Bmc Fam Pract
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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) - study protocol for a pragmatic randomized controlled trial.
Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information leaflet with standard information on risk factors for side effects. ⋯ Despite extensive evidence of risk factors for adverse drug reactions, there are few prospective trial data about an individualized risk assessment including pharmacogenetic information to increase patient safety. By conducting a health economic analysis, we will evaluate if the application of an individualized drug therapy in daily routine is cost-effective.
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A prerequisite for early lung cancer diagnosis is that individuals with respiratory alarm symptoms (RAS) contact a general practitioner (GP). This study aims to determine the proportion of individuals in the general population who contact a GP with RAS and to analyse the association between lifestyle factors and contact to GPs with RAS. ⋯ Among individuals with RAS, less than one-half contacted a GP. Gender, age, smoking status, and alcohol intake significantly influenced whether individuals with RAS contacted a GP.
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Pragmatic Clinical Trial
Using theory to improve low back pain care in Australian Aboriginal primary care: a mixed method single cohort pilot study.
Low back pain (LBP) care is frequently discordant with research evidence. This pilot study evaluated changes in LBP care following a systematic, theory informed intervention in a rural Australian Aboriginal Health Service. We aimed to improve three aspects of care; reduce inappropriate LBP radiological imaging referrals, increase psychosocial oriented patient assessment and, increase the provision of LBP self-management information to patients. ⋯ A systematic intervention model resulted in partial improvements in LBP care. Determinants of practice change amongst GPs were increased knowledge of clinical guidelines, education delivered by someone considered a trusted source of information, and awareness of the negative consequences of inappropriate practices, especially radiological imaging on patient outcomes. Inconsistent and non-evidence based practices amongst locum GPs was an issue that emerged and will be a significant future challenge. The systematic approach utilised is applicable to other services interested in improving LBP care.
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The practice of clinical medicine rests on a foundation of ethical principles as well as scientific knowledge. Clinicians must artfully balance the principle of beneficence, doing what is best for patients, with autonomy, allowing patients to make their own well-informed health care decisions. The clinical communication process is complicated by varying degrees of confidence in scientific evidence regarding patient-oriented benefits, and by the fact that most medical options are associated with possible harms as well as potential benefits. ⋯ Whether or not the overall benefit-harm balance justifies the use of a medication for an individual patient cannot be determined by a guidelines committee, a health care system, or even the attending physician. Instead, it is the individual patient who has a fundamental right to decide whether or not taking a drug is worthwhile. Researchers and professional organizations should endeavor to develop shared decision-making tools that provide up-to-date best evidence in easily understandable formats, so as to assist clinicians in helping their patients to make the decisions that are right for them.