Updates in College Health: A Review of the Literature

ACHA National ConferencePhiladelphia, Pennsylvania

June, 2010

Objectives

• Discuss newly published important research studies and their relevance to clinical practice

• Understand common research study designs• Demonstrate evidence based medicine and

its application in College Health

Team• Cheryl Flynn, MD, MS, MA

– Interim Medical Director, Syracuse University– Family Medicine; epidemiology; family therapy

• David Reitman, MD, MBA– University Physician, George Washington University– Pediatrics and Adolescent Medicine

• Samuel Seward, MD– Assistant Vice President, Columbia University– Internal Medicine and Pediatrics

• Sarah Van Orman, MD– Executive Director, University of Wisconsin-Madison– Internal Medicine and Pediatrics

Process Overview

• Team members conducted literature review of studies published during past 24 months

• Key search words:– patient population-adolescent, college student,

university, young adult

• Avoid redundancy of topics presented in 2008 & 2009 Updates

Steroids for reducing throat pain

Hayward et al. Corticosteroids for pain relief in sore throat: systematic review and meta-analysis. BMJ 2009; 339: b2976

Background and Question

• Sore throat common problem in primary care and college health– Most viral; ~10% Group A Strep– SU experience: 8.7% of provider visits

• Question: Are systemic corticosteroids effective in reducing symptoms of sore throat?

Study Design

• Systematic review with meta-analysis– Only included placebo controlled randomized

controlled trials (RCTs)– Mathematically combined data where possible• Performed sensitivity analyses to assess robustness of

findings

Study Methods

• Population– ambulatory setting only (ED or primary care)– adults or children with acute tonsillitis/pharyngitis or

clinical syndrome of “sore throat”– excluded studies of infectious mono, post-tonsillectomy or

intubation, or peri-tonsillar abscess

• Intervention– systemic corticosteroids vs placebo– (many concurrently received antibiotics &/or

acetaminophen)

Results

• 8 RCTs met inclusion criteria– Population

• 743 patients, nearly balanced between adults/children• 47% exudative ST; 44% Strep positive

– Intervention• Betamethasone IM, dexamethasone IM or PO, prednisone PO• All doses fairly equivalent; ~60mg PO prednisone

– Quality of included studies• High; all with adequately concealed allocation

Results—quantitative (meta-analysis)

• Complete pain relief– At one day: RR 3.16; NNT = 3.7– At two days: RR 1.65; NNT = 3.3

• Mean time to onset pain relief– Steroid group 6.3 hr earlier (p<0.001)

• Sensitivity analyses found no changes in results – Adult vs child; PO vs IM; Strep vs viral; exudative

vs not

Results--Qualitative

• Adverse effects (reported in only 1 trial)– 5 hospitalized for IVF (3 steroid, 2 placebo)– 3 developed peri-tonsillar abscess (1 steroid, 2 placebo)

• No difference or trend favoring steroids in– Time to complete resolution of pain– Time missed work/school– Recurrent symptoms

Conclusion

• Addition of systemic corticosteroids significantly reduces pain in patients with sore throat

Limitations

• Possible confounding of antibiotic use– Don’t know effect of steroids independent of antibiotics

• Relatively small number of RCTs– Unable to assess publication bias

Clinical Bottom Line

• Consider adding steroids in patients with severe sore throat in non-mono pharyngitis– 60mg prednisone PO x 1 dose

LBP in Children & Adolescents

• Ahlqwist, A et al. Physical therapy treatment of back complaints on children and adolescents. Spine 2008; 33: E721-E727.

Background

• LBP is common in college health• Risk factors: – poor physical conditioning, intense exercise,

inadequate strength/impaired flexibility, family history

• Question:– How does individualized physical therapy compare

to a self-training program in adolescents with lower back pain?

Study Methods

• Design– Randomized controlled trial– Concealed allocation; blinding not possible

• Setting– Primary care

• Population– 12-18 y.o., lumbar pain at least 2/10 on pain scale– Excluded those w/serious physical or mental disease, or

those who had PT in prior month– N = 45; baseline comparison between groups similar

Study Design

• Intervention – Intervention group: individualized PT and exercise plus self-

training (PT 1x/wk, exercises 2x/wk)

– Control group: self-training only; 3x/wk– Duration: 12 weeks

• Outcomes– Measured using validated instruments perceived health,

disability, pain, flexibility/endurance• Pre/post within groups• Compared change scores between groups

Results

• Perceived health (CHQ-CF)

– Both groups had statistically significant improvement in nearly all sub-measures pre/post

– No differences between groups

• Disability (Roland & Morris Disability Questionnaire)

– Both groups had improvement pre/post• PT -4.6; Control -2.7

– p = 0.016 between groups

Results

• Pain (visual analogue scale 0-10)– Drop in pain scores pre/post

• PT -3.6; Control -3.3

– No difference between groups

• No difference in pain duration or quality of pain

• Flexibility & muscle endurance (back saver sit and reach) – Both groups had

improvement pre/post– No differences between

groups

Conclusions

• Both groups improved on all parameters measured

• Small additional benefit with addition of physical therapy– Perceived health status– Disability ratings

Limitations

• Attribution error– Improvement of health attributed to time or

interventions?– Benefits of PT could be attributed to increased

“medical attention”

• Small #s– Lack power to find differences between groups

Clinical Bottom Line

• The benefit of PT for adolescents with back pain is modest at best– If available, reasonable addition– If not, most will improve anyway

Contraception and Weight

• Dinger et al. Oral Contraceptive effectiveness according to body mass index, weight, age, and other factors. Am J Obstet Gynecol 2009; 201: 263 e 1-9.

• Chi et al. Early weight gain predicting later weight gain among depo medroxyprogesterone acetate users. Obst Gynecol 2009; 114: 279-84

OCP effectiveness across BMI

• Research Question– Are OCPs effective across varying BMIs?

• Design: Cohort– Subset of prospective surveillance study – Followed ~58K women Q6mo x 5 yr– Contraceptive failure rate was an a priori

secondary outcome

Results

• Population– 142,475 women years; avg duration follow-up 2.4 years– Mean age 25.2; mean BMI 22.1; 20.4% first time OCP users

• Outcomes– OCP failure rate 0.75% year 1 1.67% year 4– NO DIFFERENCE in effectiveness across BMI range

• Limitations– Lower than expected failure rates– Did not enroll morbidly obese women

Predicting weight gain in DMPA users

• Research Question:– Does early weight gain in depo-users predict

continued excessive weight gain? • Design: Cohort

• 240 women 16-33 y.o. choosing depo followed Q 3-6 months for 3 yrs• Depo-users divided into two categories

– Avg (<5% by 6mo) vs early wt gainers (>5% by 6mo) – Predictors of excessive gain at 6 mo included

» past pregnancy (RR 2.2), BMI<30 (RR 4.0)

Results

• Adjusting for other factors, early gainers had 7.03 kg more wt gain at 36mo vs avg group

• Limitations– Small n; stats controlled for confounding– Some who gained wt at 3 months dropped out

12 mo 24 mo 36 mo

Avg (N=144) 0.63 kg 1.48 kg 2.49 kg

Early (N=51) 8.04 kg 10.86 kg 11.08 kg

Clinical Bottom Lines

OCPs effectiveness/wt• OCPs are equally

effective across weight/BMI spectrum in women who are not morbidly obese

Depo/wt gain• Significant weight gain

from depo use can be predicted within the first two doses

Treatment of Irritable Bowel Syndrome (IBS)

• Ford AC, Talley NJ, Spiegel BMR, Foxx-Orenstein AE, Schiller L, Quigley EM, Moayyedi, P. Effect of fibre, antispasmotics, and peppermint oil in the treatment of irritable bowel syndrome: systemic review and meta-analysis. BMJ, 2008; 337a:2313.

Background and Question

• Primary care providers frequently treat irritable bowel syndrome (IBS)

• Many studies lack sufficient power to demonstrate efficacy of treatments

• Conflicting outcomes in various studies• What effect, if any, do fibre, antispasmodics

or peppermint oil have on the treatment of IBS symptoms?

Study Methods

• Meta-Analysis of randomized controlled trials:• Peppermint Oil (4 studies)• Antispasmodics (22 studies)• Fiber (12 studies)

• Primary, Secondary and Tertiary care settings• Population-not specified

• Could not have other GI diagnosis

Study Design

• Treatment initiated• Follow-up 1 wk – 60 months

• Needed to report• Global assessment of cure• Improvement of symptoms

• 35 studies met criteria

Results – Peppermint Oil (4 studies, 293 Patients)

Results- Antispasmodics (22 studies, 12 drugs, 1778 Patients)

Results – Fiber (12 Trials, 591 Pts)

Conclusions

• Fiber, antispasmodics (e.g. scopolamine) and peppermint oil each more effective than placebo in treating IBS

• NNTT • Fiber 11• Antispasmodics 5• Peppermint Oil 2.5

Clinical Bottom Line

• Of three interventions studied, peppermint oil shows the highest promise for efficacy in treating IBS

Sleep Quality

• Lund H, Reider B, Whiting A, Prichard, J. Sleep Patterns and Predictors of Disturbed Sleep in a Large Population of College Students. J Adol Health 46 (2010) 124-142

Background / Question• Much data exists re: consequences of poor sleep in

children/younger adolescents• Relatively little data in college age group• NCHA Data

• 53% reported sleep problems • 37% sleep had negative impact on academics

• In college population…..• What are the predominant sleep habits?• Can quality of sleep hygiene predict physical or behavioral

symptoms?• What physical, emotional and psychosocial factors predict poor

sleep quality?

Study Methods and Design

• Cross-sectional Online Study• Setting: Midwestern University• Population:

• College students, age 17-24• 1125 participants • 27% 1st years, 27% Sophomores, 24% Juniors, 20% Seniors• 420 male, 705 Female

• Asked to complete 5 validated surveys to rate– sleep quality, sleepiness, mood, distress, and diurnal

symptom variability

Results: Sleep Quality and Quantity

• Mean total sleep time 7.02 hrs • 25% < 6.5 hrs• 29.4% ≥ 8hrs

• Quality Sleep (PQSI)– 34% “good” – 38% “poor”

• Sleepiness (Eppworth Sleepiness Scale)– 25% scored >10 (significant daytime sleepiness)

Results: Sleep Quality, Mood, & Health

• Poor Quality Sleepers:– Higher levels of weekday stress (p<0.001)

– SUDS : 70.7 vs. 49.9

– Self reported negative moods (p<0.001)– e.g. POMS Depression: 10.66 vs. 7.01

– More physical illnesses (p<0.05)– 12% missed class in a month 3x+

– Increased use of Rx, OTCs and recreational drugs to stay awake and to fall asleep >1x/month

Results: Predictors of Poor Quality Sleep

• Stress– Stress about school (39%)– Emotional stress (25%)

• Excess noise (33%)• Sleeping Partners (7%)• Talking with friends prior to sleep (6%)

Conclusions

• “Epidemic” of insufficient and poor-quality sleep in college students

• Perceived stress tends to predict poorquality/ quantity of sleep

• Consequences of poor quality sleep include higher stress, poorer moods, increased physical symptoms, missed classes

Limitations

• One-time, non-longitudinal survey• Students were from one university• Self-report• No mention of role of ETOH/Drug use

Clinical Bottom Line

• Clinicians need to proactively focus on both the quality as well as the quantity of sleep in patient history

• Poor Quality Sleepers increased risk of mood disorders, substance abuse disorders and somatic complaints

Douching and STIs

• Tsai CS, Shepherd BE, Vermund SH. Does douching increase risk for sexually transmitted infections? A prospective study in high-risk adolescents. Amer J Obstetrics and Gynecology. January 2009. 38e1-e8.

Douching and STIs• Question: Is there an association between douching and

Trichomonas, Chlamydia, Gonorrhea and Herpes• Design: Observational Prospective (Longitudinal) Cohort• Results:

– Assessed time to STI in women who never, sometimes, or always douched– Average age 16.9 yrs. 73% Black. 65% HIV infected– “Always douched” had a shorter STI-free time than those who “never

douched.” (2:1)

• Commentary/Limitations– High risk adolescents, slightly younger than college age. 2/3 HIV– Couching = independent risk factor for STI acquisition

• Clinical bottom line:• Clinicians should counsel female patients about potential STI risks

with frequent douching

Antidepressant Treatment

• Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, and J. Fawcett. Antidepressant Drug Effects and Depression Severity. JAMA. 2010; 303(1):47-53.

Background and Question

• Most studies for antidepressant effectiveness in severely depressed patients

• Majority of patients treated with antidepressants have mild to moderate symptoms

Question: What is the relative benefit of antidepressant medication vs. placebo across a range of depression symptom severity?

Study Methods

• Meta-analysis of 6 randomized placebo controlled trials

• Setting-outpatient• Population– Adults > age 18 yrs– 5 Major depression; 1 minor depression

Study Design

• Intervention– Treatment Range 6-11weeks– 434 Antidepressant vs. 284 placebo– 3 imipramine and 3 paroxetine

• Outcome– Hamilton Depression Rating Scale (HDRS)

• Mild to moderate < 18• Severe 19-22• Very severe > 23

– HDRS 3-point difference-clinically significant

Results

• Baseline HDRS 10-39• Threshold for effect initial HDRS > 25

• Medium effect HDRS > 25• Large effect HDRS > 27

• Drop-out rates 9-34%

Conclusions

• Antidepressant drug effect varies as function of disease severity

• Antidepressant drug effect appears to be negligible with mild to moderate depression

• Antidepressant drug effect was large only for very severe depression

Commentary/Limitations

• Few patients with HDRS scores < 13 • Considered only acute treatment• Did not include newer antidepressants • Increased effectiveness of anti-depressant vs.

reduced effectiveness of placebo

Clinical Bottom Line

Effect of antidepressant therapy on mild to moderate depression unclear

Hair SheddingKunz M, Seifert B, and RM Trueb. Seasonality of Hair Sheddingin Healthy Women Complaining of Hair Loss. Dermatology.2009;219:105-110.

Hair Shedding

• Question: Is hair shedding seasonal?• Study Design: Retrospective Case Study• Results/Conclusions–Assessed telogen rates –823 women, aged 18-78–79% with female pattern hair loss (FPHL)– Telogen rates showed annual periodicity

with peak in July and April

Hair Shedding

• Commentary– Most marked in women with FPHL–Student population may have higher

rates of telogen effluvium • Clinical Bottom Line: Seasonal variation

may be important to consider for patient counseling and for response to treatment

Value of Family History

• Wilson B, Quresh N, Santaguida P, Little J, Carroll J, Allanson J, and P Raina. Systematic Review: Family History in Risk Assessment for Common Diseases. Annals of Internal Medicine. 151(12):878-887.

Background

• Family history associated with risk for many common diseases

• Knowledge of family history may motivate behavior change

• Collecting family history is associated with risks and benefits

• Collecting family history requires clinician time

Questions#1 Improved Health

What is the direct evidence that getting a family history will improve health outcomes for the patient or family?”

#2 Harm What is the direct evidence that getting a family history will result in adverse outcomes for the patient or family?

#3 Key ElementsWhat are the key elements of a family history in a primary caresetting for the purposes of risk assessment for common diseases?

#4 Accuracy What is the accuracy of family history, and under what conditionsdoes the accuracy vary?

Study Methods

• Systematic Review, 1995-2009– 137studies met criteria– 69 reviewed

• Unable to perform meta-analysis

Results #1: Improved Health

• Studies– 2 uncontrolled studies, high-study bias

• Outcomes– No studies with direct health effects– Increased uptake in breast cancer screening only

Results #2-Harm

• Studies– 1 randomized controlled; 2 uncontrolled studies – 2 generic family history; 1 cancer risk

• Outcomes– 1 study found short-term increase in anxiety, gone at 3

months– No long-term adverse effect found

Results #3-Key Elements

• Studies – 20 longitudinal, 21 cross-sectional studies– Cancer, coronary heart disease, stroke, diabetes– 40 definitions of positive history

• Outcomes– Sensitivity greatest

• Parents or other 1st degree relatives– Specificity greatest

• Relative identified• > 1 relative required• Age of onset

Results #4-Accuracy• Studies– Specialized disease clinics– 23-Longitudinal, Case-control, and Case series– Patient report vs. relative’s medical records

• Outcomes– Informants disease status did not affect accuracy– Less accurate for 2nd and 3rd degree relatives– Widely varying sensitivity and specificity – Specificity (absence of disease) better than

sensitivity (presence of history)

Conclusions

• No evidence that family history leads to improved health– Insufficient evidence of changed health behaviors

• No definitive evidence of lack of harm• Best method in primary care unclear• Best for 1st degree relatives• Accuracy often low, better for absence of

disease

Commentary/Limitations

• Few well done studies• Most included patients with the condition of

interest leading to selection bias• Many studies not done in primary care

settings• Better studies are needed

Clinical Bottom Line

Family history collectionis considered to be astandard of good care, butvalue is unknown. Ifcollected, practitionersshould focus on 1stdegreerelatives.

Dexamethasone for Migraine

• Singh A, Alter H, Zaia B. Does the Addition of Dexamethasone to Standard Therapy for Acute Migraine Headache Decrease the Incidence of Recurrent Headache for Patients Treated in the Emergency Department? A Meta-analysis and Systematic Review of the Literature. Acad Emerg Med. Dec, 2008.

Background and Question

• Migraine is common• Recurrent migraine after abortive therapy is

common:– Up to 2/3 patients treated in ED within 48 hours

• Does addition of Decadron to standard therapy decrease incidence of recurrent migraine?

Study Methods

• Meta-analysis of RCT’s• Inclusion criteria:– Double blind– Acute Migraine Dx– Emergency Department (ED) – Presence of control group– Adequate follow-up

• 7 studies fulfilled criteria (n=742)

Study Design

• Intervention: “standard therapy” + Decadron (IV or PO)

• Outcome: moderate or severe migraine at 24 to 72 hours

Results

• Modest but statistically significant benefit to adjunctive Rx with Decadron– ARR = 9.7%– RR = 0.87– 95% CI = 0.80 to 0.95

• Adverse side effects:– 26% of Decadron pts– 23% placebo pts

Conclusions

• Decadron, in this analysis, shown to decrease rate of moderate or severe headache 24-72 hours after initial ED Rx

Commentary/Limitations

• “Standard Treatment” defined broadly—and, in some studies, arguably unusually

• ED setting • Not a large n• Dose and route of Decadron

Clinical Bottom Line

• Decadron may have some value in abortive Rx of acute migraine

X-rays and Harm

• Fazel R, Krumholz H, Yongei Wang SM, et al. Exposure to Low-Dose Ionizing Radiation from Medical Imaging. NEJM. August, 2009.

Background

• Patients, over their lifetimes, are getting increasing #’s of studies with radiation

• Ongoing concern about link between low-dose radiation and– solid tumors– leukemia

• Patients often unaware of potential risk• Not all imaging procedures evidence-based

Background

Growth in Use of Advanced Imaging under Medicare, 1995–2005

Background

Imaging Procedure Average Effective Radiation Dose

Plain Film 0.01 – 10 mSv

CT 2 – 20 mSv

Nuclear 0.3 – 20 mSv

Interventional 5 – 70 mSv

Study Methods

• Retrospective cohort study• United Healthcare enrollee records

Study Design

• January 1, 2005 to December 31, 2007• Ages 18 – 64 yo• 5 sites– Arizona, Dallas, Orlando, South Florida, Wisconsin

• CPT codes• Standard definitions of “Effective Dosing” for

radiation

Results

• 1M total patients – 68.8% at least one imaging procedure– 655,613 patients• Higher in older age groups:

– 85.9% of 60-64 years– 49.5% 18-34 years

• Higher by gender:– Women: 78.7% and Men: 57.9%

– Mean: 1.2 +/- 1.8 procedures/patient/year– Median: 0.7 procedures/patient/year

Results

Distribution of Annual Effective Doses of Radiation Stratified by Gender

Conclusions

• Nearly 70% study population underwent ≥1 imaging procedure during 3-year study period

• Gender-specific findings bear further study

Commentary/Limitations

• Imagining procedures are a source of radiation exposure in the United States– can result, over time, in high cumulative effective

doses – Young people included

• Challenge = balancing immediate clinical need with LT dose effect

• Selection bias• Claims data

Clinical Bottom Line

• More is being discovered about imaging practices in the U.S. and their potential negative relation to long-term health effects.

• Primum non nocere

Radiologic Work-Up for Acute Abd Pain—What Helps Nail the Dx?

• Lameris W, van Randen A, van Es HW, et al. Imaging strategies for detection of urgent conditions in patients with acute abdominal pain: diagnostic accuracy study. BMJ. March 2009.

Background

• Abdominal pain is common:– 5-10% ED visits– Columbia AY 08-09: 830 cases

• CT and U/S have both been shown to – Positively effect diagnostic accuracy– Impact management decisions

• Both costly• CT = radiation exposure

Question

• What is the optimal imaging strategy for accurate diagnosis of urgent conditions related to acute abdominal pain?

Study Methods

• Prospective, paired diagnostic accuracy study• 6 academic medical centers– Adults ≥ 18yo with acute non-traumatic

abdominal pain– ED setting– Exclude:• Pregnancy• Shock• Ruptured AAA• Patients for whom no imaging indicated

Study Design

• Diagnostic Strategies:1. Diagnosis following clinical evaluation (CE) 2. CE + plain films3. CE + U/S4. CE + CT5. CE + U/S + CT (if U/S negative or inconclusive)

Results

• 1021 patients– ED/Urgent Care settings– Mean age: 47 years– 55% female– Ethnicity/Race not specified

• 66% of patients hospitalized following ED evaluation

• 47% required surgical procedure

Results

Diagnosis No (%)

Appendicitis 284 (28)

Cholecystitis 52 (5)

Gynecological 27 (3)

Urological 22 (2)

Pneumonia 11 (1)

Total 661 (65)

Final Diagnoses: URGENT

Results

Diagnosis No (%)

Non-specific Abdominal Pain 183 (18)

IBD 30 (3)

Gynecological 9 (1)

Total 360 (35)

Final Diagnoses: NON-URGENT

Conclusions

Imaging Strategy Sensitivity Specificity False Negatives

False Positives

1) Clinical Exam 88 41 12 27

2) CE + Plain Films 88 43 12 26

3) CE + U/S 70 85 30 11

4) CE + CT 89 77 11 12

5) CE + U/S +/- CT 94 68 6 16

All values in percentages (95% confidence intervals)

Strategy 5 approximately ½ total number of CTs completed in strategy 4

Commentary/Limitations

• More than one way to peel a banana• Stepped approach to w/u may or may not be

practical depending on patient/sx severity– And, if time allows, U/S before CT has merits

• Non-randomized• Most patients referred to ED—selection bias

Clinical Bottom Line

• As a single imaging strategy, CT is overall better than U/S for urgent conditions

• A conditional strategy with CT reserved for -/inconclusive U/S provides:– highest sensitivity– reduced population-based radiation exposure