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PubMed1999

Patient based methods for assessing adverse events in clinical trials in rheumatology. Progress report for the OMERACT Drug Toxicity Working Party. Outcome Measures in Rheumatology.

There has been increasing recognition in recent years that the measurement of drug related toxicities in rheumatology clinical trials has been sub-optimal. The OMERACT Drug Toxicity Working Party was established to address this issue. The first task of the working party was to identify a minimum set of attributes of drug related toxicity that would be important to patients, clinicians, investigators, and policymakers. The working party then developed consensus on a standard set of properties for instruments to measure these attributes. Existing instruments in the field of rheumatology were ascertained by literature review and by contact with experts in the field. Four instruments were ascertained and evaluated using the guidelines developed by the working party. This report outlines the progress and preliminary results of these activities.

Antirheumatic Agents↗
PubMed1968

The Medical Library Center of New York: a progress report.

An article published in the Bulletin in 1963 outlined the proposed program of the Medical Library Center of New York. This progress report describes actual functions of the Center and attempts to evaluate them after four years of experience. Details of adapting a building intended for other use, financing this cooperative enterprise, applying standard library techniques and equipment to an atypical library, and acquiring materials that complement, rather than duplicate, the collections of member libraries are given. New services, not envisioned in detail in the initial program, but initiated during this period of operation, are mentioned. The report ends with a tentative look into the future.

Libraries, Medical↗
PubMed1981

Progress report on chlorambucil therapy in postsplenectomy patients with progressive hairy cell leukemia.

Of eight patients with progressive hairy cell leukemia who were treated with daily doses of an alkylating agent (chlorambucil, 4 mg) for at least 6 mo, seven have had an objective response, as measured by improved blood counts. Two patients were pancytopenic and had almost total bone marrow replacement with hairy cells at the initiation of chemotherapy; approximatley 6 mo later, their blood counts and bone marrow had improved dramatically. The five other patients had the leukemic form of the disease, and all responded to therapy. It is important to identify postsplenectomy patients with progressive disease in order to initiate low-dose single-agent chemotherapy.

Allopurinol↗
PubMed1979

Bloom's syndrome. VII. Progress report for 1978.

The Bloom's Syndrome Registry was published in this journal in 1977. Now, in the first in a series of progress reports, recent accessions to the Registry are recorded, new instances of neoplasia are listed, and recent clinical observations and experimental results of general interest are cited.

Abnormalities, Multiple↗
PubMedDate not supplied

CQI progress reports: the dashboard approach provides a better way to keep board informed about quality.

Once continuous quality improvement is under way, nearly all healthcare organizations send progress reports to the board. Typically, however, the board gets a potpourri of data--from written and oral reports of quality improvement projects to clinical outcome measurements, and customer satisfaction data. That's why top executives are trying to determine more precisely what information trustees and other leaders really need. One solution is a "dashboard" of critical indicators based on the organization's strategic plan.

Documentation↗
PubMed1982

Progress report on two clinical trials in women with advanced breast cancer. Trial I: tamoxifen versus tamoxifen plus aminoglutethimide. Trial II: aminoglutethimide in patients with prior tamoxifen exposure.

A progress report is presented on two on-going clinical trials in women with advanced breast cancer. In Trial I to date, 56 patients have been randomized to tamoxifen (TAM) alone or TAM plus aminoglutethimide (AG) (plus hydrocortisone). Patients failing TAM can then receive AG. The two groups are reasonably well balanced with respect to prior hormonal therapy exposure (TAM, 19%; TAM plus AG, 17%), age, disease-free interval, performance score, and estrogen receptor status. The TAM plus AG group has a higher incidence of visceral dominant disease (41 versus 26%) and prior chemotherapy exposure (41 versus 33%). Responses have been observed in 7 of 27 (26%) patients on TAM and 11 of 28 (39%) on TAM plus AG. Median times to treatment failure (defined as disease progression, unacceptable toxicity, or patient refusal) are 211 and 123 days, respectively (log-rank on time to treatment failure, p = 0.87). Toxicity is greater for TAM plus AG with a higher incidence of skin rash, lethargy, and dizziness. Thrombotic events were seen in one patient on TAM and two patients on TAM plus AG. One patient on TAM plus AG developed leukopenia and sepsis. The data are too preliminary for one to draw firm conclusions regarding relative efficacy. In TRial II to date, 35 patients with prior tamoxifen exposure have received AG. The mean number of prior systemic therapies is 3.2 (range, 1 to 7). The response rate is 20% and similar with (21%) or without (19%) prior chemotherapy exposure. The median time to treatment failure is 92 days. One patient developed leukopenia and sepsis. Additional patient accrual is necessary to allow characterization of potential efficacy within prognostically important subsets.

Adult↗
PubMedDate not supplied

Written progress report materials: blood usage review.

The following article is the third in a series of articles specifying the types of documentation and evidence organizations should include in the written progress reports (WPRs) they submit to clear contingencies. Since it is difficult to anticipate all conditions that may result in contingencies, the guidelines presented here address the most common response areas for organizations. Contingencies directed to more specific problems may require a more precise response than these guidelines set forth.

Accreditation↗
PubMedDate not supplied

Meeting the 1990 hypertension objectives for the nation--a progress report.

The National High Blood Pressure Education Program (NHBPEP) effort got underway in 1972 following hypertension research findings and continues to be influenced and, when necessary, redirected, by further findings. Its coordinating committee is composed of representatives from 32 national organizations, and the program itself includes several Federal agencies, all State health departments, and more than 2,000 community-based programs. The goals of NHBPEP and the 1990 prevention objectives for the nation center around the same basic theme: high blood pressure is a serious condition leading to major diseases and premature death. It can be easily detected and effectively brought under control. In the summer of 1984, Admire and co-workers provided a general review and status report of the 1990 Hypertension Objectives and the progress made in meeting those objectives. In the remarkably short period of time since that review, there is even more progress to report. There is good evidence of progress in preventing disease and premature death from hypertension, in bringing hypertension under long term control, and in giving Americans a better understanding of the consequences of uncontrolled high blood pressure. There is also evidence in the fact that while visits to physicians generally have increased only slightly, hypertension visits have increased more markedly. And there is evidence that stroke mortality continues to decline in an almost linear fashion.

Adult↗
PubMed1998

Therapeutic trials in the murine model of hereditary tyrosinaemia type I: a progress report.

We have studied a knockout mouse with fumarylacetoacetate hydrolase (FAH) deficiency as a model of human hereditary tyrosinaemia type (I (HT1). These mice have a phenotype very similar to the human disease, which is characterized by acute hepatic failure, renal tubular disease and hepatocarcinoma. We have previously reported on the efficacy of 2-(2-nitro-4-trifluoromethylbenzyol)-1,3-cyclohexanedione (NTBC) in preventing acute liver disease in HT1 mice. Here we present a progress report on long-term follow up (> 1 year) of high-dose NTBC therapy in combination with tyrosine restriction. In vivo retroviral gene therapy was also effective in abolishing the acute liver failure of HT1. Retrovirally treated mice remained completely healthy and active for 12 months after retroviral gene transfer. However, hepatocarcinoma developed in 2/3 treated animals after 1 year. Southern blot analysis showed that the tumours did not arise from retrovirally transduced hepatocytes but from non-corrected FAH-deficient cells. These results highlight the extreme danger for tumour formation in HT1 and indicate the need for improved gene therapy that leads to the elimination of endogenous FAH-deficient liver cells.

4-Hydroxyphenylpyruvate Dioxygenase↗
PubMed1992

Progress report from the International Bone Marrow Transplant Registry.

The International Bone Marrow Transplant Registry receives and analyses detailed information contributed by more than 200 transplant teams worldwide. This collaborative research program has grown rapidly; there are now more than 15,000 cases in the database. This progress report summarizes the current status of bone marrow transplantation, the results of recent investigations and studies planned for the coming year.

Anemia, Aplastic↗
PubMed1996

Progress report on new antiepileptic drugs: a summary of the Third Eilat Conference.

The Third Eilat Conference on New Antiepileptic Drugs was held at the Royal Beach Hotel from May 27 to May 30, 1996. Epileptologists and scientists from 20 countries attended the conference, which was held to discuss critical issues in drug development, new antiepileptic drugs (AEDs) in development, progress reports and recent findings of newly marketed AEDs, the use of AEDs in special populations and their utilization in non-epileptic disorders. Over the last seven years, six new AEDs have been introduced worldwide and new information on their safety and efficacy has become available. These include felbamate, gabapentin, lamotrigine, oxcarbazepine, topiramate and vigabatrin. Drugs in development include those at an advanced stage, such as remacemide and tiagabine, as well as those just entering clinical trials, such as rufinamide (CGP 331010) and levetiracetam (ucb LO59). The following is a summary of the presentations for drugs in development and recent findings on newly marketed drugs.

Acetamides↗
PubMed1998

Benefit of early Class II treatment: progress report of a two-phase randomized clinical trial.

Preadolescent children with overjet greater than 7 mm were randomly assigned to observation only, headgear (combination), or functional appliance (modified bionator) and were monitored for 15 months. Of the 166 patients who completed this first phase of the trial, 147 continued to a second phase of treatment. The data from the first 107 patients to complete phase 2 are available and form the basis of this progress report. During phase 1, on average there was no change in the jaw relationship of untreated children, but 5% showed considerable improvement and 15% demonstrated worsening. Both early-treatment groups had a significant average reduction in ANB angle, more by change in maxillary dimensions in the headgear group and mandibular growth in the functional appliance group. There were wide variations in response, however, with only 75% of the treated children showing favorable skeletal response. Failure to respond favorably could not be explained by lack of cooperation alone. The preliminary results from phase 2 show that, on average, time in fixed appliances was shorter for children who underwent early treatment, but the total treatment time was considerably longer if the early phase of treatment was included. Only small differences were noted in anteroposterior jaw position between the groups at the completion of treatment, and the changes in dental occlusion, judged on the basis of Peer Assessment Rating scores, were similar between groups. Neither the severity of the initial problem nor the duration of treatment was correlated with the occlusal result. The number of patients who required extraction of permanent teeth was greater in the early functional appliance group than in the headgear or control group. The option of orthognathic surgery was presented more often in the cases of children who did not undergo early treatment, but surgery was accepted or was still being considered almost as frequently in the previous headgear group as in the controls, less often in the patients previously treated with functional appliances.

Activator Appliances↗
PubMed1984

Bloom's syndrome XI. Progress report for 1983.

During the 30 years since its description as a clinical entity, Bloom's syndrome has been diagnosed in more than 100 persons. It is believed that most of these have been accessioned to the Bloom's Syndrome Registry, which now includes 103 persons. Of those 103, 80 are alive, with a mean age of 18.2 years. Twenty-eight malignant neoplasms have been detected, at a mean age of 20.7 years. Periodically, progress reports are being made in this journal of the long-term surveillance of affected families.

Adolescent↗
PubMed1999

Progress report: the Arizona phase III study of the effect of wheat bran fiber on recurrence of adenomatous colon polyps.

A double-blind, placebo-controlled Phase III cancer prevention trial in subjects with previous resection of adenomatous colon polyps is nearing completion. The study's primary objective is to evaluate the effects of daily dietary supplementation with large (13.5 g/day) versus small (2.0 g/day) doses of wheat bran fiber for 3 years. A summary of the study design and a progress report are presented.

Adenomatous Polyposis Coli↗
PubMed1999

Progress report on new antiepileptic drugs: a summary of the fourth Eilat conference (EILAT IV).

The Fourth Eilat Conference on New Antiepileptic Drugs (AEDs) was held at the Royal Beach Hotel, Eilat, Israel, from 6th to 10th September 1998. Epileptologists and scientists from 20 countries attended the conference, which was held to discuss a number of issues in drug development, including outcome assessment in epilepsy (long-term efficacy, quality of life, safety), cost-effectiveness, an update on drugs in development, a progress report on recently marketed AEDs, and controversies in strategies for drug development. This review focuses on drugs in development and recently marketed AEDs. Drugs in development include ADCI, AWD 131-138, DP16, ganaxolone (CCD 1042), levetiracetam (ucb L059), losigamone, pregabalin (isobutyl GABA [CI-1008]), remacemide hydrochloride, retigabine (D-23129), rufinamide (CGP 33101), soretolide (D2916), TV1901, and 534U87. New information on the safety and efficacy of recently marketed drugs (felbamate, fosphenytoin, gabapentin, lamotrigine, oxcarbazepine, tiagabine, topiramate, vigabatrin, zonisamide) and of a new antiepileptic device, the neurocybernetic prosthesis (NCP), has become available. This paper summarizes the presentations made at the conference.

Animals↗
PubMed1984

The Louisiana Mental Health Client-Outcome Evaluation Project: an initial progress report.

The Louisiana Mental Health Client-Outcome Evaluation Project is assessing the effectiveness of the Schainblatt - Hatry system of client-oriented outcome monitoring as applied to Louisiana CMHC outpatient settings. This system involves incorporating a self-administered mental health questionnaire into the routine center intake procedures and use of a combination mail-out and telephone follow-up data collection method. Follow-up procedures can be operated by a small evaluation staff through the State central office. This initial progress report provides an overview of the instruments and procedures being utilized and discusses results of the project obtained thus far.

Adolescent↗
PubMedDate not supplied

Diabetogenic activity of the anterior pituitary (a progress report).

The exact nature of the diabetogenic activity of the anterior pituitary gland remains a mystery. While growth hormone (GH) fractions clearly can produce a diabetogenic effect, there is increasing evidence that GH itself does not exert this effect. Several new theories that purport to explain the nature of diabetogenic activity are discussed. The current evidence supports the view that the activity is the result of a GH fragment or some other closely related protein such as the one ("diabetogenic protein") first described by LOUIS and CONN. A progress report of the research on this new "diabetogenic protein" is given.

Adipose Tissue↗
PubMed2001

How well can blood pressure be controlled? Progress report on the Systolic Hypertension in Europe Follow-Up Study (Syst-Eur 2).

BACKGROUND: The randomised, double-blind, placebo-controlled Systolic Hypertension in Europe trial (Syst-Eur 1) proved that blood pressure (BP) lowering therapy starting with nitrendipine reduces the risk of cardiovascular complications in elderly patients with isolated systolic hypertension. In an attempt to confirm the safety of long-term antihypertensive therapy based on a dihydropyridine, the Syst-Eur patients remained in open follow-up after the end of Syst-Eur 1. This paper presents the second progress report of this follow-up study (Syst-Eur 2). It describes BP control and adherence to study medications. METHODS: After the end of Syst-Eur 1 all patients, treated either actively or with placebo, were invited either to continue or to start antihypertensive treatment with the same drugs as previously used in the active treatment arm. In order to reach the target BP (sitting SBP <150 mmHg), the first line agent, nitrendipine, could be associated with enalapril and/or hydrochlorothiazide. RESULTS: Of the 3787 eligible patients, 3516 (93%) entered Syst-Eur 2. At the last available visit, 72% of the patients were taking nitrendipine. SBP/DBP at entry in Syst-Eur 2 averaged 160/83 mmHg in the former placebo group and 151/80 mmHg in the former active-treatment group. At the last follow-up visit SBP/DBP in the patients previously randomised to placebo or active treatment had decreased by 16/5 mmHg and 7/5 mmHg, respectively. The target BP was reached by 74% of the patients. CONCLUSION: Substantial reductions in systolic BP may be achieved in older patients with isolated systolic hypertension with a treatment strategy starting with the dihydropyridine calcium-channel blocker, nitrendipine, with the possible addition of enalapril and/or hydrochlorothiazide.

Journal Article↗