Outpatient paracentesis for the management of ovarian hyperstimulation syndrome: study protocol for the STOP-OHSS randomised controlled trial.

INTRODUCTION: Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women. METHODS AND ANALYSIS: This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022. ETHICS AND DISSEMINATION: London-Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups. TRIAL REGISTRATION NUMBER: ISRCTN71978064.

Managing ovarian hyperstimulation syndrome: A qualitative interview study with women and healthcare professionals.

AIM: To explore the experiences of women who have had ovarian hyperstimulation syndrome, and healthcare professionals who care for them. BACKGROUND: Ovarian hyperstimulation syndrome is a side effect of fertility treatment. Little research exists internationally that explores the experiences of women who have had this condition, or the healthcare professionals who manage it. DESIGN: Qualitative study using semi-structured interviews. METHODS: Eighteen interviews with women who had experienced ovarian hyperstimulation syndrome (n = 10) and healthcare professionals (n = 8) in six UK fertility centres. Framework analysis was used. This paper is reported following COREQ guidelines. RESULTS: Women described a range of symptoms and severity, sometimes experiencing worrying physical health problems such as abdominal swelling and shortness of breath. The combination of the symptoms, and their management, on delaying future fertility treatment could cause emotional distress. Healthcare professionals at different centres described variation in practice, which generally involved 'active monitoring' until symptoms became severe, when women would be hospitalised. Women expressed feeling 'left in limbo' while waiting for symptoms to improve or worsen, and described a lack of control during this waiting period. Healthcare professionals felt they provided adequate information about ovarian hyperstimulation syndrome and its management. This, however, did not align with women's perceptions that information, including potential delays to their fertility treatment, was missing. There was similar mismatch between women's and healthcare professionals' views of decision-making about fertility treatment following ovarian hyperstimulation syndrome, including women's concerns about having to make rushed, unplanned decisions about their fertility treatment when they did not feel adequately informed to do so. CONCLUSION: Ovarian hyperstimulation syndrome and its management can have a significant physical and emotional impact on women, and influence their fertility treatment. Improvements could be made to the information women receive about this condition, its management and its implications for wider fertility treatment. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Nurses have the skills and knowledge to support women through the physical and emotional stresses of fertility treatment. Therefore, they are well placed to provide specialist information and support for OHSS and ensure women are fully informed about all aspects of the condition, including how its management might delay fertility treatment.

Can electronic assessment tools improve the process of shared decision-making? A systematic review.

BACKGROUND: Patient involvement in decision-making plays a prominent role in improving the quality of healthcare. Despite this, shared decision-making is not routinely implemented. However, electronic assessment tools that capture patients' history, symptoms, opinions and values prior to their medical appointment are used by healthcare professionals during patient consultations to facilitate shared decision-making. OBJECTIVE: To assess the effectiveness of electronic assessment tools to improve the shared decision-making process. METHOD: A systematic review was conducted following PRISMA guidelines. Published literature was searched on MEDLINE, EMBASE and PsycINFO to identify potentially relevant studies. Data were extracted and analysed narratively. RESULTS: Seventeen articles, representing 4004 participants, were included in this review. The main findings were significant improvement in patient-provider communication and provider management of patient condition in the intervention group compared to the control group. In contrast, patient-provider satisfaction and time efficiency were assessed by relatively few included studies, and the effects of these outcomes were inconclusive. CONCLUSION: This review found that communication and healthcare professional's management of a patient's condition improves because of the use of electronic questionnaires. This is encouraging because the process of shared decision-making is reliant on high-quality communication between healthcare professionals and patients. IMPLICATIONS: We found that this intervention is especially important for people with chronic diseases, as they need to establish a long-term relationship with their healthcare provider and agree to a treatment plan that aligns with their values. More rigorous research with validated instruments is required.

Managing the delivery of venous leg ulcer services: A willingness to pay study.

Background and Aims: There is widespread variation in venous leg ulcer (VLU) wound care contributing to inadequate service provision resulting in poor outcomes to patients. Little has been published on the perspectives of where treatments should be carried out. The aim of the study was to quantify respondents' preferences for the preferred place of treatment for VLU. Methods: A UK general population sample was interviewed to elicit preferences for clinic or home care treatment using the willingness to pay elicitation method. Participants were presented with two vignettes describing clinic or home care of VLU, and were asked to select the treatment process that they preferred and provide a detailed explanation for selecting that choice. Then they were asked to state their maximum hypothetical amounts that they were willing to pay for the treatment processes. Results: One hundred fifty-four participants completed the interviews. Respondents were willing to pay £498.96 to receive VLU treatment at a clinic and £505.60 to receive care at home. This difference between the clinic compared to home care was not statistically significant. Advantages of clinic care include being able to book an appointment allowing participants to plan events around the booking and for home care the convenience for those with impaired mobility who may have difficulty traveling. Conclusions: The results show that respondents placed an equal valuation on the place of treatment suggesting no strong preference for either home or clinic care. However, qualitative findings emphasized that impaired mobility may be a barrier to accessing VLU services for some therefore, individuals should be given the choice to select their preferred setting to receive treatment where possible.

Objective Nebuliser Adherence Data as "Proof" of Adherence in the Management of Cystic Fibrosis: A Qualitative Interview Study.

Purpose: Low adherence to medication via nebulisers is linked to poor clinical outcomes for people with Cystic Fibrosis (PWCF). Advances in technology allow electronic monitoring of nebuliser usage and feedback of objective adherence data to PWCF and clinical teams caring for them. CFHealthHub is a new intervention that collects and displays objective adherence data in easy-to-read formats with the aim of improving nebuliser adherence and health. There is little understanding of how objective adherence data is perceived by PWCF and healthcare professionals (HCPs). Patients and Methods: A qualitative study using semi-structured interviews with 22 PWCF and 31 HCPs who had used the CFHealthHub intervention. Results: Objective adherence data was welcomed by the majority of PWCF in the sample, and HCP delivering the intervention, because the data allowed PWCF to reflect on patterns of adherence or non-adherence. Ease of use and characteristics of data display were important, particularly the use of a "traffic light" system to allow PWCF to easily see if they were meeting their adherence targets. For PWCF objective adherence data was used as "proof to self", offering reassurance to high adherers, and a wake-up call to those with lower levels of adherence. It could also provide 'proof to others' where PWCF had higher levels of adherence than HCP or family members believed. The data could sometimes change HCP perceptions of PWCF's identities as poor adherers. Where adherence was not high, data was used to facilitate honest discussions between PWCF and HCPs about how to increase adherence. HCPs perceived that it was important to use the data positively to motivate, rather than criticise, PWCF. Conclusion: Objective nebuliser adherence data in CFHealthHub can offer proof of adherence to PWCF and HCPs. It is important to use it constructively to facilitate discussions on how to improve adherence.

Mixed methods study to develop the content validity and the conceptual framework of the electronic patient-reported outcome measure for vascular conditions.

OBJECTIVE: The aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions. DESIGN: A mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in the new instrument. However, due to scarcity of validated PROMs, the items of the new instrument were mainly based on a large qualitative study of patients and systematic reviews of the qualitative evidence . This was followed by a quantitative clinicians' consensus study and, finally, a qualitative face validity study with patients. PARTICIPANTS: Vascular patients participated in the primary qualitative study and the face validity study. In the qualitative study, 55 patients were interviewed, and for the face validity, 19 patients gave feedback. Twelve clinicians completed the survey and 13 completed two cycles of the clinicians' consensus study. RESULTS: The items and scales in the electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) were generated based on the results of five systematic reviews evaluating existing PROMs for possible inclusion in ePAQ-VAS, five systematic reviews of qualitative evidence, a primary qualitative study involving 55 patients and clinicians' input. One hundred and sixty-eight items were initially generated, of which 59 were eliminated by the expert panel due to repetition. The instrument was divided into one generic and three disease-specific sections (abdominal aortic aneurysm, carotid artery disease and lower limb vascular conditions). In each section, items were grouped together into putative scales. Fifty-five items were grouped across eight scales; the remaining items were kept as individual items, because of relevance to service users. CONCLUSIONS: This multidimensional electronic questionnaire covers the most common vascular conditions. This is particularly important for patients presenting with mixed symptoms or multiple conditions. This tool captures symptomatology, health related quality of life (HRQoL) and other clinically relevant data, such as experience with services and comorbidities.

Experiences of living with varicose veins: A systematic review of qualitative research.

AIM: To identify the symptoms and quality of life impacts that are important from the perspective of patients with varicose veins and to compare identified themes to items in varicose vein patient-reported outcome measures (PROMs). BACKGROUND: Varicose veins are common worldwide and are considered a chronic condition with implications for quality of life. Treatment is predominantly conservative; therefore, understanding patients' experiences of living with varicose veins is important to inform the provision of clinical care. PROMs are often used to collect data about patients' quality of life. DESIGN: Thematic synthesis of qualitative research reported according to ENTREQ guidelines. METHODS: Multiple electronic databases, including MEDLINE and CINAHL, were systematically searched to identify qualitative research examining experiences of adults with varicose veins. Thematic synthesis was then conducted on the included studies. RESULTS: Three studies met the inclusion criteria; the quality of the studies was high. The range and intensity of reported symptoms and participant's experiences of living with varicose veins were varied. Five overarching themes were identified: physical, psychological and social impact of varicose veins, adapting to varicose veins and reasons for seeking treatment. The overall key theme to emerge was adaptation, with patients demonstrating how they adapted to the various impacts. CONCLUSION: This review demonstrates that varicose veins have a wide range of symptoms and may have a significant impact on quality of life; people made significant adaptations to enable them to live their lives as fully as possible. RELEVANCE TO CLINICAL PRACTICE: Healthcare professionals need to be aware of the range of symptoms and their impact on quality of life. The use of PROMs to gather information about quality of life and symptoms is well established globally; however, PROMs currently used may not capture the full extent of the impact on patient's quality of life.

Themes that Determine Quality of Life in Patients with Peripheral Arterial Disease: A Systematic Review.

OBJECTIVES: The aim of this study was to identify domains that determine quality of life in patients with peripheral arterial disease and find the patient-reported outcome measures that can examine the identified themes. METHODS: A systematic review of all the main six databases was undertaken to identify primary qualitative studies reporting on the health and/or quality of life of patients with peripheral arterial disease. The quality of studies was assessed using the Critical Appraisal Skills Program criteria. Findings from the included studies were analysed using framework analysis methodology. The identified themes were mapped against the items/domains of validated patient-reported outcome measures used in patients with peripheral arterial disease. RESULTS: The systematic review identified eight papers that fulfilled the inclusion criteria. The included papers reported the views of 186 patients with peripheral arterial disease including patients with intermittent claudication, critical ischaemia and amputation secondary to peripheral arterial disease. The overall quality of the included studies was good based on Critical Appraisal Skills Program criteria. Framework analysis identified 35 themes that were divided into six main groups: symptoms, impact on physical functioning, impact on social functioning, psychological impact, financial impact and process of care. The best-fit generic and disease-specific patient-reported outcome measures were the Nottingham Health Profile and the Vascular Quality of Life Questionnaire, respectively. None of the patient-reported outcome measures covered all the themes important to patients with peripheral arterial disease. DISCUSSION: The findings from the review identified the important domains that affect patients living with peripheral arterial disease. None of the current generic and disease-specific patient-reported outcome measures provide a comprehensive measure for all themes that impact the daily living of patients with peripheral arterial disease.

A systematic review of qualitative research into people's experiences of living with venous leg ulcers.

AIM: To systematically identify, evaluate and synthesize qualitative research that examined the symptoms and health-related quality of life themes that are important from the perspective of patients with venous leg ulceration. BACKGROUND: Venous leg ulceration is a common chronic condition; the symptoms and associated treatments have a negative effect on health-related quality of life. Qualitative research methods can provide insight into the personal experiences of patients with venous leg ulceration. DESIGN: Qualitative evidence synthesis (using framework synthesis). DATA SOURCES: Multiple electronic databases including MEDLINE, EMBASE, PsycINFO and CINAHL were comprehensively searched from inception to November 2015. REVIEW METHODS: Systematic identification, quality assessment and synthesis of existing qualitative research were performed; framework synthesis was conducted on included studies. An inductive approach was used and emergent themes were identified. The final stage in the synthesis involved the development of new interpretations. RESULTS: Thirteen studies met the inclusion criteria; the overall quality of the included studies was good. Four overarching themes were identified; physical impact, psychological impact, social impact and treatment and, in these, further subthemes were identified. Ulcer and treatment-related pain, as well as odour and exudate appeared to have significant and direct negative effects on quality of life, with additional and cumulative effects on sleep, mobility and mood. CONCLUSION: The themes identified in this review should be considered by professionals providing services, care and treatment for venous leg ulcer patients and in the selection, or development, of patient-reported outcome measures for use with this population.

A qualitative study to explore the attitude of clinical staff to the challenges of caring for obese patients.

AIMS AND OBJECTIVES: To examine, from the perspective of staff, if obese patients have any additional care needs, and what the impact of these care requirements are on care provision. We have selected obese patients with venous leg ulceration as an example patient population to explore these questions. BACKGROUND: Anecdotal evidence indicates obesity can increase care requirements and have implications for obesity for care provision. However, little research exists nationally or internationally that provides evidence from a health care perspective. Obesity is a contributory causative factor of lower limb ulceration. In addition to affecting the development of venous leg ulceration, obesity may also impact on the care an obese patient may require and receive. DESIGN: Qualitative study using semi-structured in interviews and framework analysis. METHODS: Interviews were conducted with 18 health care professionals and one focus group with 12 health care professionals who cared for patients with venous ulceration. Data were analysed to identify recurring themes relating to the impact of obesity on care provision. RESULTS: This study found that the increasing numbers of obese patients with leg ulcers are currently presenting challenges to care delivery in many different ways. There was an impact of obesity on patient experience in terms of dignity, safety and quality. Data indicated that neither hospital nor community care services were adequately set up to meet the needs of obese patients in general. CONCLUSION: Health care providers need to recognise that increasing numbers of overweight and obese patients are presenting challenges to care delivery. The study also indicated the need for senior strategic leadership in planning for meeting the needs of obese patients. RELEVANCE TO CLINICAL PRACTICE: Nursing is well placed to provide specialist support to co-ordinate services for obese/oversize patients if a suitable strategic and leadership role is developed. Nurses are used to offering patients help in areas of health promotion such as smoking cessation. Lessons learnt from this area could be applied to help and encourage staff to support patients with weight management.