Health sequelae of human cryptosporidiosis-a 12-month prospective follow-up study.

To investigate long-term health sequelae of cryptosporidiosis, with especial reference to post-infectious irritable bowel syndrome (PI-IBS). A prospective cohort study was carried out. All patients with laboratory-confirmed, genotyped cryptosporidiosis in Wales, UK, aged between 6 months and 45 years of age, over a 2-year period were contacted. Five hundred and five patients agreed to participate and were asked to complete questionnaires (paper or online) at baseline, 3 and 12 months after diagnosis. The presence/absence of IBS was established using the Rome III criteria for different age groups. Two hundred and five of 505 cases completed questionnaires (40% response rate). At 12 months, over a third of cases reported persistent abdominal pain and diarrhoea, 28% reported joint pain and 26% reported fatigue. At both 3 and 12 months, the proportion reporting fatigue and abdominal pain after Cryptosporidium hominis infection was statistically significantly greater than after C. parvum. Overall, 10% of cases had sufficient symptoms to meet IBS diagnostic criteria. A further 27% met all criteria except 6 months' duration and another 23% had several features of IBS but did not fulfil strict Rome III criteria. There was no significant difference between C. parvum and C. hominis infection with regard to PI-IBS. Post-infectious gastrointestinal dysfunction and fatigue were commonly reported after cryptosporidiosis. Fatigue and abdominal pain were significantly more common after C. hominis compared to C. parvum infection. Around 10% of people had symptoms meriting a formal diagnosis of IBS following cryptosporidiosis. Using age-specific Rome III criteria, children as well as adults were shown to be affected.

Indication-specific 6-h systolic blood pressure thresholds can approximate 24-h determination of blood pressure control.

Ambulatory blood pressure monitoring (ABPM) is an accurate method for evaluating hypertension, yet its use in clinical practice may be limited by availability, cost and patient inconvenience. The objective of this study was to investigate the ability of a 6-h ABPM window to predict blood pressure control, judging by that of the full 24-h ABPM session across several clinical indications in a cohort of 486 patients referred for ABPM. Sensitivities and specificities of the 6-h systolic blood pressure mean to accurately classify patients as hypertensive were determined using a fixed reference point of 130 mm Hg for the 24-h mean. For four common indications, in which ABPM was ordered, prediction tables were constructed varying the thresholds for the 6-h mean to find the optimal value that best predicted the 24-h hypertensive status as determined from the full 24-h interval. Using a threshold of 137 mm Hg for the indications of borderline hypertension, evaluation of current antihypertensive regimen and suspected white-coat hypertension, sensitivity and specificity ranged from 0.83-0.88 to 0.80-0.88, respectively, for the ability of 6-h ABPM to correctly categorize hypertensive status. Using 133 mm Hg as the threshold for treatment resistance resulted in a sensitivity and specificity of 0.93 and 0.83, respectively. We conclude that a shortened ABPM session of 6 h can be used to accurately classify blood pressure as controlled or not, based on the results of a 24-h session. The optimal 6-h threshold for comparison depends upon indication for referral.

[Improving blood pressure control with physician/pharmacist collaboration]. / Zlepsení kontroly krevního tlaku jako výsledek spolupráce lékare a farmaceuta.

Studies have shown that it is very important to control blood pressure in patients with diabetes. Unfortunately, blood pressure control throughout the world is poor. Numerous studies have used interdisciplinary team-based care to improve the control of many chronic conditions including hypertension and diabetes. This discussion will focus on the results of a study we recently conducted involving clinical pharmacists located in physician offices. The study was a randomized, cluster trial in five clinics. The pharmacists assessed patients with poorly controlled blood pressure and made recommendations to the physicians to change therapy. The patients in control sites received usual care. Blood pressure was controlled in 89% of patients in the intervention group compared to 53% in the control group (p < 0.001). Blood pressure was controlled in 82% of patients with diabetes in the intervention group compared to 24% in the control group (p = 0.002). This was the first study of team-based care that used ambulatory BP monitoring. Ambulatory blood pressure was reduced significantly more in the intervention group compared to the control group. The primary reason for the superior results in the intervention group was more intensive use of medications to control blood pressure. This study demonstrates that blood pressure can be controlled in a high number of patients with diabetes following our physician/pharmacist collaborative model.

Development of explicit criteria to measure adherence to hypertension guidelines.

Measures of adherence to hypertension guidelines have historically been based on prescription data or physician survey data regarding treatment practices. These methods have limitations that decrease their accuracy. As part of a randomized controlled study testing the effects of pharmacist/physician collaboration on adherence to hypertension guidelines, the investigators and an expert panel developed a JNC 7 measurement tool. The final guideline adherence measurement tool includes 22 explicit criteria in four domains of care. An exploratory factor analysis, conducted to assess the structure of the tool, suggests three underlying treatment dimensions in hypertension care. The adherence measurement tool will allow researchers to link specific elements of care to improved blood pressure control. In addition, use of the tool will provide clinicians with a taxonomy for evaluating practice and describing the effect of improved patient care on patient outcomes.

Reduced quality of life in veterans at risk for drug-related problems.

The relationships between drug therapy and health-related quality of life in 1054 patients who received care from Department of Veterans Affairs medical centers (VAMCs) were assessed. Patients at high risk for drug-related problems were enrolled into a pharmaceutical care study at nine VAMCs. On enrollment, the short form (SF)-36 was completed and medical records were examined for evidence of coexisting illness. Drug therapy in the year before enrollment was analyzed in relation to SF-36 scores. Mean +/- SD SF-36 scores ranged from 37.99+/-41.70 for role physical to 70.78+/-18.97 for mental health domains, with all domain scores significantly below age-adjusted national norms (p<0.05). Patients taking a drug that required therapeutic monitoring had significantly lower SF-36 scores (p=0.0001 to p=0.0033) across all domains except for bodily pain and mental health, compared with patients not taking these agents.

The cue-availability paradigm: the effects of cigarette availability on cue reactivity in smokers.

Researchers have hypothesized that drug availability should influence addicts' reactions to drug-related stimuli, but manipulations of the extent to which drug users have access to their drugs following a session of exposure to drug cues have not produced strong availability effects. This study used within-session manipulations of drug availability to examine cigarette smokers' reactions to smoking cues. Smokers (N = 60) were exposed to 48 trials of either a lit cigarette or a glass of water while they were informed of the probability (0%, 50%, or 100%) that they would be able to consume the cue on each trial. Results from measures of craving, mood, skin conductance, and latency to access the cues indicated that the trial-by-trial manipulation of drug availability had a pronounced impact on reactivity to cigarette cues.

Interpreting the findings of the IMPROVE study.

Various findings of the Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers (IMPROVE) study are reviewed. Suggestions for future methodologies that will enhance this study are discussed. The IMPROVE study is one of the largest pharmaceutical care studies conducted. Although it was an intervention study that examined global outcomes following management by pharmacists, it was designed as an effectiveness study. Several new practice and research methods were developed, including a method to identify patients at high risk for drug-related problems utilizing pharmacy databases, a method to identify chronic diseases using pharmacy databases, a method to evaluate the structure and process for delivering pharmaceutical care in Veterans Affairs medical centers (VAMCs), and guidelines for providing care to patients in the IMPROVE study. Nine VAMCs participated in the study, and 1054 patients were randomized to either an intervention group (n = 523) or a control group (n = 531). Pharmacists documented a total of 1855 contacts with the intervention group patients and made 3048 therapy-specific interventions over the 12-month study period. There was no meaningful difference in patient satisfaction or quality of life in the two groups. Selected disease-specific indicators found an improved rate of measurement of hemoglobin A1c tests and better control of total and low-density-lipoprotein (LDL) cholesterol levels in the intervention group compared with the control group. Total health care costs increased in both groups over the 12-month period. The mean increase in costs in the intervention group was $1020, which was lower than the control group's value of $1313. The lessons learned from the IMPROVE study suggest to future investigators how to study and measure the effects of clinical pharmacy services on patient outcome.

Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems?

BACKGROUND: An objective of pharmaceutical care is for pharmacists to improve patients' health-related quality of life (HRQOL) by optimizing medication therapy. OBJECTIVES: The objective of this study was to determine whether ambulatory care clinical pharmacists could affect HRQOL in veterans who were likely to experience a drug-related problem. RESEARCH DESIGN: This was a 9-site, randomized, controlled trial involving Veterans Affairs Medical Centers (VAMCs). Patients were eligible if they met > or = 3 criteria for being at high risk for drug-related problems. Enrolled patients were randomized to either usual medical care or usual medical care plus clinical pharmacist interventions. HRQOL was measured with the SF-36 questionnaire administered at baseline and at 6 and 12 months. RESULTS: In total, 1,054 patients were enrolled; 523 were randomized to intervention, and 531 to control. After patient age, site, and chronic disease score were controlled for, the only domain that was significantly different between groups over time was the bodily pain scale, which converged to similar values at the end of the study. Patients' rating of the change in health status in the past 12 months was statistically different between groups, intervention patients declining less (-2.4 units) than control subjects (-6.3 units) (P < 0.004). This difference was not considered clinically meaningful. However, a dose-response relationship was observed for general health perceptions (P = 0.004), vitality (P = 0.006), and change in health over the past year (P = 0.007). CONCLUSIONS: These results suggest that clinical pharmacists had no significant impact on HRQOL as measured by the SF-36 for veterans at high risk for medication-related problems.

Clinical and economic impact of ambulatory care clinical pharmacists in management of dyslipidemia in older adults: the IMPROVE study. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers. This was a randomized, controlled trial involving patients at high risk of drug-related problems. Only those with dyslipidemia are reported here. In addition to usual medical care, clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group. The control group did not receive pharmaceutical care. Seventy-two percent of the intervention group and 70% of controls required secondary prevention according to the National Cholesterol Education Program guidelines. Significantly more patients in the intervention group had a fasting lipid profile compared with controls (p=0.021). The absolute change in total cholesterol (17.7 vs 7.4 mg/dl, p=0.028) and low-density lipoprotein (23.4 vs 12.8 mg/dl, p=0.042) was greater in the intervention than in the control group. There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists. Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting designed to manage many medical and drug-related problems.

An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: the IMPROVE study. Impact of Managed Pharmaceutical Care Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

STUDY OBJECTIVE: To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high-risk population. DESIGN: Prospective, randomized, controlled study. SETTING: Nine Veterans Affairs medical centers. PATIENTS: Patients who were at high risk for medication-related problems. INTERVENTION: Patients were randomized to usual medical care with input from a clinical pharmacist (intervention group) or just usual medical care (control group). MEASUREMENTS AND MAIN RESULTS: Of 1,054 patients enrolled, 523 were randomized to the intervention group and 531 to the control group. The number of clinic visits increased in the intervention group (p=0.003), but there was no difference in clinic costs. Mean increases in total health care costs were $1,020 for the intervention group and $1,313 for the control group (p=0.06). CONCLUSION: Including the cost of pharmacist interventions, overall health care expenditures were similar for patients randomized to see a clinical pharmacist versus usual medical care.

Clinical pharmacy in disease-specific clinics.

The literature that describes and evaluates clinical pharmacy services in disease-specific clinics is briefly reviewed. Various evaluation techniques are discussed, highlighting examples of sites using these techniques in published studies. The evaluation of clinical pharmacy services has evolved from examining a single parameter such as disease outcome to examining the broader perspective of the value of clinical pharmacists in the health care system, taking into account structure and process as well as outcomes. Assessment tools should consider all of these aspects to satisfactorily evaluate the value of clinical pharmacists in clinics.

Challenges in the manipulation, assessment and interpretation of craving relevant variables.

The nature of drug craving and its role in the addictive process is a contentious issue in the addiction sciences. There are numerous disputes regarding the definition, assessment, manipulation and interpretation of craving, and progress toward resolving the enigmas of craving confronts numerous conceptual and methodological challenges. Greater attention to certain fundamental principles of measurement and manipulation should generate immediate and substantial improvements in efforts to understand and control alcohol craving. This paper provides suggestions for enhancing the measurement of self-reported alcohol craving and improving the manipulation of alcohol craving under controlled laboratory conditions. With regard to measurement, single-item scales commonly employed in craving research tend to be handicapped by limited reliability and validity. Multi-item craving scales are more likely to provide the accuracy required to accurately discriminate between different levels of craving across individuals or across different settings. Conceptual and practical considerations for the selection of multi-item craving instruments are discussed. With regard to the manipulation of alcohol craving in the laboratory, recent meta-analyses suggest that alcohol craving effects in such research may be relatively weaker than craving effects found in similar research with other addicts. Therefore, laboratory-based investigations into the nature of alcohol craving should utilize procedures and assessments that are particularly sensitive to the detection of alcohol craving. This paper offers methodological recommendations for enhancing the magnitude of alcohol craving effects generated in laboratory research.

Associative and non-associative fentanyl tolerance in the rat: evaluation of cross tolerance with mu-and kappa-specific opioids.

RATIONALE: Associative tolerance to the analgesic effects of morphine is most pronounced when morphine is paired with a distinctive context at a long interdose interval (IDI). In contrast, morphine administered at a short IDI promotes the development of non-associative tolerance and disrupts the acquisition of associative tolerance. The impact of IDI on the development of associative tolerance to opioids other than morphine has not been investigated previously. OBJECTIVES: This research examined associative and non-associative tolerance to the analgesic effects of fentanyl in rats. Cross tolerance for these two forms of tolerance with morphine (mureceptor agonist) and U50,488H (kappa-receptor agonist) analgesia was also investigated. METHODS: Animals were given eight fentanyl injections (0.10 mg/kg) paired or unpaired with a distinctive context at either a 3-h (short) or 96-h (long) IDI. Subjects were then tested for tolerance in the distinctive context using the tail-flick procedure and dose-response curve methodology. RESULTS: At the short IDI, animals developed non-associative tolerance to fentanyl that was receptor specific, i.e., cross tolerant with morphine analgesia but not with U50,488H analgesia. At the long IDI, fentanyl-tested animals displayed tolerance that appeared to be controlled primarily by associative processes. This associative form of tolerance was also receptor specific, displaying cross tolerance with morphine but not with U50,488H. CONCLUSIONS: The impact of IDI on the development of non-associative and associative fentanyl tolerance is consistent with findings obtained with morphine showing that conditions conducive to the development of non-associative tolerance disrupt the acquisition of associative tolerance. The cross-tolerance data, however, did not parallel previous research examining the cross-tolerance profiles of associative and non-associative morphine tolerance.

The relationship between drug therapy noncompliance and patient characteristics, health-related quality of life, and health care costs.

The objectives of this study were to determine the relationship between drug therapy compliance and risk of hospitalization and economic outcomes, and to identify potential indicators of compliance. We used computerized prescription records from 1,054 patients at high risk for drug-related problems. We calculated a compliance ratio for a 12-month period and correlated it with health care use, demographic variables, drug-related variables, and scores for health-related quality of life. Univariate results suggested that increased age (p=0.05), high number of chronic conditions (p<0.001), and high number of concurrent drugs (p<0.001) were positively correlated with compliance. That is, increased values for these variables were associated with better compliance. Using logistic regression, the odds of being noncompliant was 0.665 as the number of chronic conditions increased. Compliance was not a predictor of concurrent or future hospitalizations or mortality, nor was it a significant predictor of health care costs.

Ambulatory care pharmacy services: has the agenda changed?

OBJECTIVE: To provide an extensive review of ambulatory care clinical pharmacy services and evaluate the services and research data in the field. DATA SOURCES: MEDLINE was searched from January 1992 through July 1999. Search terms included pharmacy, clinical pharmacy, and pharmaceutical care, cross-referenced with ambulatory care, primary care, family medicine, and managed care. STUDY SELECTION: Relevant peer-reviewed studies and reports since our previous article in 1992 were selected and described. Literature prior to 1992 was briefly reviewed. DATA SYNTHESIS: The relevant literature was reviewed and some examples from the authors' institutions are provided. Much research has continued to be published documenting the value of clinical pharmacy services in ambulatory care, including in community pharmacy, anticoagulation services, family medicine, primary care clinics, Veterans Affairs Medical Centers, and managed care. However, these innovative services are underrepresented in the community at large. The vast majority of the public does not have access to these types of services. CONCLUSIONS: There will be continued and dramatic expansion of ambulatory care pharmacy services in the new decade beginning in the year 2000. It will be critical that standards of practice be very high. We believe there is a critical need for visible demonstration projects and large multicenter research projects that demonstrate the value of these services.

Types of interventions made by clinical pharmacists in the IMPROVE study. Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers.

The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug-related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug-related problems addressed and resolved during each contact. Seventy-eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 +/- 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In-person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug-related problems addressed and resolved were 1.64 +/- 1.16 and 1.14 +/- 0.98, respectively. More drug-related problems were addressed and resolved when visits were 15 minutes or longer (p=0.001) and when the contact was in person (p=0.001). These data may provide information to clinical pharmacists developing pharmacy-managed clinics for patients at high risk for drug-related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.

Assessing the structure and process for providing pharmaceutical care in Veterans Affairs medical centers.

The structure and process used in providing pharmaceutical care to ambulatory care patients at nine Veterans Affairs medical centers (VAMCs) were studied. Institutions participating in the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study were selected. To assess the level of pharmaceutical care services provided to ambulatory care patients, 10 critical domains were identified. Six instruments with questions related to each domain were then designed, including a clinical pharmacist survey and an outpatient pharmacist survey. Each center was assessed through three surveys and an onsite visit. The investigators used both direct observation and a consensus approach to score the level of ambulatory care pharmaceutical services provided. The clinics in which IMPROVE study patients would be seen were run by pharmacists (33%), physicians (44%), and multidisciplinary teams (22%). Of the 51 clinical pharmacists surveyed, 23 (45%) had prescribing authority via protocols, 14 (28%) had unrestricted prescribing privileges, and 14 did not have prescribing authority. The sites varied greatly in referral patterns, methods of identifying patients, and whether patient visits were scheduled or on a walk-in basis. There was a strong correlation between observed activities by clinical pharmacists and their self-reports and between observed activities by outpatient pharmacists and their self-reports. Activities reported by clinical pharmacists were moderately but not significantly correlated with consensus scores, and activities reported by outpatient pharmacists were poorly correlated with consensus scores. The structure and process for providing pharmaceutical care to ambulatory care patients at VAMCs were evaluated with surveys, direct observation, and a consensus-based scoring system.

Meta-analysis of cue-reactivity in addiction research.

AIMS: The cue-reactivity procedure exposes addicts to a variety of drug-related stimuli while self-report of craving and physiological responses are monitored. The present review sought to determine the magnitude and overall pattern of responses typically found in cue-reactivity research and which, if any, learning-based model of cue reactivity is best supported by the findings. DESIGN: Meta-analytical techniques were used to select and evaluate results from 41 cue-reactivity studies that compared responses of alcoholics, cigarette smokers, cocaine addicts or heroin addicts to drug-related versus neutral stimuli. Effect sizes were calculated, separately by addict type, for self-report of craving and physiological responses (heart rate, sweat gland activity and skin temperature). FINDINGS: Across all addict groups, the effect size for craving was +0.92. Alcoholics had a significantly smaller craving effect size (+0.53) compared to other addict groups (+1.18 to +1.29). Relatively smaller effect sizes were found for physiological responses. The general profile of effect sizes across all addict groups was increased heart rate (+0.26) and sweat gland activity (+0.40) and decreased skin temperature (-0.24) when addicts were presented with drug-related stimuli. CONCLUSIONS: The cue-reactivity paradigm can produce a stable profile of significant effects and, therefore, has a number of potential applications for investigating addictive phenomena. The implications of these findings for conditioning-based models of cue-reactivity phenomena are discussed.