Women’s experiences of routine care during labor and childbirth and the influence of medicalization: A qualitative study from Iran

Objective: To understand women’s experiences of routine care during labor and childbirth in a medicalized context. Design: Twenty-six in-depth interviews were conducted during the late postpartum period and thematic analysis was applied. Setting: Four public hospitals in Tehran with a high rate of births, providing services to low and middle income families. Participants: Women who had a low risk pregnancies and gave a birth to a healthy baby by normal vaginal delivery. Findings: Two main themes emerged: ‘An ethos of medicalization’ which indicates that women’s perception of childbirth was influenced by the medicalized context of childbirth. And ‘The reality of fostered medicalization’ which illustrates the process by which interventions during labor affected women’s pathway through childbirth, and how the medicalization resulted in a birth experience which often included a preference for Caesarean Section rather than vaginal delivery with multiple interventions. Implications for Practice: Contextual factors such as legal issues, state’s regulations and the organisational framework of maternity services foster medicalized childbirth in Tehran public hospitals. These factors influence the quality of care and should be considered in any intervention for change. The aim should be a high quality birth experience with minimal interventions during normal vaginal delivery. A midwifery model of care combining scientific evidence with empathy may address this need for change

Asking the right questions to get the right answers: Using cognitive interviews to review the acceptability, comprehension and clinical meaningfulness of patient self-report adverse event items in oncology patients

Background: Standardized reporting of treatment-related adverse events (AE) is essential in clinical trials, usually achieved by using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) reported by clinicians. Patient-reported adverse events (PRAE) may add value to clinician assessments, providing patient perspective on subjective toxicity. We developed an online patient symptom report and self-management system for real-time reporting and managing AE during cancer treatment integrated with electronic patient records (eRAPID). As part of this program we developed a patient version of the CTCAE (version 4.0), rephrasing terminology into a self-report format. We explored patient understanding of these items via cognitive interviews. Material and method: Sixty patients (33 female, 27 male) undergoing treatment were purposively sampled by age, gender and tumor group (median age 61.5, range 35–84, 12 breast, 12 gynecological, 13 colorectal, 12 lung and 11 renal). Twenty-one PRAE items were completed on a touch-screen computer. Subsequent audio-recorded cognitive interviews and thematic analysis explored patients’ comprehension of items via verbal probing techniques during three interview rounds (n = 20 patients/round). Results: In total 33 item amendments were made; 29% related to question comprehension, 73% response option and 3% order effects. These amendments to phrasing and language improved patient understanding but maintained CTCAE grading and key medical information. Changes were endorsed by members of a patient advisory group (N = 11). Conclusion: Item adaptations resulted in a bank of consistently interpreted self-report AE items for use in future research program. In-depth analysis of items through cognitive interviews is an important step towards developing an internationally valid system for PRAE, thus improving patient safety and experiences during cancer treatment

Patient perspective on decisions to switch disease-modifying treatments in relapsing-remitting multiple sclerosis

Background: There are now large cohorts of people with relapsing-remitting multiple sclerosis (pwRRMS) who have taken several Disease-Modifying Treatments (DMTs). Studies about switching DMTs mostly focus on clinical outcomes rather than patients' decision-making. Neurologists are now required to support decisions at various times during the relapsing disease course and they do so with concerns about DMTs risks. This qualitative study investigates how pwRRMS weigh up the pros and cons of DMTs, focusing on perceptions of effectiveness and risks when new treatments are considered. / Objective: To increase understanding of people's experiences of decision-making when switching DMTs. / Methods: 30 semi-structured interviews were conducted with pwRRMS in England. 16 participants had switched DMT and their experiences were compared with those who had only taken one DMT. Interviews were analysed thematically to answer: what main factors influence people's decision-making to switch DMTs and why? / Results: Of the 16 participants with experience of switching DMT, eight had taken two or more DMTs; eight had taken three or more. Two was the DMT median. This study demonstrated that despite the term "switching" implying that similar treatments are inter-changeable, for pwRRMS taking new treatments involves different emotions, routines, risks, prognosis and communication experiences. Two meta themes identified were: 1) A distinctive, rapid and emotional decision-making process where old emotions related to MS prognosis are revisited. 2) Switching has a different impact on communication for escalation or de-escalation processes. / Conclusion: Switching DMT involves different routines, risks, prognosis and communication experiences. These decisions are emotionally difficult because of the fear about transitioning to secondary progressive MS, and DMT effectiveness uncertainty. Patient centred decision aids should include information about first and consecutive treatment decisions

Understanding treatment decisions from the perspective of people with relapsing remitting multiple Sclerosis: A critical interpretive synthesis

Background: Multiple Sclerosis (MS) is a chronic inflammatory demyelinating disorder of the central nervous system that mainly affects young adults. While there is no cure for MS, disease modifying treatments (DMTs) reduce the relapse rate and partial accrual of disability. More effective DMTs may have higher risks including life-threatening infections or secondary autoimmunity. The complexity and novelty of available treatments cause challenges for clinicians when prescribing treatments and for people with MS (PwMS) when deciding what trade-offs they are willing and ready to make. / Objective: To explore the experience of people with relapsing remitting MS (PwRRMS) and their perspectives in choosing treatments. / Methods: Critical interpretive synthesis was employed to review and synthesis the published literature. Eighty-three publications were selected in a multi-step systematic process. / Results: Findings are presented in four interrelated areas: the influence of the clinical evidence-base in decision making; the meaning of DMT efficacy for PwRRMS; the influence of models of decision-making and information acquisition practices in PwRRMS; and the importance of psychosocial dimensions in DMT decision making. Synthesis of the findings revealed that alongside medical and individual reasoning, contextual circumstances play an important role in making treatment decisions. / Conclusion: This review identifies and explains the importance of diverse contextual circumstances (clinical, social, psychological) that are important for PwRRMS when making treatment decisions. The findings demonstrate the importance of eliciting, understanding and addressing such contextual factors

Health state utilities of patients with heart failure: a systematic literature review

Background and Objectives New treatments and interventions are in development to address clinical needs in heart failure. To support decision making on reimbursement, cost-effectiveness analyses are frequently required. A systematic literature review was conducted to identify and summarize heart failure utility values for use in economic evaluations. Methods Databases were searched for articles published until June 2019 that reported health utility values for patients with heart failure. Publications were reviewed with specific attention to study design; reported values were categorized according to the health states, ‘chronic heart failure’, ‘hospitalized’, and ‘other acute heart failure’. Interquartile limits (25th percentile ‘Q1’, 75th percentile ‘Q3’) were calculated for health states and heart failure subgroups where there were sufficient data. Results The systematic literature review identified 161 publications based on data from 142 studies. Utility values for chronic heart failure were reported by 128 publications; 39 publications published values for hospitalized and three for other acute heart failure. There was substantial heterogeneity in the specifics of the study populations, methods of elicitation, and summary statistics, which is reflected in the wide range of utility values reported. EQ-5D was the most used instrument; the interquartile limit for mean EQ-5D values for chronic heart failure was 0.64–0.72. Conclusions There is a wealth of published utility values for heart failure to support economic evaluations. Data are heterogenous owing to specificities of the study population and methodology of utility value elicitation and analysis. Choice of value(s) to support economic models must be carefully justified to ensure a robust economic analysis

eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice: a pilot study protocol in pelvic radiotherapy.

Background: An estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT). Methods: Eligible patients are those attending St James's University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/-chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews. Discussion: The objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets. Trial registration: ClinicalTrials.gov NCT02747264

Incentivised case finding for depression in patients with chronic heart disease and diabetes in primary care: an ethnographic study

Objective: To examine the process of case finding for depression in people with diabetes and coronary heart disease within the context of a pay-for-performance scheme. Design: Ethnographic study drawing on observations of practice routines and consultations, debriefing interviews with staff and patients and review of patient records. Setting: General practices in Leeds, UK. Participants: 12 purposively sampled practices with a total of 119 staff; 63 consultation observations and 57 patient interviews. Main outcome measure: Audio recorded consultations and interviews with patients and healthcare professionals along with observation field notes were thematically analysed. We assessed outcomes of case finding from patient records. Results: Case finding exacerbated the discordance between patient and professional agendas, the latter already dominated by the tightly structured and time-limited nature of chronic illness reviews. Professional beliefs and abilities affected how case finding was undertaken; there was uncertainty about how to ask the questions, particularly among nursing staff. Professionals were often wary of opening an emotional ‘can of worms’. Subsequently, patient responses potentially suggesting emotional problems could be prematurely shut down by professionals. Patients did not understand why they were asked questions about depression. This sometimes led to defensive or even defiant answers to case finding. Follow-up of patients highlighted inconsistent systems and lines of communication for dealing with positive results on case finding. Conclusions: Case finding does not fit naturally within consultations; both professional and patient reactions somewhat subverted the process recommended by national guidance. Quality improvement strategies will need to take account of our results in two ways. First, despite their apparent simplicity, the case finding questions are not consultation-friendly and acceptable alternative ways to raise the issue of depression need to be supported. Second, case finding needs to operate within structured pathways which can be accommodated within available systems and resources