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PubMed2003

Comparison of two strategies for administering nevirapine to prevent perinatal HIV transmission in high-prevalence, resource-poor settings.

Universal nevirapine (NVP) therapy (provision of the drug without HIV testing) has been suggested as potentially superior to targeted NVP therapy (provision of the drug to seropositive patients identified through voluntary HIV counseling and testing [VCT]) for perinatal HIV prevention in low-resource, high-prevalence settings. The authors postulated that uptake (the proportion of women who accept the strategy when offered) may be higher for universal therapy, since it does not require a woman to learn her serostatus; they further postulated that adherence (the proportion of women who actually ingest the NVP tablet at labor onset) may be higher for targeted therapy, since knowledge of serostatus could motivate better adherence. Two clinics in Lusaka, Zambia were assigned to provide either the targeted or universal strategy. Halfway through the study period, the approach offered at each clinic was crossed over. Adherence was assessed by liquid chromatographic assay for NVP of cord blood. Regarding uptake, 1524 pregnant women were offered participation, and 1025 (67%) accepted. Of 694 women offered enrollment in the universal strategy, 496 (71%) accepted; of 830 women offered enrollment in the targeted strategy, 529 (64%) accepted (p <.01). Uptake was similar at both clinics for the universal strategy: 250 of 339 (74%) at clinic A and 246 of 355 (69%) at clinic B (p =.2), but differed significantly between clinics for the targeted strategy: 229 of 316 (72%) at clinic A and 300 of 514 (58%) at clinic B (RR, 1.51; 95% CI, 1.23, 1.86). Increased uptake correlated with having been offered the universal rather than the targeted strategy (AOR, 1.5; 95% CI, 1.1, 2.1), attendance at clinic A (AOR, 1.4; 95% CI, 1.01, 2.0), and maternal report of a prior fetal or infant death (AOR, 1.6; 95% CI, 1.1, 2.5). Regarding adherence, in the universal strategy, 40 of 103 women (39%) were nonadherent compared with 25 of 98 women (26%) in the targeted strategy (RR, 1.5; 95% CI, 1.004, 2.3). Failure to adhere correlated with participation in the universal strategy (AOR, 2.0; 95% CI, 1.04, 4.2) and illiteracy (AOR, 2.6; 95% CI, 1.2, 5.3). In high-prevalence settings with adequate VCT services, uptake of NVP using the universal or targeted approach appears comparable. However, the universal strategy may result in better uptake in clinics with less well-functioning VCT services (as with clinic B). Adherence to the single-dose NVP intervention was lower among women who did not learn their HIV status. Programs that seek to save the greatest possible number of infants from perinatal HIV acquisition should consider a combination approach, in which women who desire HIV testing can access NVP through a targeted strategy, and women who do not desire testing can access NVP through a universal strategy.

Adult↗
PubMed2005

Double-blind 18-month trial of lithium versus divalproex maintenance treatment in pediatric bipolar disorder.

OBJECTIVE: To determine whether divalproex sodium (DVPX) was superior to lithium carbonate (Li+) in the maintenance monotherapy treatment of youths diagnosed with bipolar disorder who had been previously stabilized on combination Li+ and DVPX (Li+/DVPX) pharmacotherapy. METHOD: Youths ages 5-17 years with bipolar I or II disorder were initially treated with Li /DVPX. Patients meeting remission criteria for four consecutive weeks were then randomized in a double-blind fashion to treatment with either Li+ or DVPX for up to 76 weeks. Study participation ended if the subject required additional clinical intervention or if the subject did not adhere to study procedures. RESULTS: Patients were recruited between July 1998 and May 2002. One hundred thirty-nine youths with a mean (SD) age of 10.8 (3.5) years were initially treated with Li+/DVPX for a mean (SD) duration of 10.7 (5.4) weeks. Sixty youths were then randomized to receive monotherapy with Li+ (n = 30) or DVPX (n = 30). The Li+ and DVPX treatment groups did not differ in survival time until emerging symptoms of relapse (p = .55) or survival time until discontinuation for any reason (p = .72). CONCLUSIONS: DVPX was not found to be superior to Li+ as maintenance treatment in youths who stabilized on combination Li+/DVPX pharmacotherapy.

Adolescent↗
PubMed2006

Radiosensitive functional dye: clinical application for estimation of patient skin dose.

Institutional review board approval and informed patient consent were obtained. The purpose of the study was to prospectively evaluate the use of radiosensitive indicators to estimate patient entrance skin dose (ESD). Forty-six patients wore a jacket with 48 or 52 indicators adhered to the back during percutaneous coronary interventions; they had eight additional indicators on their upper arms. The patients' ESDs were calculated according to the change in color of the indicators. There were good correlations between the ESDs estimated by using color measurements performed with an optical instrument and those estimated at visual observation (P < .001) and between the ESDs estimated by using a thermoluminescent dosimeter and those estimated by using color measurements (P < .001). The radiosensitive indicator method seems to be useful for estimating ESDs and their distribution during percutaneous coronary intervention; however, visual observation is reliable for estimating doses of up to 5 Gy only. (c) RSNA, 2006.

Aged↗
PubMed2004

Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care.

BACKGROUND: Evidence suggests that cluster randomized trials are often poorly designed and analysed. There is little recent research on the methodologic quality of cluster randomized trials and none focuses on primary health care where these trials are increasingly common. METHODS: We conducted a systematic review of recent cluster randomized trials in primary health care, searching the Cochrane Controlled Trials Register. We also searched for unpublished trials in conference proceedings, and the UK National Research Register. We assess methodologic quality using a checklist, articulate problems facing investigators conducting these trials, and examine the extent to which carrying out a cluster randomized trial (as opposed to an individually randomized trial) in primary care may reduce power. RESULTS: We found 367 trial reports. Many trials were reported more than once. We characterize 152 independent cluster randomized trials in primary health care published between 1997 and 2000, and briefly describe 47 trials unpublished at December 2000. The quality of design and analysis was variable. Of published trials reporting sample size calculations 20% accounted for clustering in these calculations, 59% of published trials accounted for clustering in analyses. Unpublished trials were more recent and of higher quality. Reporting quality was better in journals reporting more cluster randomized trials. Many trial investigators reported problems with adherence to protocol, recruitment and type of intervention. CONCLUSIONS: Methodologic quality of cluster randomized trials in primary health care is variable and reporting needs improvement. The use of cluster randomization should be indicated in the title or abstract so these kinds of trials are easier to identify. Communicating appropriate methodology to health care researchers continues to be a challenge. Cluster randomized trials should always be piloted and information from pilots and unsuccessful trials shared more widely.

Cluster Analysis↗
PubMedDate not supplied

Establishing an on-site pharmacy in a community health center to help indigent patients access medications and to improve care.

OBJECTIVES: To describe the establishment of an on-site pharmacy in a community health center (CHC) to improve access to medications for indigent patients, the implementation of pharmaceutical care programs and clinical pharmacy services to improve patient care and therapeutic outcomes, and the development of an ambulatory care site for training pharmacy students. SETTING: Partnership Health Center (PHC), a federally funded CHC in Missoula, Mont. PRACTICE DESCRIPTION: Establishment of an on-site pharmacy and strategies for accessing medications for indigent patients, including participation in the U.S. Public Health Service pricing program, pharmaceutical manufacturers' assistance programs, and drug sampling, are described. The clinical pharmacy, disease management, and pharmaceutical care programs developed at the site to improve medication use and therapeutic outcomes are discussed. Development of an ambulatory care clerkship site at the CHC for training University of Montana pharmacy students is reviewed. PRACTICE INNOVATION: Partnership between PHC and the University of Montana School of Pharmacy and Allied Health Sciences (SPAHS) to establish an on-site pharmacy to help medically indigent patients access medications and to improve care. INTERVENTIONS: Programs to help indigent patients access, adhere, and appropriately use needed medications while decreasing clinic expenditures for medications. MAIN OUTCOME MEASURES: Number of prescriptions dispensed per month, clinic expenditures on medications per month, and number of clinical services and pharmaceutical care programs developed. RESULTS: Between November 1, 1999, and April 30, 2000, the average number of prescriptions filled for PHC clients increased from 219/month to 838/month and the average expenditure per prescription decreased from $16.55/month to $0.51/month. A pharmacist-assisted refill program was implemented. Programs in diabetes, hypertension, dyslipidemia, asthma, anticoagulation, and peptic ulcer disease were developed. CONCLUSION: Establishing an on-site pharmacy in a CHC in collaboration with a school of pharmacy significantly improved indigent patients' access to medications while decreasing clinic expenditures. Pharmaceutical care programs improved therapeutic outcomes, and clinical pharmacy services complemented the clinical activities of other health care providers in managing chronic diseases and resolving drug-related problems. The CHC provided an excellent setting for training pharmacy students in ambulatory care.

Community Health Centers↗
PubMed2006

One small step for manuals: Computer-assisted training in twelve-step facilitation.

OBJECTIVE: The burgeoning number of empirically validated therapies has not been met with systematic evaluation of practical, inexpensive means of teaching large numbers of clinicians to use these treatments effectively. An interactive, computer-assisted training program that sought to impart skills associated with the Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity) Twelve-Step Facilitation (TSF) manual was developed to address this need. METHOD: Twenty-five community-based substance use-treatment clinicians were randomized to one of two training conditions: (1) access to the computer- assisted training program plus the TSF manual or (2) access to the manual only. The primary outcome measure was change from preto posttraining in the clinicians' ability to demonstrate key TSF skills. RESULTS: The data suggested that the clinicians' ability to implement TSF, as assessed by independent ratings of adherence and skill for the key TSF interventions, was significantly higher after training for those who had access to the computerized training condition than those who were assigned to the manual-only condition. Those assigned to the computer-assisted training condition also demonstrated greater gains in a knowledge test assessing familiarity with concepts presented in the TSF manual. CONCLUSIONS: Computer-based training may be a feasible and effective means of training larger numbers of clinicians in empirically supported, manual-guided therapies.

Adult↗
PubMed2004

SARS in healthcare facilities, Toronto and Taiwan.

The healthcare setting was important in the early spread of severe acute respiratory syndrome (SARS) in both Toronto and Taiwan. Healthcare workers, patients, and visitors were at increased risk for infection. Nonetheless, the ability of individual SARS patients to transmit disease was quite variable. Unrecognized SARS case-patients were a primary source of transmission, and early detection and intervention were important to limit spread. Strict adherence to infection control precautions was essential in containing outbreaks. In addition, grouping patients into cohorts and limiting access to SARS patients minimized exposure opportunities. Given the difficulty in implementing several of these measures, control measures were frequently adapted to the acuity of SARS care and level of transmission within facilities. Although these conclusions are based only on a retrospective analysis of events, applying the experiences of Toronto and Taiwan to SARS preparedness planning efforts will likely minimize future transmission within healthcare facilities.

Canada↗
PubMed1996

Malaria treatment and prevention in pregnancy: indications for use and adverse events associated with use of chloroquine or mefloquine.

In sub-Saharan Africa, women frequently report a variety of symptoms during pregnancy, some of which indicate possible illness. Given the adverse impact of malaria in pregnancy, these events may be important for at least two reasons: it may be possible to use reported fever illness as a determinant of which women need an antimalarial intervention, and, it is possible that adverse symptoms following the antimalarial intervention may be important determinants of continued adherence to the prevention regimen. In a cohort of pregnant women enrolled at first antenatal clinic visit in rural Malawi, we evaluated reported fever, determined parasitemia, and placed the women on antimalarial regimens containing chloroquine (CQ) or mefloquine (MQ). We then systematically evaluated reported symptoms following antimalarial drug use after initial therapeutic doses and subsequent prophylactic doses, and monitored women throughout their pregnancy and at delivery. Among 4,187 enrolled women, 1,048 (25%) reported at least one febrile episode during pregnancy before their first antenatal clinic visit. Factors associated with this reported fever included low parity, enrollment in the rainy season, human immunodeficiency virus seropositivity, use of antimalarial prophylaxis before enrollment, high socioeconomic status, normal (compared to low) maternal height and weight, and literacy. Fever before the first antenatal clinic visit was reported by 24.4% of parasitemic women and 25.4% of aparasitemic women; the sensitivity and specificity of fever to identify parasitemic women was 24% and 71%, respectively. In contrast, the sensitivity and specificity of first or second pregnancy to identify parasitemic women was 71% and 57%, respectively. Among women on a CQ or MQ regimen, approximately 60% reported side effects (e.g., itching, dizziness, and gastrointestinal disturbances) after a treatment dose and approximately 25% reported side effects after a prophylactic dose; rates and types of symptoms reported were similar in the CQ and MQ groups. Few serious side effects were observed and rates of fetal loss were low and similar in the groups. Reliance on fever illness will be wholly inadequate to identify parasitemic women; therefore, our findings support existing World Health Organization recommendations that presumptive treatment and prevention regimens should be offered to all pregnant women. When resources are inadequate to offer antimalarial prophylaxis to all pregnant women, women in their first or second pregnancy may be a more appropriate target group than pregnant women with reported fever. Education regarding expected minor side effects may reduce rates of poor compliance and improve the effectiveness of the prevention effort.

Adolescent↗
PubMed2003

Integration of occupational health and safety: case study of a successful program.

1. Occupational health nurses are key players in formulating a diagnosis, designing a plan of care, and implementing any interventions needed to promote safety. 2. While adhering to accepted confidentiality parameters, occupational health nurses share findings with appropriate individuals and teams when they are relevant to the health and safety of others. 3. No individual or department works alone to effect successful safety outcomes. Members of Occupational Health Services, Human Resources and Personnel, and the Safety Team depend on each other to improve work processes and create a safer work environment.

Humans↗
PubMed1992

Community work project in Gazankulu: a community-based training experience.

Speech Pathology and Audiology students at the University of the Witwatersrand participated in a field trip to learn about rural community work. In collaboration with rehabilitation workers at Tintswalo Hospital, Gazankulu, projects in pre-school language stimulation, aphasia assessment and intervention, and hearing screening were undertaken. Projects adhered to community work principles. These were successful in terms of both providing a service to the community and teaching students principles and practice of community work.

Audiology↗
PubMed1997

The foundations of effective management of bipolar disorder.

OBJECTIVES: To understand the epidemiology and course of bipolar disorder; to outline the importance of accurate and reliable diagnosis of bipolar disorder both on a cross-sectional and longitudinal basis; and to emphasize the value of a collaborative therapeutic relationship, psychoeducation, and psychotherapy. METHODS: A brief review of relevant literature to deal with the issues of diagnosis and laying the foundations for effective treatment. RESULTS: Bipolar disorder may well be a heterogeneous group of conditions with varying forms of biphasic mood dysregulation and a changing course across a lifetime. A collaborative therapeutic relationship, psychoeducation, and psychotherapy can be the basis for effective management. CONCLUSIONS: As the concept of bipolar disorder has broadened, the condition is being identified with increasing frequency in many clinical settings. It is a relapsing and recurring condition. It is now recognized that in addition to rational pharmacotherapy, there is a need to encourage a high level of treatment adherence while providing a holistic package of interventions.

Bipolar Disorder↗
PubMed1999

Adherence by African American men to prostate cancer education and early detection.

BACKGROUND: This study was designed to identify factors that predict adherence by African American men to prostate cancer education and early detection. METHODS: In the spring of 1995, the authors identified 548 African American men who were patients at the University Health Services of the University of Chicago, were ages 40-70 years, and did not have a personal history of prostate cancer. Baseline telephone survey data were collected from 413 men (75%). Participants were randomly assigned to either a minimal or an enhanced intervention group. Men in the former group were mailed a letter and a reminder that invited them to a urology clinic for prostate cancer education and early detection. Men in the enhanced intervention group were sent the same correspondence and were also given print material and telephone contacts, which were tailored to each recipient. RESULTS: Adherence was significantly higher (OR = 2.6, CI: 1.7-3.9) in the enhanced intervention group than in the minimal intervention group (51% and 29%, respectively). Men who were age 50 years or older (OR = 1.7, CI: 1.1-2.8), were married (OR = 1.8, CI: 1.2-2.9), believed that prostate cancer early detection examination should be performed in the absence of symptoms (OR = 2.3, CI: 1.3-4.0), and self-reported an intention to have an early detection examination (OR = 1.9, CI: 1.2-2.9) were also more likely to adhere. CONCLUSIONS: A tailored behavioral intervention can influence adherence to prostate cancer early detection among African American men. Individual background and cognitive and psychosocial characteristics may also affect behavior. Future studies should assess the impact of this type of intervention on cognitive and psychologic correlates of decision-making and behavior along the continuum of prostate cancer care. [See editorial on pages 1-2, this issue.]

Adult↗
PubMed2002

First vs multiple episode schizophrenia: two-year outcome of intermittent and maintenance medication strategies.

Results of studies on intermittent neuroleptic treatment strategies in first episode (FE) schizophrenia have not been published. Aims of the present study were to elucidate the comparative efficacy of prodrome-based neuroleptic intervention in first vs multiple episode (ME) schizophrenia. As to the methods, three randomly assigned open neuroleptic treatment strategies were compared over 2 years in 363 schizophrenic outpatients (115 FE, 248 ME; ICD-9, RDC): maintenance medication vs two intermittent medication strategies (prodrome-based intervention and crisis intervention). Concerning relapse prevention, the results demonstrate that ME patients seemed to profit most from maintenance medication compared to both intermittent treatments, whereas FE patients did equally well under maintenance medication and prodrome-based intervention treatment. Psychopathology, social adjustment, subjective well-being, and side-effects after two years did not differ significantly between the FE and ME patients irrespective of treatment strategy. Concerning treatment adherence, FE patients complied better with prodrome-based intervention than with maintenance medication. Cumulative neuroleptic dosage was lowest in FE patients under intermittent treatment. In conclusion, maintenance medication is the best strategy for relapse prevention in ME patients. In FE patients, prodrome-based intermittent intervention seems to be equivalent or even better with respect to compliance and dosage applied.

Adult↗
PubMed2005

How do patients use antimalarial drugs? A review of the evidence.

Patient adherence is a major determinant of the therapeutic response to antimalarial drugs, as most treatments are taken at home without medical supervision. With the introduction of new, effective, but more expensive antimalarials, there is concern that the high levels of efficacy observed in clinical trials may not be translated into effectiveness in the normal context of use. We reviewed available published evidence on adherence to antimalarial drugs and community drug usage; 24 studies were identified of which nine were 'intervention' studies, seven were classified as 'outcome studies', and the remainder were purely descriptive studies of antimalarial adherence. Definitions, methods, and results varied widely. Adherence was generally better when treatments were effective, and was improved by interventions focusing on provider knowledge and behaviour, packaging, and provision of correct dosages. There is insufficient information on this important subject, and current data certainly do not justify extrapolation from results with ineffective drugs to new effective treatments. Research in this area would benefit from of standardization of methodologies and the application of pharmacokinetic modelling.

Antimalarials↗
PubMed2006

High-intensity resistance and cardiovascular training improve physical capacity in cancer patients undergoing chemotherapy.

The purpose of the study was to examine the effects of a supervised high- and low-intensity structured training program in cancer patients concurrently undergoing chemotherapy. Seventy patients, in different stages of the disease and with different diagnoses (48 females, 22 males), between 18 and 65 years of age (mean age 42.8) participated in a 9-h weekly training program over 6 weeks. The intervention involved physical exercise, relaxation, massage, and body-awareness training. Physical capacity (one-repetition maximum tests (1RM), VO2max) and body composition (weight, skin-fold) were compared before and after the exercise intervention. The average increase in muscular strength was 41.3% (P<0.001) and 14.5% in aerobic fitness (pre: 2.27+/-0.597 L/min, post: 2.56+/-0.644 L/min, (P<0.001). The exercise intervention significantly increased the weight of the subjects by 1% (pre: 72.62+/-13.42 kg, post: 73.25+/-13.44 kg, P=0.016). There was a significant decrease in skin-fold measurements by 3% (P=0.031). The exercise intervention was well tolerated, provided that daily screening criteria were adhered to. The effects of resistance and cardiovascular training observed in this short-term study support the theory that exercise is a beneficial intervention strategy for increasing muscle strength and aerobic fitness during antineoplastic chemotherapy. This type of exercise program can be an important component of complementary treatment for cancer patients undergoing chemotherapy.

Adolescent↗
PubMed1995

Long-term metered-dose inhaler adherence in a clinical trial. The Lung Health Study Research Group.

Poor adherence to medication regimens is a well-documented phenomenon in clinical practice and an ever-present concern in clinical trials. Little is known about adherence to inhaled medication regimens over extended periods. The present paper describes the 2-yr results of the Lung Health Study (LHS) program, which was developed to maintain long-term adherence to an inhaled medication regimen in 3,923 special intervention participants (as measured by self-report and medication canister weight). The LHS is a double-blind, multicenter, randomized controlled clinical trial of smoking intervention and bronchodilator therapy (ipratropium bromide or placebo) for early intervention in chronic obstructive pulmonary disease (COPD). At the first 4-mo follow-up visit, nearly 70% of participants reported satisfactory or better adherence. Over the next 18 mo, self-reported satisfactory or better adherence declined to about 60%. Canister weight classified adherence as satisfactory or better in 72% of participants returning all canisters at 1 yr, and in 70% of the participants returning all canisters at the 2-yr follow-up. Self-reporting confirmed by canister weight classified 48% of participants at 1 yr as showing satisfactory or better adherence. Overusers were 50% more likely than others to misrepresent their true smoking status, suggesting that canister weights indicating overuse may be deceptive. Results of multiple logistic regression analysis indicate that the best compliance was found in participants who were married, older, white, had more severe airways obstruction, less shortness of breath, and fewer hospitalizations, and who had not been confined to bed for respiratory illnesses.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2005

Psychosocial treatments for bipolar disorders.

Psychosocial problems may be causes or consequences of BP relapses,and adding psychologic therapies to usual-treatment approaches may improve the prognosis of those at risk of persistent symptoms or frequent episodes. The three core individual manualized therapies (IPSRT, cognitive therapy, and FFT) have all developed specific models for use in BP. Colom et al's group psychoeducation model also has a clearly developed rationale and format, and it allows individuals to share their views of BP with others, to learn adaptive coping strategies from the other 8 to 12 members of the group, and to have regular contact with an expert therapist. Careful review of the four more extended and comprehensive approaches and the brief technique-driven interventions demonstrates that the effective therapies incorporate one or more of the modules show in Box 1. At present,the choice between the four extended models is more likely to be dictated by patient choice or the availability of a trained therapist. The technique-driven interventions are briefer than the specific therapies (about 6-9 sessions compared with about 20-22 sessions) and usually offer a generic, fixed treatment package targeted at a circumscribed issue such as medication adherence or managing early symptoms of relapse. These brief interventions can be delivered by a less-skilled or less-experienced professional than the specific model. They potentially seem to be useful in day-to-day clinical practice in general adult psychiatry settings; additional larger-scale, randomized trials should be encouraged. Given the reduction in relapse rates and hospitalizations associated with the use of psychologic therapy as an adjunct to medication, it is likely that these approaches will prove to be clinically and cost effective. They may provide a significant improvement in the quality of life of individuals with BP (and indirectly to that of their partners and family members). Brief,evidence-based therapies represent an important component of good clinical practice in the management of BP. Studies of a comprehensive, whole-system approach to the collaborative psychobiosocial management of BP are being undertaken in the United States. If these approaches improve the quality and continuity of care for individuals with BP, they will have further implications for the delivery and organization of mental health services. The number and variety of trials of psychosocial interventions is exciting for researchers and clinicians interested in BP. Enthusiasm for advocating these approaches should be tempered by an acknowledgment that the trials undertaken so far largely demonstrate efficacy in selected samples of patients treated at specialist BP clinics or psychologic treatment research centers. Translating efficacy into effectiveness requires evidence that the approaches used in the treatment trials are equally beneficial when used by the wider therapist community treating patients seen routinely in non-specialist or nonresearch centers. These patients often have multiple problems or complex presentations that preclude their involvement in pharmacologic or psychologic treatment studies, but monitoring the outcomes of these representative samples will be important in determining the true place of psychologic approaches in the management of BP. Large-scale studies are now underway on both sides of the Atlantic (the Medical Research Council study in the United Kingdom and the STEP-BD project in the United States). These trials are likely to answer basic questions about the benefits and limitations of psychologic therapies in the acute and maintenance treatment of BP in the clinical realm and will increase understanding of the effectiveness-versus-efficacy question.

Antimanic Agents↗