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What do pri mary care pa tients think about ge neric drugs? Ab stract. Ob jec tive: To ex am ine the at titude of pa tients to wards ge neric drugs and pre scriptions con tain ing ge neric drugs as an al ter na tive to brand-name prod ucts, with a spe cial fo cus on in for ma tion on pa tients at titude to ge neric drugs pro vided by their general prac ti tio ners (GPs). Meth ods: A to tal of 804 pa tients in 31 gen eral prac tices were surveyed us ing a self-ques tion naire. The in fluence of age, sex, ed u ca tion, dis ease, knowledge of ge neric drugs, ex pe ri ence with generic sub sti tu tion and in for ma tion pro vided by the GP on pa tient at ti tudes to wards ge neric drugs and sub sti tu tions were ex am ined. Results: Nearly two thirds of the pa tients (509/804) stated that they knew of the dif ference be tween brand-name drugs and generics; of these, one third were not sat is fied with the in for ma tion given by their GPs and 37% of pa tients ex pressed gen eral skep ti cism to wards ge neric drugs be cause of their lower price. This at ti tude was more fre quent among those who felt that ge neric pre scrib ing was "in vented" to solve the fi nan cial cri sis in the Ger man health in sur ance sys tem at their expense (odds ra tio (OR): 6.2; 95% con fi dence in ter val: 4.0-9.8) and those who had not been con fronted per son ally with a ge neric sub sti tu tion (OR: 1.8; 1.3-3.0). Pa tients who had been skep ti cal when first con fronted with a ge neric sub sti tu tion were more fre quently among those who con sid ered in ex pen sive drugs to be in fe rior (OR: 4.5; 2.0-10.4) and they were fre quently not sat is fied with the infor ma tion on sub sti tu tion pro vided by their GP (OR: 2.7; 1.2-5.9). Con clu sion: GPs are in an ideal po si tion to in form their pa tients ade quately about the equiv a lence of brandname and ge neric drugs. How ever, the pa tient view that in ex pen sive drugs must be in fe rior may be dif fi cult to rec tify in the short term. Key words ge neric drugs-prescriptions-cost-ef fec tive ness-in for ma tion on drug ther apy-fam ily prac tice Re ceived De cem ber 8, 2004; ac cepted

BackgroundHypertension is one of the key factors causing cardiovascular diseases. A substantial proportion of treated hypertensive patients do not reach recommended target blood pressure values. Shared decision making (SDM) is to enhance the active role of patients. As until now there exists little information on the effects of SDM training in antihypertensive therapy, we tested the effect of an SDM training programme for general practitioners (GPs). Our hypotheses are that this SDM training (1) enhances the participation of patients and (2) leads to an enhanced decrease in blood pressure (BP) values, compared to patients receiving usual care without prior SDM training for GPs.MethodsThe study was conducted as a cluster randomised controlled trial (cRCT) with GP practices in Southwest Germany. Each GP practice included patients with treated but uncontrolled hypertension and/or with relevant comorbidity. After baseline assessment (T0) GP practices were randomly allocated into an intervention and a control arm. GPs of the intervention group took part in the SDM training. GPs of the control group treated their patients as usual. The intervention was blinded to the patients. Primary endpoints on patient level were (1) change of patients’ perceived participation (SDM-Q-9) and (2) change of systolic BP (24h-mean). Secondary endpoints were changes of (1) diastolic BP (24h-mean), (2) patients’ knowledge about hypertension, (3) adherence (MARS-D), and (4) cardiovascular risk score (CVR).ResultsIn total 1357 patients from 36 general practices were screened for blood pressure control by ambulatory blood pressure monitoring (ABPM). Thereof 1120 patients remained in the study because of uncontrolled (but treated) hypertension and/or a relevant comorbidity. At T0 the intervention group involved 17 GP practices with 552 patients and the control group 19 GP practices with 568 patients. The effectiveness analysis could not demonstrate a significant or relevant effect of the SDM training on any of the endpoints.ConclusionThe study hypothesis that the SDM training enhanced patients’ perceived participation and lowered their BP could not be confirmed. Further research is needed to examine the impact of patient participation on the treatment of hypertension in primary care.Trial registrationGerman Clinical Trials Register (DRKS): DRKS00000125

Although network-based recruitment of GPs increases participation rates, sample effects are similar in size and direction as effects of non-participation in the regionally defined population. Careful analysis of participants based on publicly available data is therefore crucial for the assessment of generalizability.

When registering Traditional Herbal Medicinal Products the criterion of evidence-based medicine will only be met if all the facts available are assessed and evaluated, over and above the formally stipulated regulatory provisions (30 years, product reference). To this end, the scientific methods (from among the natural, life or cultural sciences), which are recognized as authoritative in each case, must be applied.