Mix of methods is needed to identify adverse events in general practice: A prospective observational study

Contains fulltext : 69425.pdf ( ) (Open Access)BACKGROUND: The validity and usefulness of incident reporting and other methods for identifying adverse events remains unclear. This study aimed to compare five methods in general practice. METHODS: In a prospective observational study, with five general practitioners, five methods were applied and compared. The five methods were physician reported adverse events, pharmacist reported adverse events, patients' experiences of adverse events, assessment of a random sample of medical records, and assessment of all deceased patients. RESULTS: A total of 68 events were identified using these methods. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. No overlap between the methods was detected. The patient survey accounted for the highest number of events and the pharmacist reports for the lowest number. CONCLUSION: A mix of methods is needed to identify adverse events in general practice

A review of significant events analysed in general practice: implications for the quality and safety of patient care

<p>Abstract</p> <p>Background</p> <p>Significant event analysis (SEA) is promoted as a team-based approach to enhancing patient safety through reflective learning. Evidence of SEA participation is required for appraisal and contractual purposes in UK general practice. A voluntary educational model in the west of Scotland enables general practitioners (GPs) and doctors-in-training to submit SEA reports for feedback from trained peers. We reviewed reports to identify the range of safety issues analysed, learning needs raised and actions taken by GP teams.</p> <p>Method</p> <p>Content analysis of SEA reports submitted in an 18 month period between 2005 and 2007.</p> <p>Results</p> <p>191 SEA reports were reviewed. 48 described patient harm (25.1%). A further 109 reports (57.1%) outlined circumstances that had the potential to cause patient harm. Individual 'error' was cited as the most common reason for event occurrence (32.5%). Learning opportunities were identified in 182 reports (95.3%) but were often non-specific professional issues not shared with the wider practice team. 154 SEA reports (80.1%) described actions taken to improve practice systems or professional behaviour. However, non-medical staff were less likely to be involved in the changes resulting from event analyses describing patient harm (p < 0.05)</p> <p>Conclusion</p> <p>The study provides some evidence of the potential of SEA to improve healthcare quality and safety. If applied rigorously, GP teams and doctors in training can use the technique to investigate and learn from a wide variety of quality issues including those resulting in patient harm. This leads to reported change but it is unclear if such improvement is sustained.</p

Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351]

<p>Abstract</p> <p>Background</p> <p>The efficacy and safety of a dietary supplement derived from South American botanicals was compared to glucosamine sulfate in osteoarthritis subjects in a Mumbai-based multi-center, randomized, double-blind study.</p> <p>Methods</p> <p>Subjects (n = 95) were screened and randomized to receive glucosamine sulfate (n = 47, 1500 mg/day) or reparagen (n = 48, 1800 mg/day), a polyherbal consisting of 300 mg of vincaria (<it>Uncaria guianensis</it>) and 1500 mg of RNI 249 (<it>Lepidium meyenii</it>) administered orally, twice daily. Primary efficacy variable was response rate based on a 20% improvement in WOMAC pain scores. Additional outcomes were WOMAC scores for pain, stiffness and function, visual analog score (VAS) for pain, with assessments at 1, 2, 4, 6 and 8 weeks. Tolerability, investigator and subject global assessments and rescue medication consumption (paracetamol) were measured together with safety assessments including vital signs and laboratory based assays.</p> <p>Results</p> <p>Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. Using related criteria response rates to reparagen were favorable when compared to glucosamine. Compared to baseline both treatments showed significant benefits in WOMAC and VAS outcomes within one week (P < 0.05), with a similar, progressive improvement over the course of the 8 week treatment protocol (45–62% reduction in WOMAC or VAS scores). Tolerability was excellent, no serious adverse events were noted and safety parameters were unchanged. Rescue medication use was significantly lower in the reparagen group (p < 0.01) at each assessment period. Serum IGF-1 levels were unaltered by treatments.</p> <p>Conclusion</p> <p>Both reparagen and glucosamine sulfate produced substantial improvements in pain, stiffness and function in subjects with osteoarthritis. Response rates were high and the safety profile was excellent, with significantly less rescue medication use with reparagen. Reparagen represents a new natural productive alternative in the management of joint health.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN25438351.</p

What do family physicians consider an error? A comparison of definitions and physician perception

BACKGROUND: Physicians are being asked to report errors from primary care, but little is known about how they apply the term "error." This study qualitatively assesses the relationship between the variety of error definitions found in the medical literature and physicians' assessments of whether an error occurred in a series of clinical scenarios. METHODS: A systematic literature review and pilot survey results were analyzed qualitatively to search for insights into what may affect the use of the term error. The National Library of Medicine was systematically searched for medical error definitions. Survey participants were a random sample of active members of the American Academy of Family Physicians (AAFP) and a selected sample of family physician patient safety "experts." A survey consisting of 5 clinical scenarios with problems (wrong test performed, abnormal result not followed-up, abnormal result overlooked, blood tube broken and missing scan results) was sent by mail to AAFP members and by e-mail to the experts. Physicians were asked to judge if an error occurred. A qualitative analysis was performed via "immersion and crystallization" of emergent insights from the collected data. RESULTS: While one definition, that originated by James Reason, predominated the literature search, we found 25 different definitions for error in the medical literature. Surveys were returned by 28.5% of 1000 AAFP members and 92% of 25 experts. Of the 5 scenarios, 100% felt overlooking an abnormal result was an error. For other scenarios there was less agreement (experts and AAFP members, respectively agreeing an error occurred): 100 and 87% when the wrong test was performed, 96 and 87% when an abnormal test was not followed up, 74 and 62% when scan results were not available during a patient visit, and 57 and 47% when a blood tube was broken. Through qualitative analysis, we found that three areas may affect how physicians make decisions about error: the process that occurred vs. the outcome that occurred, rare vs. common occurrences and system vs. individual responsibility CONCLUSION: There is a lack of consensus about what constitutes an error both in the medical literature and in decision making by family physicians. These potential areas of confusion need further study

Garlic for the common cold (2014 Review)

Garlic is popularly believed to be useful for the common cold. This belief is based on traditional use, and some laboratory evidence that garlic has antibacterial and antiviral properties. On average, adults have two to four common colds per year. The evidence is current to the 7 August 2014. Of the eight studies identified, only one fulfilled the criteria for the review. This study assessed 146 participants over a three-month period. Half the participants took a placebo tablet and half took a garlic tablet during this time. The participants then wrote in a diary when they had symptoms of a cold. The included study found that people who took garlic every day for three months (instead of a placebo) had fewer colds. That is, over the three-month period, there were 24 occurrences of the common cold in the garlic group, compared to 65 in the placebo group. When participants experienced a cold, the length of illness was similar in both groups (4.63 versus 5.63 days)

Regulatory authority and clinical acceptability: Physicians’ responses to regulatory drug safety warnings

Aim Medicines regulators issue post-market safety warnings to advise of newly uncovered risks, but with mixed impacts. We aimed to identify factors influencing the use of regulatory warnings by primary care and specialist physicians in the US and Australia. Methods Semi-structured qualitative interviews with 40 primary care physicians, endocrinologists, and other generalist specialists in Boston USA and Australia. Coding and analysis were carried out inductively and iteratively to identify and examine key factors. Analysis centred around four areas; physicians’ awareness of drug safety information, preferred information sources, opinion-forming, and sharing of information with patients. Results Uncertainty, trust, and clinical authority emerged as factors influencing use of advisories. Although regulators were trusted as authoritative institutions, they appeared to lack clinical authority, and physicians validated regulatory information against other trusted sources including evidence, expert opinion, and experience. Specialists became aware of drug safety issues through specialised literature, using evidence and clinical consensus to form opinions. Primary care physicians, fielding high volumes of information, relied on convenient, accessible information sources including the media and the ‘clinical grapevine’ for awareness, and on clinical colleagues, specialists, and experience for interpretation. Communicating risk to patients was complicated by uncertainty; physicians tailored information to patients’ health literacy and information needs. US physicians were more aware of their national regulator’s post-market safety role than Australian physicians of theirs. Conclusion Drug safety warnings may not be optimally received or used. Regulators should consider strategies that increase trust, clinical relevance, and accessibility, and address physicians’ needs in communicating risk to patients