Controlled clinical trials in cystic fibrosis--are we doing better?

We have previously reported the time trends, design and interventions in randomised controlled trials (RCTs) in cystic fibrosis (CF) from 1961 through 1997 [Cheng K, Smyth RL, Motley J, O'Hea U, Ashby D, Randomised controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention. Pediatr Pulmonol 2000, 29:1-7.]. We maintain an ongoing register of all RCTs and controlled clinical trials (CCTs) in CF and have noted that in the five years since 1997 there has been a 48% increase in published trials. We aimed to assess whether this increase has been associated with an improvement in design quality. All RCTs and CCTs from 1961-2002 were assessed. Two epochs were then compared, 1961-1997 and 1998-2002. For each trial we recorded the design, participant numbers and the intervention studied. 261 trials in 1998-2002 were compared with 544 trials in 1961-1997. Comparing the two epochs a similar proportion of trials were parallel, double-blind and placebo controlled; also the median number of participants was similar. In the later epoch 25% of trials were multicentre, compared with 11% previously. Whilst this recent increase in clinical trials in CF is welcome, this has not been associated with improvements in quality. The trend for an increasing proportion of trials to be multicentre is encouraging. There are however, still deficiencies in the design of clinical trials in CF.     

Evaluation of a mass dispensing exercise in a Cities Readiness Initiative setting.

PURPOSE: The effectiveness of a point of dispensing (POD) used in a mass dispensing exercise was evaluated. METHODS: Public Health-Seattle & King County (PHSKC), in conjunction with the University of Washington, conducted a functional exercise of mass dispensing plans to test the effectiveness of a POD. Specifically, the organization and maintenance of patient flow, staffing model, signage, and dissemination of public information were evaluated. A data collection application using cellular telephones was used to record time and patient flow data to evaluate patient flow. Questionnaires distributed to staff and volunteer patients at the end of the exercise obtained feedback regarding the setup, organization, and operations of the POD. RESULTS: The POD was operational for approximately 68 minutes. The majority of POD staff reported feeling comfortable with their specific job tasks and duties within 15 minutes of opening the doors to the POD to the public. Staff questionnaires also revealed a high level of self-reported confidence in their ability and in the ability of their colleagues to perform the job-specific responsibilities required of them or respond to this hypothetical event. The majority of volunteer patients found the signs helpful and easy to follow and the check-in form easy to complete. Despite efforts to provide patients with oral and written information about the medications being dispensed, only 80% indicated that they knew how to take the medication, and only 73% reported understanding the medication instructions for all the individuals for whom they picked up medication. CONCLUSION: The majority of volunteer patients and staff who participated in a functional exercise of mass dispensing plans found the POD to be effective. Time-flow analysis provided preliminary estimates of the total amount of time needed to complete the dispensing process for each head of household.     

Physical Therapy and Complementary and Alternative Medicine: An Educational Tool for Enhancing Integration

In an outpatient rehabilitation setting, both patients’ use and therapists’ knowledge of complementary and alternative medicine (CAM) varies widely. Based on this observation and a recognition of CAM as an emerging practice area for rehabilitation professionals, it was felt that a thorough and consistent approach to the education and orientation of physical therapists to the world of CAM and integrative care was needed. This special interest paper will describe one center’s approach, development, and use of a unique and comprehensive training manual designed to provide both a structured and standardized approach for educating physical therapists about CAM and related therapeutic modalities. This innovative teaching tool allows for multiple methods of content delivery within a multidisciplinary format and can be used for those who practice currently or desire to practice in an integrative care environment.     

Reliability of dual diagnosis. Substance dependence and psychiatric disorders.

The Structured Clinical Interview for DSM-III-R was used to examine the effects of the co-occurrence of psychiatric and substance dependence disorders on diagnostic reliability. The test-retest reliability over a 1-week period was studied in groups of: a) individuals with current substance abuse diagnoses (N = 97), b) individuals with past, but not current, drug histories (N = 146), and c) individuals without substance abuse diagnoses (N = 356; primarily psychiatric patients). A measurement of reliability (Kappa coefficients) was estimated for four general psychiatric categories (psychotic, mood, anxiety, and eating disorders), along with specific most-frequent diagnoses in each category (schizophrenia, major depression, panic disorders, and bulimia nervosa, respectively). Past use and non-drug-use groups were similar in their generally reliable reporting of current and past psychiatric disorders. However, current mood and psychotic disorders were less reliably diagnosed in the group with current substance use disorders.     

An anti-CD44 antibody does not enhance engraftment of DLA-identical marrow after low-dose total body irradiation

920 cGy total body irradiation (TBI) is adequate for consistently successful engraftment of marrow from dog leukocyte antigen (DLA)-identical littermates; however, the dose is inadequate to ensure a marrow graft from DLA-nonidentical unrelated donors. Such mismatched grafts are successful only after 1800 cGy, given in three fractions. While anti-T-cell reagents enhance engraftment of DLA-identical littermate marrow after 920 cGy, they fail to be effective in the DLA-nonidentical setting. However, a monoclonal antibody (mAb) to CD44, S5, was found to be very effective in enhancing engraftment of DLA-nonidentical marrow. The current study asked whether mAb S5 was also effective in the setting of DLA-identical littermate transplants. To this purpose, the TBI dose was lowered to 450 cGy, a dose after which 70% of such grafts failed. Four dogs were treated with antibody S5, 0.2 mg/kg on days −7 though −2 (per previously published protocol), given 450 cGy TBI followed by marrow grafts from their DLA-identical littermates. All four dogs rejected their grafts; two of these died from marrow aplasia, and two survived with endogenous marrow recovery. This result was not statistically significantly different from that in 17, historical (n = 5) and concurrent (n = 12), control dogs where 11 of 17 animals rejected. Even if ten experimental animals were transplanted and all six remaining dogs engrafted, the results still would not have been significantly different from control. This result is in contrast to the successful engraftment promoted by pretreatment with antibody S5 of DLA-nonidentical unrelated dogs, consistent with the notion that different host cells are involved in graft rejection in the two disparate histocompatibility settings.     

Finishing techniques for amalgam restorations: Clinical assessment at three years

Use of the optimum finishing technique for an amalgam restoration may enhance the marginal integrity of the restoration and discourage its unnecessary early replacement. Two hundred and twenty-eight high copper amalgam restorations in 56 patients were evaluated, using clinical assessment criteria, up to three years after placement. Each patient had received at least one carved-only amalgam, at least one immediately finished restoration, and at least one amalgam that was polished at a subsequent appointment. Regardless of the finishing technique, the restorations exhibited similar marginal integrity up to three years after placement. Polished restorations were found to have substantially superior surface texture and less likelihood of surface discoloration. No evidence was found to support the use of immediate finishing techniques. The clinical significance of these findings, with respect to the need to polish amalgam restorations, is discussed.