Part of the Big O’s plans to improve clinical effectiveness involves setting up registries to monitor patient outcomes after interventions like chemotherapy or the insertion of a medical device.

Come to think of it, that’s how Robert Hauser first detected problems with Medtronic’s mission-critical heart defibrillator a few years back.

Using data from a small registry at the Minneapolis Heart Institute, Hauser deduced that cables connecting the Sprint Fidelis defibrillator to the heart tended to crack causing the charge-box to either deliver shocks at inopportune times or fail to discharge at the moment of truth. 

In early 2007, Hauser raised the matter with Medtronic, which recalled the product 8 months later. The company indicated at the time that 5 deaths may have resulted from the problem.

Last week, Hauser and a colleague published another registry-based study suggesting the problem was worsening for patients who still have the hardware in their chests, and that physicians should consider replacing the cables proactively.

Medtronic disputes the findings, claiming its own analysis is based on a much larger sample and the ruckus is likely to continue for the foreseeable future.

A properly funded, well-designed national registry would settle the matter in a heartbeat, not to mention detecting the problem more quickly than Hauser was able to manage, according to cardiologist Alan Kadish of Northwestern.

Funny thing though, in 2004 Medicare required formation of a defibrillator registry as a condition for approving the devices for use in a new class of patients in whom only equivocal evidence suggested they were helpful.

But Medicare never put a dime towards funding it and support from the device companies tailed off after the first year.

Now, hospitals pay for a stripped-down version of the registry and get marginally useful benchmarking data in return.

The mini-registry can’t merge its data with Medicare claims, meaning among other things it can’t track longer term outcomes, which is pretty much the whole point.

A congressionally mandated report by the National Research Council concludes that our nation’s crime labs are understaffed, underfunded and lack proper oversight.

The report concludes that aside from DNA analysis, no forensic method has been demonstrated to be consistently reliable and accurate as a tool linking crime scene evidence to specific suspects. 
 

In fact outside of forensic DNA analyses, there are remarkably few peer-reviewed studies in the literature that even bother to validate the basic premises underlying forensic procedures, according to BurrillReport.

 “Reliable forensic evidence increases the ability of law enforcement officials to identify those who commit crimes, and it protects innocent people from being convicted of crimes they didn’t commit,” co-author Harry Edwards told Burrill.

The senior circuit judge and chief judge emeritus of the US Court of Appeals added that “judicial review alone will not cure the infirmities of the forensic science community.”
 
The NRC report recommends establishing a National Institute of Forensic Science to spearhead necessary research, set standards for forensic experts and labs, and oversee educational initiatives.
 
It also suggests that forensic lab governance should be separate from prosecutor’s offices and police departments. This would improve budgeting processes and eliminate cultural issues arising from the sometimes conflicting missions of these organizations.
 
And it favors mandatory certification for forensic science experts, which would involve written exams, internship-like programs, proficiency testing, and development of a code of conduct.

Forensic labs themselves should have to be accredited, and be required to establish quality-control procedures and assure adherence to best practice guidelines, the report recommended.

Adding a skosh of reason to the endless cacophony emanating from Atkins advocates, Ornish impresarios  and South Beach braggadocios, scientists at the Harvard School of Public Health have shown they all work equally well and what really matters is total caloric intake…pure, plain and simple.

Frank Sacks and colleagues randomly assigned 811 overweight or obese men and women to one of 4 heart-healthy, reduced-calorie diets that differed in the proportions of carbohydrates, fats and protein.

They followed participants for 2 years, asking that they exercise for 90 minutes per week and inviting them to attend group support sessions along the way. There was some periodic individual counseling as well.

The dieters recorded details of their food intake and tracked progress on a Web site.

Eighty percent of the subjects hung in there for the duration. By 6 months they had lost an average of 13 pounds, and they weighed-in at a minus 9 soaking wet when the study ended.

But the key was that subjects in all 4 groups had lost the same amount of weight and reduced waist girth by the same 2 inches. And all 4 groups experienced similar, modest beneficial effects on serum cholesterol and triglyceride levels and blood pressure.

The most successful dieters were those who regularly attended counseling sessions. They were good for a drop of 22 pounds on average.

“It’s just the calories that count,” Sacks underlined for the Boston Globe.

“The most important thing…to lose weight is to choose a heart-healthy diet and to keep the amounts down.”