A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989

A methodological review is presented of 16 non-therapeutic intervention trials published over the last decade which have randomized intact clusters rather than individuals in treatment groups. Each of the trials was surveyed as to the information supplied on six methodological criteria. Although there is increasing recognition of the methodological issues associated with cluster randomization, many investigators are still not aware of the impact of this design on sample size requirements and analysis considerations. Investigators are urged to publish the cluster-specific event rates observed in their trials as a guide for the planning of future studies.     

Impact of a Pharmacist-Based Consult Service on Nutritional Rehabilitation of Nonambulatory Patients with Severe Developmental Disabilities

A pharmacist consult service was developed to evaluate the appropriateness of enteral feeding through a permanent ostomy in 24 nonambulatory patients with severe developmental disabilities. Several problems with enteral nutrition were identified. Policies to improve them were instituted, and several educational presentations were made. Pharmacists' actions were implemented, including assessment of energy needs by indirect calorimetry and rearrangement of enteral feeding schedules to achieve optimal nutrition support and pharmacotherapy administration. By the fourth month of the consult service, body weight in these patients increased from 101 ± 6% of baseline to 109 ± 7% (p<0.05). Weight continued to increase through the seventh month of the consult service to 116 ± 12% of baseline (p<0.0001). Measured resting energy expenditure for the group was 889 ± 170 kcal/day compared with the predicted 1055 ± 163 kcal/day.     

Binucleated and multinucleated forms of plasma cells in synovia from patients with rheumatoid arthritis

A morphological examination of synovial tissue from 25 patients with rheumatoid arthritis revealed that binucleated or multinucleated plasma cells were present in all samples and absent in synovia obtained from 16 control patients. Plasma cells containing two, three of four nuclei constitutet a mean 3% of the total plasma cell population. They were aways found amongst plasma cell infiltrates and in close association with small blood vessels. Ultrastructural analysis found no evidence of cellular membranes separating the individual nuclei in binucleated or multinucleated plasma cells, suggesting that the cells did not arise from fusion. Some of these plasma cells had a diameter approaching 100 μm, and many were in intimate contact with macrophages. The demonstration of a few cells with mitotic figures within the infiltrates suggests that the maintenance of plasma cell numbers in rheumatoid synovium may depend, in part, upon their local proliferation. Received: 25 August 1997 / Accepted: 2 October 1997     

Creating empowering meaning: an interactive process of promoting health with chronically ill older Canadians

Many health promotion approaches afford education about disease prevention and enhancement of one's health status. But strategies for enabling older people with chronic illness to better mobilize their resources for everyday living still require development. This practical action research study explored the experiences of 13 purposefully selected older persons who participated in a health promotion intervention premised on the adult education theory of perspective transformation. Findings illuminate health promotion through a holistic interactive process in which professional and chronically ill older person together evolved a caring relationship and enhanced conscious awareness of life and health experiences. Five health-promoting strategies were identified: building trust and meaning; connecting; caring; mutual knowing; and mutual creating. Researchers suggest several important directions to refine professional practice approaches and health care delivery systems in order to promote the health of older persons with chronic conditions.     

Spinal cord stimulation in the treatment of failed back surgery syndrome

A significant number of patients undergoing lumbar spine surgery do not obtain pain relief. Such patients with chronic low back or lower extremity pain may be difficult to treat. A frequent component of therapy is the use of spinal cord stimulation to help control pain. With careful patient selection, many patients can achieve reasonable levels of pain relief. We review recent clinical reports, including prospective and randomized studies, that demonstrate up to three quarters of patients implanted with a spinal cord stimulator for the treatment of failed back surgery syndrome may benefit from its use. This technology must not be indiscriminately applied. Careful patient selection and a period of trial stimulation are vital to the successful use of spinal cord stimulation as treatment for chronic pain.     

Synthesis and in vitro LTD4 antagonist activity of bicyclic and monocyclic cyclopentylurethane and cyclopentylacetamide N-arylsulfonyl amides

The dissociation constants (KB) at the LTD4 receptor on guinea pig trachea of a series of monocyclic and bicyclic cyclopentylurethane and cyclopentylacetamide N-arylsulfonyl amides have been measured. The KB was found to be remarkably tolerant of changes in the electronic constitution and lipophilicity of the bicyclic ring system (template). Thus, N-[4[[6-[[(cyclopentyloxy)carbonyl]amino]benzimidazol-1- yl]methyl]-3-methoxybenzoyl]benzenesulfonamide (11a) and N-[4-[[5-[[(cyclopentyloxy)carbonyl]amino]benzo[b]thien-3- yl]methyl]-3-methoxybenzoyl]benzene-sulfonamide (25a) had closely similar affinities (pKB, 9.20 and 9.31, respectively; LTE4 as agonist). It has been shown that the hetero-ring of the template need not be aromatic in order to achieve high affinity, since indoline 31 and 2,3-dihydrobenz-1,4-oxazines 37a-c had pKBs greater than 9. Further, it has been shown that an o-aminophenone (see 42 and Figure 3) can function as a template; the template in 42 [see iii] is bicyclic by virtue of the presence of an intramolecular hydrogen bond. In contrast, when the template is a phenyl ring (48), receptor affinity is markedly reduced. These findings support the notion that central bicyclic ring system in this family of peptidoleukotriene antagonists is a molecular feature which helps to preorganize the acylamino and acidic chains and thereby facilitate the molecular recognition event.