How pharma can amplify product value with implementation science.

Achieving blockbuster status requires more than clinical trial success. Crucial barriers often include real-world factors like patient acceptance, prescriber behavior and timely and full reimbursement. Implementation science can be used to identify such barriers, develop strategies to overcome them, as well as test their effect. Used correctly and at the right time, implementation science can amplify product value and lead to a triple win for patients, healthcare systems and pharma. Three easy steps that focus on context, strategies and outcomes, can be followed by pharma to bring implementation thinking and research into their processes. A 'what if' case study is shared to give an indication of how this might work and the impact it might have.

Nonadherence to immunosuppressives and treatment in kidney transplant: ADHERE BRAZIL Study.

OBJECTIVE: To estimate the prevalence and variability of nonadherence to immunosuppressives and nonpharmacological treatment across kidney transplantation centers and two health access-disparate regions in Brazil. METHODS: In a cross-sectional design, a random multistage sample of 1,105 patients was included, based on center transplantation activity (low/moderate/high) and region (R1: North/Northeast/Mid-West; and R2: South/Southeast). Nonadherence to immunosuppressives (implementation phase) was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS)©. Self-report questionnaires assessed nonadherence to physical activity, smoking cessation, alcohol intake, and appointment keeping. We compared regions using the adjusted-χ2 or t-test. RESULTS: Most patients were men (58.5%), white (51.4%), and had a mean age of 47.5 (SD = 12.6) years. Regarding kidney transplantation centers, 75.9% were from R2 and 38.2% had low activity. The patients in R2 were older, white-majority, had more frequently steady partners, and received peritoneal dialysis. Nonadherence to immunosuppressives ranged from 11-65.2%; 44.5-90% to physical activity; 0-23.7% to appointment keeping; and 0-14% to smoking cessation. The total prevalence of nonadherence and by region (R1 versus R2) were: for immunosuppressives, 39.7% (44.9% versus 38.1%, p = 0.18); for smoking, 3.9% (1% versus 5%, p < 0.001); for physical activity, 69.1% (71% versus 69%, p = 0.48); for appointment keeping, 13% (12.7% versus 12%, p = 0.77); and for alcohol consumption, 0%. CONCLUSION: Despite differences among centers and high variability, only the nonadherence to smoking cessation was higher in the region with greater access to kidney transplantation. We suppose that differences in healthcare access may have been overcome by other positive aspects of the post kidney transplantation treatment.

Nonadherence to immunosuppressives and treatment in kidney transplant: Adhere Brazil Study

ABSTRACT OBJECTIVE To estimate the prevalence and variability of nonadherence to immunosuppressives and nonpharmacological treatment across kidney transplantation centers and two health access-disparate regions in Brazil. METHODS In a cross-sectional design, a random multistage sample of 1,105 patients was included, based on center transplantation activity (low/moderate/high) and region (R1: North/Northeast/Mid-West; and R2: South/Southeast). Nonadherence to immunosuppressives (implementation phase) was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS)©. Self-report questionnaires assessed nonadherence to physical activity, smoking cessation, alcohol intake, and appointment keeping. We compared regions using the adjusted-χ2 or t-test. RESULTS Most patients were men (58.5%), white (51.4%), and had a mean age of 47.5 (SD = 12.6) years. Regarding kidney transplantation centers, 75.9% were from R2 and 38.2% had low activity. The patients in R2 were older, white-majority, had more frequently steady partners, and received peritoneal dialysis. Nonadherence to immunosuppressives ranged from 11-65.2%; 44.5-90% to physical activity; 0-23.7% to appointment keeping; and 0-14% to smoking cessation. The total prevalence of nonadherence and by region (R1 versus R2) were: for immunosuppressives, 39.7% (44.9% versus 38.1%, p = 0.18); for smoking, 3.9% (1% versus 5%, p < 0.001); for physical activity, 69.1% (71% versus 69%, p = 0.48); for appointment keeping, 13% (12.7% versus 12%, p = 0.77); and for alcohol consumption, 0%. CONCLUSION Despite differences among centers and high variability, only the nonadherence to smoking cessation was higher in the region with greater access to kidney transplantation. We suppose that differences in healthcare access may have been overcome by other positive aspects of the post kidney transplantation treatment.

Prevalence of prednisolone (non)compliance in adult liver transplant recipients.

Limited evidence is available concerning (non)compliance with the immunosuppressive regimen in adult liver transplant recipients. In our study we prospectively assessed prednisolone (non)compliance in 108 adult liver transplant recipients using electronic event monitoring (EEM) in an outpatient setting. The EEM is a pill bottle fitted with a cap containing a microelectronic circuit that registers date and time of bottle openings and closings. Median taking compliance was 100% (range 60-105%), median dosing compliance was 99% (range 58-100%); median timing compliance (TIC) was 94% (42-100%). A drug holiday (DH) of > or =48 h was found in 39% of the patients of > or =72 h in 16% of the patients. Using EEM in liver transplant recipients, we found an overall high level of compliance for prednisolone, except that TIC was low in about one third of the patients. Age below 40 years was found a significant risk factor for decreased TIC and for DHs of > or =48 h.

The Strain of Care for Delirium Index: a new instrument to assess nurses' strain in caring for patients with delirium.

This study evaluated content validity, internal consistency and construct validity of the Strain of Care for Delirium Index (SCDI), a newly constructed instrument to measure the strain nurses experience in caring for patients with delirium. Content validity, evaluated by eight experts, reduced the initial pool of items from 38 to 28. Using a convenience sample of 190 nurses, Cronbach's alpha for the 28-item version was 0.88. Using non-linear principal components analysis another eight items were eliminated and a four-factor structure was identified. The proportion of variance explained by the remaining 20 items was 61.51%. Preliminary psychometric evaluation of the SCDI supported content validity, internal consistency and construct validity; however additional psychometric evaluation is warranted.