An evaluation of pre-registration midwifery education in England. Research design: a case study approach.

In this paper some aspects of research design are described and discussed. A national study to evaluate pre-registration midwifery education in England is currently in progress. As part of that study six case study sites have been selected. How those sites were selected and the theory and method of the case study approach are discussed in this paper. The value of the case study approach is discussed as are methodological issues of the case study method. What is a case? Are case studies representative? How can you generalise from case studies? What is theoretical sampling? What is the difference between statistical and logical inference? These are some of the questions raised and examined. It is suggested that an understanding of these theoretical issues and the research process is important to understand the research findings. By making the research design explicit and describing the research process the study also adopts a reflexive approach.     

Our unrequited love for simple explanation.

In the complex and often perplexing field of perinatology, it is often tempting to extrapolate the results of the latest published study to our daily clinical practice, especially when the study appears to provide simple answers to difficult questions. This tendency is further encouraged by sensational media coverage and commentaries that, by necessity, further simplify the issues and hype the speculation. Without a critical appraisal of the study population, methodology, analysis and conclusions stated, globalizing a single study's results to anyone's clinical practice can be well-intentioned but misguided. As an example, approximately 1 year ago the results of an NICHD study involving home uterine activity monitoring (HUAM) were released. The study concluded that, while the likelihood of preterm delivery increased with an increased baseline frequency of uterine contractions, measurement of this contractility was not a clinically efficient predictor of preterm delivery. Through the media and editorials that followed, the study results became translated so as to indicate that HUAM was not effective in preventing preterm delivery or improving perinatal outcomes. In our desire for a simple and definitive conclusion on HUAM, key facts about this study were forgotten. In the NICHD study, uterine contraction data were blinded to both physician and patient, and only intermittent preterm monitoring was used with no provision for emergency monitoring; a study design that guaranteed patient management and outcomes would not be affected by HUAM. Using the NICHD HUAM study as an example to be learned from, we should be more critical and independent in our appraisal of published trials. Evidence-based medicine is only useful when we pay as much attention to the methodology as we do to the results.     

中药治疗儿童支气管哮喘临床研究方法的新选择

通过介绍随机对照试验与真实世界研究及其特征,使真实世界研究走入人们的视野。通过阐述中药治疗儿童支气管哮喘临床研究方法的不足,分析真实世界研究应用于中药临床研究的可行性,为中药治疗儿童支气管哮喘使用真实世界研究方法提供新选择。     

The term breech trial: the rise and fall of a randomized controlled trial--a critical survey

Six years after publication of the results of the first international randomized controlled trial with the main question which mode of delivery is the best for term breech babies, there are increasing concerns about the validity of the study data concluding caesarean delivery was safer for breech babies. In January 2006 published article in the American Journal of Obstetrics and Gynecology the data of the study has been analysed again. The author comes to the conclusion that because of mistakes in the study design the results are unreliable and that the study group should withdraw the recommendations. Furthermore in his article he quotes from the study and emphasizes the mistakes.     

Recruitment strategies for a randomized clinical study

BACKGROUND: To value the level of acceptance of the Memphis Study, (a random clinical study suggested verifying the efficacy of a diet enriched with phytoestrogens to prevent menopausal problems), and underlining the reasons which induce the acceptance or refusal of the study. Study design: Prospective study. METHODS: Meeting groups have been held with 82 women needing Day Hospital treatment for Menopause at III Department of Obstetrics and Gynecology of the University of Bari. The features of women and the reasons that induce these++ acceptance or refusal of the study were valued by an anonymous questionnaire with a precoded reply. RESULTS: 92.9% of the women accepted participation in the study. The main reasons for acceptance were: 1) believing that the study was drawn up for women; 2) it was done by expert physicians; 3) it was not done for financial gain. The random standard was the main reason for refusal. CONCLUSIONS: With this method we had a very high acceptance, talking over the goals and problems that study aimed to address and to resolve. The chance offered to judge the reliability and competence of physicians is important.     

Venous thromboembolism and oral contraceptive use: a methodological study of diagnostic suspicion and referral bias

Background In studies of oral contraceptive oral contraceptive use and risk of venous thromboembolism, bias related to heightened diagnostic suspicion and preferential referral of oral contraceptive users has been an issue. The aim of our study was to determine the presence and potential impact of diagnostic suspicion and referral bias.

Methods We conducted a case/non-case study in 21 regional study centers in Germany and, in parallel, a conventional case-control study using the same cases but randomly selected population controls from the same areas. Women with symptoms compatible with venous thromboembolism were included in the study between 1994 and 1999, and classified as cases or non-cases (first reference group) according to the diagnostic work-up (case/non-case study). A second reference group consisted of population controls (conventional case-control study as an internal comparison for the case/non-case study): 606 cases, 462 non-cases and 2942 population controls aged 15–49 years. Adjusted unconditional regression analyses were performed.

Results Adjusted odds ratios for venous thromboembolism in oral contraceptive users were systematically higher in the classical case-control study compared to the case/non-case approach (using the same cases) across all subgroup analyses (e.g. for idiopathic cases, the odds ratio was 67% higher in the case-control study: 4.33 (95% confidence interval (CI) 3.27–5.74) versus 2.60 (95% CI 1.75–3.88)). We found a significantly increasing trend of oral contraceptive use in four categories of increasingly sophisticated diagnostic tests that were applied to 1067 women with a suspicion of venous thromboembolism, irrespective of the outcome. Stratified analysis showed the diagnostic level to be a confounder.

Conclusion In our population-based study with the possibility of internal comparison, we found clear evidence that diagnostic suspicion and referral bias does play an important role in case-control studies of venous thromboembolism risk among oral contraceptive users. This underlines the importance of making an effort to avoid this bias when designing a new study.     

Evaluating midwifery units (EMU): Lessons from the pilot study

Objective

this paper describes the pilot study that was undertaken to test the feasibility of the recruitment plan designed to recruit women who booked to give birth in two freestanding midwifery units in NSW, Australia. The pilot preceded the full prospective cohort study, Evaluating Midwifery Units (EMU), which aimed to examine the antenatal, birth and postnatal outcomes of women planning to give birth in freestanding midwifery units compared to those booked to give birth in tertiary level maternity units in Australia and New Zealand.

Design

a prospective cohort study with two mutually-exclusive cohorts.

Setting

two freestanding midwifery units in NSW and their corresponding tertiary referral hospitals.

Participants

a total of 146 women with few identified risk factors recruited between 13 September 2009 and 31 March 2010 whose planned place of birth was either a freestanding midwifery unit or tertiary maternity unit.

Measurements and findings

the pilot study identified the feasibility of relying on the booking midwife to recruit eligible women from several antenatal booking clinics to the study. Low rates of eligible women were invited resulting in a lower than expected consent rate. In addition, although mostly only low-risk women were invited to participate, some women requiring medical consultation at the time of booking were inadvertently recruited into the study. The results of this pilot study led us to revise the study protocol to find ways of including the outcomes of all women without identified risk factors who booked at either the freestanding midwifery units or the tertiary referral hospital in that area. This paper describes the revisions that were made to the study plan.

Key conclusions

five lessons were learned from the pilot study. We found that recruitment protocols employed for the cohort study were too complicated and required simplification to maximise the potential of the study. The study protocol needed to be changed for the main study to ensure a larger sample size and to ensure the risk profile of each cohort was as similar as possible. Sources of data needed to be expanded to produce a complete data set.

Implications for practice

pilot studies are extremely useful tools in testing methods to inform research protocols. We found that the first months spent undertaking a pilot study ensured a stronger design with the potential to show more meaningful results.     

Venous thromboembolism and oral contraceptive use: a methodological study of diagnostic suspicion and referral bias.

BACKGROUND: In studies of oral contraceptive oral contraceptive use and risk of venous thromboembolism, bias related to heightened diagnostic suspicion and preferential referral of oral contraceptive users has been an issue. The aim of our study was to determine the presence and potential impact of diagnostic suspicion and referral bias. METHODS: We conducted a case/non-case study in 21 regional study centers in Germany and, in parallel, a conventional case-control study using the same cases but randomly selected population controls from the same areas. Women with symptoms compatible with venous thromboembolism were included in the study between 1994 and 1999, and classified as cases or non-cases (first reference group) according to the diagnostic work-up (case/non-case study). A second reference group consisted ofpopulation controls (conventional case-control study as an internal comparison for the case/non-case study): 606 cases, 462 non-cases and 2942 population controls aged 15-49 years. Adjusted unconditional regression analyses were performed. RESULTS: Adjusted odds ratios for venous thromboembolism in oral contraceptive users were systematically higher in the classical case-control study compared to the case/non-case approach (using the same cases) across all subgroup analyses (e.g. for idiopathic cases, the odds ratio was 67% higher in the case-control study: 4.33 (95% confidence interval (CI) 3.27-5.74) versus 2.60 (95% CI 1.75-3.88)). We found a significantly increasing trend of oral contraceptive use in four categories of increasingly sophisticated diagnostic tests that were applied to 1067 women with a suspicion of venous thromboembolism, irrespective of the outcome. Stratified analysis showed the diagnostic level to be a confounder. CONCLUSION: In our population-based study with the possibility of internal comparison, we found clear evidence that diagnostic suspicion and referral bias does play an important role in case-control studies of venous thromboembolism risk among oral contraceptive users. This underlines the importance of making an effort to avoid this bias when designing a new study.     

A Quasi‐experimental Outcomes Analysis of a Psychoeducation Intervention for Pregnant Women with Abuse‐related Posttraumatic Stress

ObjectiveTo test the effectiveness of a trauma‐specific, psychoeducational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes.DesignQuasi‐experimental study comparing women from a single‐group, pretest–posttest pilot intervention study with women matched from a prospective observational study.SettingRural and university‐based prenatal clinics.ParticipantsPregnant women entered the study by responding to an advertisement or by referral from a maternity care provider. Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria. Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants.InterventionsParticipants in the observational study received usual care. Participants in the pilot intervention study received usual care plus the intervention, a fully manualized, self‐study program supported by weekly phone tutoring sessions with a health professional.Main Outcome MeasuresThe National Women's Study PTSD Module, the Peritraumatic Dissociation Experience Questionnaire, the Perception of Care Questionnaire, the Postpartum Depression Screening Scale, the Postpartum Bonding Questionnaire, and a semantic differential appraisal of the labor experience.ResultsParticipants in the intervention study had better scores on all measures. Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor, rating of labor experience, and perception of care in labor and small effect sizes for postpartum posttraumatic stress disorder (PTSD) symptoms, postpartum depression symptoms, and motherinfant bonding.ConclusionThis trauma‐specific intervention reaches and benefits pregnant women with a history of childhood maltreatment.     

The effect of terodiline treatment in women with motor urge incontinence. Results from a double-blind study and long-term treatment

The effects of terodiline were evaluated in 24 women with genuine motor urge incontinence: Twelve patients participated in a double-blind crossover study and 12 in a subsequent long-term study. All patients were investigated by simultaneous urethrocystometry before and after treatment. During the controlled study the subjects were treated with placebo or 37.5 mg of terodiline daily for two 3-week periods. The long-term study covered a period from 6 months to 3 years. A significantly higher increase in both bladder volume at urinary leakage (from 170 to 270 ml, p less than 0.001) and bladder capacity (from 320 to 390 ml, p less than 0.01) was registered after terodiline treatment compared to placebo. In the long-term study the effects on these parameters were still more pronounced with an increase in bladder volume at leakage (from 180 to 300 ml, p less than 0.001) and in bladder capacity (from 290 to 430 ml, p less than 0.0001). Subjective improvement with terodiline treatment was reported by all but two patients in the double-blind study and by all in the long-term study. Side effects such as dryness of the mouth were reported by four patients receiving terodiline in the double-blind study and by six in the long-term study. No patient discontinued the treatment. Terodiline seems to be a promising alternative for treatment of motor urge incontinence in women.     

Lymphocyte changes in pregnancy: a comparison of the human immunodeficiency virus infected and non-infected women.

The aim of this study was to assess cellular immunological changes in HIV infected and non-infected normal pregnancies. This was a cross-sectional study of women in the three trimesters of pregnancy and the postpartum period. All participants were asymptomatic. This study showed that absolute numbers of CD4 counts in the HIV infected group were significantly lower than that in the non-infected group, for all periods of gestation studied. The CD8 counts were found to increase postdelivery and may have clinical significance in relation to mother to child transmission. This needs further study with a larger sample size and a longitudinal design method of study.     

妊高征患者血浆中末端补体复合物的测定及其意义

目的 探讨末端补体复合物在妊高征发病中的作用及其与血管内皮细胞损伤的关系。方法 采用酶联免疫吸附试验（ＥＬＩＳＡ）检测４７例妊高征患者,１５例有妊高征高危因素者和４０例正常孕妇血浆中ＳＣ５ｂ－９含量,同时测定循环免疫复合物,纤维结合蛋白含量。     

Expression of beta-human chorionic gonadotropin in ovarian cancer tissue

The purpose of the present investigation was to determinate expression of human chorionic gonadotropin gene in ovarian cancer tissue. The study included 15 patients with epithelial ovarian carcinoma. The expression of mRNA hCGbeta was determinated by the RT PCR method and the distribution of the hormone in study tissue was analyzed immunohistochemicaly. In all 15 study specimens of the ovarian carcinoma tissue the active hCGbeta gene was found, whereas noncancerous tissue demonstrated lack of the hormone expression. Thus, the study clearly shows that the expression of hCGbeta is the feature of ovarian cancer tissue.     

The cervical balloon method for induction of labor

The cervical balloon (Embrey & Mollison) was used to induce labor in a study group of 87 patients. The control group included 97 patients, where induction of labor was performed using oxytocin-drip. In the study group oxytocin-drip was added in 34 patients. The cases of the study and control groups were classified as "favorable" cervix. The patients classified as "unfavorable" cervix showed a shorter mean induction-delivery interval in the study group, and a shorter mean duration of oxytocin-drip in the cases of the study group where it was needed. It was concluded that the cervical balloon is a convenient method for the induction of labor, for its effectivity, simplicity and innocuity, especially in the "unfavorable" cervix cases.     

The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: results from two studies on oestrogen-related symptoms and dysmenorrhoea.

OBJECTIVES: To evaluate the effects of an oestrogen-free oral contraceptive (Cerazette; 75 mcg/day desogestrel) in women with oestrogen-related symptoms during previous combined oral contraceptive (COC) use (ERS study) and in women with dysmenorrhoea (DYS study). METHODS: Two similarly designed prospective, non-comparative multicentre observational studies were carried out in Germany. Altogether, 403 women with oestrogen-related symptoms during previous COC use and 406 women with dysmenorrhoea took Cerazette continuously. Symptom-related assessments were made at baseline and after 3-4 months, along with bleeding pattern and treatment satisfaction. RESULTS: In the ERS study, the four oestrogen-related symptoms studied resolved or improved in over 70% of women. Nausea improved/resolved most (92% of women), followed by breast tenderness (90%), oestrogen-related headache (84%) and oedema (74%). In the DYS study, dysmenorrhoea resolved or considerably improved in 93% of the study population. Correspondingly, use of analgesics dropped from 70% of women at baseline to 8% at study end. Adverse events were reported by 7-8% of both study populations and were mainly bleeding irregularities. Most women in both studies were satisfied with treatment (approximately 90%) and wished to continue treatment after study completion (approximately 85%). CONCLUSIONS: Cerazette in this study set-up improved oestrogen-related symptoms and dysmenorrhoea in women affected and treatment was well accepted.     

The use of aromatherapy in intrapartum midwifery practice an observational study

The authors report the process and results of an evaluation of a midwifery aromatherapy service for mothers in labour: This study of 8058 mothers in childbirth, is the largest research initiative in the use of aromatherapy within a health-care setting. The study involved a wide range of participants, from mothers who experienced a low risk, spontaneous labour and birth, to those whose labour was induced, and those who had vaginal operative delivery and Caesarean section. The study-took place over a period of 8 years, which enabled a more challenging test of the effect of aromatherapy on intrapartum midwifery practice and outcomes. In the study a total of 10 essential oils were used, plus a carrier oil, which were administered to the participants via skin absorption and inhalation. The study found little direct evidence that the practice of aromatherapy per se reduces the need for pain relief during labour, or the incidence of operative delivery. But a key finding of this study suggests that two essential oils, clary sage and chamomile are effective in alleviating pain. The evidence from this study suggests that aromatherapy can be effective in reducing maternal anxiety, fear and/or pain during labour. The use of aromatherapy appeared to facilitate a further reduction in the use of systemic opioids in the study centre, from 6% in 1990 to 0.4% in 1997 (per woman). Aromatherapy is an inexpensive care option. In 1997 when 1592 mothers used aromatherapy, the total cost was 769.17 Pounds. The study reports a minimal incidence of associated symptoms. Out of 8058 mothers, 1% (100) recorded an associated symptom. These were mild in nature. The successful model of integrated practice that this aromatherapy study presents, offers a useful example for other units to consider.     

Risk factors for failure of transvaginal sacrospinous uterine suspension in the treatment of uterovaginal prolapse.

BACKGROUND AND PURPOSE: The purpose of this study was to elucidate the risk factors for failure of transvaginal sacrospinous uterine suspension (SSUS) in the treatment of uterine prolapse and to examine methods for controlling these risk factors. METHODS: Sixty patients with second degree uterine prolapse or greater were included in this 2-stage study, with 33 in the risk factor assessment and 27 in the clinical study of a modified treatment to eliminate identified risk factors. Patients were followed for at least 5 years. The first part of the study evaluated the risk factors for operative failure and the efficacy of the operative procedure. The second part of the study evaluated a modified treatment plan to eliminate risk factors identified in the first part of the study. RESULTS: The failure rate for those with an elongated cervix (3 of 4, 75%) and those with third degree uterine prolapse (3 of 4, 75%) was significantly higher than for patients without either of these risk factors (6.9%, 2/29) [p = 0.007]. Concomitant partial trachelectomy for those with elongated cervix significantly reduced the failure rate from 75% to 0% (0/7) [p = 0.024]. In the risk factor study, SSUS was successful in 84.8% (28/33) of patients. In the clinical study of modified therapy to prevent significant risk factors, the success rate was 96.3% (26/27). CONCLUSIONS: This study found that an elongated cervix and third degree uterine prolapse were the 2 main risk factors for recurrent uterine prolapse after SSUS. Concomitant partial trachelectomy as an adjuvant treatment of SSUS for treatment of uterovaginal prolapse in patients with an elongated cervix significantly reduces the rate of failure in these patients.     

A study on intrauterine fetal resuscitation with terbutaline

A randomized study on the effect of terbutaline on fetal distress was carried out in 20 patients who showed evidence of ominous fetal heart rate patterns and fetal scalp blood pH values of less than 7.25. Of those, 11 received terbutaline (study group) and nine did not (control group). There was a significant improvement in the acid-base status of the fetus in the study group compared with those in the control group (p less than 0.01). No significant maternal or fetal morbidity occurred in the study group. Apgar scores at 1 minute were 7 or greater in 10 of the 11 study subjects whereas only four of the nine control subjects had a score of 7 or greater. These results suggest that terbutaline may become a useful agent in the treatment of intrauterine fetal distress.