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O'Connor E, Lin JS, Burda BU, et al. Behavioral Sexual Risk Reduction Counseling in Primary Care to Prevent Sexually Transmitted Infections: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Sep. (Evidence Syntheses, No. 114.)

Cover of Behavioral Sexual Risk Reduction Counseling in Primary Care to Prevent Sexually Transmitted Infections: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force

Behavioral Sexual Risk Reduction Counseling in Primary Care to Prevent Sexually Transmitted Infections: An Updated Systematic Evidence Review for the U.S. Preventive Services Task Force [Internet].

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Appendix ADetailed Methods

Systematic Review Search Strategies

Cochrane Database of Systematic Reviews search strategy

#1.

(hiv OR aids OR hepatitis OR herpes* OR warts OR papilloma*):ti or (hpv OR chlamydia* OR gonorrh* OR syphil*):ti or (std OR stds OR sti OR stis OR sexual*):ti in Cochrane Reviews

#2.

(promot* OR educat* OR counsel* OR advice):ti or (advise OR behavio* OR prevent* OR control*):ti in Cochrane Reviews

#3.

(#1 AND #2), from 2007 to 2012

Database of Abstracts of Reviews of Effects search strategy

  1. (hiv OR aids OR hepatitis OR herpes* OR warts OR papilloma* OR hpv OR chlamydia* OR gonorrh* OR syphil* OR std OR stds OR sti OR stis OR sexual*):TI
  2. AND
  3. (promot* OR educat* OR counsel* OR advice OR advise OR behavio* OR prevent* OR control*):TI IN FROM 2007 TO 2012

PubMed search strategy

#1.

hiv[mesh:noexp] OR hiv infections[mesh:noexp] OR Acquired Immunodeficiency Syndrome[mesh:noexp] OR Hepatitis B[mesh:noexp] OR Hepatitis B, Chronic[mesh:noexp] OR Hepatitis C[mesh:noexp] OR Herpes Simplex[mesh:noexp] OR Herpes Genitalis[mesh:noexp] OR Condylomata Acuminata[mesh:noexp] OR Papillomaviridae[mesh] OR Papillomavirus Infections[mesh:noexp] OR Chlamydia Infections[mesh:noexp] OR Chlamydia[mesh:noexp] OR Chlamydia trachomatis[mesh:noexp] OR Gonorrhea[mesh:noexp] OR Syphilis[mesh:noexp] OR Trichomonas Infections[mesh] OR safe sex[mesh:noexp] OR unsafe sex[mesh:noexp] OR sexual behavior[mesh:noexp] OR Sexually Transmitted Diseases[mesh:noexp] OR Sexually Transmitted Diseases, Bacterial[mesh:noexp] OR Sexually Transmitted Diseases, Viral[mesh:noexp]

#2.

health promotion[mesh:noexp] OR Health Education[mesh:noexp] OR patient education as topic[mesh:noexp] OR Counseling[mesh:noexp] OR Directive Counseling[mesh:noexp] OR cognitive therapy[mesh:noexp] OR “motivational interviewing”[tiab] OR behavior therapy[mesh:noexp] OR physician's role[mesh:noexp] OR preventive health services[mesh:noexp] OR student health services[mesh:noexp] OR “preventive intervention”[tiab] OR “preventive interventions”[tiab] OR “prevention intervention”[tiab] OR “prevention interventions”[tiab] OR “behavior intervention”[tiab] OR “behavior interventions”[tiab] OR “behavioral intervention”[tiab] OR “behavioral interventions”[tiab] OR “behaviour intervention”[tiab] OR “behavior interventions”[tiab] OR “behavioural intervention”[tiab] OR “behavioural interventions”[tiab]

#3.

#1 AND #2

#4.

hiv OR aids OR Hepatitis B OR Hepatitis C OR Herpes OR Herpes OR Condylomata Acuminata OR genital warts OR Papilloma* OR Chlamydia OR Gonorrhea OR Syphilis OR Trichomonas OR “safe sex” OR “unsafe sex” OR “Sexually Transmitted” OR std OR stds OR sti OR stis

#5.

“health promotion” OR “Health Education” OR “patient education” OR Counsel* OR “motivational interviewing” OR “preventive intervention”[tiab] OR “preventive interventions”[tiab] OR “prevention intervention”[tiab] OR “prevention interventions”[tiab] OR “behavior intervention”[tiab] OR “behavior interventions”[tiab] OR “behavioral intervention”[tiab] OR “behavioral interventions”[tiab] OR “behaviour intervention”[tiab] OR “behavior interventions”[tiab] OR “behavioural intervention”[tiab] OR “behavioural interventions”[tiab]

#6.

#4 AND #5 AND (in process[sb] OR publisher[sb] OR pubmednotmedline[sb])

#7.

(#3 OR #6) AND systematic[sb] Filters: Publication date from 2007/01/01; English

Key Question Search Strategies

Database: Ovid MEDLINE(R) without Revisions <1996 to October Week 4 2013 >, Ovid MEDLINE(R) Daily Update <November 1, 2013>, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations <November 1, 2013>

Search Strategy:

--------------------------------------------------------------------------------

  1. HIV Infections/ ()
  2. Acquired Immunodeficiency Syndrome/ ()
  3. Hepatitis B/ ()
  4. Hepatitis B, Chronic/ ()
  5. Hepatitis C/ ()
  6. Hepatitis C, Chronic/ ()
  7. Herpes Simplex/ ()
  8. Herpes Genitalis/ ()
  9. Herpes Labialis/ ()
  10. Condylomata Acuminata/ ()
  11. Warts/ ()
  12. Chlamydia Infections/ ()
  13. Gonorrhea/ ()
  14. Syphilis/ ()
  15. Papillomavirus Infections/ ()
  16. Human papillomavirus 6/ ()
  17. Human papillomavirus 11/ ()
  18. Human papillomavirus 16/ ()
  19. Human papillomavirus 18/ ()
  20. Trichomonas Infections/ ()
  21. Trichomonas Vaginitis/ ()
  22. Sexually Transmitted Diseases/ ()
  23. Sexually Transmitted Diseases, Bacterial/ ()
  24. Sexually Transmitted Diseases, Viral/ ()
  25. (hiv or hepatitis or herpes or warts or chlamydia or gonorrhea or syphilis).ti,ab. ()
  26. (sexually transmitted or std or stds or sti or stis).ti,ab. ()
  27. (papilloma$ or hpv or trichomonas).ti,ab. ()
  28. condylomata acuminata.ti,ab. ()
  29. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 or 28 ()
  30. health promotion/ ()
  31. Health Education/ ()
  32. patient education/ ()
  33. counseling/ ()
  34. directive counseling/ ()
  35. cognitive therapy/ ()
  36. behavior therapy/ ()
  37. physician's role/ ()
  38. preventive health services/ ()
  39. student health services/ ()
  40. teaching materials/ ()
  41. counsel$.ti,ab. ()
  42. advice.ti,ab. ()
  43. advise.ti,ab. ()
  44. motivational interview$.ti,ab. ()
  45. prevent$ intervention$.ti,ab. ()
  46. health promotion.ti,ab. ()
  47. health education.ti,ab. ()
  48. patient education.ti,ab. ()
  49. cognitive therapy.ti,ab. ()
  50. behavio$ therapy.ti,ab. ()
  51. behavio$ intervention$.ti,ab. ()
  52. 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49 or 50 or 51 ()
  53. 29 and 52 ()
  54. Safe Sex/ ()
  55. Unsafe Sex/ ()
  56. Sexual Behavior/ ()
  57. safe sex.ti,ab. ()
  58. unsafe sex.ti,ab. ()
  59. risky sex$.ti,ab. ()
  60. 54 or 55 or 56 or 57 or 58 or 59 ()
  61. 52 and 60 ()
  62. HIV Infections/pc ()
  63. Acquired Immunodeficiency Syndrome/pc ()
  64. Hepatitis B/pc ()
  65. Hepatitis B, Chronic/pc ()
  66. Hepatitis C/pc ()
  67. Hepatitis C, Chronic/pc ()
  68. Herpes Simplex/pc ()
  69. Herpes Genitalis/pc ()
  70. Herpes Labialis/pc ()
  71. Condylomata Acuminata/pc ()
  72. Warts/pc ()
  73. Chlamydia Infections/pc ()
  74. Gonorrhea/pc ()
  75. Syphilis/pc ()
  76. Papillomavirus Infections/pc ()
  77. Trichomonas Infections/pc ()
  78. Trichomonas Vaginitis/pc ()
  79. Sexually Transmitted Diseases/pc ()
  80. Sexually Transmitted Diseases, Bacterial/pc ()
  81. Sexually Transmitted Diseases, Viral/pc ()
  82. 62 or 63 or 64 or 65 or 66 or 67 or 68 or 69 or 70 or 71 or 72 or 73 or 74 or 75 or 76 or 77 or 78 or 79 or 80 or 81 ()
  83. intervention$.ti,ab,hw. ()
  84. 82 and 83 ()
  85. 53 or 61 or 84 ()
  86. limit 85 to (clinical trial or controlled clinical trial or meta analysis or randomized controlled trial) ()
  87. clinical trials as topic/ or controlled clinical trials as topic/ or randomized controlled trials as topic/ ()
  88. Meta-Analysis as Topic/ ()
  89. (control$ adj3 trial$).ti,ab. ()
  90. random$.ti,ab. ()
  91. 87 or 88 or 89 or 90 ()
  92. 85 and 91 ()
  93. 86 or 92 ()
  94. limit 93 to english language ()
  95. limit 94 to yr=“2007 - 2013” ()
  96. remove duplicates from 95 ()

PubMed search strategy (searched only for “publisher” unindexed references)

#1.

hiv[tiab] OR aids[tiab] OR “Hepatitis B”[tiab] OR “Hepatitis C”[tiab] OR Herpes[tiab] OR warts[tiab] OR “Condylomata Acuminata”[tiab] OR Papilloma*[tiab] OR hpv[tiab] OR Chlamydia[tiab] OR Gonorrhea[tiab] OR Syphilis[tiab] OR Trichomonas[tiab] OR “safe sex”[tiab] OR “unsafe sex”[tiab] OR “Sexually Transmitted”[tiab] OR std[tiab] OR stds[tiab] OR sti[tiab] OR stis[tiab]

#2.

“health promotion”[tiab] OR “Health Education”[tiab] OR “patient education”[tiab]

#3.

counsel*[tiab]

#4.

“cognitive therapy”[tiab] OR cbt[tiab]

#5.

behavio*[tiab] AND (therapy[tiab] OR intervention*[tiab])

#6.

advice[tiab] or advise[tiab]

#7.

(prevention[tiab] OR preventive[tiab]) AND intervention*[tiab]

#8.

motivational[tiab] AND interview*[tiab]

#9.

#2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8

#10.

#1 AND #9

#11.

#10 AND (trial[tiab] OR trials[tiab] OR random*[tiab] OR metaanaly*[tiab] OR “meta analysis”[tiab] OR “meta analyses”[tiab] OR “meta analytic”[tiab] OR systematic[tiab])

#12.

#11 AND publisher[sb]

#13.

((#12) AND English[Language]) AND (“2007”[Date - Publication] : “2013”[Date - Publication])

Cochrane Central Register of Controlled Trials

#1.

(hiv or aids or “acquired immunodeficiency” or “human immunodeficiency” or hepatitis or herpes*):ti,ab,kw from 2007 to 2013, in Trials

#2.

(hpv or papilloma* or warts or condylomata or trichomonas or chlamydia* or gonorrh* or syphil*):ti,ab,kw from 2007 to 2013, in Trials

#3.

(std or stds or sti or stis or sexual*):ti,ab,kw from 2007 to 2013, in Trials

#4.

(“safe sex” or “unsafe sex”):ti,ab,kw from 2007 to 2013, in Trials

#5.

#1 or #2 or #3 or #4 from 2007 to 2013, in Trials

#6.

(“health promotion” or “health education” or “patient education”):ti,ab,kw from 2007 to 2013, in Trials

#7.

(counsel* or advise or advice):ti,ab,kw from 2007 to 2013, in Trials

#8.

(motivational next interview*):ti,ab,kw from 2007 to 2013, in Trials

#9.

(prevention next intervention*):ti,ab,kw from 2007 to 2013, in Trials

#10.

“cognitive therapy”:ti,ab,kw from 2007 to 2013, in Trials

#11.

“physician's role”:ti,ab,kw from 2007 to 2013, in Trials

#12.

“preventive health services”:ti,ab,kw from 2007 to 2013, in Trials

#13.

“student health services”:ti,ab,kw from 2007 to 2013, in Trials

#14.

“teaching materials”:ti,ab,kw from 2007 to 2013, in Trials

#15.

“client education”:ti,ab,kw from 2007 to 2013, in Trials

#16.

(behavio* next intervention*):ti,ab,kw from 2007 to 2013, in Trials

#17.

(behavio* next therapy):ti,ab,kw from 2007 to 2013, in Trials

#18.

(behavio* next change*):ti,ab,kw from 2007 to 2013, in Trials

#19.

(behavio* next modification*):ti,ab,kw from 2007 to 2013, in Trials

#20.

“preventive medicine”:ti,ab,kw from 2007 to 2013, in Trials

#21.

(health next behavio*):ti,ab,kw from 2007 to 2013, in Trials

#22.

intervention*:ti,ab,kw

#23.

#21 and #22

#24.

#6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #23 from 2007 to 2013, in Trials

#25.

#5 and #24 from 2007 to 2013, in Trials

PsycInfo <1806 to October Week 4 2013>

#Searches
1sexually transmitted diseases/ ()
2Acquired Immune Deficiency Syndrome/ ()
3Human Immunodeficiency Virus/ ()
4GONORRHEA/ ()
5HERPES GENITALIS/ ()
6HERPES SIMPLEX/ ()
7AIDS Prevention/ ()
8SYPHILIS/ ()
9HEPATITIS/ ()
10Human Papillomavirus/ ()
11Sexual Risk Taking/ ()
12safe sex/ ()
13Psychosexual Behavior/ ()
14sexually transmitted.ti,ab,id. ()
15aids.ti,ab,id. ()
16hiv.ti,ab,id. ()
17hepatitis b.ti,ab,id. ()
18hepatitis c.ti,ab,id. ()
19herpes.ti,ab,id. ()
20condylomata acuminata.ti,ab,id. ()
21warts.ti,ab,id. ()
22chlamydia.ti,ab,id. ()
23gonorrhea.ti,ab,id. ()
24papillomavirus.ti,ab,id. ()
25hpv.ti,ab,id. ()
26trichomonas.ti,ab,id. ()
27syphilis.ti,ab,id. ()
281 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26 or 27 ()
29Health Education/ ()
30Health Promotion/ ()
31Cognitive behavior therapy/ ()
32Behavior Therapy/ ()
33Behavior Change/ ()
34Behavior Modification/ ()
35Client Education/ ()
36Counseling/ ()
37Preventive Medicine/ ()
38student personnel services/ ()
39Lifestyle Changes/ ()
40advice.ti,ab,id. ()
41advise.ti,ab,id. ()
42counsel$.ti,ab,id,hw. ()
43prevention intervention$.ti,ab,id. ()
44motivational interview$.ti,ab,id. ()
45behavio$ intervention$.ti,ab,id. ()
46Health Behavior/ ()
4746 and intervention$.ti,ab,id. ()
48health promotion.ti,ab,id. ()
49health education.ti,ab,id. ()
50behavio$ therapy.ti,ab,id. ()
51behavio$ change$.ti,ab,id. ()
52behavio$ modification$.ti,ab,id. ()
53client education.ti,ab,id. ()
5429 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45 or 47 or 48 or 49 or 50 or 51 or 52 or 53 ()
5528 and 54 ()
56random$.ti,ab,id,hw. ()
57controlled trial$.ti,ab,id,hw. ()
58clinical trial$.ti,ab,id,hw. ()
59treatment outcome clinical trial.md. ()
6056 or 57 or 58 or 59 ()
6155 and 60 ()
62limit 61 to english language ()
63limit 62 to yr=“2007 - 2014” ()
Appendix Figure 1 is a flow chart that summarizes the search and selection of articles. There were 7,083 citations identified through literature databases. An additional 169 citations were identified from outside sources such as reference lists and suggestions from peer reviewers. After duplicates were removed, 3,241 unique citations were screened at the title/abstract stage. The full-text of 218 citations were examined for inclusion for one or more of the four Key Questions. The following number of article were included for Key Question 1 (n=41), Key Question 2 (n=46), Key Question 3 (n=15), and Key Question 4 (n=4). Reasons for excluding the other articles are available in Appendix B.

Appendix A Figure 1Literature Flow Diagram

Abbreviations: CE = comparative effectiveness; KQ = key question.

Appendix A Table 1Inclusion and Exclusion Criteria

CategoryInclusionExclusion
AimTargeting sexual behavior change to prevent HIV/STIs (may also target additional behaviors)Only targeting sexual behavior change to prevent unintended pregnancy or another behavior associated with risky sexual behavior (e.g., alcohol misuse, drug abuse)
ConditionAn STI is any infection that is transmitted through sexual contact (i.e., oral, vaginal, or anal)1Other methods by which bloodborne STIs can be acquired (e.g., maternal-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with a potentially infected person)
Population
  • Men and women of all ages, of any sexual orientation, including pregnant women
  • Sexually active or not
  • HIV-positive (>10% of study population)
  • Current inmates, juvenile offenders, court-involved individuals
  • Psychiatric inpatients
InterventionsPrimary care conducted, feasible,* or referable intervention involving behavioral counseling to prevent or reduce HIV/STIs (i.e., some provision of education, skills training, or guidance on how to change sexual behaviors) delivered alone or in combination with other interventions intended to promote sexual risk reduction or risk avoidance

Interventions may include, but are not limited to, individual-, family-, couple-, or group-based counseling (e.g., motivational interviewing, cognitive behavioral counseling), abstinence contracts with provider, virtual- or technology-based interventions (e.g., text messages), HIV counseling and testing, case management, and skills training

*Criteria for feasibility:
  • Whom targeted: individual-level identification of being a patient/in need of intervention
  • Who delivered: usually involves primary care clinicians (family practice, internal medicine, obstetrics/gynecology, pediatrics, or general practitioners), other physicians, nurses, nurse practitioners, physician assistants, or related clinical staff (dietitians, health educators, mental health practitioners, or other counselors) in some direct or indirect way, or is seen as connected to the health care system by the participant
  • How delivered: to individuals or in small groups (≤15 patients)
  • Where delivered: could be delivered anywhere (including via the Web, interactive technology, in the home), as long as linked to a health care provider or system
  • Components: must not include components that cannot be replicated in most health care settings, including environmental components (media messages, signage), or that intervenes on groups in closed (preexisting) social networks (e.g., worksites, churches) or uses authority figures (e.g., military commanders, workplace supervisors)
  • Trials within closed preexisting social networks (e.g., worksite or church programs)
  • School programs outside school-based health clinics
  • Social marketing (e.g., media campaigns)
  • Policy (e.g., state or local public or health policy; health care delivery)
  • Circumcision to prevent HIV/STIs; circumcision counseling
  • Biomedical HIV/STI prevention interventions (e.g., prophylactic vaccinations, antiretroviral therapy in high-risk individuals) or counseling to increase use
  • Promoting HIV/STI testing
  • Maternal-to-fetal transmission prevention counseling
  • Sexual abuse prevention
  • Cash incentives for behavior change (e.g., condom use)
  • Counseling to increase partner referral or notification only
  • Contraceptive use
  • Complementary and alternative medicine (e.g., hypnosis)
Comparators
  • No intervention (e.g., waitlist)
  • Usual care
  • Minimal intervention (e.g., usual care limited to ≤15 min of information)
  • Attention control (e.g., similar in format and intensity, but intervention is on a different content area, such as general sex education, wellness promotion, or nutrition education)
Active intervention (i.e., comparative effectiveness)
Outcomes

KQ1: Health outcomes

  • STI incidence (testing and self-report)
  • STI-related morbidity and mortality, including: cancer (e.g., liver, oral, cervical, vulvular, vaginal, anal, penile, Kaposi's sarcoma, non-Hodgkin's lymphoma), reproductive health problems (e.g., pelvic inflammatory disease, ectopic pregnancy, spontaneous abortion, infertility, epididymitis, prostatitis), maternal problems (e.g., preterm delivery, premature rupture of membranes, puerperal sepsis, postpartum infection), infant problems (e.g., stillbirth, low birth weight, ophthalmia neonatorum [caused by gonorrhea, herpes simplex virus, or chlamydia], pneumonia, neonatal sepsis, congenital HIV, congenital syphilis, acute hepatitis, neurologic damage, congenital abnormalities), AIDS, other (e.g., oral lesions, meningitis, neurosyphilis, chronic liver disease, pelvic pain, genitourinary complaint), or death from any of these conditions

KQ 2: Behavioral outcomes

  • Changes in sexual behavior, including risky behaviors (e.g., multiple [new] partners, high-risk partners, unprotected vaginal or anal intercourse, other contact with bodily fluid, sex while intoxicated with alcohol or other substances, sex in exchange for money or drugs)
  • Changes in protective behaviors (e.g., abstinence, mutual monogamy, delayed initiation of intercourse or age of sexual debut, decreased contact with bodily fluids [use of condoms, other barrier methods, chemical barriers, or other changes in sexual behavior])
  • Sexual negotiation skills (trial must also report change in risky or protective behavior listed above or a health outcome)

KQ 3: Other positive outcomes

  • Reduction in unintended pregnancy
  • Others based on target populations (e.g., decrease in substance abuse/misuse among current drug users)

KQ 4: Adverse events

  • Paradoxical increase in STI incidence or risky sexual behaviors or decrease in protective behaviors
  • Care avoidance
  • Shame, guilt
  • Stigma
Self-reported measures of attitude, knowledge, ability, or self-efficacy (e.g., knowledge of HIV/STI risk and transmission, knowledge of protective behaviors, perception of HIV/STI risk in self or partners, regretted intercourse, participation in AIDS-related community activities, perceived powerlessness), sexual negotiation skills, scheduling a health care appointment or discussing its importance with family, intention to use protective barriers, or carrying barrier protection
Intervention setting
  • Primary care settings (e.g., pediatric, obstetrics/gynecology, internal medicine, family practice, family planning, military, adolescent and school-based health clinics)
  • Mental health clinics
  • STI and family planning clinics
  • Virtual (e.g., online counseling)
  • Community/university research laboratories or other nonmedical centers
  • Correctional facilities
  • School classrooms
  • Worksites
  • Substance abuse treatment facilities or methadone maintenance clinics
  • Inpatient/residential facilities
  • Emergency departments
Study designRandomized, controlled trials and nonrandomized, controlled trials (controlled clinical trials)Observational studies, comparative effectiveness trials without a control group
Timing of outcome assessment≥3 months postbaseline<3 months postbaseline
Publication date (not search date)Published after 1987 (1988 to present; post-HIV/AIDS era)Published in or before 1987
CountryCountries with a Human Development Index of “Very High”Countries with a Human Development Index below “Very High”
LanguageEnglish onlyNon-English publications
Study qualityFair or goodPoor (e.g., <60% retention overall)

Appendix A Table 2Quality Assessment Tool

DesignU.S. Preventive Services Task Force Quality Rating Criteria56
Systematic reviews and meta-analyses
  • Comprehensiveness of sources considered/search strategy used
  • Standard appraisal of included studies
  • Validity of conclusions
  • Recency and relevance are especially important for systematic reviews
Randomized, controlled trials
  • Initial assembly of comparable groups employs adequate randomization, including first concealment and whether potential confounders were distributed equally among groups
  • Maintenance of comparable groups (includes attrition, crossovers, adherence, contamination)
  • Important differential loss to followup or overall high loss to followup
  • Measurements are equal, reliable, and valid (includes masking of outcome assessment)
  • Clear definition of the interventions
  • All important outcomes considered

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