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Effect of educational leaflets and questions on knowledge of contraception in women taking the combined contraceptive pill: randomised controlled trial.

OBJECTIVE: To assess whether provision of educational leaflets or questions on contraception improves knowledge of contraception in women taking the combined contraceptive pill. DESIGN: Randomisation of women into three groups according to type of educational leaflet on contraceptive information. These groups were subdivided into two on the basis of questions on contraception asked by the doctor or practice nurse. The women were followed up by postal questionnaire 3 months later. SETTING: 15 general practices in South and West region. SUBJECTS: 636 women attending check up appointment for repeat prescription of the combined contraceptive pill. MAIN OUTCOME MEASURES: Knowledge of: factors causing pill failure, subsequent action, emergency contraception, and all the rules (pill rules) that apply to the contraceptive pill. RESULTS: 523 women returned completed questionnaires (response rate 82%). Knowledge of contraception with no intervention was low with only 10 (12%) women knowing all the pill rules. Educational intervention had a highly significant effect on knowledge of: factors causing pill failure (likelihood ratio chi2=22); subsequent action (21); emergency contraception (24); and all the pill rules (22) (P<0.01 in all cases). Improvement in knowledge of all the pill rules occurred with provision of the summary leaflet (28% knew all the rules, adjusted odds ratio 4.04, 95% confidence interval 1.68 to 9.75), the Family Planning Association's leaflet (27%, 3.43, 1.45 to 8.09), and asking questions (26%, 3.03, 1.30 to 7.00). Asking questions in addition to provision of leaflets improved knowledge of contraception further for the summary leaflet (39%, 6.81, 2.85 to 16.27) but not for the Family Planning Association leaflet (21%, 2.58, 1.07 to 6.18). CONCLUSION: Women attending check ups for repeat prescriptions of the contraceptive pill should be provided with educational leaflets on contraception or asked relevant questions to help improve their knowledge of contraception. Asking questions in addition to providing a summary leaflet is time consuming, but results in the most knowledge gained.

Adolescent↗

Randomised controlled trial comparing effectiveness of touch screen system with leaflet for providing women with information on prenatal tests.

OBJECTIVE: To compare the effectiveness of touch screen system with information leaflet for providing women with information on prenatal tests. DESIGN: Randomised controlled trial; participants allocated to intervention group (given access to touch screen and leaflet information) or control group (leaflet information only). SETTING: Antenatal clinic in university teaching hospital. SUBJECTS: 875 women booking antenatal care. INTERVENTIONS: All participants received a leaflet providing information on prenatal tests. Women in the intervention arm also had access to touch screen information system in antenatal clinic. MAIN OUTCOME MEASURES: Women's informed decision making on prenatal testing as measured by their uptake of and understanding of the purpose of specific tests; their satisfaction with information provided; and their levels of anxiety. RESULTS: All women in the trial had a good baseline knowledge of prenatal tests. Women in the intervention group did not show any greater understanding of the purpose of the tests than control women. However, uptake of detailed anomaly scans was significantly higher in intervention group than the control group (94% (351/375) v 87% (310/358), P=0.0014). Levels of anxiety among nulliparous women in intervention group declined significantly over time (P<0.001). CONCLUSIONS: The touch screen seemed to convey no benefit over well prepared leaflets in improving understanding of prenatal tests among the pregnant women. It did, however, seem to reduce levels of anxiety and may be most effective for providing information to selected women who have a relevant adverse history or abnormal results from tests in their current pregnancy.

Attitude to Health↗

Randomised controlled trial of self management leaflets and booklets for minor illness provided by post.

OBJECTIVE: To assess the effectiveness of providing information by post about managing minor illnesses. DESIGN: Randomised controlled trial. SETTING: Six general practices. PARTICIPANTS: Random sample of 4002 patients from the practice registers. INTERVENTION: Patients were randomised to receive one of three kinds of leaflet or booklet endorsed by their general practitioner: control (surgery access times), booklet, or summary card. MAIN OUTCOME MEASURES: Attendance with the 42 minor illnesses listed in the booklet. Perceived usefulness of leaflets or booklets, confidence in managing illness, and willingness to wait before seeing the doctor. RESULTS: 238 (6%) patients did not receive the intervention as allocated. Of the remaining 3764 patients, 2965 (79%) had notes available for review after one year. Compared with the control group, fewer patients attended commonly with the minor illnesses in the booklet group (>/=2 consultations a year: odds ratio 0.81, 95% confidence interval 0.67 to 0.99) and the summary card group (0.83; 0.72 to 0.96). Among patients who had attended with respiratory tract infections in the past year there was a reduction in those attending in the booklet group (0.81; 0.62 to 1.07) and summary card group (0.67; 0.51 to 0.89) compared with the control group. The incidence of contacts with minor illness fell slightly compared with the previous year in the booklet (incidence ratio 0.97; 0.84 to 1.13) and summary card groups (0.93; 0.80 to 1.07). More patients in the intervention groups felt greater confidence in managing illness (booklet 32%, card 34%, control 12%, P<0.001), but there was no difference in willingness to wait score (all groups mean=32, P=0.67). CONCLUSION: Most patients find information about minor illness provided by post useful, and it helps their confidence in managing illness. Information may reduce the number attending commonly with minor illness, but the effect on overall contacts is likely to be modest. These data suggest that posting detailed information booklets about minor illness to the general population would have a limited effect.

Adult↗

Assessment of impact of information booklets on use of healthcare services: randomised controlled trial.

OBJECTIVES: To investigate the effect of patient information booklets on overall use of health services, on particular types of use, and on possible interactions between use, deprivation category of the area in which respondents live, and age. To investigate the possibility of a differential effect on health service use between two information booklets. DESIGN: Randomised controlled trial of two patient information booklets (covering the management and treatment of minor illness). SETTING: 20 general practices in Lothian, Scotland. PARTICIPANTS: Random sample of patients from the community health index (n=4878) and of those contacting out of hours services (n=4530) in the previous 12 months in each of the study general practices. INTERVENTION: Booklets were posted to participants in intervention groups (3288 were sent What Should I Do?; 3127 were sent Health Care Manual). Patients randomised to control group (2993) did not receive a booklet. MAIN OUTCOME MEASURES: Use of health services audited from patients' general practice notes in 12 months after receipt of booklet. RESULTS: Receipt of either booklet had no significant effect on health service use compared with a control group. However, nine out of ten matched practices allocated to receive Health Care Manual had reduced consultation rates compared with matched practices allocated to What Should I Do? CONCLUSION: Widespread distribution of information booklets about the management of minor illness is unlikely to reduce demand for health services.

Family Practice↗

Reducing antibiotic use for acute bronchitis in primary care: blinded, randomised controlled trial of patient information leaflet.

OBJECTIVE: To assess whether sharing the uncertainty of the value of antibiotics for acute bronchitis in the form of written and verbal advice affects the likelihood of patients taking antibiotics. DESIGN: Nested, single blind, randomised controlled trial. SETTING: Three suburban general practices in Nottingham Participants: 259 previously well adults presenting with acute bronchitis. INTERVENTION: In group A, 212 patients were judged by their general practitioner not to need antibiotics that day but were given a prescription to use if they got worse and standard verbal reassurance. Half of them (106) were also given an information leaflet. All patients in group B (47) were judged to need antibiotics and were given a prescription and encouraged to use it. MAIN OUTCOME MEASURES: Antibiotic use in the next two weeks. Reconsultation for the same symptoms in the next month. RESULTS: In group A fewer patients who received the information leaflet took antibiotics compared with those who did not receive the leaflet (49 v 63, risk ratio 0.76, 95% confidence interval 0.59 to 0.97, P=0.04). Numbers reconsulting were similar (11 v 14). In group B, 44 patients took the antibiotics. CONCLUSION: Most previously well adults with acute bronchitis were judged not to need antibiotics. Reassuring these patients and sharing the uncertainty about prescribing in a information leaflet supported by verbal advice is a safe strategy and reduces antibiotic use.

Acute Disease↗

Qualitative study of evidence based leaflets in maternity care.

OBJECTIVE: To examine the use of evidence based leaflets on informed choice in maternity services. DESIGN: Non-participant observation of 886 antenatal consultations. 383 in depth interviews with women using maternity services and health professionals providing antenatal care. SETTING: Women's homes; antenatal and ultrasound clinics in 13 maternity units in Wales. PARTICIPANTS: Childbearing women and health professionals who provide antenatal care. INTERVENTION: Provision of 10 pairs of Informed Choice leaflets for service users and staff and a training session in their use. MAIN OUTCOME MEASURES: Participants' views and commonly observed responses during consultations and interviews. RESULTS: Health professionals were positive about the leaflets and their potential to assist women in making informed choices, but competing demands within the clinical environment undermined their effective use. Time pressures limited discussion, and choice was often not available in practice. A widespread belief that technological intervention would be viewed positively in the event of litigation reinforced notions of "right" and "wrong" choices rather than "informed" choices. Hierarchical power structures resulted in obstetricians defining the norms of clinical practice and hence which choices were possible. Women's trust in health professionals ensured their compliance with professionally defined choices, and only rarely were they observed asking questions or making alternative requests. Midwives rarely discussed the contents of the leaflets or distinguished them from other literature related to pregnancy. The visibility and potential of the leaflets as evidence based decision aids was thus greatly reduced. CONCLUSIONS: The way in which the leaflets were disseminated affected promotion of informed choice in maternity care. The culture into which the leaflets were introduced supported existing normative patterns of care and this ensured informed compliance rather than informed choice.

Adult↗

Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice.

OBJECTIVE: To assess the effect of leaflets on promoting informed choice in women using maternity services. DESIGN: Cluster trial, with maternity units randomised to use leaflets (intervention units) or offer usual care (control units). Data collected through postal questionnaires. SETTING: 13 maternity units in Wales. PARTICIPANTS: Four separate samples of women using maternity services. Antenatal samples: women reaching 28 weeks' gestation before (n=1386) and after (n=1778) the intervention. Postnatal samples: women at eight weeks after delivery before (n=1741) and after (n=1547) the intervention. INTERVENTION: Provision of 10 pairs of Informed Choice leaflets for service users and midwives and a training session for staff in their use. MAIN OUTCOME MEASURES: Change in the proportion of women who reported exercising informed choice. SECONDARY OUTCOMES: changes in women's knowledge; satisfaction with information, choice, and discussion; and possible consequences of informed choice. RESULTS: There was no change in the proportion of women who reported that they exercised informed choice in the intervention units compared with the control units for either antenatal or postnatal women. There was a small increase in satisfaction with information in the antenatal samples in the intervention units compared with the control units (odds ratio 1.40, 95% confidence interval 1.05 to 1.88). Only three quarters of women in the intervention units reported being given at least one of the leaflets, indicating problems with the implementation of the intervention. CONCLUSION: In everyday practice, evidence based leaflets were not effective in promoting informed choice in women using maternity services.

Attitude to Health↗

Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial.

OBJECTIVES: To determine whether consumer involvement would help to solve some of the ethical problems associated with research into thrombolysis for acute ischaemic stroke, with its inherent risk of fatal intracranial haemorrhage. DESIGN: Quantitative and qualitative research. SETTING AND PARTICIPANTS: CONSULTATION PHASE: three meetings were held to discuss the planned research, and participants completed a questionnaire. QUALITATIVE WORK: focus group meetings explored the issues raised during the consultation phase. Design of information leaflets for patients and relatives: trial materials were drafted during the consultation phase and revised in the light of feedback from the focus group meetings and review by patients and carers on a stroke rehabilitation unit. RESULTS: 54 people attended the consultation meetings. Four (9%) participants considered the risks of thrombolysis too great, but most (89%) were prepared to accept the treatment in a clinical trial. Nearly all would accept treatment if it was shown to be effective. Most (85%) would give their consent to enter the planned trial. The focus group meetings and feedback from patients and carers led to significant changes in the information leaflets. The revised trial materials were considered ethical by a national multicentre research ethics committee. CONCLUSIONS: Consumers generally supported a planned trial, and their involvement helped to refine trial consent procedures and led to an ethically acceptable trial design.

Acute Disease↗

Self help smoking cessation in pregnancy: cluster randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of a self help approach to smoking cessation in pregnancy. DESIGN: Pragmatic cluster randomised controlled trial with community midwife as the unit of randomisation. SETTING: Three NHS hospital trusts in England. PARTICIPANTS: 1527 women who smoked at the start of pregnancy. INTERVENTION: A series of five self help booklets comprising a step by step programme to increase motivation for quitting smoking and to teach strategies for cessation and relapse prevention. The first booklet was given to the women by a midwife at the earliest opportunity in antenatal care, together with a booklet for partners, family members, and friends. The remaining four booklets were mailed directly to the women. MAIN OUTCOME MEASURES: The primary outcome was smoking cessation validated by cotinine measurement at the end of the second trimester of pregnancy. Other outcomes were self reported smoking status and cigarette consumption among daily smokers. Qualitative data exploring the acceptability of the intervention and the way that smoking cessation advice was delivered in both trial arms were also collected. RESULTS: Smoking cessation rates were low: the cotinine validated rates were 18.8% (113/600) in the intervention group and 20.7% (144/695) in the normal care group (difference 1.9%, 95% confidence intervals -3.5% to 7.3%). Self reported quit rates were higher. In the intervention group, 156 (25.6%) women reported not smoking for at least seven days, compared with 207 (29.1%) in the normal care group. In both groups, median self reported daily cigarette consumption among daily smokers was 10 cigarettes per day. Pregnant women and midwives approved of the intervention, but the way in which it was delivered varied considerably. For the primary smoking outcome, the degree of clustering at the midwife level was non-trivial (intracluster correlation coefficient 0.031). CONCLUSION: The self help intervention was acceptable but ineffective when implemented during routine antenatal care. More intensive and complex interventions, appropriately targeted and tailored, need to be developed and evaluated. Validated smoking cessation rates among pregnant women are substantially lower than the self reported rates on which current smoking policy is based.

Cluster Analysis↗