Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term "ABI" is new, it encompasses fragmented "tools" that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision-making, and manage expectations through rapid-cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision-making, a core element of ABI, provides a framework for structuring decision-making designed to manage two types of uncertainty - the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.

Accelerated access to innovative medicines for patients in need.

There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.

Adaptive licensing: taking the next step in the evolution of drug approval.

Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.

Assessment of new onset postcoronary artery bypass surgery atrial fibrillation: current practice pattern review and the development of treatment guidelines.

BACKGROUND: The incidence of postcoronary artery bypass graft (CABG) atrial fibrillation (AF) is 22.5% at the QEII Health Sciences Centre and the mean length of stay is 5.5 days greater than for those patients who do not experience this complication. Appropriate pharmacological management is important to prevent the potential morbidity from AF, such as thromboembolism, congestive heart failure, cardiogenic shock and coronary ischemia. This project compared current practice patterns in the management of post-CABG AF with local practice pattern beliefs and evidence from the primary literature. Subsequently, treatment guidelines were designed to help guide a rationale treatment approach. OBJECTIVE: To promote appropriate treatment strategies for post-CABG AF and increase local practitioner awareness of drug-use outcomes by developing consensus treatment guidelines. DESIGN: There were three phases. In phase 1, a retrospective chart analysis of 35 post-CABG AF patients over three consecutive months was conducted to assess current practice patterns. All published studies on this subject were also collected and analysed. A survey of pharmacological treatment preferences was distributed to local stakeholders during phase 2. The third phase involved the development and implementation of treatment guidelines. RESULTS: This study identified a highly variable approach to the treatment of post-CABG AF. The mean number of agents used to treat AF post-CABG was two (range 1-4); all patients (100%) were prescribed rate-controlling agents and 37% were prescribed an antiarrhythmic drug. There was also a mismatch between practice pattern beliefs and actual practice. CONCLUSIONS: This reinforced the need for a consistent treatment approach that was facilitated with the development and implementation of local guidelines.

Waiting for cardiac surgery: results of a risk-stratified queuing process.

BACKGROUND: The Queen Elizabeth II Health Sciences Centre uses a weekly peer-review conference of cardiovascular experts to prioritize each surgical case to 1 of 4 queues with the use of standardized criteria of coronary anatomy, stress test result, and symptoms. We examined the hazard of waiting as well as the impact of waiting on surgical outcomes. METHODS AND RESULTS: Analysis was performed for 2102 consecutive patients queued for CABG, aortic valve replacement, or CABG+aortic valve replacement between January 1, 1998, and December 31, 1999. Among 1854 patients undergoing surgery, median waiting times on the respective queues were as follows: in-house urgent group, 8 days; semiurgent A group, 37 days; semiurgent B group, 64 days; and elective group, 113 days. There were 13 deaths (12 cardiac) that occurred during the waiting period (0.7% of the patients). Of the 8.7% patients upgraded to a more urgent queue, 86.1% required hospitalization before surgery. Although female sex was not associated with prolonged waiting time, it was predictive of urgent status (P=0.001). The incidence of postoperative complications was 25.0%, and operative mortality was 2.86%. Both were more frequent among patients undergoing surgery early (P=0.01); however, this difference was attributable to the in-house urgent queue. The median length of stay was 7 days for all patients and was not affected by waiting time. CONCLUSIONS: Death and upgrades while the patients were waiting tended to occur early in the queuing process, and prolonged waiting was not associated with worse surgical outcomes. The cost of reducing waiting times could in part be offset by prevention of hospital admissions among upgraded patients.

Physician career management: organizational strategies for the 21st century.

Burnout is a state of physical, emotional, and mental exhaustion caused by long-term involvement in situations that are emotionally demanding. It is not stress, per se, that causes burnout, as many thrive in stressful, demanding careers. Rather, burnout results when stress continuously outweighs the sense of effectiveness, accomplishment, and reward. And, this fate is sealed when one feels helpless to effect significant change in the conditions that fuel the stress. Establishing an organizational environment that reduces the risk of physician burnout requires a new commitment of resources, one that can be challenging to justify to decision-makers with a strictly short-term, bottom line orientation. The key issues to consider in shaping a physician career management program include: (1) entry of new physician employees into the organization; (2) productivity measures; (3) responsiveness to safety concerns; (4) administrative and policy issues; and (5) variety and growth opportunities.

Serial lumbar dynamometry in low back pain.

To determine the significance of changes in motor performance as measured by lumbar dynamometry, serial lumbar dynamometry was performed on a group of 45 male Workers' Compensation patients with chronic "mechanical" low back pain and in a group of 20 healthy male volunteers. The patients were men aged 20-60 years, whose current episode of low back pain had lasted for at least 3 months (mean 19.5 weeks, range 12-47 weeks). Testing was performed at entry into a "back school" program of therapy and again 2 weeks and 4 weeks later. The control group showed a slight improvement in almost all variables of strength and range of motion between the first and second tests but no significant change between the second and third tests. This was consistent with a learning effect. The patient group was analyzed as a whole and also in two groups based on their response to the Waddell maneuvers at entry: Waddell score 0-2 (no excessive illness behavior) and 3-5 (excessive illness behavior). As a whole, the patients showed significant progressive improvement in most variables on successive tests. The group with the low Waddell score had significantly greater strength and range of motion than the group with the high Waddell score but the trend of improvement with time was similar in the two groups. The authors conclude that in this sample of patients with low back pain, serial lumbar dynamometry reveals a progressive improvement in performance, which is greater than the improvement expected from the natural history of physical recovery and greater than the improvement expected from an increase in strength and range of motion attributable to the therapeutic exercises performed and is much larger than any learning effect related to the test procedure.

Assessment of interpersonal problem-solving skills.

A new instrument for assessing social skills of schizophrenic patients, Assessment of Interpersonal Problem-Solving Skills (AIPSS), is a videotaped-based test with an examiner's administration and scoring manual. The test measures an examinee's ability to describe an interpersonal social problem, to derive a solution to the problem, and to enact a solution in a role-played simulation test. In a study using a sample of schizophrenic outpatients and a comparison group of nonpatients, we found that the test had adequate psychometric properties, and the patients demonstrated deficits on all scales relative to the nonpatients. The results of the study also provided partial support for the validity of an information-processing model of social skills, which was used as a basis for constructing the AIPSS. Thus, the AIPSS represents a departure from previous methods of assessing social skills.

Strategic modelling for health care managers.

The Medical Director of a new HMO thinks the patient load warrants hiring three new internists. What additional factors should he consider? How will this move affect the other needs and plans of the HMO? What effect will it have on the organization's financial condition? Here's the way a large corporation would tackle these questions.