STEPS Information

Safety

  • “Harms” is a term used to refer to a number of safety issues that can occur with the use of many medications, encompassing allergic reactions, adverse reactions, and cessation of the medication due to adverse events.
  • Examining the benefits of one medication compared with another addresses only part of what physicians and patients need to know. Patients also want to know about potential treatment harms.
  • Identification of the types of harms that occur and how often they occur is a weakness of current clinical research. Too often harms may not be searched for in a systematic way. The more detail provided regarding how harms were elicited, the more confidence once can have that a balanced view of treatment efficacy and harms is being presented.

Tolerability

  • Patients often articulate preferences regarding medication choice.
  • This can be based on previous experience with the drug, discussions with family members, other patients, and through media exposure including direct to consumer advertisement.
  • When patients express a preference, it can be helpful to elicit from the patient where the preference came from, and then provide the patient with the best evidence regarding advantages and disadvantages of various medications and formulations.
  • AHRQ and Consumers Union provide information for that is easily accessible to consumers.

Effectiveness

  • It is important to determine if the alternative medication is more efficacious compared with older drugs for the same indications. The best evidence is found through head-to-head comparisons among the medications; however, in psychiatry, these trials are relatively uncommon. The most important recent example is the CATIE trial of antipsychotic agents. These head to head trials provide the ‘gold standard’ evidence of benefit.
  • Randomized controlled trials can be of poor quality. Well developed guides for the quality of randomized trials have been developed by AHRQ and Jadad and colleagues. Although there are many systems to rate the quality of trials, there are common elements among these systems. These elements include:
    • Adequate randomization between groups being compared. (Was the study indicated to be randomized? Was the method of randomization described?)
    • Baseline similarity of the groups being compared on important demographic and clinical characteristics. (Were both groups assessed to ensure similar severity of illness?)
    • Modest loss to follow-up. This is generally operationalized as less than 20% and non-differential between the groups being compared.
    • Masking of both patients and treating providers to the identity of the agents they are being given as part of the study. For medication, this often involves the use of placebos or not telling the patient or treating provider the identity of the pill.
  • The best evidence for comparative benefit is randomized trials directly comparing one medication with another. When such evidence is lacking, researchers may attempt to compare medications through what are called indirect methods, including comparison of treatment groups of cohort studies or the active treatment groups of different randomized trials. These methods are of low statistical power and caution is advised in their interpretation.

Price

  • Many patients are concerned about medication costs. Adherence to medications may be sensitive to direct patient cost.
  • Patients with psychiatric disorders are often uninsured, and even those with insurance are often in plans with high deductibles and high co-pays.
  • It can be helpful to identify and discuss all potential out-of-pocket expenses with patients.

Simplicity

  • Convenience to the patient is an important factor to consider.
  • When given a choice, many patients will prefer simpler once daily drug dosing regimens compared with more complex regimens. Once daily dosing may also be associated with improved adherence to medications.
  • It is important to note that while extended-release medication may be the simplest regimen, it can be more expensive, thus offsetting any increased adherence.

Sources:
Jadad, A.R., Moore, R.A., Carroll, D., Jenkinson, C., Reynolds, D.J., Gavaghan, D.J., McQuay, H.J., (1996). Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Controlled Clinical Trials,17(1):1-12.

Schneeweiss, S., Patrick, A.R., Maclure, M., Dormuth, C.R., Glynn, R.J. (2007). Adherence to statin therapy under drug cost sharing in patients with and without acute myocardial infarction: a population-based natural experiment. Circulation,115:2128-2135.