether differences in economic end points are directly attributable to the interventions. However, the economic evaluations of acetylcholinesterase inhibitors estimated costs from retrospective analysis of available datasets Qonsson et al, 1999b), analysis of published literature (e.g. Stewart et al, 1998) and expert opinion (e.g. O Brien et al, 1999 Neumann et al, 1999). This means that it is not clear whether differences in costs were due to the anticholinesterase inhibitors or to other factors such as availability of services in different areas, the living situation of the patient, or disease severity. 

Rieke K, Schwab S, Krieger D, von Kutnmer R, Aschoff A, Schuchardt V, Hacke W. Decompressive surgery in space-occupying hemispheric infarction results of an open, prospective trial. Crit Care Med 1995 23(9) 1576-1587. 

Unlike systolic HF, few prospective trials have evaluated the safety and efficacy of various cardiac medications in patients with diastolic HF or preserved ejection fraction. The Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) study demonstrated that angiotensin receptor blockade with candesartan resulted in beneficial effects on HF morbidity in patients with preserved LVEF similar to those seen in depressed LV function.25... 

TABLE 28-3. Randomized, Prospective Trials Comparing Treatments for Status Epilepticus in Adults... 

The term adjuvant therapy refers to the use of chemotherapy or radiotherapy following surgical resection of a tumor mass. The rationale behind adjuvant chemotherapy is to eradicate micrometastases or other tumor cells that may have been missed during removal of the primary tumor. The recent results of five relatively large prospective trials (n = 344—1867) suggest that there is benefit from adjuvant chemotherapy. The largest study, the International Adjuvant Lung Trial (IALT),24 has led to the... 

The 4-month regimen According to the MMWR, rifampin given daily for 3 months has resulted in better protection than placebo in treatment of LTBI in non-HIV patients with silicosis in a randomized prospective trial. However, because the patients receiving rifampin had a high rate of active tuberculosis (4%), experts have concluded that a 4-month regimen would be more prudent when using rifampin alone. This option may be useful for patients who cannot tolerate isoniazid or pyrazinamide. 

Cox JD, Azamia N, Byhardt RW, et al. N2 (clinical) non-small cell carcinoma of the lung Prospective trials of radiation therapy with total doses of 60 Gy by the Radiation Therapy Oncology Group, hit J Radiat Oncol Biol Phys 1991 20 7-12. 

Janjan NA, Crane CN, Feig BW, et al. Prospective trial of preoperative concomitant boost radiotherapy with continuous infusion 5 -fluorouracil for locally advanced rectal cancer. Int J Radiat Oncol Biol Phys 2000 47 713-718. 

Prospective Trials of Preoperative Radiation Therapy With and Without Chemotherapy and Rate of Sphincter-Sparing Procedures... 

Fung CE, Shipley WU, Young RH, et al. Prognostic factors in invasive bladder carcinoma in a prospective trial of preoperative adjuvant chemotherapy and radiotherapy. J Clin Oncol 1991 9 1533-1542. 

North American prospective trials of radiation sensitizers for cervical cancer have focused on the use of cisplatin, fluorouracil, and hydroxyurea. However, a number of other drugs also hold promise as effective radiation sensitizers for cervical cancer, including mitomycin C, epirubicin, paclitaxel, and carboplatin. 

Other potential radiation sensitizers for cervical cancer are being explored in phase I and II trials. Paclitaxel has been combined with cisplatin in several small phase I studies. Pignata et al. (29) found that 50 mg/m2 per week of paclitaxel could be combined with weekly cisplatin (30 mg/m2) and radiation therapy with acceptable toxicity, although 10 of 18 patients in their study had grade 3-4 hematologic toxicity. Chen etal. (30) also were able to give weekly paclitaxel at a dose of 50 mg/m2 (in this case combined with 50 mg/m2 of cisplatin every three weeks) with tolerable toxicity and minimal delay in planned radiation therapy. In both studies, the dose-limiting side effect appeared to be diarrhea. It should be noted that the total dose of cisplatin delivered in these trials was lower than that used in the most successful prospective trials of cisplatin or cisplatin and fluorouracil (Table 3). 

Because patients with very severe social problems tend to be excluded from prospective trials, additional problems may emerge now that many clinicians have accepted chemoradiation as the standard treatment for locoregionally advanced disease. There is no evidence that the use of concurrent chemotherapy permits significant reductions in total treatment dose there is also no evidence that chemoradiation overcomes the detrimental effects of treatment protraction. It is therefore critical that multidisciplinary teams work closely with patients and social services to educate patients and facilitate the timely and complete administration of this complex treatment. 

K. Ott, U. Fink, K. Becker, A. Stahl, H.J. Dittler, R. Busch, H. Stein, F. Lordick, T. Link, M. Schwaiger, J.R. Siewert, W.A. Weber, Prediction of response to preoperative chemotherapy in gastric carcinoma by metabolic imaging Results of a prospective trial, J. Clin. Oncol. 21(24) (2003) 4604 610. 

Soon after the TCAs were introduced, it was noted that fatal overdoses were usually secondary to heart block or ventricular arrhythmias ( 412). This observation led to the concern that, in vulnerable patients, these drugs might produce similar complications at therapeutic plasma concentrations. Over the past 25 years, however, prospective trials have led to a more accurate understanding of their cardiac effects. The best way to review the present state of knowledge is to categorize these effects as follows ... 

What is clear is that without some form of effective maintenance treatment, the relapse rate is substantial (i.e., greater than 50% within the first 12 months after acute remission). Thus, prospective trials are needed to address questions such as which factors predict the likelihood of a good response to maintenance medication versus maintenance ECT and which combination strategies are best to prevent relapse after a successful acute ECT trial ( 1). 

Most of the major institutional and collaborative study groups on treatment of childhood ALL extensively assess prognostic factors on a regular basis in prospective trials. It can be extremely helpful for advancing our current knowledge on thiopurines in childhood ALL, if the evaluation of data on thiopurine response would be included in these studies on a broader basis. Initially, collection and comparison of information from different large clinical trial populations of children with ALL exposed to different background as well as thiopurine treatment may truly help to more clearly define the critical issues associated with thiopurine therapy. 

FGFR4), as well as the TNM classification, was predictive of tumor recurrence. A large prospective trial is being conducted to validate this preliminary finding. 

Nitric oxide released from nitroglycerin stimulates guanylyl cyclase in platelets as in smooth muscle. The increase in cGMP that results is responsible for a decrease in platelet aggregation. Unfortunately, recent prospective trials have established no survival benefit when... 

Kim YS, Kim MS, Kim SI, Lim SK, Lee HY, Han DS, Park K. Post-transplantation diabetes is better controlled after conversion from prednisone to deflazacort a prospective trial in renal transplants. Transpl Int 1997 10(3) 197-201. 

Burge MR, Schmitz-Fiorentino K, Fischette C, Qualls CR, Schade DS. A prospective trial of risk factors for sulfonylurea-induced hypoglycemia in type 2 diabetes mellitus. JAMA I998 279(2) l 37 13. 

---