Do clinical guidelines enhance safe practice in obstetrics and gynaecology?

Clinical guidelines are increasingly used to promote a more uniform standard of high-quality evidence-based health care. International agencies advocate guideline development methods founded on three principles: that recommendations are evidence-based, are explicitly linked to the type and quality of evidence, and are developed by multidisciplinary stakeholder groups. Numerous interventions have been described to support the implementation of guidelines. Systematic reviews suggest that most interventions produce modest to moderate improvements in care; multifaceted interventions appear to be no more effective than single interventions, and the lowest-cost implementation strategy (dissemination of printed materials) may improve care and be feasible in many settings. Given the considerable costs of developing valid guidelines de novo, we advocate local adaptation of existing guidelines if available. We suggest a pragmatic framework to assist policy-makers and clinicians in deciding how best to use the scarce resources available for quality-improvement activities.

Near miss audit in obstetrics.

PURPOSE OF REVIEW: Over the past decade, there has been increasing interest internationally in studying maternal near misses, or severe morbidity, to complement traditional audit of maternal mortality. This review summarizes studies in this field published during 2005-2006. RECENT FINDINGS: There is wide variation among published studies in terms of definitions of near miss, sources of data, and assessment of quality of care. Some investigators focus on single categories of near miss (e.g. postpartum haemorrhage, obstetric hysterectomy, intensive care unit admission), whereas others include multiple categories (ranging from two to 14). Some groups identify cases from routinely collected administrative data; whereas others search hospital registers and individual case records. Many investigators make no attempt to assess quality of care or preventability, but restrict their studies to the reporting of rates of severe morbidity. Others assess care by means of interviews with survivors or case note review, but study only a sample of cases and cannot report incidence rates. A minority of investigators both report incidence rates and assess quality of care. SUMMARY: Near miss audit is increasingly used to complement maternal mortality review. Standardization of inclusion criteria and of methods for case assessment would facilitate comparisons over time and among countries.

Impact on maternity professionals of novel approaches to clinical audit feedback.

The authors compared three approaches to feedback of clinical audit findings relating to miscarriage in 15 Scottish maternity services (printed report alone; report plus action planning letter; report plus face-to-face facilitated action planning). Clinicians were surveyed to measure theory of planned behavior constructs (in the context of two audit criteria) before and after feedback (n = 253) and assessed perceptions of the audit through in-depth interviews (n = 17). Prefeedback, clinicians had positive attitudes and strong subjective norms and intentions to comply, although perceived behavioral control was lower. Generally, positive attitudes, subjective norms, and intentions increased after feedback but for one of the two criteria (providing a 7-day miscarriage service), perceived behavioral control decreased. No changes over time reached statistical significance, and analysis of covariance (adjusting for prefeedback scores) showed no consistent relationships between method of feedback and postfeedback construct scores. Interviews revealed positive perceptions of audit but frustration at lack of capacity to implement changes. Although interventions that increased intensity of feedback proved feasible and acceptable to clinicians, the authors were unable to demonstrate that they increased intention to comply with audit criteria.

The effect of the national demonstration project Healthy Respect on teenage sexual health behaviour.

BACKGROUND: As part of the independent evaluation of Healthy Respect (a national demonstration project to improve teenage sexual health in Scotland) this study examined the effect of the school-based sexual health education intervention comprising multiprofessional classroom delivery and alongside drop-in clinics on teenage sexual behaviour outcomes. METHODS: Before-and-after cross-sectional surveys of secondary school pupils (average age 14 years and 6 months) were used in 10 Healthy Respect intervention schools in Lothian region and 5 comparison schools without intervention in Grampian region (2001 and 2003). RESULTS: By 2003, the proportion of pupils in Lothian feeling confident about getting condoms and using condoms properly significantly increased, more Lothian pupils (particularly boys) showed improved knowledge about condoms being protective against sexually transmitted infections. No further evidence of improved knowledge, attitudes, or intentions was evident after the intervention. Pupils in Lothian remained more likely to think using a condom would be embarrassing (especially girls), would reduce sexual enjoyment (especially boys), and intentions about condom use (as closer predictors of actual behaviour change) showed no significant improvement. More Lothian ( approximately 24%) than Grampian ( approximately 19%) pupils report having had sexual intercourse at age <16 years, both before and after the intervention, with no evidence of a significant reduction in Lothian by 2003. Overall differences in attitudes to condom use by gender were noted. Findings remain consistent in both unadjusted and adjusted comparisons. CONCLUSION: These findings demonstrate limited impact on sexual health behaviour outcomes, and raise questions about the likely and achievable sexual health gains for teenagers from school-based interventions.

Treatment of pain during medical abortion.

A structured literature review was undertaken to determine, in the context of early medical abortion, the proportion of women who require analgesia, the predictors of analgesia requirement and the most appropriate analgesia regimen. Studies from different centers show wide variations in analgesia use, but, overall, around 75% of women use narcotic analgesics on the day of prostaglandin administration. Differences are likely to be due to differences in policies for offering analgesia rather than differences in patient characteristics. The following characteristics are consistently associated with increased requirement for analgesia: increasing gestation, younger patient age, nulliparity and White race. A regimen comprising 325-500 mg of paracetamol (acetaminophen) with 10 mg of dihydrocodeine or 30 mg of codeine has been used by thousands of women without apparent problems.

Terminology in early pregnancy loss: what women hear and what clinicians write.

OBJECTIVE: The Royal College of Obstetricians and Gynaecologists recommends that patient-focused terminology be used in early pregnancy care. The objective of the study was to evaluate whether inappropriate terminology is continuing to be used in Scottish gynaecology services. METHODS: A case note review (1259 records) and a patient survey (648 replies) assessed usage of four inappropriate terms ('abortion', 'blighted ovum', 'incompetent cervix' and 'pregnancy failure') in 18 Scottish hospitals providing secondary care to women with early pregnancy loss. RESULTS: Women reported hearing 'abortion' in 4.2% of hospital episodes (95% CI 2.9-6.0), but the term was used in 9.9% (95% CI 8.4-11.7) of hospital records. CONCLUSION: In order to meet national recommendations on terminology for early pregnancy loss, clinicians should not only say 'miscarriage' but also write it.

FFPRHC Guidance (July 2005): The use of contraception outside the terms of the product licence.

This Guidance provides information for clinicians and women considering the use of contraception outside the terms of the product licence. A key to the grades of recommendations, based on levels of evidence, is given at the end of this document. Details of the methods used by the Clinical Effectiveness Unit (CEU) in developing this Guidance and evidence tables summarising the research basis of the recommendations are available on the Faculty website (www.ffprhc.org.uk). Abbreviations (in alphabetical order) used include: CEU, Clinical Effectiveness Unit; COC, combined oral contraception/contraceptive; DMPA, depot medroxyprogesterone acetate; ENG, etonogestrel; IUD, copper-bearing intrauterine contraceptive device; LNG-IUS, levonorgestrel-releasing intrauterine system; NET-EN, norethisterone enantate; PGD, Patient Group Direction; PIL, Patient Information Leaflet; POC, progestogen-only contraception/contraceptive; POEC, progestogen-only emergency contraception; POP, progestogen-only pill; RCT, randomised controlled trial; SPC, Summary of Product Characteristics; UPSI, unprotected sexual intercourse; WHO, World Health Organization; WHOMEC, WHO Medical Eligibility Criteria for Contraceptive Use; WHOSPR, WHO Selected Practice Recommendations for Contraceptive Use.

The acceptability of home medical abortion to women in UK settings.

OBJECTIVE: To assess the acceptability of home medical abortion to women in UK settings. DESIGN: Questionnaire survey. SETTING: Four NHS gynaecology units in England and Scotland. SUBJECTS: Women undergoing conventional, hospital-based, medical abortion up to nine weeks of gestation. METHODS: A self-complete questionnaire explored the acceptability of abortion in hospital (including pain and bleeding experienced) and at home. Comparisons were made between centres (English and Scottish). MAIN OUTCOME MEASURE: Women's views on home administration of misoprostol for medical abortion; perceived acceptability and perceived ability to cope with the process at home. RESULTS: Sixty-six percent (366/553) of the questionnaires were returned: Edinburgh, 204 (56%); London, 92 (25%); Hull, 43 (12%); and Glasgow, 27 (7%). Individual questionnaire items were answered by varying numbers of women: 228/320 (71%; 95% CI: 66-76%) said there was nothing that happened during abortion in the hospital that they would have been unable to cope with at home; 123/342 (36%; 95% CI: 31-41%) said they would have opted to have home abortion, had that choice been available. However, 219/342 (64%; 95% CI: 59-69%) indicated that they would prefer to have abortion in the hospital. The majority of women said they would have coped at home with bleeding (280/355, 79%; 95% CI: 74-83%) and with pain if given analgesia (203/268, 76%; 95% CI: 70-81%). CONCLUSION: This study suggests that most women would welcome being offered the choice of having medical abortion at home or in hospital. The development of home abortion must be seen as complementary, not an alternative, to hospital services.

Theory-based identification of barriers to quality improvement: induced abortion care.

BACKGROUND: The UK Royal College of Obstetricians and Gynaecologists published the clinical guideline, The Care of Women Requesting Induced Abortion, to address recognized variations in care. There is little empirical evidence on factors that influence compliance with the guideline. A better understanding of such factors is needed for quality improvement initiatives. OBJECTIVE: To identify factors that influence compliance with two key guideline recommendations: offer of an assessment appointment within 5 days of referral, and supply of contraceptives at discharge. SETTING: Thirteen hospital gynaecology units in Scotland. METHODS: Guideline compliance was measured by a case note review. Barriers and facilitators were identified using a combination of approaches: semi-structured interviews with local gynaecologists and a survey of clinical staff. The questionnaire, based upon constructs from the Theory of Planned Behaviour, measured behavioural intention, attitude, subjective norm (perceived social pressure), and perceived behavioural control. RESULTS: Of 507 cases reviewed, median unit compliance was 46% for the assessment appointment and 59% for contraceptive supplies. Questionnaires were returned by 151 (74%) of 205 staff in 12 units. The interviews and open-ended questions highlighted organizational barriers to guideline implementation. Staff generally had strong intentions and positive attitudes to follow both recommendations. For the assessment appointment, perceived behavioural control was low. The Theory of Planned Behaviour accounted for 27% of the variation in intentions, with subjective norm being the strongest predictor. Intention and perceived behavioural control best explained unit compliance, together explaining 15% of the variation. For contraceptive supplies, the theory accounted for 34% of the variation in intentions, with perceived behavioural control being the strongest predictor. CONCLUSION: Clinical staff were highly motivated to implement the guideline but hindered by organizational constraints. Quality improvement initiatives need to target organizational barriers as well as individual professionals.

Are national recommendations regarding examination and disposal of products of miscarriage being followed? A need for revised guidelines?

BACKGROUND: National guidance documents advise that tissue obtained from treatment of miscarriage should be submitted for histological examination to exclude trophoblastic disease and ectopic pregnancy, and require sensitive disposal of human tissue. The aim of this study was to determine the extent to which health professionals have adopted these recommendations. METHODS AND RESULTS: Fifteen Scottish Obstetric and Gynaecology services participated in an audit of early pregnancy loss care. Three audit tools were used. In a case note review, 484 women completed medical or surgical treatment for miscarriage. 71% of records contained evidence of histological examination of tissue. Documentation of discussion of disposal of tissue with the woman was found in 29% of records. In a patient survey, 648 women with threatened or confirmed miscarriage returned questionnaires. Active treatment occurred in 134 cases. Only 55%, 50.9% and 47.4% reported being 'informed', 'consented' and 'involved', respectively, with decisions about tissue disposal. In a staff survey, a postal questionnaire was administered to 224 gynaecologists, with 144 replies. Self reported practice as 'seldom' or 'occasional' for sending tissue for histological examination was 34% for surgical evacuation and 57% for medical management. Reporting of 'seldom' or 'occasional' discussion of disposal of tissue with the woman was 42% and 49% for surgical and medical treatment, respectively. CONCLUSIONS: National guidance on these issues was found to be contentious and implementation was variable. Wide consultation with stakeholders is needed prior to the publication of revised guidance.

The impact of guidelines on mild hypertension in pregnancy: time series analysis.

OBJECTIVE: To determine the impact of a national strategy to promote implementation of a guideline on the management of mild, non-proteinuric hypertension in pregnancy. DESIGN: Simple, interrupted time series analysis. SETTING: Four maternity units in Scotland. POPULATION: Women delivering a live or stillborn baby. METHODS: Dissemination of the guideline under the auspices of a national clinical effectiveness programme, supported by a national launch meeting and feedback from a survey of obstetricians highlighting aspects of care that could be improved. MAIN OUTCOME MEASURES: Appropriateness of initial investigation and subsequent clinical management, and costs of guideline development and implementation activities. DATA COLLECTION: Twenty-four months pre-intervention and 12 months post-intervention data were abstracted from a random sample of case notes. RESULTS: Initial investigation was consistent with recommendations for 59.9% out of 1263 women and subsequent clinical management for 67.6% out of 1081 in whom a diagnosis could be made from available data. There were no significant changes in the appropriateness of initial investigation (10.6%; 95% confidence interval [CI] -0.1% to 19.3%; decreasing by 1.2% per month post-implementation, 95% CI -2.5% to 0.1%) or clinical management (-0.3%; 95% CI -8.7% to 11.2%). Guideline development and implementation cost an estimated pound 2784 per maternity unit in Scotland. CONCLUSIONS: Clinical care of mild hypertension in pregnancy remains highly inconsistent. The lack of the intervention effect may be related to the complexity of the guideline recommendations and the nature of the implementation strategy.

Quantifying severe maternal morbidity: a Scottish population study.

OBJECTIVE: To quantify the incidence of severe maternal morbidity in Scotland and determine the feasibility of doing so. DESIGN: Prospective observational study. SETTING: All 22 consultant led maternity units in Scotland, between 1 October 2001 and 30 September 2002. POPULATION: Women during pregnancy and the puerperium. METHODS: Definitions for 13 categories of severe maternal morbidity were developed from published work. Recruitment of maternity units, and training of staff, took place at a national meeting. Each month, every unit reported cases meeting the agreed definitions, the category of incident and date. Data were collated centrally and analysed to determine the frequency of incidents. The number of maternal deaths occurring in Scotland over the same period was obtained from the Confidential Enquiry into Maternal Deaths. MAIN OUTCOME MEASURES: Number and rate of defined events being reported. A subjective view of the feasibility of collecting national data routinely. RESULTS: Severe morbidity was reported in 196 women, out of 51,165 deliveries in Scotland (rate 3.8 per 1000 deliveries). Thirty percent of cases fell into more than one defined category. Major obstetric haemorrhage accounted for 50% of events. Only a third of identified patients were admitted to intensive care units. Four relevant maternal deaths occurred. CONCLUSIONS: Categories of severe maternal morbidity can be defined and may provide a useful measure of the quality of maternity services, particularly in developed countries where maternal mortality is very rare. It appears feasible to set up a national reporting system for maternal morbidity, as well as mortality.

FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception.

This Guidance provides information for clinicians providing women with copper-bearing intrauterine devices as long-term contraception. A key to the grades of recommendations, based on levels of evidence, is given at the end of this document. Details of the methods used by the Clinical Effectiveness Unit (CEU) in developing this Guidance and evidence tables summarising the research basis of the recommendations are available on the Faculty website (www.ffprhc.org.uk). Abbreviations (in alphabetical order) used include: acquired immune deficiency syndrome (AIDS); actinomyces-like organisms (ALOs); automated external defibrillator (AED); blood pressure (BP); British National Formulary (BNF); confidence interval (CI); copper-bearing intrauterine contraceptive device (IUD); emergency contraception (EC); Faculty Aid to Continuing Professional Development Topic (FACT); levonorgestrel-releasing intrauterine system (IUS); human immunodeficiency virus (HIV); Medicines and Healthcare products Regulatory Agency (MHRA); non-steroidal antiinflammatory drugs (NSAIDs); odds ratio (OR); pelvic inflammatory disease (PID); relative risk (RR); Royal College of Obstetricians and Gynaecologists (RCOG); Scottish Intercollegiate Guidelines Network (SIGN); sexually transmitted infection (STI); termination of pregnancy (TOP); World Health Organization (WHO); WHO Medical Eligibility Criteria (WHOMEC); WHO Selected Practice Recommendations (WHOSPR).