PICOS PICO P Patient characteristics I Intervention C

PICOS

PICO • P: Patient characteristics • I: Intervention • C: Control (alternative interventions) • O: Outcomes • (S): Study Design

How does bleaching affect patients who have active caries and/or are considered high risk for caries? P I C O

How does bleaching affect patients who have active caries and/or are considered high risk for caries? P I patients who have active caries and/or are considered high risk for caries bleaching C Not specified O Not specified

For a patient with periodontitis, generalized bone loss and deep pockets, does adding deep cleaning + chlorhexidine rinse help obtain better results ? P I C O

For a patient with periodontitis, generalized bone loss and deep pockets, does adding deep cleaning + chlorhexidine rinse help obtain better results ? P patient with periodontitis, generalized bone loss and deep pockets I deep cleaning + chlorhexidine rinse C Not specified O Not specified

In patients with a localized vestibular swelling due to spread of an endodontic infection, is incision and drainage alone an appropriate treatment, or should the patient also be prescribed an antibiotic? P I C O

In patients with a localized vestibular swelling due to spread of an endodontic infection, is incision and drainage alone an appropriate treatment, or should the patient also be described an antibiotic? P patients with a localized vestibular swelling due to spread of an endodontic infection I I &D C I &D + antibiotic (which one? ) O Not specified

Does the NTI (Nociceptive Trigeminal Inhibition) device have an effect on migraine incidence? P I C O

Does the NTI device have an effect on migraine incidence? P Not specified I NTI C Not specified O Migraine incidence

Is topical fluoride effective? P I C O

Is topical fluoride effective? P Not specified I Topical fluoride C Not specified O Not specified

Is the zirconia reinforced ceramic crown a reliable alternative to the traditional metalceramic crown when it comes to restoring teeth? P I C O

Is the zirconia reinforced ceramic crown a reliable alternative to the traditional metalceramic crown when it comes to restoring teeth? P Not specified I zirconia reinforced ceramic crown C metal-ceramic crown O Not specified

PICOs “A great deal of influence rests in the hands of parties who control the framing of a health issue” “K. D. Brownell and K. E. Wagner, 2009”

Canto, 27, on a restricted diet, and Owen, 29, a control subject at the Wisconsin National Primate Research Center in 2009. Wisconsin’s study concluded that calorie restriction lengthened life, but a later study suggested the opposite. Credit. Jeff Miller/University of Wisconsin-Madison

Doess a calorie-restricted diet increase longevity? P rhesus monkeys I zirconia reinforced ceramic crown C 1 “eat like the American population at large — as much as they wanted of a not particularly healthy diet, loaded with sucrose, and in which all foods were laboratory purified” “whole foods and were given fixed portions, based on what they naturally ate before the study started. ” Longevity C 2 O

Asking corporate sponsors to conduct pivotal trials on their own products is like asking a painter to judge his or her own painting so as to receive an award. If a manufacturer can be allowed to manipulate the system to create a blockbuster product from an ineffective drug, the temptation is hard to resist. Vinay Prasad, MD Adam Cifu, MD John P. A. Ioannidis, MD, DSc JAMA 2012

Smoking when compared to no smoking is associated with an increased lung cancer risk among British physicians P British physicians I Smoking (various doses) C No smoking O Lung cancer incidence

“The clinical evidence implicating frequent consumption of sugar in the etiology of caries is much stronger than the evidence supporting the widely held belief that caries is an infectious disease caused by mutans streptococci. This contention is mainly based on studies in coprophagous rodents, and attempts to control caries using this approach have been unsuccessful thus far. However, there are not any multi-billion dollar industries with a vested interest in discounting the role of a specific micro-organism. ” D. T. Zero. Caries Research 2004; 38: 277 -285

THE OBVIOUS ?

Journal of the American Medical Association June 9, 1928

Adolf Hitler Martin Borman Reidar Sognnaes 1911 -1948

ADVERTISING Framing the Health Issue

Sugar in the child’s diet is a support to his growth … a necessary fuel

Máh-to-tóh-pa, Four Bears, Second Chief, in Full Dress, 1832 George Catlin (1796 – 1872)

Sugar is the most prominent fuel burned in the body

Fear of decay…. The remedy is to keep the teeth clean

Sugar will… “hit the spot…. ” 1930

Sugar is not an essential part of the diet

Coca-Cola has the same level of acidity as many other foods and drinks. And when you think about it, drinks like Coca-Cola are swallowed quite quickly and the saliva in your mouth washes away the liquid. Dental hygiene is the key! Make sure you look after your teeth by brushing regularly and visiting your dentist. In fact, tooth decay is declining globally, even as soft drink consumption has increased. This all means there’s no real reason why you can’t enjoy Coca-Cola.

PROFESSIONAL ORGANIZATIONS

The belief that… pure sugar may cause tooth decay has received considerable attention. The consensus of opinion is that sugar in itself has no harmful effect… Bing – Secretary of AMA – Authorized by CDT October 1932

In light of current laboratory and epidemiological research findings, the Association recognizes that it is neither advisable nor appropriate to eliminate from the American diet sugarcontaining foods that provide necessary energy value for optimal nutrition. http: //www. ada. org/sections/about/pdfs/doc_policies. pdf Current Policies

“dental health problems do not require any dietary recommendations” and “frequent consumption of candy did not seem to be a significant determinant of caries”

ACADEMIA

F. J. Stare Science 1968. Like Hansel and Gretel Linus Pauling is lost in the woods – of health and nutrition, areas outside his competence”.

PICOS

Lipid Research Clinics Coronary Prevention Trial ($140 million) Screen 500, 000 Enroll: 3806 Cholesterol distribution Middle-aged Males Middle-aged Females

Drug and Death + - 68 (3. 57%) 1839 1906 Placebo 71 (3. 74%) 1828 1900 Drug NNT=591 JAMA, 1984

Drug and CHD + - 160 (8. 4%) 1746 1906 Placebo 188 (9. 9%) 1712 1900 Drug NNT=67 JAMA, 1984

Conclusion: those benefits “could and should be extended to other age groups and woman and … other more modest elevations of cholesterol levels”

Enrollment of patients in NSAIDS trials Age >65 yrs old <65 yrs old Rochon, 1998 CMA 159(11) Bodenheimer, 2000, NEJM 1539

Rofecoxib Are the patients in the trial similar to the patients in our chair?

Rofecoxib and dental pain Condition Mean Exclusion criteria Age Post-Dental 18 Surgery Pain Duration Allergies to any anti-inflammatory, 1 day asthma, diabetes, renal, cardiovascular or neoplastic disease, neurological disorders or clinically significant abnormalities on prestudy clinical examination or laboratory tolerability tests including a complete blood count, serum chemistries, and urine analysis

P ICOS

Cox-2 inhibitor for dental pain • Two double-blind randomized trials published in JADA • 406 subjects • Comparison of: – 20 mg Cox-2 – 40 mg Cox-2 – 10 mg oxycodone/1000 mg acetaminophen • Conclusion: Cox-2 is an efficacious and safe alternative to Percocet

Surprise? • Oxycodone — Half Life: 3 - 4. 5 Hours • Valdecoxib — Half Life: 8 to 11 Hours

“Madison Ave. Has Growing Role In the Business of Drug Research” • The FDA specifically refused thatthis drug be prscribed for pain control • “Contrived control” (NYT)

“…efforts to encourage doctors to prescribe Bextra … for uses that the US Food & Drug Administration had specifically refused to authorise. ”

Contrived control groups • Antibiotics and meningitis – Give controls 1/3 of standard dose (Science, 2001 Sept. 7 Vol 293, p. 1742)

Fluconazole vs. Amphotericin B Fungal skin infection + - Fluconazole 7 (1. 7%) 413 420 Amph B 11 (2. 7%) 396 400 Ann Intern Med. 1994; 120: 913 -918 JAMA 1999; 282(18): 1756

“The majority of patients (79%) were provided with oral amphotericin B, which is poorly absorbed and poorly documented” JAMA 1999 In the United States, only an intravenous (IV) form of amphotericin B is available. http: //www. thebody. com/content/art 4743. html

PIC Os

A example of a surrogate

Surrogates are scary • Medication lowers the rate of ventricular arrhythmias (TRUE) • Ventricular arrhythmias increase mortality risk (TRUE) • Medication lowers the rate of mortality: (FALSE)

Additional Examples Disease Surrogate Tangible Outcome Misleading AIDS CD-4 AIDS event yes Osteoporosis Bone density Fracture yes Cancer Tumor size Mortality yes Periodontitis Pocket depth Tooth loss ? Caries Enamel caries Pain/tooth loss ?

Outcome Measures – a surrogate outcome is a laboratory sign or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint (Temple, 1995). – a true outcome reflects unequivocal evidence of tangible patient benefit. True endpoints include Quality of life measures

The acceptance of drugs based on surrogate endpoints may potentially reflect a fundamental flaw in the drug approval process … possibly, a major drug tragedy will be required to lead to revisions in the drug-approval process in the United States [Psaty et al. 1999].

PICO and implants

PICO • Surrogates: – Chewing time: The time between the beginnings of mastication to the swallowing of the food bolus. – Cleaning time: the time between the end of rhythmic mastication and the final swallow Awad et al. , 2000 J. Dent. Res. 79: 1659

PICO: surrogates • Chewing time and cleaning time of different types of foods were not depended on treatment allocation. • Correlations between the laboratory assessment of masticatory efficiency and subjects’ ratings of ease of chewing the same foods were low and non-significant. Awad et al. , 2000 J. Dent. Res. 79: 1659

PICO: True Endpoints Functional limitations Physical Pain Psychological comfort Physical disability Psychological disability Social disability Handicap Implant 14. 4 12. 5 7. 1 12. 1 7. 9 5. 5 6. 7 Conventional 18. 5 18. 7 10. 3 15. 8 10. 6 7. 0 8. 3

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What to put in the search box • Words related to PICO question • Use wildcard Floss* (flossing, flossed, flosser, …. ) • Me. SH terms • Capitalize boolean (AND or OR) operators

Clinical Queries