Jill Mollison

Cluster trials in implementation research: estimation of intracluster correlation coefficients and sample size

The cluster randomized trial with a concurrent economic evaluation is considered the gold standard evaluative design for the conduct of implementation research evaluating different strategies to promote the transfer of research findings into clinical practice. This has implications for the planning of such studies, as information is needed on the effects of clustering on both effectiveness and efficiency outcomes. This paper describes the design considerations specific to implementation research studies, focusing particularly on the estimation of sample size requirements and on the need for reliable information on intracluster correlation coefficients for both effectiveness and efficiency outcomes.

Midwife managed delivery unit: a randomised controlled comparison with consultant led care.

Abstract Objective: To examine whether intrapartum care and delivery of low risk women in a midwife managed delivery unit differs from that in a consultant led labour ward. Design: Pragmatic randomised controlled trial. Subjects were randomised in a 2:1 ratio between the midwives unit and the labour ward. Setting: Aberdeen Maternity Hospital, Grampian. Subjects—2844 low risk women, as defined by existing booking criteria for general practitioner units in Grampian. 1900 women were randomised to the midwives unit and 944 to the labour ward. Main outcome measures: Maternal and perinatal morbidity. Results: Of the women randomised to the midwives unit, 647 (34%) were transferred to the labour ward antepartum, 303 (16%) were transferred intrapartum, and 80 (4%) were lost to follow up. 870 women (46%) were delivered in the midwives unit. Primigravid women (255/596, 43%) were significantly more likely to be transferred intrapartum than multigravid women (48/577, 8%). Significant differences between the midwives unit and labour ward were found in monitoring, fetal distress, analgesia, mobility, and use of episiotomy. There were no significant differences in mode of delivery or fetal outcome. Conclusions: Midwife managed intrapartum care for low risk women results in more mobility and less intervention with no increase in neonatal morbidity. However, the high rate of transfer shows that antenatal criteria are unable to determine who will remain at low risk throughout pregnancy and labour.

Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial

Objective To compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility. Design Three arm parallel group, pragmatic randomised controlled trial. Setting Four teaching hospitals and a district general hospital in Scotland. Participants Couples with infertility for over two years, confirmed ovulation, patent fallopian tubes, and motile sperm. Intervention Expectant management, oral clomifene citrate, and unstimulated intrauterine insemination. Main outcome measures The primary outcome was live birth. Secondary outcome measures included clinical pregnancy, multiple pregnancy, miscarriage, and acceptability. Results 580 women were randomised to expectant management (n=193), oral clomifene citrate (n=194), or unstimulated intrauterine insemination (n=193) for six months. The three randomised groups were comparable in terms of age, body mass index, duration of infertility, sperm concentration, and motility. Live birth rates were 32/193 (17%), 26/192 (14%), and 43/191 (23%), respectively. Compared with expectant management, the odds ratio for a live birth was 0.79 (95% confidence interval 0.45 to 1.38) after clomifene citrate and 1.46 (0.88 to 2.43) after unstimulated intrauterine insemination. More women randomised to clomifene citrate (159/170, 94%) and unstimulated intrauterine insemination (155/162, 96%) found the process of treatment acceptable than those randomised to expectant management (123/153, 80%) (P=0.001 and P<0.001, respectively). Conclusion In couples with unexplained infertility existing treatments such as empirical clomifene and unstimulated intrauterine insemination are unlikely to offer superior live birth rates compared with expectant management. Trial registration ISRCT No: 71762042

Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects

Abstract Objective: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. Design: Prospective randomised controlled trial. Setting: Obstetrics and gynaecology department of a large teaching hospital. Subjects: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women)). Main outcome measures: Mental state, marital relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. Results: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss of sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. Conclusions: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. Key messages Key messages Hitherto hysterectomy has been the preferred procedure, though women may be ill postoperatively The introduction of hysteroscopic procedures demands an evaluation of different surgical methods according not only to gynaecological criteria but also in terms of their psychiatric and psychosocial outcome This randomised trial of hysterectomy and hysteroscopic surgery found that both methods had satisfactory outcomes in terms of anxiety, depression, and psychosocial adjustment

Size does matter

Journal of Family Planning and Reproductive Health Care 2003: 29(1) Introduction When designing an epidemiological study or clinical trial it is important to make it large enough to have a reasonable chance of detecting differences between groups that really exist. In other words, the study should have adequate statistical power. Unfortunately the scientific literature is cluttered with numerous small studies reporting negative results. Individually, each study can only make a modest contribution to clinical practice since it is impossible to know whether a negative result was due to a true lack of effect or limited ability to detect an effect. Absence of evidence is not the same as evidence of absence. In this paper we describe the concepts behind statistical power, including the pieces of information needed when determining the sample size of a study (i.e. how many individuals need to be selected from the study population).

A comparison of bladder and ovarian function two years following hysterectomy or endometrial ablation.

Objective To test the hypothesis that at two years bladder and ovarian function function are no different following either simple hysterectomy or endometrial ablation (transcervical resectiodlaser ablation).

Simulated patients in the community pharmacy setting. Using simulated patients to measure practice in the community pharmacy setting.

Background: Performance measurement and quality of care in community pharmacy settings is problematic because of the lack of formal patient registration and the resultant risk of selection bias. Although simulated patients have been used for teaching and education purposes, particularly in medical settings, their use as a research tool requires exploration in other health settings. The purpose of this paper is to describe how we used simulated patients to measure professional performance of community pharmacy staff.Method: Sixty pharmacies participated in a randomised controlled trial (RCT) to evaluate the effectiveness and efficiency of two guideline implementation strategies in the community pharmacy setting. The primary outcome measure for the study was derived from assessment forms completed by simulated patients following covert visits to participating pharmacies.Results: Of the 420 simulated patient visits scheduled, 384 (91%) were completed. Nine visits were reported by pharmacy staff using reply-paid postcards, four of which concurred with known SP visits. Each detected visit was made by a different SP. In a post-intervention survey, 26 (52%) pharmacists stated they had been apprehensive about the use of simulated patients as part of the study, however, 41 (82%) pharmacists agreed that SP visits were an acceptable research method to use in a community pharmacy setting.Discussion: Simulated patients are a feasible method of assessing professional performance in community pharmacy settings and overcome the methodological problems of other measurement methods. Further research is needed to assess the reliability and validity of simulated patients.

A pragmatic randomised comparison of transcervical resection of the endometrium with endometrial laser ablation for the treatment of menorrhagia

Objective To compare endometrial laser ablation (ELA) with transcervical resection of the endometrium (TCRE) in the treatment of menorrhagia.

Primary mode of delivery and subsequent pregnancy

Objective  To investigate the relationship between primary mode of delivery and subsequent pregnancy and to compare the findings with a previous study conducted on an earlier cohort from the same population.

Satisfaction and the three C's: continuity, choice and control. Women's views from a randomised controlled trial of midwife-led care

Objective 1. To explore whether there are differences in womens satisfaction with care in a midwife‐managed delivery unit compared with that in a consultant‐led labour ward. 2. To compare factors relating to continuity, choice and control between the two randomised groups.