Background
The importance of detailed and accurate reporting in randomised controlled trials
Quality of reporting—what is the current state of the literature?
Despite known effective interventions, many pregnant women do not receive best-practice smoking cessation care
What do clinicians need to know to translate evidence from smoking cessation clinical trials into clinical practice?
Aims
Methods
Literature search
Database | Search terms |
---|---|
Cochrane | [Smoking (MeSH) OR smoking cessation (MeSH)] AND [pregnant women (MeSH) OR prenatal care (MeSH) OR pregnancy (MeSH) OR postpartum period (MeSH)] AND [clinical trial (MeSH) OR intervention studies(MeSH) OR evaluation studies (MeSH)] |
Medline | [Smoking (MeSH) OR Smoking cessation (MeSH)] AND [pregnant women (MeSH) OR prenatal care (MeSH) OR pregnancy (MeSH) OR postpartum period (MeSH)] AND [clinical trial (MeSH) OR Intervention studies (MeSH) OR evaluation studies (MeSH)] |
PsycInfo | [Tobacco smoking (subject heading) OR smoking cessation (subject heading)] AND [prenatal care (subject heading) OR pregnancy (subject heading) OR postnatal period (subject heading)] AND [clinical trial (subject heading) OR intervention (subject heading) OR evaluation (subject heading)] |
Inclusion and exclusion criteria
Study selection
Development of checklist of essential elements
Domain | Descriptor |
---|---|
Recipient
| Is the target population clearly described? Minimum criteria: age, ethnicity, stage of pregnancy at enrolment, socioeconomic status (either income, education or employment) |
Setting
| Is the setting in which the intervention was implemented described? E.g., Family practice, specialist obstetrics clinic, public hospital antenatal unit, in woman’s home. |
Provider
| Is it clear who delivered the intervention? E.g., Nurse, Doctor, Midwife, Counsellor. |
Delivery
| Is the mode of delivery of the intervention components described? E.g., Face-to-face, telephone, mail, internet |
Is the method of delivery of the intervention described? E.g., is it part of usual care or a separate program | |
Schedule
| Is the timing of the first and last contact described |
Intensity and Duration
| Is the total number of intended contacts for the intervention described? Must be reported for each mode of contact |
Is the total time period the intervention was delivered over clear? E.g., 12 week intervention | |
Is the frequency of contact (the time period between each contact) described? E.g., daily, fortnightly | |
Is the approximate duration of each contact described? E.g., 15 minute face-to-face session | |
Intervention fidelity
| Is the number of participants who received the intervention as intended reported? |
Intervention materials
| Is the method of quit advice provided described? E.g., recommendation to quit immediately, set quit date |
Are the behavioural change approaches adequately described? Needs to refer to specific techniques used in enough detail for replication, or refer to detailed manual that is available to reader. | |
Are written materials (brochures, pamphlets) adequately described? Needs to be described in a level of detail that is replicable, OR materials publically available | |
Was the type, strength, frequency and duration of use of NRT described? | |
Was the use of incentives clearly described? Needs to describe type (financial or other), amount, frequency, conditions under which they were provided | |
Was social support adequately described? Needs to include type of support (support groups, quit buddy) | |
Clinical Pathway
| Is the process of care for women unwilling to quit described? E.g., are they approached again? If so, in what timeframe and how? |
Is the process of care for women who relapse described? What support is provided? How soon after relapse and how? | |
Skills and Qualifications
| Are the skills and professional qualifications of the individual delivering the intervention described? |
Training
| Is the process of training in the intervention adequately described? Duration/format/training manual |
Data coding
Results
Search results
Description of included studies
Quality of reporting of intervention strategies
Criteria | Criteria reported | Criteria not reported | Criteria not applicable |
---|---|---|---|
N (%) | N (%) | N | |
Recipient
| 36 (80%) | 9 (20%) | 0 |
[35b, 36, 37c, 38, 40-44, 45b, 47b, 49b, 51b, 52c, 54, 55, 56b, 57b, 58, 59, 61, 63b, 64b] | [39, 46, 48, 50, 53, 60, 62c] | ||
Setting
| 36 (80%) | 9 (20%) | 0 |
[36, 37c, 39, 41-44, 45b, 47b, 49b, 50, 51b, 52c, 53-55, 56b, 57-61, 62c, 64b] | [35b, 38, 40, 46, 48, 57, 63b] | ||
Provider delivering intervention
| 43 (96%) | 2 (4%) | 0 |
[35b, 36, 37c, 38, 40-44, 45b, 46, 47b, 49b, 50, 51b, 52c, 53-55, 56b, 57b, 58-61, 62c, 63b, 64b] | [39, 48] | ||
Mode of delivery
| 45 (100%) | 0(0%) | 0 |
[35, 36, 37c, 38-44, 45b, 46, 47b, 48, 49b, 50, 51b, 52c, 53-55, 56b, 57b, 58-61, 62c, 63b, 64b] | |||
Timing of first and last contact
| 22 (49%) | 23 (51%) | 0 |
[38-40, 42, 43, 45b, 47b, 51b, 53, 56b, 57b, 59, 62, 63b, 64b] | [35b, 36, 37c, 41, 44, 46, 48, 49b, 50, 52c, 54, 55, 58, 60, 61, 62b] | ||
Total number of intended contacts
| 31 (69%) | 14 (31%) | 0 |
[37c, 38, 40-44, 48, 49b, 50, 51b, 53, 55, 56b, 57b, 59-61, 62c, 63b, 64b] | [35b, 36, 39, 45b, 46, 47b, 52c, 54, 58] | ||
Total time period of intervention delivery
| 27 (60%) | 18 (40%) | 0 |
[35b, 37c, 38, 40-43, 45b, 48, 53, 56b, 57b, 58-62, 63b, 64b] | [36, 39, 44, 46, 47b, 49b, 50, 51b, 52c, 54, 55, 62b] | ||
Frequency of contact
| 33 (73%) | 12 (27%) | 0 |
[37c, 38, 40-43, 45b, 46, 47b, 48, 49b, 51b, 53, 55, 56b, 57b, 59, 61, 62c, 63b, 64b] | [35b, 36, 39, 44, 50, 52c, 54, 58, 60] | ||
Approximate duration of each contact
| 20 (45%) | 24 (55%) | 1 |
[37b, 38, 40, 42, 44, 49b, 50, 53, 56b, 57b, 58-61, 64b] | [35b, 36, 39, 41, 43, 45b, 46, 47b, 48, 51b, 52c, 54, 55, 62c, 63b] | [37] | |
Intervention fidelity
| 28 (63%) | 17 (37%) | 0 |
[38, 39, 41-43, 46, 47b, 48, 49b, 50, 51b, 56b, 57b, 58-60, 62c, 63b, 64b] | [35b, 36, 37c, 40, 44, 45b, 52c, 53-55, 61] | ||
Method of quitting advised
| 11 (24%) | 34 (76%) | 0 |
[38-42, 52c, 59, 63b] | [35b, 36, 37c, 43, 44, 45b, 46, 47b, 48, 49b, 50, 51b, 53-55, 56b, 57b, 58, 60, 61, 62c, 64b] | ||
Behavioural counselling approach
| 13 (30%) | 30 (70%) | 2 |
[38, 40, 43, 44, 49b, 50, | [53, 62] | ||
54, 57b, 59, 63b] | [35b, 36, 37c, 39, 41, 42, 45b, 46, 47b, 48, 51b, 52c, 55, 56b, 58, 60, 61, 62b, 64b] | ||
Written materials
| 17 (52%) | 16 (48%) | 12 |
[36, 37b, 42, 43, 49b, 50, 51b, 52b, 53, 56b, 58, 60] | [39, 40, 45b, 46, 47b, 55, 57b, 59, 61, 63b, 64b] | [35b, 37, 38, 41, 44, 48, 52, 54, 62c] | |
NRT
| 5 (83%) | 1 (17%) | 39 |
[44, 48, 56, 63b] | [51] | [35b, 36, 37c, 38-43, 45b, 46, 47b, 49b, 50, 51, 52c, 53-56, 57b, 58-61, 62c, 64b] | |
Incentives
| 8 (100%) | 0 (0%) | 37 |
[45b, 47b, 62b, 64b] | [35b, 36, 37c, 38-44, 46, 48, 49b, 50, 51b, 52c, 53-55, 56b, 57b, 58-62, 63b] | ||
Social support
| 4 (36%) | 7 (64%) | 34 |
[37b, 46, 50] | [35b, 42, 44, 51, 52b] | [36-41, 43, 45b, 47b, 48, 49b, 51-55, 56b, 57b, 58-61, 62c, 63b, 64b] | |
Process of care for women unwilling to quit
| 10 (22%) | 35(78%) | 0 |
[36, 38, 40, 42, 55, 58, 62b, 63b] | [35b, 37c, 39, 41, 43, 44, 45b, 46, 47b, 48, 49b, 50, 51b, 52c, 53, 54, 56b, 57b, 59-62, 64b] | ||
Process of care for women who relapse
| 2 (4%) | 43 (96%) | 0 |
[38, 55] | [35b, 36, 37c, 39-44, 45b, 46, 47b, 48, 49b, 50, 51b, 52c, 53, 54, 56b, 57b, 58-61, 62c, 63b, 64b] | ||
Skills and professional qualifications of provider delivering intervention
| 31 (69%) | 14 (31%) | 0 |
[35b, 36, 37c, 38, 40-44, 49b, 50, 51b, 52c, 53-55, 57b, 58-61, 63b] | [39, 45b, 46, 47b, 48, 56b, 62c, 64b] | ||
Specific training given to providers
| 10 (23%) | 34 (77%) | 1 |
[38, 49b, 50, 52, 57b, 60, 64b] | [35b, 36, 37b, 39-44, 45b, 46, 47b, 48, 51b, 52b, 53-55, 56b, 58, 59, 61, 62c, 63b] | [37] |
Intervention arms | |
---|---|
N (%) | |
90% – 100% of relevant criteria | 1 (2%) |
[38] | |
80% – 89% of relevant criteria | 0 (0%) |
70% – 79% of relevant criteria | 10 (22%) |
[40, 42, 43, 49b, 57b, 59, 63b] | |
60% – 69% of relevant criteria | 9 (20%) |
[37b, 41, 50, 53, 56b, 64b] | |
50% – 59% of relevant criteria | 9 (20%) |
[37, 44, 51b, 55, 58, 60-62] | |
40% – 49% of relevant criteria | 9 (20%) |
[36, 45b, 47b, 52b, 62b] | |
30% – 39% of relevant criteria | 3 (7%) |
[48, 52, 54] | |
20% – 29% of relevant criteria | 4 (9%) |
[35b, 39, 46] |