Beverley Lawton

Main morbidities recorded in the women's international study of long duration oestrogen after menopause (WISDOM): a randomised controlled trial of hormone replacement therapy in postmenopausal women

Objective To assess the long term risks and benefits of hormone replacement therapy (combined hormone therapy versus placebo, and oestrogen alone versus combined hormone therapy). Design Multicentre, randomised, placebo controlled, double blind trial. Setting General practices in UK (384), Australia (91), and New Zealand (24). Participants Postmenopausal women aged 50-69 years at randomisation. At early closure of the trial, 56 583 had been screened, 8980 entered run-in, and 5692 (26% of target of 22 300) started treatment. Interventions Oestrogen only therapy (conjugated equine oestrogens 0.625 mg orally daily) or combined hormone therapy (conjugated equine oestrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily). Ten years of treatment planned. Main outcome measures Primary outcomes: major cardiovascular disease, osteoporotic fractures, and breast cancer. Secondary outcomes: other cancers, death from all causes, venous thromboembolism, cerebrovascular disease, dementia, and quality of life. Results The trial was prematurely closed during recruitment, after a median follow-up of 11.9 months (interquartile range 7.1-19.6, total 6498 women years) in those enrolled, after the publication of early results from the womens health initiative study. The mean age of randomised women was 62.8 (SD 4.8) years. When combined hormone therapy (n=2196) was compared with placebo (n=2189), there was a significant increase in the number of major cardiovascular events (7 v 0, P=0.016) and venous thromboembolisms (22 v 3, hazard ratio 7.36 (95% CI 2.20 to 24.60)). There were no statistically significant differences in numbers of breast or other cancers (22 v 25, hazard ratio 0.88 (0.49 to 1.56)), cerebrovascular events (14 v 19, 0.73 (0.37 to 1.46)), fractures (40 v 58, 0.69 (0.46 to 1.03)), and overall deaths (8 v 5, 1.60 (0.52 to 4.89)). Comparison of combined hormone therapy (n=815) versus oestrogen therapy (n=826) outcomes revealed no significant differences. Conclusions Hormone replacement therapy increases cardiovascular and thromboembolic risk when started many years after the menopause. The results are consistent with the findings of the womens health initiative study and secondary prevention studies. Research is needed to assess the long term risks and benefits of starting hormone replacement therapy near the menopause, when the effect may be different. Trial registration Current Controlled Trials ISRCTN 63718836

Exercise on prescription for women aged 40-74 recruited through primary care: two year randomised controlled trial.

Objective To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period. Design Randomised controlled trial. Setting 17 primary care practices in Wellington, New Zealand Participants 1089 women aged 40-74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week Intervention Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months. Main outcome measure Physical activity assessed at baseline and 12 and 24 months. Secondary outcomes were quality of life (SF-36), weight, waist circumference, blood pressure, concentrations of fasting serum lipids, glycated haemoglobin (HbA1c), glucose, insulin, and physical fitness. Results Mean age was 58.9 (SD 7) years. Trial retention rates were 93% and 89% at 12 and 24 months, respectively. At baseline, 10% of intervention participants and 11% of control participants were achieving 150 minutes of at least moderate intensity physical activity a week. At 12 months rates increased to 43% and 30% and at 24 months to 39.3% and 32.8% (P<0.001), respectively. SF-36 physical functioning (P=0.03) and mental health (P<0.05) scores improved more in intervention compared with control participants, but role physical scores were significantly lower (P<0.01). There were no significant differences in clinical outcomes. More falls (P<0.001) and injuries (P=0.03) were recorded in the intervention group. Conclusions This programme of exercise on prescription increased physical activity and quality of life over two years, although falls and injuries also increased. This finding supports the use of exercise on prescription programmes as part of population strategies to reduce physical inactivity. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ANZCTRN012605000490673.

Health related quality of life after combined hormone replacement therapy: randomised controlled trial

Objective To assess the effect of combined hormone replacement therapy (HRT) on health related quality of life. Design Randomised placebo controlled double blind trial. Setting General practices in United Kingdom (384), Australia (94), and New Zealand (24). Participants Postmenopausal women aged 50-69 at randomisation; 3721 women with a uterus were randomised to combined oestrogen and progestogen (n=1862) or placebo (n=1859). Data on health related quality of life at one year were available from 1043 and 1087 women, respectively. Interventions Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year. Main outcome measures Health related quality of life and psychological wellbeing as measured by the women’s health questionnaire. Changes in emotional and physical menopausal symptoms as measured by a symptoms questionnaire and depression by the Centre for Epidemiological Studies depression scale (CES-D). Overall health related quality of life and overall quality of life as measured by the European quality of life instrument (EuroQol) and visual analogue scale, respectively. Results After one year small but significant improvements were observed in three of nine components of the women’s health questionnaire for those taking combined HRT compared with those taking placebo: vasomotor symptoms (P<0.001), sexual functioning (P<0.001), and sleep problems (P<0.001). Significantly fewer women in the combined HRT group reported hot flushes (P<0.001), night sweats (P<0.001), aching joints and muscles (P=0.001), insomnia (P<0.001), and vaginal dryness (P<0.001) than in the placebo group, but greater proportions reported breast tenderness (P<0.001) or vaginal discharge (P<0.001). Hot flushes were experienced in the combined HRT and placebo groups by 30% and 29% at trial entry and 9% and 25% at one year, respectively. No significant differences in other menopausal symptoms, depression, or overall quality of life were observed at one year. Conclusions Combined HRT started many years after the menopause can improve health related quality of life. Trial registration ISRCTN 63718836.

Effectiveness of a Falls‐and‐Fracture Nurse Coordinator to Reduce Falls: A Randomized, Controlled Trial of At‐Risk Older Adults

OBJECTIVES: To assess the effectiveness of a community‐based falls‐and‐fracture nurse coordinator and multifactorial intervention in reducing falls in older people.

Impact of long-acting reversible contraception on return for repeat abortion.

OBJECTIVE The objective of the study was to determine the rate of return for repeat abortion in relation to postabortion contraceptive method choice 24 months onward from an intervention study. STUDY DESIGN This was a prospective cohort study involving a hospital note search for 510 women 24 months after an abortion. RESULTS Women using long-acting reversible contraceptive (LARC) methods (intrauterine device [IUD] and depot medroxyprogesterone acetate) had significantly lower return rates for repeat abortion (6.45%; 95% confidence interval [CI], 4.0-9.8) than non-LARC users, of whom 14.5% returned (95% CI, 9.9-20.2). A Cox proportional hazard analysis showed that the postabortion method choice was significantly related to the likelihood of returning for a repeat abortion (P = .002), controlling for major demographic factors and previous pregnancy history. Using the pill as a reference group for risk of repeat abortion, the IUD hazard ratio (HR) was 0.36 (95% CI, 0.17-0.77), the depot medroxyprogesterone acetate HR was 0.55 (95% CI, 0.21-1.45), and the HR for all other methods was 1.8 (95% CI, 0.83-3.92). CONCLUSION This study provides strong support for the promotion of immediate postabortion access to LARC methods (particularly intrauterine devices) to prevent repeat abortion.

Uptake and adherence to long-acting reversible contraception post-abortion

BACKGROUND This study aimed to increase use of long-acting reversible contraceptive (LARC) methods by women post-abortion. STUDY DESIGN Ten-week intervention at a public abortion clinic involving free access to three LARC methods (DMPA, LNG-IUS, Multiload Cu375); posters promoting LARC; updated information for clinic staff. OUTCOME MEASURES change in the proportion of women choosing LARC prior to and during the intervention; rate of follow-up and method retention at 6 weeks and at 6 months post-abortion. RESULTS Use of post-abortion LARC increased significantly from 44% at baseline (226/510) to 61% (310/510) during the intervention (p<.001). Use of LNG-IUS increased almost sixfold from 6% to 36%. Follow-up rates were 71% at 6 weeks (221/310) and 74% at 6 months (184/249). Method retention was 89% at 6 weeks (197/221) and 86% at 6 months (159/184). CONCLUSION Uptake of LARC by women post-abortion can be achieved by increasing access to these methods - by eliminating cost and raising awareness and benefits of long-acting methods among both clinicians and patients.

Attitudes toward long-acting reversible contraception among young women seeking abortion.

AIMS Use of long-acting reversible contraceptive (LARC) methods can reduce rates of unplanned pregnancy and abortion, but for a range of reasons, these methods are underused by young women. A third of women seeking abortion return for a subsequent abortion during their reproductive years and could benefit from using effective long-acting methods. We aimed to explore the attitudes of women seeking abortion toward contraception, with a focus on long-acting methods. METHODS Thirty women aged 16-25 (of Maori, Pacific Island, and European ethnicities) were recruited at a public hospital abortion clinic to participate in a semistructured interview. Participants were asked about past use of contraception, their understanding of pregnancy risk, reasons for method choice; and views on long-acting methods. Qualitative data were analyzed using thematic content analysis. RESULTS There was a lack of prior knowledge about LARC methods (particularly intrauterine devices [IUD] and implants). Once information was provided, these methods were generally viewed favorably. Cost was a key factor in contraceptive choice, prohibiting choice of the Mirena® levonorgestrel intrauterine system (LNG-IUS) or an implant for many women. Other important factors that determined method use and choice were familiarity with methods, whether or not they contained hormones, likely effect on periods, and other side effects. CONCLUSIONS Access issues relating to LARC methods (including cost and awareness) need to be urgently addressed. When discussing postabortion contraceptive options, women would benefit from simple explanations about LARC: their appropriateness for women of all reproductive ages, reversible nature, mechanisms of action, impact on menstruation, and other potential side effects.

Preventability of severe acute maternal morbidity

OBJECTIVE We sought to assess potential preventability of severe acute maternal morbidity (SAMM) cases admitted to intensive-care units (ICUs) or high-dependency units (HDUs). STUDY DESIGN Inclusion criteria were admissions to ICUs or HDUs of women who were pregnant or within 42 days of delivery in 4 District Health Board areas (accounting for a third of annual births in New Zealand) during a 17-month period. Cases were reviewed by external multidisciplinary panels using a validated model for assessing preventability. RESULTS In all, 98 SAMM cases were assessed; 38 (38.8%) cases were deemed potentially preventable, 36 (36.7%) not preventable but improvement in care was needed, and 24 (24.5%) not preventable. The most frequent preventable factors were clinician related: delay or failure in diagnosis or recognition of high-risk status (51%); and delay or inappropriate treatment (70%). The most common causes of preventable severe morbidity were blood loss and septicemia. CONCLUSION The majority of SAMM cases were potentially preventable or required improvement in care. Themes around substandard care related to delay in diagnosis and treatment for postpartum hemorrhage and septicemia. These findings can inform clinical educational programs and policies to improve maternal outcomes. This study has now been expanded to a national New Zealand audit of all SAMM cases admitted to an ICU/HDU.

Self-obtained vaginal swabs for PCR chlamydia testing: A practical alternative

This study shows that given a choice, New Zealand women at high risk for sexually transmitted infections (STI) opt to provide a self‐taken vaginal swab over a clinician‐taken sample for STI testing. Self‐obtained vaginal swabs have previously been shown to have equal sensitivity and specificity to endocervical swabs and greater sensitivity than urine for the detection of Chlamydia trachomatis by polymerase chain reaction (PCR). We suggest that self‐obtained vaginal swabs should be a readily available option offered to women for chlamydia testing by PCR in New Zealand.

Promoting Uptake of the HPV Vaccine: The Knowledge and Views of School Staff

BACKGROUND School-based human papillomavirus (HPV)/cervical cancer vaccination programs have been implemented widely, but few studies have investigated the knowledge and views of school staff about this new vaccine. METHODS Prior to the introduction of the HPV vaccine in 2009, we surveyed staff at 14 socioeconomically diverse schools to assess views toward this new program, including staffs information needs, ideas on promoting return of consent forms, and uptake of the vaccine among minority groups. RESULTS Of 583 invited staff, 456 participated (78%). About 58% of the participants knew about the link between HPV and cervical cancer, and that HPV is passed on during sexual contact. When asked if vaccination would increase sexual activity at a younger age, 71% disagreed, 6% agreed, and 23% were unsure. The majority of staff agreed that vaccine uptake could be improved through provision of information and consent forms in indigenous and Pacific languages; ensuring parents are well informed and girls educated about the vaccine; involving community groups and by extending availability of the vaccine into community settings as well as school and primary care. Three fourths of the staff surveyed wanted more information about the program before and during its implementation. CONCLUSIONS This important group of stakeholders requires appropriate information so that they can support girls and their parents in deciding whether to have the vaccine. School staff members are potential health advocates with whom consultation should occur before and during the implementation of such programs.