BIOE 301Lecture 21Review of Last Time Sample size calculations Ensure differences between treatment & control group are real Type I Error: (False Positive) Mistakenly conclude there is a difference between the two groups, when in reality there is no difference p-value = probability of making type I error Type II Error: (False Negative) Mistakenly conclude that there is not a difference between the two, when in reality there is a difference Beta = probability of making type II error Choose our sample size: Acceptable likelihood of Type I or II error Enough $$ to carry out the trialDrug Eluting Stent – Sample Size Treatment group: Receive stent Control group: Get angioplasty Primary Outcome: 1 year restenosis rate Expected Outcomes: Stent: 10% Angioplasty: 45% Error rates: p = .05 Beta = 0.2 SD = 0.7855 patients required in each armScience of Understanding DiseaseEmerging Health TechnologiesPreclinical TestingClinical TrialsAdoption & DiffusionAbandoned due to:• poor performance• safety concerns• ethical concerns• legal issues• social issues• economic issuesBioengineeringEthics of researchCost-EffectivenessDiffusion is historically slow…. 1497: Vasco Da Gama lost 100 out of 160 crew members to scurvy sailingaround Cape of Good Hope 1601: British Navy Captain James Lancaster was in command of 4 ships traveling from England to India Required sailors to take 3 tsp of lemon juice daily on 1 ship The other 3 ships served as the control Results: 110/278 sailors died in control group 0 deaths in the experimental group 1747: British Navy Physician James Lind repeated study with similar results 1865: British Navy finally adopted innovation, 264 years after first recorded evidenceBerwick, Donald M., Disseminating Innovations in Health Care. JAMA April 16, 2003 – Vol 289, No. 15Characteristics of people who adopt change Innovators Mavericks, “willing to leave the village”, weird, incautious, socially disconnected, risk takers Early Adopters Well connected, social opinion leaders, watched by communities Early Majority Local in perspective, follow the lead of the early adopters Late Majority Watch for local proof Laggards Traditional, prefer the “tried and true”, archivistsBerwick, Donald M., Disseminating Innovations in Health Care. JAMA April 16, 2003 – Vol 289, No. 15Tipping Point – often between 15% - 20% adoption; spread becomes difficult to stop.A Case StudyCholecystectomy:Removal of the Gall BladderThe Gall Bladderhttp://gensurg.co.uk/images/Biliary%20anatomy%20-%20hsk.jpgThe Gall Bladder Function: Stores bile made by liver After eating: Gall bladder contracts Secretes bile into duct which empties into small intestine Aids in digestion Gallstones: Liquid bile may precipitate into solid stones Common: 1/5 of North Americans and ¼ Europeans develop gallstones at some pointhttp://www.thaiclinic.com/images/biliary_anatomy.gifGallstones Symptoms If gallstones block outflow of bile: Abdominal discomfort Pain Heartburn Indigestion Acute inflammationhttp://www.qualitysurgical.com/gblad.jpg Treatment of Gallstones Before 1990: Open surgery to remove the gall bladder Effective Low mortality rate (0.3-1.5%) 7 day hospital stay 30 days lost time from work Most common non-obstetric surgical procedure in many countriesA Case Study: Laparoscopic Cholecystectomy Most significant major surgical advance of the 1980s Allows shorter hospitalization Rapid recovery Early return to work Significant financial savings Forerunner of new era of minimally invasive surgeryLaparoscopic Removal of Gall Bladder Patient receives general anesthesia Small incision is made at navel and thin tube carrying video camera is inserted Surgeon inflates abdomen with carbon dioxide Two needle-like instruments inserted; serve as tiny hands. Pick up gallbladder & move intestines around. Several instruments inserted to clip gallbladder artery & bile duct, to safely dissect & remove gallbladder & stones Gallbladder is teased out of tiny navel incision. Entire procedure normally takes 30 to 60 minutes. Three puncture wounds require no stitches; may leave very slight blemishes. Navel incision is barely visible Laparoscopic Cholecystectomy http://www.laparoscopy.com/pictures/lap_chol.htmlhttp://www.lapsurgery.com/gallblad.jpg Advantages/Disadvantages Benefits: Ease of recovery No incision pain as occurs with standard abdominal surgery Up to 90% of patients go home the same day Within several days, normal activities can be resumed No scar on the abdomen Complications: Complication rate is about the same for this procedure as for standard gallbladder surgery: Nausea and vomiting may occur after the surgery Injury to the bile ducts, blood vessels, or intestine can occur,requiring corrective surgery 5 to 10% of cases, the gallbladder cannot be safely removed by laparoscopy. Standard open abdominal surgery is then immediately performed. Did this technology diffuse slowly or rapidly?An Important Innovator Kurt Semm (1927-2003) Gynecologist 80 medical device inventions Electronic insufflator Thermocoagulation Loop ligator Laparoscopic suturing Brother and father owned a medical instrument company which rapidly produced instruments for him Allowed more complex procedures to be performed endoscopically Gynecology General surgeryLaparoscopic Appendectomy 1985: Semm’s techniques used to perform the world’s first laparoscopic appendectomy Said to reduce problem of adhesions formed during opens surgeriesPublic Response “He’s gone absolutely crazy.” Was asked to undergo a brain scan by his colleagues Lectures were initially greeted with laughter and derision Technique was initially viewed as too expensive and too dangerous Semm exaggerated problems of adhesions Surgeons saw no reason to change a well established working method into a complex technical mannerPublic Response Semm: “Both surgeons and gynecologists were angry with me. All my initial attempts to publish on laparoscopic appendectomy were refused with the comment that such nonsense does not and will never belong to general surgery.”
View Full Document
Unlocking...