**APPENDIX G: Article Review Forms**

**Acne: STUDY ARTICLE ID________ REVIEWER A____________     B_____________YEAR: _______**

# Date

**Exclude:***Check ANY that apply*

Does not discuss acne management



No human data



More than 20% of the patients have chloracne, rosacea, venanta, fulminans, necroticans, agminata



Patients are not baseline normal (e.g., industrial-caused acne)



Surrogate outcome measures only (e.g., sebum production, *P acnes* colony counts)



No original data



Article not in English



Fewer than 5 patients



 DO NOT PROCEED FURTHER IF ANY ITEMS CHECKED ABOVE!!!

READ PAPER BEFORE ANSWERING THE FOLLOWING QUESTIONS.............................USE PENCIL!!!!!!

QUESTIONS FOR

PI:(Harold and John)

Experts

**STUDY CHARACTERISTICS**

**AUTONUM Design**

*Treatment was assigned prospectively, randomly or no*

Controlled trial 

(

**

*Group of patients followed prospectively without treatment assignment*

Cohort study

(

**

*Groups defined as those with or without outcome*

Case-control 

(

**

*One or more groups of patients are examined at one point in time*

Cross-sectional

(

**

*Data are available on a single group of patients before and after/during the intervention*

Before–after

(

**

*Single-arm study with more than four patients (note subjectivity)*

Case series

(

**

*You cannot say based on the information provided*

Unspecified 

(

**AUTONUM Arms**

*How many distinct treatment groups were there?*

Number of arms**

_______

**

**AUTONUM Dates**

*From first patient enrolled to last data collected (xx/19xx or ??? if unclea)r You can enter only the year if that’s all you know*

Enrollment**

____/_____

*xx/19xx or ??? if unclear*

End of data collection**

____/_____

*If dates aren’t given, perhaps the duration is*

Study duration

__________

**

Units

Wks (

Mos (

Yrs(

**AUTONUM Number of sites**

*Single city/locale*

Single

(

*One country*

Multicenter

(

*Multiple countries*

Multicountry

(

*Not enough data*

Can’t say

(

**AUTONUM Location**

*Primary, or coordinating (for multistudy), country of the study*

Country

____________

*Primary, or coordinating (for multistudy) state/province of the study*

State/Province

__________

*Primary, or coordinating (for multistudy) city of the study*

City

__________

Inferred from author address only

(

STUDY QUALITY

*How did patients get into this study?***AUTONUM Assembly**

*All patients who came in through the door were enrolled/included*

Consecutive **

(

*Do the authors state the patients were recruited?*

Recruited

(

Other **

(

Can’t say**

(

*What patients were excluded from  this study, according to the design description?***AUTONUM Exclusion criteria**

Tanner I



Female



Mild acne



Tanner II



Male



Moderate acne



Tanner  III



Severe acne



Tanner  IV



Asian



Secondary acne



Tanner  V



Black



Hispanic



Pregnancy



Other race _______________



Lactation



Allergy to study meds



 < 31 days 



White



31 d to 10 y



11 y to 14 y 



Other comorbid condition ____________________



15 y to 18 y



19 y to 34 y 



Dry skin



35 y to 54 y



Oily skin



Comedonal acne



> 54 y



Inflammatory acne



Pustular acne



Nodularcystic acne



None listed

(

*For what prior treatment regimens were patients excluded?***AUTONUM Treatment Exclusion criteria**

*Treatment*

*Duration*

*Units*

( Days ( Weeks ( Months

( Days ( Weeks ( Months

( Days ( Weeks ( Months

( Days ( Weeks ( Months

( Days ( Weeks ( Months

None listed (

**AUTONUM Research design**

*The standard CCT*

Parallel 

(

**

*With or without initial washout*

Cross-over

(

**

*There was only one group of patients*

Single-arm

(

**

*There are not enough data to make a determination*

Can’t say

(

**

**9a.                 Matched control**

*One or more controlled patient(s) were specified in each experimental patient*

Yes

(

*Design is called matched ,but their are few data or no data to support that*

Maybe

(

*No mention or evidence of matching*

No

(

**

**

**

Can’t say

(

**AUTONUM Research funding**

*NIH, etc.*

Federal 

(

**

*Drug-company funded, but evaluated in usual peer way*

Drug/peer-eval

(

**

*Drug-company funded and published in a supplement or worse*

Drug/supplement

(

**

*There are not enough data to make a determination*

Can’t say

(

**

*E.g., Foundation*

Other

**

*How were patients assigned to treatment***AUTONUM Assignment across patients**

*Based on random numbers, from a table or computer*

Randomized **

(

**

*The authors*call*it “randomized,” but give no details*

Maybe Randomized

(

**

*A method that results in assignment that is clearly known in advance, e.g., odds/even clinic days, birthdays, odd/even clinic numbers*

Deterministic **

(

**

*Not enough information to say how assignment was actually made*

Can’t say **

(

**

*There were no assignments made to treatment in a prospective manner*

Not applicable**

(

**

*Were different sides of the face (back, etc.) treated differently?***AUTONUM **Assignment within patient**

**

Split face (or other body part), random

(

**

**

Split face (or other) deterministic

(

**

**

Can’t say

(

**

*There was no such assignment made*

Not applicable

(

**

*Were the patients ignorant about what treatment they got?***AUTONUM Patient blinded**

*There is clear attempt at documenting whether they knew, and it shows that they didn’t*

Yes

(

**

*There may be documentation, and it shows that they didn’t know, or, from implicit data, you infer that there was fair patient blinding (also if author says”double blind”but no other information provided)*

Somewhat

(

**

*There is clear attempt at documenting whether they knew, and it shows that they did*

No

(

**

*There are no implicit or explicit data*

Can’t say

(

**

**

Not applicable

(

**

*Was the person enrolling patients ignorant about what treatment would be assigned? This is somewhat dependent on the method of treatment assignment***AUTONUM Enroller blinded**

*There is clear attempt at documenting whether they were ignorant, and it shows that they were ignorant*

Yes

(

**

*Either the method (based on your background knowledge) or the data suggest that there was some unblinded enrollment (also if author says “double blinded” but no other information provided)*

Somewhat

(

**

*The method or the data make it clear that enrollers knew the prospective enrollment*

No

(

**

*There are no implicit or explicit data*

Can’t say

(

**

*There was no assignment made*

Not applicable

(

**

*Was compliance of the patients to their assigned treatment monitored?***AUTONUM Compliance monitoring**

*Monitoring was planned from the outset and was followed*

Prospectively

(

**

*Although not planned, there are data about compliance*

Retrospectively

(

**

*There was a plan for monitoring, but the results are not reported or no plan and no*

Maybe

(

**

*data reported*

**

*Neither explicit (e.g., survey) nor implicit (e.g., side effect rates) data are available to make this assessment*

Can’t say

(

**

*There was no assignment made*

Not applicable

(

**

*What part(s) of the body was treated?***AUTONUM Body area**

Face

(

**

Chest

(

**

Back

(

**

Systemic

(

**

Other

(

**

*What was the nature of the medical care that patients received in ALL arms?***AUTONUM Type of care**

*Community office*

Clinic visits

(

**

*Includes academic clinic*

Hospital visits

(

**

Home

(

**

Other

            ___________________________________________________________

**

Can’t say

(

*What was the nature of the things excluded from  ALL arms?***AUTONUM Ancillary Rx: Excluded Rx**

Medication

(

**

Soaps

(

**

Diet

(

**

Other

            _____________________________________________________________________

(

**

Can’t say

(

**

*Was ancillary treatment similar across arms?***AUTONUM Equal ancillary Rx across arms**

**

Yes

(

**

*Some doubt about the consistency, based on data or your background knowledge*

Maybe

(

**

*Clearly differences in ancillary treatment that are important*

No

(

**

*There are not enough data to determine*

Can’t say

(

**

*There was no assignment made*

Not applicable

(

**

*“LTFU” includes any patient for whom (primary)**outcome data are NOT available***

**AUTONUM Losses to follow-up**

*The number of patients LFTU comprise less than 5% of the sample, and were evenly distributed across arms*

None

(

**

*LTFU comprises between 5 and 20%, evenly distributed*

Minor

(

**

*LTFU comprise greater than 20% or grossly asymmetric*

Major

(

**

*There are no data on LTFU*

Can’t say

(

**

*This was a retrospective study*

Not applicable

(

**

*“PD”  includes dropouts, withdrawals, and unintended cross-overs for whom **outcome data ARE available***

**AUTONUM Protocol departures**

*The number of PD comprise less than 5% of the sample, were evenly distributed across arms, and outcome data are available on any that did depart.*

None

(

**

*PD comprises between 5% and 20%, are evenly distributed, and outcome data are 80% known.*

Minor

(

**

*PD comprises greater than 20% or what PD there is unaccounted for or outcome data are not known and could subvert the study’s conclusion so*

Major

(

**

*There are no data on protocol departures*

Can’t say

(

**

*There was no protocol*

Not applicable

(

**

*Was the process by which patient came to have their outcomes assessed consistent across arm? Examples of not consistent would be inpatients vs outpatients or other more subtle differences***AUTONUM Ascertainment consistent across arms**

*No doubt about the consistency*

Yes

(

**

*Some doubt about the consistency*

Maybe

(

**

*Clearly differences in ascertainment*

No

(

**

*There are not enough data to determine*

Can’t say

(

**

*There was no assignment made*

Not applicable

(

**

*Were the person/people assessing the outcomes blinded to assignment? These may be the same as the treaters. If there was blinding for some outcomes, but not for others, list here the best level of blinding, and make a Comment about the worse level on the data table about that outcom*e (in ARM form)**AUTONUM    Outcomes assessor blinded**

*Totally blinded*

Yes

(

**

*Some degree of blinding, but the lack of blinding is unimportant (also if author says”double blinded” but no other information provided)*

Somewhat

(

**

*Clearly differences in ascertainment*

No

(

**

*There are not enough data to determine*

Can’t say

(

**

*There was only one arm*

Not applicable

(

**

*Based on your judgment, paying attention especially to “Table 1,” the table of baseline characteristics of the patients in each arm. If a couple of characteristics are statistically significantly different between the groups, they may still be comparable if those characteristics are unimportant.***AUTONUM **Comparability of the arms.**

*Many important characteristics were assessed, and they are equally represented in the different arms*

Yes

(

**

*Some important characteristics were not assessed, or at most one or two of those characteristics that were assessed are different among the groups, but probably not important*

Maybe

(

**

*Several characteristics are different, and they are important*

No

(

**

*There are not enough data about the execution to permit a conclusion*

Can’t say

(

**

*There is only one arm in this study*

Not applicable

(

*Based upon your judgment. This judgment synthesizes what you’ve read***AUTONUM Execution true to study desig**n

*The execution followed the design, and any problems you detected do not detract from inferences assuming that that study was performed ideally*

Yes

(

**

*The execution essentially followed the design, but some departures from design may invalidate the results*

Somewhat

(

**

*The study as executed is different enough from design that inferences are called fundamentally into question*

No

(

**

*There are not enough data about the execution to permit a conclusion*

Can’t say

(

**

*What is the most general group of patient for which this study’s results are valid, in your opinion, taking the designand results into account***AUTONUM Generalizability**

*E.g., all peoples*

General population

(

**

*E.g., all white 14-year olds*

Specific population

(

**

*E.g., all white 14 olds in Baltimore*

Local population

(

**

*E.g., all patient referred to a specialty clinic*

Referral population

(

**

*E.g., patients in the study only, because selection bias or other issues prevents generalizability*

Study patients

(

**

*There are not enough data about the execution to permit a conclusion*

Can’t say

(

**

*SECONDARY REVIEWER **ONLY**!!!***AUTONUM Number of Disagreements**

*Compare your review with the primary review. Include all study areas(i.e,on green form only) where your changes made substantive changes. Addenda, misspelling, etc., are not included in this assessment*

Number

_______

**

*Please enter one sentence summary of the conclusions of the study.*

**28. Bottom line**

****

*Please add any additional information you think a reader of the evidence report would like to know about this study*.

**29.Comments**

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