SYSTEMATIC REVIEW

Interventions for preventing unintended pregnancies among adolescents

NU517 Clinical Scholarship for Evidence Based PracticeCornelia C. Campbell (Roline)

22 September 2010

PROBLEM AND PURPOSE

CLINICAL PROBLEM PURPOSE OF THIS SYSTEMATIC REVIEW

Unintended pregnancy among adolescents Public health challenge Developed &

developing countries Numerous prevention

strategies have been employed

Uncertainty exists regarding the effect of these strategies

To assess the effects of primary prevention interventions on unintended pregnancy in adolescents

SAMPLE SELECTION PROCESS

Search process: Used Cochrane Fertility Regulation

Group methods Searched:

a. Electronic resourcesb. Other resources

SAMPLE SELECTION PROCESS (CONT.)A. ELECTRONIC RESOURCES

Cochrane Central Register of Controlled Trials (CENTRAL) Specialist Health Promotion Register, Social Science Research Unit

(SSRU) Databases:

La Literatura Latinoamericana y del Caribe de Informacion en Ciencias de la Salud (LILACS) (Database 2008)

Social Science Citation Index (1981 – June 2007) Science Citation Index (1981 – June 2007) MEDLINE (1966 – Dec 2008) EMBASE (1980 – Nov 2008) Dissertations Abstracts Online

(http://library.dialog.com/bluesheets/html/bl0035.html) The Gray Literature Network (http://www.asti.gov/graylit/) HealthStar PsycINFO CINAHL POPLINE

SAMPLE SELECTION PROCESS (CONT.)A. OTHER RESOURCES

Contacted individual researchers Contacted National & International

research institutes, centers and organizations working in field of adolescent reproductive health Goal to obtain info on unpublished and/or

ongoing trials Read through references of all

selected studies Ensure no relevant studies left out

CRITIQUE SELECTION OF DATABASES

Appropriate = yes Focus on information

resources with special interest in adolescent reproductive health

Comprehensive = yes Looked at registers,

databases, citation indexes and gray literature.

Also contacted organizations and individuals

Reviewed references

Search methods (FYI) No language

restrictions (Translations sought were needed)

No restrictions on journal of publication

No country or geographical restrictions

Search terms listed in appendix

SAMPLE SELECTION PROCESS (CONT.)INCLUSION AND EXCLUSION CRITERIA

INCLUSION EXCLUSION

Individual and cluster randomized controlled trials (RCTs) which evaluated interventions aimed at :

Increasing knowledge and attitudes relating to risk of unintended pregnancies,

Promoting delay in the initiation of sexual intercourse and

Encouraged consistent use of birth control methods to reduce unintended pregnancies

• Participants were adolescents aged 10-19 years.

Quasi experimental studies Non-randomized controlled

studies None of the desired

outcomes were measured, Participants were pregnant Participants were couples Participants were above the

required age range Did not use the desired

intervention Stated method of

randomization not adequate.

QUALITY APPRAISALPROCESS USED TO EVALUATE THE METHODOLOGICAL QUALITY OF THE RESEARCH REPORTS

Clearly described in the report = yes Six parameters used:

1. Generation of allocation sequence2. Concealment of allocation3. Blinding4. Incomplete outcome data5. Selective outcome reporting6. Other sources of bias

Set of criteria is well defined and appears to be defensible

METHODOLOGICAL QUALITY1. GENERATION OF ALLOCATION SEQUENCE

This criterion was defined as: “Yes” when:

Method described was suitable to prevent bias Examples: computer generated random numbers;

table of random numbers; drawing lots “Unclear” when:

Method was not described but trail was described as “randomized”

“No” when: Sequences could be related to prognosis Examples: case record number; date of birth;

day, month or year of admission

METHODOLOGICAL QUALITY2. CONCEALMENT OF ALLOCATION

This criterion was defined as: “Yes” if:

Evidence that authors took proper measures to conceal allocation (example = centralized randomization)

“Unclear” if: Authors did not report concealment scheme,

or Reported a concealment approach that is

unclear “No” if:

Concealment of allocation was inadequate

METHODOLOGICAL QUALITY3. BLINDING

This criterion was defined as: “Yes” if:

Evidence of no blinding and outcomes are unlikely to be influenced by lack of blinding, or

Blinding of participants and key study personnel was ensured and unlikely that it was broken, or

Outcome assessment was blinding and non-blinding of others unlikely to introduce bias

“Unclear” if: Insufficient information, or Outcome not addressed

“No” if: No blinding and outcome likely to be influenced by blinding, or Blinding carried out but likely to be broken

METHODOLOGICAL QUALITY4. INCOMPLETE OUTCOME DATA

This criterion was defined as: “Yes” if:

Evidence of no missing outcome data, or Reason for missing outcome data unlikely to be related to true

outcome, or Missing outcome data balanced in numbers across intervention

groups and with similar reasons across groups for dichotomous outcome data

Proportion of missing outcome data not enough to have clinically relevant impact

“Unclear” if: Insufficient reporting of attrition/exclusions to permit judgment of

“yes” or “no” “No” if:

Reason for missing outcome data likely related to true outcome Proportion of missing outcome data enough to induce clinically

relevant bias

METHODOLOGICAL QUALITY5. SELECTIVE OUTCOME REPORTING

This criterion was defined as: “Yes” if:

All of the pre-specified (primary & secondary) outcomes of interest in the review have been reported as stated in protocol, or

Evident that published reports include all expected outcomes “Unclear” if:

Insufficient information to permit judgment of “yes” or “no” “No” if:

Not all of the study’s pre-specified outcomes have been reported, or

One/more primary outcomes were reported using measurements, analyses or subsets of data which were not pre-specified, or

One/more reported primary outcomes were not pre-specified One/more outcomes of interest are reported incompletely Study report fails to include results for key outcome that would be

expected to have been reported

METHODOLOGICAL QUALITY6. OTHER SOURCES OF BIAS

This criterion was defined as: “Yes” if:

Study is free of other sources of bias “Unclear” if:

Insufficient information to assess if an important risk of bias exists, or

Insufficient rationale or evidence that an identified problem will introduce bias

“No” if: Has extreme baseline imbalance, or Claimed to have been fraudulent, or Stopped early due to some data-dependent process, or Potential source of bias related to specific study design used

DATA ANALYSIS

Data extracted from each study Methods Participants Interventions Outcome measures and results Missing data

DATA ANALYSIS

Were individual patient data or aggregate data used in the analysis? Both

11 studies randomized individuals 27 studies randomized clusters (schools, classrooms,

communities) 3 studies had a mix of individual and cluster randomized

data

Does it include meta-analysis or meta-synthesis? Meta-analysis was performed using 10 of the

original 41 included studies

DATA SYNTHESIS

Models used included: Fixed Effect Model (FEM) and Random Effects Model (REM) for cases

where heterogeneity were detected Assessment of effect size and

confidence interval 95% Confidence Intervals (CI) Relative Risk (RR):

RR < 1 (negative RR) favors treatment/intervention RR > 1 (positive RR) favors no treatment/intervention

OUTCOME MEASURES

Primary outcomes:• Unintended pregnancy

Secondary outcomes:• Report changes in knowledge and attitudes about the risk

of unintended pregnancies• Initiation of sexual intercourse• Use of birth control methods• Abortion• Childbirth• Morbidity related to pregnancy, abortion or childbirth• Mortality related to pregnancy, abortion or childbirth• Sexually transmitted infections (including HIV)

Table 1Effect of Multiple Interventions on Primary Outcome (Unintended Pregnancy) and Secondary Outcome (Sexually Transmitted Diseases)

Outcome or subgroup title

Intervention Effect Size Intervention precision

expressed as Relative Risk

(R.R)expressed as Fisher’s Z

Level ofSignificance (p) Confidence Interval (C.I.)

Unintended pregnancy(Individually RCT) 0.72 (0.51 – 1.03) 1.82 p = 0.069 95%

Unintended pregnancy(Cluster RCT) 0.50 (0.23 – 1.09) 1.73 p = 0.083 95%

Sexually Transmitted Diseases

(Individually RCT) 0.45 (0.18 – 1.15) 1.67 p= 0.096 95%

Sexually Transmitted Diseases

(Cluster RCT) 0.76 (0.27 – 2.14) 0.51 p = 0.61 95%

OUTCOME TABLE

Table 2Effect of Single Intervention on Primary Outcome (Unintended Pregnancy) and Secondary Outcome (Sexually Transmitted Diseases)

Outcome or subgroup title

Intervention Effect Size Intervention precision

expressed as Relative Risk

(R.R)expressed as Fisher’s Z

Level ofSignificance (p)

Confidence Interval (C.I.)

Unintended pregnancy

(Individually RCT) 1.01 (0.81 – 1.26) 0.06 p = 0.96 95%

Sexually Transmitted Diseases

(Individually RCT) 0.92 (0.75 – 1.13) 0.83 p= 0.40 95%

OUTCOME TABLE

RESULTSEFFECTS OF MULTIPLE INTERVENTIONS ONPRIMARY OUTCOME - UNINTENDED PREGNANCY (UP)

2 RCT’s found the risk of UP lower in intervention group Results approached statistical significance (p = 0.069) RR 0.72 (95% CI 0.51 – 1.03)

5 Cluster RCTs found risk of UP lower in intervention group Results were not statistically significant (p = 0.083) RR 0.50 (95% CI 0.23 – 1.09)

Sensitivity analysis excluding trials with high attrition rates found significantly lower risk of UP in intervention group RR 0.20 (95% CI 0.10 – 0.39)

Sensitivity analysis combining cluster RCTs with individual RCTs found statistically significant lower risk of UP in intervention group. RR 0.49 (95% CI 0.33 – 0.74)

RESULTSEFFECTS OF SINGLE INTERVENTION ONPRIMARY OUTCOME – UNINTENDED PREGNANCY

Effect of contraceptive promotion Two individually RCTs indicated no

statistically significant difference between intervention and control group

RR 1.01 (95% CI 0.81 to 1.26)

RESULTSEFFECTS OF MULTIPLE INTERVENTIONS ONSECONDARY OUTCOME – SEXUALLY TRANSMITTED DISEASES

No results reported None of the included RCTs analyzed

effect of multiple interventions on STDs

RESULTSEFFECTS OF SINGLE INTERVENTION ON SECONDARY OUTCOME –SEXUALLY TRANSMITTED DISEASES

Effect of Contraceptive Use on STD’s One individual RCT found lower rate of STD among members of

intervention group RR 0.52 (95% CI 0.20 to 1.31)

Two cluster RCTs measured reporting of STDs among intervention group members compared to control group members

RR 0.72 (95% CI 0.26 to 2.02) Neither individual nor cluster RCTs yielded statistically significant

findings Effect of Contraceptive Promotion on STD’s

Two individual RCTs indicated no statistically significant difference found in risk of STDs between intervention group & control group

RR 0.92 (95% CI 0.75 to 1.13)

RESULTS & CONCLUSIONSPRIMARY OUTCOME: UNINTENDED PREGNANCY

Results were consistent across those studies that measured this outcome

Findings were not always statistically significant

Combined intervention effect was not statistically significant

Authors concluded that: Limited information suggests use of

multiple interventions can reduce rates of unintended pregnancies in adolescents

RESULTS & CONCLUSIONSSECONDARY OUTCOME: SEXUALLY TRANSMITTED DISEASES

No conclusive determination could be made due to: Insufficient data Variations in methods of reporting

IMPLICATIONS Implications for nursing practice

Concurrent use of multiple interventions (education, skill-building & contraception promotion) reduces risk of unintended pregnancy in adolescents

However, offers little evidence about effect of each of these interventions offered alone

Overall: evidence remains inconclusive

IMPLICATIONS What changes in practice were

proposed? None Evidence cannot be used as basis to

recommend the use or discontinuation of interventions

IMPLICATIONS How can nurses use the findings in

practice? Although findings does not change

practice, nurses can use it in their role as researchers by: Developing uniform approach in reporting

outcomes Conducting more trials in low-income

countries to provide a balance of evidence with regard to obvious disparities in socio-cultural and economic situations.

REFERENCE Oringanje, C., Meremikwu, M. M., Eko,

H., Esu, E., Meremikwu, A., & Ehiri, J. E. (2009). Interventions for preventing unintended pregnancies among adolescents. Cochrane Database of Systematic Reviews, (4). doi: 10.1002/14651858.CD005215.pub2