Lisa Dolovich

Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies.

Abstract Objective: To determine if exposure to benzodiazepines during the first trimester of pregnancy increases risk of major malformations or cleft lip or palate. Design Meta-analysis. Setting: Studies from 1966 to present. Subjects: Studies were located with Medline, Embase, Reprotox, and from references of textbooks, reviews, and included articles. Included studies were original, concurrently controlled studies in any language. Interventions:Data extraction and quality assessment were done independently and in duplicate. Main outcome measures: Maternal exposure to benzodiazepines in at least the first trimester; incidence of major malformations or oral cleft alone, measured as odds ratios and 95% confidence intervals with a random effects model. Results:Of over 1400 studies reviewed, 74 were retrieved and 23 included. In the analysis of cohort studies fetal exposure to benzodiazepine was not associated with major malformations (odds ratio 0.90; 95% confidence interval 0.61 to 1.35) or oral cleft (1.19; 0.34 to 4.15). Analysis of case-control studies showed an association between exposure to benzodiazepines and development of major malformations (3.01; 1.32 to 6.84) or oral cleft alone (1.79; 1.13 to 2.82). Conclusions:Pooled data from cohort studies showed no association between fetal exposure to benzodiazepines and the risk of major malformations or oral cleft. On the basis of pooled data from case-control studies, however, there was a significant increased risk for major malformations or oral cleft alone. Until more research is reported, level 2 ultrasonography should be used to rule out visible forms of cleft lip.

Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial

Background: Diabetes mellitus is a complex disease with serious complications. Electronic decision support, providing information that is shared and discussed by both patient and physician, encourages timely interventions and may improve the management of this chronic disease. However, it has rarely been tested in community-based primary care. Methods: In this pragmatic randomized trial, we randomly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care. The intervention involved shared access by the primary care provider and the patient to a Web-based, colour-coded diabetes tracker, which provided sequential monitoring values for 13 diabetes risk factors, their respective targets and brief, prioritized messages of advice. The primary outcome measure was a process composite score. Secondary outcomes included clinical composite scores, quality of life, continuity of care and usability. The outcome assessors were blinded to each patient’s intervention status. Results: We recruited sequentially 46 primary care providers and then 511 of their patients (mean age 60.7 [standard deviation 12.5] years). Mean follow-up was 5.9 months. The process composite score was significantly better for patients in the intervention group than for control patients (difference 1.27, 95% confidence interval [CI] 0.79–1.75, p < 0.001); 61.7% (156/253) of patients in the intervention group, compared with 42.6% (110/258) of control patients, showed improvement (difference 19.1%, p < 0.001). The clinical composite score also had significantly more variables with improvement for the intervention group (0.59, 95% CI 0.09–1.10, p = 0.02), including significantly greater declines in blood pressure (−3.95 mm Hg systolic and −2.38 mm Hg diastolic) and glycated hemoglobin (−0.2%). Patients in the intervention group reported greater satisfaction with their diabetes care. Interpretation: A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care. (ClinicalTrials.gov trial register no. NCT00813085.)

The Cameroon Mobile Phone SMS (CAMPS) Trial: A Randomized Trial of Text Messaging versus Usual Care for Adherence to Antiretroviral Therapy

Background Mobile phone technology is a novel way of delivering health care and improving health outcomes. This trial investigates the use of motivational mobile phone text messages (SMS) to improve adherence to antiretroviral therapy (ART) over six months. Methodology/Principal Findings CAMPS was a single-site randomized two-arm parallel design trial in Yaoundé, Cameroon. We enrolled and randomized HIV-positive adults on ART, aged 21 years and above to receive a weekly standardized motivational text message versus usual care alone. The primary outcome was adherence measured using a visual analogue scale (VAS), number of doses missed (in the week preceding the interview) and pharmacy refill data. Outcomes were measured at 3 and 6 months. Service providers and outcome assessors were blinded to allocation. Analysis was by intention-to-treat. Between November and December 2010, 200 participants were randomized, with 101 in the intervention group and 99 in the control group. At 6 months, overall retention was 81.5%. We found no significant effect on adherence by VAS>95% (risk ratio [RR] 1.06, 95% confidence interval [CI] 0.89, 1.29; p = 0.542; reported missed doses (RR 1.01, 95% CI 0.87, 1.16; p>0.999) or number of pharmacy refills (mean difference [MD] 0.1, 95% CI: 0.23, 0.43; p = 0.617. One participant in the intervention arm reported a possible disclosure of status. Conclusions/Significance Standardized motivational mobile phone text messages did not significantly improve adherence to ART in this study. Other types of messaging or longer term studies are recommended. Registration 1. Pan-African Clinical Trials Registry; PACTR201011000261458 2. Clinicaltrials.gov; NCT01247181

Patient adherence to osteoporosis medications: problems, consequences and management strategies.

Adherence to osteoporosis medications is relatively poor. Approximately 20–30% of patients taking daily or weekly treatments may suspend their treatment within 6 to 12 months of initiating therapy. Patients with poor adherence increase their risk of osteoporotic fractures and hospitalisation. The majority of patients who discontinue therapy appear to do so because of drug-induced adverse effects. Fear of adverse effects or other health risks is another commonly cited reason for discontinuing therapy. Factors associated with medication adherence include fractures, regular exercise, female sex, fewer non-osteoporosis medications and co-morbidities, early menopause, willingness to take medications, awareness of osteoporosis status based on a diagnostic test, anti-inflammatory therapy and corticosteroid therapy. Factors associated with non-adherence include adverse effects, pain and being unsure about bone mineral density (BMD) test results. Bisphosphonates, a common class of drugs for treating osteoporosis, have specific administration requirements (e.g. fasting, remaining upright and not ingesting other medications concomitantly). Patient surveys indicate that 12–18% of patients report non-compliance with at least one administration rule. Strategies to increase adherence include reducing administration frequency to weekly or monthly, monitoring patients with bone markers and BMD testing, providing adequate instructions, practitioner feedback and support, and educational materials and sessions. Future studies are needed regarding strategies to increase adherence to osteoporosis medications.

Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP)

Objective To evaluate the effectiveness of the community based Cardiovascular Health Awareness Program (CHAP) on morbidity from cardiovascular disease. Design Community cluster randomised trial. Setting 39 mid-sized communities in Ontario, Canada, stratified by location and population size. Participants Community dwelling residents aged 65 years or over, family physicians, pharmacists, volunteers, community nurses, and local lead organisations. Intervention Communities were randomised to receive CHAP (n=20) or no intervention (n=19). In CHAP communities, residents aged 65 or over were invited to attend volunteer run cardiovascular risk assessment and education sessions held in community based pharmacies over a 10 week period; automated blood pressure readings and self reported risk factor data were collected and shared with participants and their family physicians and pharmacists. Main outcome measure Composite of hospital admissions for acute myocardial infarction, stroke, and congestive heart failure among all community residents aged 65 and over in the year before compared with the year after implementation of CHAP. Results All 20 intervention communities successfully implemented CHAP. A total of 1265 three hour long sessions were held in 129/145 (89%) pharmacies during the 10 week programme. 15 889 unique participants had a total of 27 358 cardiovascular assessments with the assistance of 577 peer volunteers. After adjustment for hospital admission rates in the year before the intervention, CHAP was associated with a 9% relative reduction in the composite end point (rate ratio 0.91, 95% confidence interval 0.86 to 0.97; P=0.002) or 3.02 fewer annual hospital admissions for cardiovascular disease per 1000 people aged 65 and over. Statistically significant reductions favouring the intervention communities were seen in hospital admissions for acute myocardial infarction (rate ratio 0.87, 0.79 to 0.97; P=0.008) and congestive heart failure (0.90, 0.81 to 0.99; P=0.029) but not for stroke (0.99, 0.88 to 1.12; P=0.89). Conclusions A collaborative, multi-pronged, community based health promotion and prevention programme targeted at older adults can reduce cardiovascular morbidity at the population level. Trial registration Current controlled trials ISRCTN50550004.

Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics

The prevalence of suboptimal prescribing of medications is well documented. 1 , 2 Patients are often undertreated or not offered therapeutic treatments that are likely to confer benefit. 3 , 4 As a result, drug‐related hospital admissions are common and often preventable. 5 Improvements to the health‐care system are clearly needed in order to maximize the benefits that can be derived from medications. Many countries are changing their primary health‐care systems to improve the quality of health‐care delivery. 6 , 7 One main transformation is the use of multidisciplinary care teams to provide care in a coordinated manner often from the same location or by using the common medical record of the patients. It has been demonstrated that pharmacists can improve prescribing, reduce health‐care utilization and medication costs, and contribute to clinical improvements in many chronic medical conditions, such as cardiovascular disease, diabetes, and psychiatric illness. 8 , 9 , 10 , 11 However, the effect of integrating a pharmacist providing general services into a primary care group has not been extensively studied. The Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics (IMPACT) project was designed to provide a real‐world demonstration of the feasibility of integrating the pharmacist into primary care office practice. This article provides a description of the IMPACT project participants; the IMPACT practice model and the concepts incorporated in its development; some initial results from the program evaluation; sustainability of the model; and some reflections on the implementation of the practice model.

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials

Objectives Our objectives were to analyse the effects of text messaging versus usual care in improving adherence to antiretroviral therapy (ART) in people living with HIV using individual patient data meta-analysis. Adjusted, sensitivity and subgroup analyses were conducted. Setting 3 randomised controlled trials conducted between 2010 and 2012 in rural and urban centres in Cameroon and Kenya (two studies) were used. Participants A total of 1166 participants were included in this analysis (Cameroon=200; Kenya=428 and 538). Primary and secondary outcomes The primary outcome was adherence to ART >95%. The secondary outcomes were mortality, losses to follow-up, transfers and withdrawals. Results Text messaging improved adherence to ART (OR 1.38; 95% CIs 1.08 to 1.78; p=0.012), even after adjustment for baseline covariates (OR 1.46; 95% CI 1.13 to 1.88; p=0.004). Primary education (compared with no formal education) was associated with a greater intervention effect on adherence (OR 1.65; 95% CI 1.10 to 2.48; p=0.016) and also showed a significant subgroup effect (p=0.039). In sensitivity analysis, our findings were robust to a modified threshold of adherence, multiple imputation for missing data and aggregate level data pooling, but not to fixed-effects meta-analyses using generalised estimation equations. There was a significant subgroup effect for long weekly (p=0.037), short weekly text messages (p=0.014) and interactive messaging (p=0.010). Text messaging did not significantly affect any of the secondary outcomes. Conclusions Text messaging has a significant effect on adherence to ART, and this effect is influenced by level of education, gender, timing (weekly vs daily) and interactivity. We recommend the use of interactive weekly text messaging to improve adherence to ART, which is most effective in those with at least a primary level of education.

Pain Management Decision Making Among Long-Term Care Physicians and Nurses

The purpose of this study is to explore attitudes and beliefs that affect decisions about prescribing and administering pain medications in older adults who live in long-term care (LTC), with a particular emphasis on those with cognitive impairment. At each of the four participating LTC facilities, data were gathered from three separate groups of health care professionals: physicians, registered nurses, and registered practical nurses. Based on grounded theory, a model was developed that highlighted critical decision points for nurses and physicians regarding pain management. The major themes that emerged from the data concerned pain assessment (lack of recognition of pain, uncertainty about the accuracy of pain assessment and diagnosis) and treatment (reluctance to use opioids, working to individualize pain treatments, issues relating to physician trust of the nurse on prescribing patterns). These findings may facilitate the development of innovative approaches to pain management in LTC settings.

The effectiveness of integrated health information technologies across the phases of medication management: a systematic review of randomized controlled trials.

OBJECTIVE The US Agency for Healthcare Research and Quality funded an evidence report to address seven questions on multiple aspects of the effectiveness of medication management information technology (MMIT) and its components (prescribing, order communication, dispensing, administering, and monitoring). MATERIALS AND METHODS Medline and 11 other databases without language or date limitations to mid-2010. Randomized controlled trials (RCTs) assessing integrated MMIT were selected by two independent reviewers. Reviewers assessed study quality and extracted data. Senior staff checked accuracy. RESULTS Most of the 87 RCTs focused on clinical decision support and computerized provider order entry systems, were performed in hospitals and clinics, included primarily physicians and sometimes nurses but not other health professionals, and studied process changes related to prescribing and monitoring medication. Processes of care improved for prescribing and monitoring mostly in hospital settings, but the few studies measuring clinical outcomes showed small or no improvements. Studies were performed most frequently in the USA (n=63), Europe (n=16), and Canada (n=6). DISCUSSION Many studies had limited description of systems, installations, institutions, and targets of the intervention. Problems with methods and analyses were also found. Few studies addressed order communication, dispensing, or administering, non-physician prescribers or pharmacists and their MMIT tools, or patients and caregivers. Other study methods are also needed to completely understand the effects of MMIT. CONCLUSIONS Almost half of MMIT interventions improved the process of care, but few studies measured clinical outcomes. This large body of literature, although instructive, is not uniformly distributed across settings, people, medication phases, or outcomes.

Bupropion versus Selective Serotonin-Reuptake Inhibitors for Treatment of Depression

OBJECTIVE: To compare the benefits and risks of bupropion and selective serotonin-reuptake inhibitors (SSRIs) in adults with depression. DATA SOURCES: MEDLINE (1966–September 1999), Embase (1980–August 1999), PsycINFO (1887–August 1999), International Pharmaceutical Abstracts (1970–August 1999), and CIANHL databases were searched. References from the selected citations, review articles, and the manufacturer were also screened. STUDY SELECTION: Included studies were randomized, double-blind, controlled trials evaluating bupropion versus SSRIs for depression in adults. Studies were assessed independently in duplicate. Discrepancies were resolved by consensus. DATA ANALYSIS: Data are reported as absolute weighted mean differences or relative risks and 95% confidence intervals comparing bupropion relative to SSRIs. Data not combined are presented qualitatively. DATA SYNTHESIS: Six full-length studies were included of 257 citations identified. SSRI comparators were fluoxetine, sertraline, and paroxetine. No differences in Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions Scale for Improvement of Illness (CGI-I) were found, but data were not able to be quantitatively combined. The absolute weighted mean differences were 0.10 (95% CI −0.2 to 0.4) for the CGI for Severity of Illness and 0.37 (95% CI −0.85 to 1.6) for the Hamilton Rating Scale for Anxiety measurements. Relative risks of bupropion compared with SSRIs were 0.6 (95% CI 0.41 to 0.89), 0.31 (95% CI 0.16 to 0.57), and 0.27 (95% CI 0.15 to 0.48) for nausea, diarrhea, and somnolence, respectively. Sexual arousal disorder, orgasmic dysfunction, and sexual desire disorder occurred less with bupropion than with SSRIs, with relative risks of 0.46 (95% CI 0.26 to 0.83), 0.22 (95% CI 0.12 to 0.40), and 0.65 (95% CI 0.51 to 0.84), respectively. CONCLUSIONS: Bupropion and SSRIs have similar effectiveness; however, bupropion was associated with less nausea, diarrhea, somnolence, and sexual dysfunction.