Elaine Denny

Endometriosis-associated dyspareunia: the impact on women's lives

Background and methodology Endometriosis is a chronic condition in which endometrial glands and stroma are present outside of the uterus. Whereas chronic pelvic pain is the most commonly experienced pain of endometriosis, many women also suffer from deep dyspareunia. In order to determine how much of an impact endometriosis-associated dyspareunia has on the lives and relationships of women a qualitative study using semi-structured interviews, supplemented with quantitative data on the extent of dyspareunia, was conducted in a dedicated endometriosis clinic in the West Midlands, UK with 30 women aged from 19 to 44 years. Results The main outcome measures were the extent of dyspareunia within the sample of women, and the impact of dyspareunia on quality of life. The experience of dyspareunia was found to be higher than in previous research. Three main themes emerged. The experience of pain was found to limit sexual activity for the majority of the sample, with a minority ceasing to be sexually active. Lack of sexual activity resulted in a lowering of self-esteem and a negative effect on relationships with partners, although the experience differed between younger and older women. Discussion and conclusions The experience of dyspareunia is a significant factor in the quality of life and relationships for women living with endometriosis. For most of the women in the study it was very severe and resulted in their reducing or curtailing sexual activity. Qualitative research can produce salient data that highlight the impact of dyspareunia on self-esteem and sexual relationships.

Outpatient versus inpatient uterine polyp treatment for abnormal uterine bleeding: randomised controlled non-inferiority study

Objective To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy. Design Pragmatic multicentre randomised controlled non-inferiority study. Setting Outpatient hysteroscopy clinics in 31 UK National Health Service hospitals. Participants 507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps. Interventions Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia. Data were collected on women’s self reported bleeding symptoms at baseline and at 6, 12, and 24 months. Data were also collected on pain and acceptability of the procedure at the time of polypectomy. Main outcome measures The primary outcome was successful treatment, determined by the women’s assessment of bleeding at six months, with a prespecified non-inferiority margin of 25%. Secondary outcomes included generic (EQ-5D) and disease specific (menorrhagia multi-attribute scale) quality of life, and feasibility and acceptability of the procedure. Results 73% (166/228) of women in the outpatient group and 80% (168/211) in the inpatient group reported successful treatment at six months (intention to treat relative risk 0.91, 95% confidence interval 0.82 to 1.02; per protocol relative risk 0.92, 0.82 to 1.02). Failure to remove polyps was higher (19% v 7%; relative risk 2.5, 1.5 to 4.1) and acceptability of the procedure was lower (83% v 92%; 0.90, 0.84 to 0.97) in the outpatient group Quality of life did not differ significantly between the groups. Four uterine perforations, one of which necessitated bowel resection, all occurred in the inpatient group. Conclusions Outpatient polypectomy was non-inferior to inpatient polypectomy. Failure to remove a uterine polyp was, however, more likely with outpatient polypectomy and acceptability of the procedure was slightly lower. Trial registration International Clinical Trials Registry 65868569.

Systematic reviews of qualitative evidence: What are the experiences of women with endometriosis?

Summary Just as systematic reviews of quantitative research have developed over the last two decades, the use of a systematic review is also superseding narrative non-systematic reviews in qualitative research in an attempt to bring rigour to reviewing research evidence. Qualitative research is concerned with the subjective world and the way in which people interpret and make sense of the reality of their lives. This paper describes procedures for conducting a systematic review on qualitative research, and the methods for assessing the quality of qualitative research papers, using published qualitative research on endometriosis as an example to demonstrate these. The conclusion from the systematic review carried out is that the values and methods utilised for a systematic review can usefully be applied to qualitative research. The review of endometriosis research revealed that despite the impact of endometriosis on the lives of women sufferers, little qualitative research has been conducted, and much of that which exists lacks rigour in a number of key areas.

The Percutaneous shunting in Lower Urinary Tract Obstruction (PLUTO) study and randomised controlled trial: evaluation of the effectiveness, cost-effectiveness and acceptability of percutaneous vesicoamniotic shunting for lower urinary tract obstruction.

BACKGROUND Congenital lower urinary tract obstruction (LUTO) is a disease associated with high perinatal mortality and childhood morbidity. Fetal vesicoamniotic shunting (VAS) bypasses the obstruction with the potential to improve outcome. OBJECTIVE To determine the effectiveness, cost-effectiveness and patient acceptability of VAS for fetal LUTO. DESIGN A multicentre, randomised controlled trial incorporating a prospective registry, decision-analytic health economic model and preplanned Bayesian analysis using elicited opinions. Patient acceptability was evaluated by interview in a qualitative study. SETTING Fetal medicine departments in the UK, Ireland and the Netherlands. PARTICIPANTS Pregnant women with a male singleton fetus with LUTO. INTERVENTIONS In utero percutaneous VAS compared with conservative care. MAIN OUTCOME MEASURES The primary outcome was survival to 28 days. Secondary outcome measures were survival and renal function at 1 year of age, cost of care and cost per additional life-year and per disability-free survival at the end of 1 year. RESULTS The trial stopped early with 31 women randomised because of difficulties in recruitment. Of those randomised to VAS and conservative management, 3/16 (19%) and 2/15 (13%), respectively, did not receive their allocated intervention. Based on intention-to-treat analysis, survival at 28 days was higher if allocated VAS (50%) than conservative management (27%) [relative risk (RR) 1.88, 95% confidence interval (CI) 0.71 to 4.96, p = 0.27]. At 12 months survival was 44% in the VAS arm and 20% in the conservative arm (RR 2.19, 95% CI 0.69 to 6.94, p = 0.25). Neither difference was statistically significant. Of survivors at 1 year, two in the VAS arm had no evidence of renal impairment and four in the VAS arm and two in the conservative arm required medical management. One baby in the conservative arm had end-stage renal failure at 1 year. VAS was more expensive because of additional surgery and intensive care. VAS cost £15,500 per survivor at 1 year and £43,900 per disability-free year. Elicited expert opinions showed uncertainty in the effect of VAS at 28 days. In a Bayesian analysis combining elicited opinion with the results, uncertainty of the benefit of VAS remained (RR 1.31, 95% credible interval 0.84 to 2.18). The acceptability study identified visualisation of the fetus during ultrasound scanning, perceiving a personal benefit, and altruism as positive influences on recruitment. Fear of the VAS procedure and the perceived severity of LUTO influenced non-participation. The need for more detailed information about the condition and its implications during pregnancy and following delivery was a further important finding of this research. Recruitment was hampered by logistical and regulatory difficulties, a lower incidence of LUTO and lower antenatal diagnosis rate [estimated to be 3.34 (95% CI 2.95 to 3.72) per 10,000 total births and 47%, respectively, in an associated epidemiological study] and high termination of pregnancy rates. In the registry women also demonstrated a clear preference for conservative management. CONCLUSIONS Survival to 28 days and 1 year appears to be higher with VAS than with conservative management, but it is not possible to prove benefit beyond reasonable doubt. Notably, prognosis in both arms for survival and renal function is poor. VAS was substantially more costly and unlikely to be regarded as cost-effective based on the 1-year data. Parents should be counselled about the risks of pregnancy loss with or without VAS insertion. The National Institute for Health and Care Excellence interventional procedures guidance (IPG 202) should be updated to reflect this new evidence. Babies in the PLUTO trial should be followed up long term for the different outcomes. TRIAL REGISTRATION ISRCTN53328556. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 17, No. 59. See the NIHR Journals Library website for further project information.

A randomised controlled trial of Outpatient versus inpatient Polyp Treatment (OPT) for abnormal uterine bleeding.

BACKGROUND Uterine polyps cause abnormal bleeding in women and conventional practice is to remove them in hospital under general anaesthetic. Advances in technology make it possible to perform polypectomy in an outpatient setting, yet evidence of effectiveness is limited. OBJECTIVES To test the hypothesis that in women with abnormal uterine bleeding (AUB) associated with benign uterine polyp(s), outpatient polyp treatment achieved as good, or no more than 25% worse, alleviation of bleeding symptoms at 6 months compared with standard inpatient treatment. The hypothesis that response to uterine polyp treatment differed according to the pattern of AUB, menopausal status and longer-term follow-up was tested. The cost-effectiveness and acceptability of outpatient polypectomy was examined. DESIGN A multicentre, non-inferiority, randomised controlled trial, incorporating a cost-effectiveness analysis and supplemented by a parallel patient preference study. Patient acceptability was evaluated by interview in a qualitative study. SETTING Outpatient hysteroscopy clinics and inpatient gynaecology departments within UK NHS hospitals. PARTICIPANTS Women with AUB - defined as heavy menstrual bleeding (formerly known as menorrhagia) (HMB), intermenstrual bleeding or postmenopausal bleeding - and hysteroscopically diagnosed uterine polyps. INTERVENTIONS We randomly assigned 507 women, using a minimisation algorithm, to outpatient polypectomy compared with conventional inpatient polypectomy as a day case in hospital under general anaesthesia. MAIN OUTCOME MEASURES The primary outcome was successful treatment at 6 months, determined by the womans assessment of her bleeding. Secondary outcomes included quality of life, procedure feasibility, acceptability and cost per quality-adjusted life-year (QALY) gained. RESULTS At 6 months, 73% (166/228) of women who underwent outpatient polypectomy were successfully treated compared with 80% (168/211) following inpatient polypectomy [relative risk (RR) 0.91, 95% confidence interval (CI) 0.82 to 1.02]. The lower end of the CIs showed that outpatient polypectomy was at most 18% worse, in relative terms, than inpatient treatment, within the 25% margin of non-inferiority set at the outset of the study. By 1 and 2 years the corresponding proportions were similar producing RRs close to unity. There was no evidence that the treatment effect differed according to any of the predefined subgroups when treatments by variable interaction parameters were examined. Failure to completely remove polyps was higher (19% vs. 7%; RR 2.5, 95% CI 1.5 to 4.1) with outpatient polypectomy. Procedure acceptability was reduced with outpatient compared with inpatient polyp treatment (83% vs. 92%; RR 0.90, 95% CI 0.84 to 0.97). There were no significant differences in quality of life. The incremental cost-effectiveness ratios at 6 and 12 months for inpatient treatment were £1,099,167 and £668,800 per additional QALY, respectively. CONCLUSIONS When treating women with AUB associated with uterine polyps, outpatient polypectomy was non-inferior to inpatient polypectomy at 6 and 12 months, and relatively cost-effective. However, patients need to be aware that failure to remove a polyp is more likely with outpatient polypectomy and procedure acceptability lower. TRIAL REGISTRATION Current Controlled Trials ISRCTN 65868569. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 61. See the NIHR Journals Library website for further project information.

Qualitative exploration of psychological factors associated with spinal cord stimulation outcome

Background and aim: Spinal cord stimulation (SCS) is a last resort treatment for chronic pain consisting of an implantable pulse generator connected to leads placed in the epidural space of the spinal cord. Effective in reducing chronic pain, however, efficacy has been found to decrease over time. Psychological factors affecting outcome of SCS have been investigated through quantitative methods, but these have failed to provide confident predictors. We aimed to investigate via a qualitative approach, the experience of SCS following 1 year of therapy. Methods: Thirteen chronic non-cancer pain participants were interviewed. All participants had been trialled with SCS. The majority had gone on to full implantation with varying degrees of pain relief. Thematic analysis was employed to analyse the data from the interviews. Results: Interviews resulted in findings that previous quantitative studies had failed to uncover. Two emergent core themes surfaced: ‘coping with pain’ and ‘SCS treatment’. The effect of emotion upon coping was recurrent. Participants divided the SCS experience into information provision, independence and unexpected experiences. Conclusion: The findings provide context for the patients’ experience of SCS. This research suggests that improved preparation prior to SCS including information provision, CBT and contact with expert patients may be of value.

The experience of pregnant women with a diagnosis of fetal lower urinary tract obstruction (LUTO)

OBJECTIVE to gain insight into the experiences and perspectives of pregnant women diagnosed antenatally with fetal lower urinary tract obstruction (LUTO) participating in an interventional fetal medicine randomised controlled trial (RCT). DESIGN a qualitative study using semi-structured interviews. Interviews were analysed using Riessmans narrative analysis. SETTING fetal medicine clinics within the United Kingdom National Health Service (NHS). PARTICIPANTS five pregnant women who were recruited as part of an RCT and two additional women who were recruited after the trial was terminated before completion. FINDINGS three themes were identified and form the basis of this article: the use of technology in pregnancy, the loss of a normal pregnancy, and decision making in uncertainty. IMPLICATIONS AND CONCLUSIONS undertaking qualitative research within an RCT can illuminate the experience of the condition being studied. Womens experience of a pregnancy where LUTO was diagnosed in the fetus entailed an emotional journey following the visualisation of the abnormality through the use of routine ultrasound screening. Women tried to make sense of the diagnosis in order to make the best, albeit less than ideal, decisions for themselves, their baby, and their family. Midwives are in a good position to support women through the emotional distress of diagnosis and to help them negotiate the uncertain terrain in which they make decisions.

A qualitative study of the impact of endometriosis on male partners

Abstract STUDY QUESTION What is the impact of endometriosis on male partners of women with the condition? SUMMARY ANSWER Endometriosis significantly impacts men across several life domains and can negatively impact emotional well-being. WHAT IS KNOWN ALREADY Endometriosis has been shown to negatively impact womens quality of life and may strain intimate relationships. Little is known about the impact on male partners. STUDY DESIGN, SIZE, DURATION The ENDOPART study was a cross-sectional, qualitative study of 22 women with endometriosis and their male partners (n = 44) in the UK (2012–2013). PARTICIPANTS/MATERIALS, SETTING, METHODS Inclusion criteria: laparoscopic diagnosis of endometriosis; the presence of symptoms for at least a year; partners living together. Data were collected via face to face, semi structured interviews with partners interviewed separately. Data were analysed thematically, assisted by NVivo 10. MAIN RESULTS AND THE ROLE OF CHANCE Men reported that endometriosis affected many life domains including sex and intimacy, planning for and having children, working lives and household income. It also required them to take on additional support tasks and roles. Endometriosis also had an impact on mens emotions, with responses including helplessness, frustration, worry and anger. The absence of professional or wider societal recognition of the impact on male partners, and a lack of support available to men, results in male partners having a marginalized status in endometriosis care. LIMITATIONS REASONS FOR CAUTION Self-selection of participants may have resulted in a sample representing those with more severe symptoms. Couples included are in effect ‘survivors’ in relationship terms, therefore, findings may underestimate the contribution of endometriosis to relationship breakdown. WIDER IMPLICATIONS OF THE FINDINGS The study extends knowledge about the impact of endometriosis on relationships, which thus far has been drawn largely from studies with women, by providing new insights about how this condition affects male partners. Healthcare practitioners need to take a more couple-centred, biopsychosocial approach toward the treatment of endometriosis, inclusive of partners and relationship issues. The findings demonstrate a need for information and support resources aimed at partners and couples. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by the Economic and Social Research Council (reference ES/J003662/1). The authors have no conflicts of interest.

The sociology of long term conditions and nursing practice

An insightful examination of the sociology surrounding major long term conditions, this is the final volume in the successful Sociology in Nursing Practice series. Demonstrating a high level of scholarship, it makes excellent use of current research to illuminate the social context of long term conditions and the patients experience.

Pakistan's CMW program—gap between theory and reality

Transferring seemingly successful public policy from one setting to another without considering the social context of each is a common failure of policy makers. The impetus to implement policy may mean that questions of the appropriateness of the program design is not addressed. Using implementation research to examine the community midwife programme in Pakistan, Mumtaz et al. have captured the complex nexus of implementing national policy at local level. At the same time, they have highlighted assumptions and realities within a specific cultural and social context. Implementation research aims to describe, assess and explain what is happening and why (Werner 2004, A Guide to Implementation Research, Baltimore, Urban Institute Press). It has been called the ‘missing link’ between research and practice, which in services involving humans is a complex process (Fixsen et al. APSAC Advisor 2007;19:4–11). For example, this article relates how it was assumed by policy makers that once the community midwives (CMW) had been trained, they would passively implement the programme as it had been taught, and that poor women would take up the service. However, this did not occur because of factors relating to the midwives, factors relating to their potential clients and factors relating to the market for childbirth services in rural Pakistan. These could have been, but were not, anticipated. Examining the theory and the assumptions underpinning the CMW program before implementation could have highlighted where adaptations needed to be made to account for specific social conditions pertaining to Pakistani society. Implementation research involves understanding and working within real world conditions and is concerned with users of the research in a wide range of health settings, and therefore not research purely as production of knowledge (Peters et al. BMJ 2013:347:f6753). This involves not only working with service users and providers but also gathering documentary evidence, which in the research reported here was in the form of policy documents that set out the assumptions inherent in adoption of the program. Quantitative, qualitative or mixed methods may be used in implementation research. The value here of including qualitative methods was to uncover the contextual factors that were key to understanding the failure of the programme, which were embedded within gender and social relations inherent in Pakistani society. Focus group discussions and interviews revealed how the low status of midwifery influenced the trained CMWs when it came to their taking up work in the community, and how they also faced barriers in terms of occupational boundaries and the lack of freedom for Pakistani women to move around freely. This meant that the CMWs were not always able to make home visits and to travel to the poorest parts of the community, where the need for skilled help was greatest. Reduction in maternal mortality was a key millennium development goal that has been achieved with greatly varying success across the world. This article provides important insight into factors influencing the implementation of health policies designed to reduce maternal mortality in countries where it remains high.