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Click on the link at left to go to your desired page:  Introduction  Page 2  Page 3  Study 1  Study 2  Study 3  Study 4  Conclusion  Implications for Social Workers  Post-Test 

Abstract:

This study was designed to look at the limiting factors of palivizumab. Namely, the compliance aspect of this once-per-month therapy. The authors note its effectiveness in preventing RSV-related hospitalizations in preterm infants as a given. In order to look at the compliance issue further, the study was designed to look at two groups of patients--those that had received their palivizumab injections at home, and those that had received them in either their doctor's or caregiver's office. Careful attention was paid to the rate of documented RSV illness in infants receiving palivizumab at home from 1998 – 2000.

The authors reviewed medical records for the number of doses received and hospitalization due to RSV-related illness. In addition, parents were surveyed to determine their satisfaction with the delivery of palivizumab.

In the home group (of Cohort #1), patients received more of their scheduled doses than did the office group. In fact, in this cohort, nearly twice as many patients received their full entire scheduled dosing as compared to the office group. Interestingly, satisfaction among the office group was higher when parents were asked about their preferences.

In the study group populations, patients receiving palivizumab at home were more likely to receive their entire scheduled course of injections than were those receiving them in the office. And the high rate of compliance in home-administered therapy was linked to a low rate of documented severe RSV.  

palivizumab, respiratory syncytial virus infections, gestation, immunoprophylaxis.

This study looked at the effectiveness and compliance of using palivizumab at home versus the office setting.  While palivizumab (Synagis), the marketed name for the drug, has been shown to be extremely effective at preventing RSV, compliance has been shown to play a key role in its overall effectiveness.  The authors looked at two groups of infants totaling 248 study enrollees.  These were divided into those receiving palivizumab at home and those receiving their injections in the office setting. 

Studies have shown that infants receiving palivizumab have required far fewer hospitalizations than those doing without.  In fact, markedly so.  In one study noted by the authors, 36% of preterm infants required hospitalization for RSV.  In another recent study, the authors saw a 55% reduction in RSV hospitalization in preterm infants receiving palivizumab than those receiving placebo.  There is no question as to the drug’s effectiveness. 

The question, as noted by the authors, is one of effectiveness as it relates to where the drug is given.  Home therapy was shown to be more effective from an outcome point of view, but loses out in everyday use due to its increased cost. 

Results:

Predictably, those receiving injections in the home setting did better. They missed fewer doses and therefore, had better outcomes (less reported cases of severe RSV).  In a perfectly controlled clinical environment, these findings would be clear cut and well defined. However, in the managed care-dictated world in which we live, the question becomes one of cost, then outcomes. 

In this study, all patients had outcomes directly related to their compliance. Simply stated, those that received more injections fared better. Also worth noting is that those infants who received their injections at home had better compliance. They received more doses. Why? Convenience, translated into compliance. When the nurse came out to the home to give the injection few doses were missed. When the family was required to go into an office for their monthly injections, compliance fell off. 

But the cost of sending out a nurse on a monthly visit to give the injections is more expensive than having the infant brought into the office. And the payers know that.  And this is why many refuse to pay for these home visits. Another statistic reported in this study that is interesting is parents, when questioned about their satisfaction, were happier bringing their infants into the office for their injections as opposed to those that received home nursing visits. The authors do not hypothesize as to why. 

One final compliance issue was cost. Parents sometimes discontinued therapy regardless of where their children received their injections due to cost. 

Summary of Study 1