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Ford JG, Howerton MW, Bolen S, et al. Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Jun. (Evidence Reports/Technology Assessments, No. 122.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Knowledge and Access to Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials.

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Appendix E. EPC Recruitment: Article General Abstraction Form

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF MEDICALLY UNDERSERVED TO CANCER TRIALS
GENERAL ABSTRACTION FORM
Article ID:______________________ First Author:_____________________
Reviewer 1: _____________________ Reviewer 2: _____________________

Exclusion criteria: (Check one)

□ not in English

□ not U.S.-based study

□ does not include human data

□ no original data

□ meeting abstract (no full article for review)

□ case report or case series (no denominator)

□ letter

□ does not address cancer treatment or prevention

□ does not report a controlled trial or discuss recruitment to a controlled trial

□ other: (specify)___________________________________________________________

***IF ANY OF THE ABOVE IS CHECKED, DO NOT CONTINUE***

  1. Key Questions: (Check all that apply)

    What methods (survey studies, focus groups, etc.) have been used to study strategies to recruit medically underserved populations (the elderly, adolescents, those of low socioeconomic status, those living in rural areas, African Americans, Hispanics/Latinos, Asian-Americans, and American Indians, etc.) in cancer prevention and treatment trials?

    What measures of success (proportional representation relative to the U.S. population; proportional representation relative to incidence of a cancer in a specified population, etc.) have been used to evaluate the efficacy and/or effectiveness of strategies for recruitment of medically underserved populations in cancer prevention and treatment trials?

    NOTE: All studies eligible for Questions 3 & 4 have been determined to be eligible for Q 1 & 2.

    In addition:

    Descriptive studies, such as studies that describe a recruitment strategy and results of that recruitment strategy, are eligible for Q 1 & 2 even if not for Q 3 & 4.

    Which recruitment strategies (media appeals, incentives, etc.) have been shown to be efficacious and/or effective in increasing participation of medically underserved populations in cancer treatment trials?

    Which recruitment strategies have been shown to be efficacious and/or effective in increasing participation of medically underserved populations in cancer prevention trials?

    NOTE: Studies will be considered eligible for Questions 3 & 4 as long as two or more recruitment strategies are compared, and may include pre- and post-comparison or historical comparisons.

    What are the documented barriers to (access, knowledge, attitudes, eligibility, fatalism, religiosity/spirituality, exclusions by design, etc.) and promoters of (attitudes, role of altruism, advanced disease, financial incentives, no-cost treatment, etc.) participation of underserved populations in cancer prevention and treatment trials?

    □ 5a. Do these barriers and promoters differ by age, gender, socioeconomic status, race/ethnicity?

    □ 5b. Are these barriers and promoters modified by cultural factors?

    What effects do the attitudes and perceptions of health care providers have on the efficacy/effectiveness of strategies for recruitment of medically underserved populations to cancer prevention and treatment trials?

    NOTE: Questions 5 & 6 include studies that assess willingness to participate in cancer trials even if they only address hypothetical trials.

    □ None of the above: IF THIS IS CHECKED, STOP HERE.

STUDY CHARACTERISTICS

2. What design was used to study the recruitment into this trial? (Check one)

□ Randomized controlled trial

□ Comparison of two or more non-randomized interventions (can include historical comparisons)

□ Case series

□ Survey

□ Qualitative (focus group or in-depth interviews)

□ Other (specify):________________________________________________________

□ Not applicable

NOTE: Complete the article review forms for Q3 & Q4 only if the study has a comparison group

3. What was the target population of the recruitment intervention? (Check all that apply)

□ Patients/participants

□ Researchers

□ Physicians

□ Organizations

□ Other (specify): ________________________________________________________

4. Where was the study conducted (study setting) OR where was the population recruited? (Check all that apply)

□ Community health facility (non-hospital)

□ Community (residents)

□ School

□ Faith-based organization

□ Work site

□ Unclear

□ Hospital inpatient

□ Hospital outpatient clinic

□ Group practice

□ Solo practice

□ Other community center (specify): ________________________________________

□ Other (specify): _____________________

5. What were the main objectives of the study on recruitment strategies?

  1. _____________________________________________________________________
    _____________________________________________________________________
  2. _____________________________________________________________________
    _____________________________________________________________________
  3. _____________________________________________________________________
    _____________________________________________________________________

6. Enter the characteristics of the main target patient population (e.g., numbers AND/OR percentages). Use comment box if intervention is targeted at more than one population. Enter “NS” where the number (or percentage) is not specified and “NA” where not applicable. Enter age range only if mean and median not provided.

Note: If the study does not define adolescent and elderly, then adolescent is defined as age between 12 and 21 years and elderly is defined as age older than 65 years.

□ Not applicable

□ No information on targeted patient population

N%
Female
Male
African American
American Indian/Alaskan Native
Asian/Pacific Islander
Caucasian
Hispanic
Adolescent: how defined __________________
____________________________________
Elderly: how defined _____________________
______________________________________
Low socioeconomic status: how defined _____
_____________________________________
Rural
MeanMedianRange
Age
Years of education
Income
Other: ______________________

Recruitment of Medically Underserved to Cancer Clinical Trials General Form - Addition

Comments:participant characteristics not captured in the previous tables:

7. What type(s) of cancer was/were the focus of the clinical trial to which the recruitment efforts were directed? ______________________________________________

8. What were the primary outcomes of the clinical trial to which the recruitment efforts were directed? (Check all that apply)

□ Cancer prevention

□ Primary

□ Secondary

□ Chemoprevention ______________________________________

□ Cancer treatment

□ Therapeutic

□ Complementary & alternative medicine (CAM)

□ Survival

□ Quality of life

□ Recurrence prevention

□ Complications _________________________

□ Other ____________________________________________________

□ Survivorship

□ Chemoprevention

□ Complementary & alternative medicine(CAM)

□ Survival

□ Quality of life

□ Recurrence prevention

□ Complications _________________________

□ Other ____________________________________________________

□ Other: ____________________________________________________

□ Other: ____________________________________________________

9. Date recruitment started: _______________________

10. Date recruitment ended: ________________________

11. Other comments about the study not already reported:

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

6

MeanMedianRange
Age (specify)
Years of education (specify)
Income (specify)
Other (define):
Other (define):
Other (define):
JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALLY UNDESERVED IN CANCER CLINICAL TRIALS
QUESTION 1 AND 2 - CONTENT REVIEW FORM
Article ID:______________________ First Author:_____________________
Reviewer 1: _____________________ Reviewer 2: _____________________

GENERAL QUESTIONS

1. How was recruitment defined?

□ Willingness to participate

□ Actual participation

□ Other (specify):___________________________________________________________

□ Not defined

□ Not applicable

RECRUITMENT METHODS

2. What method was used to design the recruitment plan? (Check all that apply)

□ Focus group
□ Survey
□ In-person interviews
□ Literature review
□ Other (specify):_________________________________________________________
□ Not reported
□ Not applicable

3. Describe the recruitment intervention(s):

  1. A. _________________________________________________________________________
    ______________________________________________________________________________
  2. B. __________________________________________________________________________
    ______________________________________________________________________________
  3. C. _________________________________________________________________________
    ______________________________________________________________________________
  4. D. ___________________________________________________________________________
    ______________________________________________________________________________
  5. E. _________________________________________________________________________
    ______________________________________________________________________________

□ F. Not applicable

□ G. Not reported

MEASURES OF SUCCESS OF RECRUITMENT

4. Was a recruitment goal for the underserved group(s) stated a priori?

□ Yes

□ No

□ Not applicable

If yes, what was the recruitment goal (percentage) for the underserved group(s)____________

5. What recruitment success measure was used in this study?

□ Geographic representation (e.g., % Asian in Baltimore compared to % Asian in study)

□ U.S. proportion of underserved group (e.g., % African-American in U.S. compared to % African-American in study)

□ Disease-specific proportion of underserved (e.g., % Native American with lung cancer compared to % Native American in study)

□ Research institution proportion of underserved (e.g., % underserved in that research institution compared to % in study)

□ Measure of recruitment success set arbitrarily by researchers.

Specify: _________________________________________________________________

□ Other (specify): _________________________________________________________

□ Not reported

□ Not applicable

6. If a measure of success was used, for which underserved group(s) was that measure reported? (Check all that apply)

□ African American

□ Asian American/Pacific Islander

□ Hispanic

□ Pacific Islander

□ Native American

□ Elderly

□ Adolescent

□ Rural

□ Low socioeconomic status

□ Other (specify): ___________________________________________________________

□ Not applicable

7. Other comments about the study not already reported:

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALLY UNDESERVED IN CANCER CLINICAL TRIALS
QUESTION 3 AND 4 - CONTENT REVIEW FORM
Article ID: _____________________ First Author: __________________
Reviewer 1: ____________________ Reviewer 2: ___________________

1. Sample size and number of individuals who participated in the study of the recruitment strategy, by target population. Enter numbers of group(s) that were the target of the intervention(s) for entire study (total for all groups). Enter “NS” where the number of participants is not specified and “NA” where not applicable (e.g., if no participants in study). “#completed” refers to the number of participants included in analysis for the entire study.

PatientsProvidersResearchersOther
# enrolled# randomized# completed study# enrolled# randomized# completed study# enrolled# randomized# completed study# enrolled# randomized# completed study

Comments:

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

2. At what level was the assignment of the recruitment intervention(s) made (i.e., if the trial was randomized, what was/were the unit(s) of randomization)? (Check all that apply)

□ Patients

□ Providers

□ Researchers

□ Organizations

□ Other (specify): __________________________________________________________

□ Not applicable

3. How many recruitment intervention arms did the study involve? ___________________

Name each group that was compared including control and each intervention group.

GroupName
A
B
C
D
E

Note: Each group listed above needs to have a Question 3 and 4 Supplemental Content Review form filled out.

4. Outcomes of recruitment intervention assessed by (check one):

□ Clinic

□ Patients

□ Providers

□ Researchers

□ Combination (specify): _____________________________________________________

□ Other (specify): ___________________________________________________________

5. Outcomes - Please provide details in boxes for ALL outcomes that are presented in the study.

Outcome of InterestN (Outcome of Interest)Point Estimate(Check one) □ SD □ CI □ SEP -value
MeanMedianRisk RatioOdds RatioDifferenceRate Ratio
A.
B.
C.
D.

6. Were the study recruitment goals met?

□ Yes

□ No

□ Unclear

7. Authors' conclusion/summary (check one):

□ Overall improvement in recruitment after intervention

□ Partial improvement or mixed results

□ No improvement after intervention

□ Decrease in recruitment

□ Unclear

□ Other (specify): ___________________________

8. Briefly summarize the authors' main conclusion(s):

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

9. Other comments about the study not already reported:

________________________________________________________________________________

________________________________________________________________________________

________________________________________________________________________________

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALLY UNDERSERVED
IN CANCER CLINICAL TRIALS
QUESTION 3 AND 4 – QUALITY REVIEW FORM
Article ID:______________________ First Author:_____________________
Reviewer 1: _____________________ Reviewer 2: _____________________

REPRESENTATIVENESS OF STUDY POPULATIONS

1. How would you characterize the authors' description of the setting and population from which the study sample was drawn, and the dates of the study?

a. Adequate (setting AND population described AND start and end date specified) 2
b. Fair (one or more of these NOT reported OR poor description) 1
c. Inadequate (not specified) 0

2. The degree to which detailed inclusion/exclusion criteria were provided was:

a. Adequate (detailed description of specific inclusion and exclusion criteria OR statement that all eligible patients enrolled) 2
b. Fair (some description, but would be difficult to replicate with the information provided) 1
c. Inadequate (minimal description or none at all) 0

3. The degree to which information provided on excluded or non-participating patients was:

a. Adequate (all reasons for exclusion AND number excluded OR no exclusions) 2
b. Fair (only one of above criteria specified or information not sufficient to allow replication) 1
c. Inadequate (none of the above criteria specified) 0

4. How well does the study describe key participant characteristics at enrollment?

Demographics: age, gender, race/ethnicity, education, income, occupation

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; screened for cancer

a. Good: Both categories described well (i.e., most items in the category described) 2
b. Fair: One of the two categories described well 1
c. Poor: No key patient characteristic categories described well 0

BIAS AND CONFOUNDING

5. The random assignment of participants to study group was:

a. Adequate (investigators could not predict assignment) 2
b. Partial (date of birth, admission date, hospital record number, or other non-random scheme for assignment OR did not state) 1
c. Not randomized 0
d. Unclear 0

6. Did the participant groups have any important differences in terms of key characteristics?

Demographics: age, gender, race/ethnicity, education, marital status, occupation, days from index MI to first day of therapy

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; screened for cancer

a. Groups equivalent in all factors examined 2
b. Groups have minor difference in one or two factors 1.5
c. Groups have an important difference in one or more factors OR a minor difference in more than two factors 1
d. Analysis not done 0

7. For the recruitment trial, the blinding of clinician, patient, and/or outcome assessors was:

a. Excellent (all three blinded, including all treatment arms) 2
b. Good (only two of the three blinded, OR some but not all of the arms) 1.5
c. Fair (only one of the three blinded) 1
d. Poor (no blinding OR not stated) 0
e. Not applicable NA

DESCRIPTION OF RECRUITMENT STRATEGY

8. Did the study describe details of the flow of participants through each stage of the clinical trial? For each group, reporting of the number of participants assigned to intervention, received intended intervention, completed the study protocol, and analyzed for the primary outcome was:

a. Adequate (all of the above described) 2
b. Fair (one of the above NOT described) 1
c. Inadequate (more than one of above NOT described) 0

9. The study description of the details of the recruitment strategy (i.e., methods of accrual, recruitment goals, measures of success) was:

a. Adequate (all of the above described) 2
b. Fair (one of the above NOT described) 1
c. Inadequate (more than one of above NOT described) 0

OUTCOMES AND FOLLOW-UP

10. How were the outcome measures of recruitment success defined?

eg., proportional representation relative to the U.S. population, proportional representation relative to incidence of a cancer in a specified population

a. Adequate(clear definitions of each outcome AND exact techniques to assess the outcome) 2
b. Fair (some description, but information not sufficient to allow replication) 1
c. Inadequate (no information provided) 0

11. The description of the measures used to define the recruitment barriers and promoters was:

Barrier measures : awareness, knowledge, attitudes/beliefs, self-efficacy, organizational environment, health literacy, access, eligibility, provider knowledge, provider attitudes/beliefs, fatalism, religiosity/spirituality, exclusions by design, eligibility, advanced disease

Promoter measures : attitudes, role of altruism, advanced disease, financial incentives, no-cost treatment, etc

a. Adequate (clear definitions of each measure AND exact techniques to assess the measure) 2
b. Fair (some description, but information not sufficient to allow replication) 1
c. Inadequate (no information provided) 0

12. Did the study report the numbers of and reasons for withdrawals from the study protocol or patients/participants otherwise lost to follow-up?

a. Numbers and reasons reported (or no withdrawals) 2
b. Only numbers OR reasons reported 1
c. Neither given 0

STATISTICAL QUALITY AND INTERPRETATION

13. The statistical analyses used to determine recruitment success were:

a. Adequate (identified for all analyses) 2
b. Fair (identified for some of the analyses) 1
c. Inadequate (not identified) 0

14. Were withdrawals, crossovers, and loss to follow-up handled appropriately in the analysis?

a. Loss to follow-up, withdrawals, or crossovers handled 2
b. By intention to treat/screen 2
c. Sensitivity analysis 1
d. None of the above 0

CONFLICTS OF INTEREST

15. The description of study's reporting or identification of the sources of funding was:

a. Adequate (source AND type or degree of involvement OR no funding) 2
b. Fair (source only) 1
c. Inadequate (neither) 0

16. Reflecting on this study as a whole, what is your overall impression of the quality of the study? (Check one)

  • Excellent
  • Very good
  • Good
  • Fair
  • Poor
JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALLY UNDERSERVED
IN CANCER CLINICAL TRIALS
QUESTION 3 AND 4 - SUPPLEMENTAL CONTENT REVIEW FORM
Article ID:______________________ First Author:_____________________
Reviewer 1: _____________________ Reviewer 2: _____________________

Group Name (From Item 3, p2, Recruitment Content Review Form for Q 3&4)

_____________________

[If no patients in study, skip to Item 2S]

1S. Enter subject characteristics as given, (e.g., numbers OR percentages) Enter “NS” where the number of participants is not specified and “NA” where not applicable. Enter age range only if mean is not provided.

If the study does not define adolescent and elderly, then adolescent is defined as age between 12 and 21 years and elderly is defined as age older than 65 years.

□ No patient information

N%
Female
Asian/Pacific Islander
African American
Caucasian
Hispanic
American Indian/Alaskan Native
Adolescent: how defined_______________________
Elderly: how defined__________________________
Low socioeconomic status: how defined___________
___________________________________________
Rural
MeanMedianRange
Age
Years of education
Income
Other

2S. Briefly describe the group intervention described on this form. Enter “NS” where number of

participants is not specified and “NA” where not applicable. “# completed” refers to total # included in analysis for this group.

Image er-recruitfu3.jpg

3S. Describe this trial group (intervention or control).

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

_____________________________________________________________________________________

4S. What recruitment methods were used in the intervention? (Check all that apply)

  • Written material
    • Book
    • Pamphlet
    • Flyer
    • Poster
    • Journal
    • Article
  • Audio-Visual (AV) material
    • Audiotape
    • Videotape
    • DVD
  • Case studies
  • Computer-based material
    • Website tutorial(w/URL)
    • E-mail
    • CD-ROM
    • DVD
  • Lecture/workshop
  • Self-study
  • Small group
  • Simulated patients/participants
  • Media
    • Newspaper
    • Radio
      • □ Public service announcements (PSAs)
      • □ Paid ads
    • Television
      • □ Public service announcements (PSAs)
      • □ Paid ads
    • Other: __________________________________________________________________
    5S. Number of training sessions for recruitment intervention?

______________sessions

  • □ Not specified
  • □ Not applicable

6S.What was the total duration for the most intensive training session for the recruitment intervention?

□ < 1 hours

□ 1 – 2 hours

□ 3 – 4 hours

□ 5 – 6 hours

□ Not specified

□ Not applicable

7S.What was the total amount of training for the recruitment intervention?

□ < 2 hrs

□ 2 – 10 hrs

□ 11 – 20 hrs

□ > 20 hrs

□ Not specified

□ Not applicable

8S. How often were the training sessions held for the recruitment intervention?

□ Once only

□ Weekly

□ Monthly

□ Other: ________________________________________________________________

□ Not specified

□ Not applicable

9S.What was the total number of training sessions held for the recruitment intervention?

□ 0

□ 1

□ 2

□ 3 – 4

□ 5 or more

10S. How much time elapsed from the beginning to the end of the intervention?

□ < 1 day

□ 1 – 29 days

□ 1 – 3 months

□ 4 – 6 months

□ 7 – 12 months

□ > 1 year

□ Not specified

11S.Was recruitment of medically underserved populations a primary outcome of this study?

□ Yes

□ No

12S.Comments about the intervention if not captured by the previous questions (i.e., brief description of the intervention, including duration and frequency).

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALLY UNERSERVED IN CANCER CLINICAL TRIALS
QUESTION 5 AND 6 - CONTENT REVIEW FORM
First ID: _____________________________ First Author: _____________________________
Reviewer 1: ______________________________ Reviewer 2: ______________________________

1. What types of barriers or promoters for recruitment of the medically underserved to cancer prevention/treatment trials did this study address? (Check all that apply)

□ Provider

□ Patient

□ Study design (e.g., restrictive inclusion and exclusion criteria)

□ Healthcare system (e.g., lack of clinical trials opened at a particular institution)

□ Other (specify): _____________________________________________________

□ Not Applicable

2. What patient barriers/promoters were associated with decreased or increased enrollment into cancer treatment/prevention trials? (Check one box in each row)

NoStatistically Significant DecreaseStatistically Significant IncreaseReported Qualitatively Important Decrease*Reported Qualitatively Important Increase*UnclearNot Addressed
Mistrust of research and medical system
Fear
Lack of knowledge about origins of cancer
Embarrassment
Transportation
Time commitment
Family considerations
Leaving care of physicians to participate in trial
Patient satisfaction with primary care doctor
Language barriers
Cultural barriers
Job issues
Indirect costs (e.g., income loss)
Lack of or inadequate health insurance
Religious/spiritual beliefs
Lack of education about clinical trials
Incentives (financial or other)
No-cost treatment
Lodging
Culturally relevant education about clinical trials
Perceived benefits/harms of clinical trial participation
Other (specify): _______________________________
Other (specify): _______________________________
*

As reported based on qualitative methods

3. What provider barriers/promoters were associated with decreased or increased enrollment into cancer treatment /prevention trials? (Check one box in each row)

NoStatistically Significant DecreaseStatistically Significant IncreaseReported Qualitatively Important Decrease*Reported Qualitatively Important Increase*UnclearNot Addressed
Mistrust of researchers (e.g., loss of clientele)
Cultural competence training
Training in communicating with patients
Provider race/ethnicity
Medical staff race/ethnicity
Provider attitudes
Incentive (financial or other)
Communication/ method of presentation
Ability to speak patient's language
Other (specify): _______________________________
Other (specify): _______________________________
*

As reported based on qualitative methods

4. What study design barriers/promoters were associated with decreased or increased enrollment into cancer treatment /prevention trials? (Check one box in each row)

NoStatistically Significant DecreaseStatistically Significant IncreaseReported Qualitatively Important DecreaseReported Qualitatively Important IncreaseUnclearNot Addressed
Comorbidity exclusion
Age exclusion
Medication exclusion
Functional status
Length of study/visit structure (e.g., interference with work hours)
Diagnostic test result cut‐off
Other (specify): _______________________________
Other (specify): _______________________________
*

As reported based on qualitative methods

5. What health care system barriers/promoters were associated with decreased or increased enrollment into cancer treatment /prevention trials? (Check one box in each row)

NoStatistically Significant DecreaseStatistically Significant IncreaseReported Qualitatively Important Decrease*Reported Qualitatively Important Increase*UnclearNot Addressed
Lack of minority doctors
Lack of other minority personnel
Lack of cultural competence among providers and/or staff
Lack of dissemination of study opportunities to provider/patient
Lack of language services
Other (specify): _______________________________
Other (specify): _______________________________
*

As reported based on qualitative methods

6. Did this study report any information about how barriers and promoters are modified by cultural factors?

□ Yes, describe briefly:_________________________________________________________________

□ No

7. Other comments about the study not already reported:

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

JOHNS HOPKINS EVIDENCE-BASED PRACTICE CENTER
RECRUITMENT OF THE MEDICALY UNDERSERVED IN CANCER CLINICAL TRIALS
QUESTION 5 AND 6 – QUALITY REVIEW FORM
Article ID: _______________________________ First Author: _____________________________
Reviewer 1: ______________________________ Reviewer 2: ______________________________

REPRESENTATIVENESS OF STUDY POPULATIONS

1. How would you characterize the authors' description of the setting and population from which the study sample was drawn, and the dates of the study?

a. Adequate (setting AND population described AND start and end date specified) 2
b. Fair (one or more of these NOT reported OR poor description) 1
c. Inadequate (not specified) 0

2. The degree to which detailed inclusion/exclusion criteria were provided was:

a. Adequate (detailed description of specific inclusion and exclusion criteria OR statement that all eligible patients enrolled) 2
b. Fair (some description, but would be difficult to replicate with the information provided)ss 1
c. Inadequate (minimal description or none at all) 0

3. The degree to which information provided on excluded or non-participating patients was:

a. Adequate (all reasons for exclusion AND number excluded OR no exclusions) 2
b. Fair (only one of above criteria specified or information not sufficient to allow replication) 1
c. Inadequate (none of the above criteria specified) 0

4. How well does the study describe key participant characteristics at enrollment?.

Demographics: age, gender, race/ethnicity, education, income, occupation

Medical characteristics: currently diagnosed with cancer (cancer survivor); never diagnosed with cancer; screened for cancer; cancer survivor

a. Good: both categories described well (i.e., most items in the category described) 2
b. Fair: one of two categories described well 1
c. Poor: neither category described well 0

5. Was the design of the study based on a conceptual model of the reported research?

a. Yes 2
b. No 0
c. Unclear 0

QUALITY REVIEW OF SURVEYS

[IF THIS IS NOT A SURVEY SKIP TO Q16]

6. What data collection methods were used in the study? (Check all that apply)

□ Self-administered questionnaire

  • □ By mail
  • □ Group-administered setting

□ Face-to-face interviews

□ Telephone interviews

□ Computer or computer assisted device (CAD)

□ Other _____________________________________________________________________

7. What was the response rate or the proportion of eligible people that actually completed the questionnaire?

a. 80 – 100 % 2
b. 60 – 79 % 1.5
c. 40 – 59 % 1
d. 20 – 39 % 0.5
e. < 20 % 0
f. Unclear 0

8. What was the intra-rater reliability of the survey instrument?

a. 80 – 100 % 2
b. 60 – 79 % 1.5
c. 40 – 59 % 1
d. 20 – 39 % 0.5
e. < 20 % 0
f. Unclear/Not reported 0
g. Not applicable N/A

9. What was the inter-rater reliability of the survey instrument?

a. 80 – 100 % 2
b. 60 – 79 % 1.5
c. 40 – 59 % 1
d. 20 – 39 % 0.5
e. < 20 % 0
f. Unclear/Not reported 0
g. Not applicable N/A

10. Was the survey instrument validated in terms of face, construct, and/or criteria validity?

Face validity: The extent to which the instrument appears to be measuring what it is supposed to measure.

Construct validity: The extent to which the measure of concern correlates with other measures in predicted ways, but for which no true criterion exists.

Criterion validity: The extent to which an instrument correlates with another more accurate (and usually more expensive) instrument (criterion).

a. Adequate: two or three of above types of validity 2
b. Fair: One of the above types of validity 1
c. Inadequate: None of the above type of validity 0

11. Was the study planned to have adequate power to detect differences between groups?

a. Yes 2
b. No 1
c. Unclear 0
d. Not applicable N/A

12. Was the study planned to have adequate power to detect changes within groups?

a. Yes 2
b. No 1
c. Unclear 0
d. Not applicable N/A

13. How well was the research question and objective(s) stated?

a. Adequate (research questions clear and objectives presented in specific terms) 2
b. Fair (research question and objectives presented but not in specific terms) 1
c. Inadequate (research question unclear AND/OR objectives not presented) 0

14. How were the study participants selected?

a. Consecutive selection 2
b. Random sampling 2
c. Other purposive sampling 1
d. Convenience sample 0
e. Unclear 0

15. Did the authors adequately justify the target population(s)?

a. Yes 2
b. Not specified 0
c. Unclear 0

QUALITY REVIEW OF QUALITATIVE STUDIES

16. How were the data generated? (Check all that apply)

□ Field observation/participant observation

□ In-depth interviews

□ Focus groups

□ Document analysis

□ Other ___________________________________________________________________

□ Not specified

17. Did the study use multiple methods of data collection?

a. Adequate (three or more methods were used) 2
b. Fair (two methods were used) 1
c. Inadequate (one method OR unclear) 0

18. Did the authors justify the method(s) of data generation?

a. Yes 2
b. No 0
c. Unclear 0

19. How were the study participants selected?

a. Random sampling 2
b. Other systematic sampling (e.g., consecutive selection) 2
c. Convenience sampling 1
d. Other 0
e. Unclear 0

20. How many times were study participants interviewed?

[If the study used an in-depth interview method, circle “not applicable”]

a. Two or more times (adequate) 2
b. Once (fair) 1
c. Never OR unclear (inadequate) 0
d. Not applicable N/A

21. How were the data captured?

a. Adequate ( both recorded AND transcribed) 2
b. Fair (recorded but not transcribed OR note taking only) 1
c. Inadequate (not recorded OR unclear) 0
d. Not applicable N/A

22. How would you rate the overall quality of this study?

[Answer Q 22 for ALL studies]

□ Excellent (excellent depth and breadth of study participant selection and data collection/analysis)

□ Good

□ Fair

□ Poor

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