ObjectiveMany treatment decisions are preference-sensitive and call for shared decision-making, notably when benefits are limited or uncertain, and harms impact quality of life. We explored if ...clinical practice guidelines (CPGs) acknowledge preference-sensitive decisions in how they motivate and phrase their recommendations.DesignWe performed a qualitative analysis of the content of CPGs and verified the results in semistructured interviews with CPG panel members.SettingDutch oncology CPGs issued in 2010 or later, concerning primary treatment with curative intent.Participants14 CPG panel members.Main outcomesFor treatment recommendations from six CPG modules, two researchers extracted the following: strength of recommendation in terms of the Grading of Recommendations Assessment, Development and Evaluation and its consistency with the CPG text; completeness of presentation of benefits and harms; incorporation of patient preferences; statements on the panel’s benefits–harm trade-off underlying recommendation; and advice on patient involvement in decision-making.ResultsWe identified 32 recommendations, 18 were acknowledged preference-sensitive decisions. Three of 14 strong recommendations should have been weak based on the module text. The reporting of benefits and harms, and their probabilities, was sufficiently complete and clear to inform the strength of the recommendation in one of the six modules only. Numerical probabilities were seldom presented. None of the modules presented information on patient preferences. CPG panel’s preferences were not made explicit, but appeared to have impacted 15 of 32 recommendations. Advice to involve patients and their preferences in decision-making was given for 20 recommendations (14 weak). Interviewees confirmed these findings. Explanations for lack of information were, for example, that clinicians know the information and that CPGs must be short. Explanations for trade-offs made were cultural-historical preferences, compliance with daily care, presumed role of CPGs and lack of time.ConclusionsThe motivation and phrasing of CPG recommendations do not stimulate choice awareness and a neutral presentation of options, thus hindering shared decision-making.
Rizatriptan is a selective 5-HT1B/1D receptor agonist for the acute treatment of migraine. It is available in a unique wafer formulation that dissolves rapidly in the mouth and can be taken without ...liquids, thereby offering patients a very convenient way to take treatment.
To investigate the long-term efficacy of rizatriptan 10-mg and 5-mg wafers in migraineurs.
19 headache clinics in 5 countries.
458 patients diagnosed with migraine according to International Headache Society criteria.
6-month, open-label, extension, which followed a double-blind, placebo-controlled study.
Patients were randomly assigned to 1 of 3 treatments for moderate or severe migraines: rizatriptan 10-mg wafer, rizatriptan 5-mg wafer, or "standard care" (usual migraine treatment -- eg, nonsteroidal anti-inflammatory drugs NSAIDs, analgesics, other triptans). Patients randomized to rizatriptan were blinded to the dose.
Headache severity (none, mild, moderate, severe) and adverse events were recorded on a diary card.
181 patients treated 3393 attacks with rizatriptan 10-mg wafer, 191 treated 3254 attacks with rizatriptan 5-mg wafer, and 86 treated 1582 attacks with standard care. The median number of treated attacks per patient was 16 for rizatriptan 10-mg wafer, 13 for rizatriptan 5-mg wafer, and 14 for standard care. The median patient on rizatriptan 10-mg wafer reported pain relief at 2 hours (reduction of headache from moderate or severe at baseline to mild or none) in 82% of attacks, vs 73% of attacks for standard care (odds ratio 95% confidence interval = 1.63 1.14, 2.34, P <.01) and 72% of attacks for rizatriptan 5-mg wafer (OR 95% CI = 1.60 1.23, 2.08, P <.001). The median patient on rizatriptan 10-mg wafer was pain free at 2 hours in 46% of attacks, vs 30% of attacks for standard care (OR 95% CI = 1.50 1.06, 2.12, P <.05) and 25% of attacks for rizatriptan 5-mg wafer (OR 95% CI = 1.93 1.50, 2.49, P <.001). All treatments were generally well tolerated. Compared with standard care, rizatriptan 5-mg wafer was associated with fewer specific adverse events of asthenia/fatigue, back pain, nausea, pharyngeal discomfort, upper respiratory infection, and vomiting (P values <.05), and, compared with rizatriptan 10-mg wafer, fewer overall drug-related adverse events (P <.05).
Rizatriptan 10-mg wafer was more effective than standard care and rizatriptan 5-mg wafer for treating intermittent moderate or severe migraine attacks occurring over periods of up to 6 months. Rizatriptan wafers were well tolerated.
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