Quality & Safety in Health Care最新文献

{"title":"When evidence says no: gynaecologists’ reasons for (not) recommending ineffective ovarian cancer screening","authors":"O. Wegwarth, N. Pashayan","doi":"10.1136/bmjqs-2019-009854","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009854","url":null,"abstract":"Most patients likely assume that physicians offer medical procedures backed by solid, scientific evidence that demonstrates their superiority—or at least non-inferiority—to alternative approaches.1 Doing otherwise would waste healthcare resources urgently needed elsewhere in the system and also would jeopardise patient health and safety as well as undermine patients’ trust in medicine2 and care. In some instances, however, physicians’ healthcare practices appear to act against scientific evidence.3–5 For example, evidence from two large randomised controlled trials6 7 on ovarian cancer screening’s effectiveness showed that the screening has no mortality benefits—neither cancer-specific nor overall—in average-risk women but considerable harms, including false-positive surgeries in women without ovarian cancer. Consequently, the US Preventive Services Task Force and medical associations worldwide recommend against ovarian cancer screening.8 Nevertheless, a considerable number of US gynaecologists persist in recommending the screening to average-risk women.9 To understand why physicians continue using a practice called into question by scientific evidence, we investigated gynaecologists’ reasons for or against recommending ovarian cancer screening, their assumptions about why other gynaecologists recommend it, and the association between their knowledge of basic concepts of cancer screening statistics10 and recommendation behaviour. We surveyed a national sample of US outpatient gynaecologists stratified by the distribution of gender and years in practice of gynaecologists in the American Medical Association (AMA) Masterfile (table 1). The survey (see online supplementary materials) was part of a larger …","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"521 - 524"},"PeriodicalIF":0.0,"publicationDate":"2019-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009854","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49302691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"‘Whatever you cut, I can fix it’: clinical supervisors’ interview accounts of allowing trainee failure while guarding patient safety","authors":"J. Klasen, E. Driessen, P. Teunissen, L. Lingard","doi":"10.1136/bmjqs-2019-009808","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009808","url":null,"abstract":"Background Learning is in delicate balance with safety, as faculty supervisors try to foster trainee development while safeguarding patients. This balance is particularly challenging if trainees are allowed to experience the educational benefits of failure, acknowledged as a critical resource for developing competence and resilience. While other educational domains allow failure in service of learning, however, we do not know whether or not this strategy applies to clinical training. Methods We conducted individual interviews of clinical supervisors, asking them whether they allowed failure for educational purposes in clinical training and eliciting their experiences of this phenomenon. Participants’ accounts were descriptively analysed for recurring themes. Results Twelve women and seven men reported 48 specific examples of allowing trainee failure based on their judgement that educational value outweighed patient risk. Various kinds of failures were allowed: both during operations and technical procedures, in medication dosing, communication events, diagnostic procedures and patient management. Most participants perceived minimal consequences for patients, and many described their rescue strategies to prevent an allowed failure. Allowing failure under supervision was perceived to be important for supporting trainee development. Conclusion Clinical supervisors allow trainees to fail for educational benefit. In doing so, they attempt to balance patient safety and trainee learning. The educational strategy of allowing failure may appear alarming in the zero-error tolerant culture of healthcare with its commitment to patient safety. However, supervisors perceived this strategy to be invaluable. Viewing failure as inevitable, they wanted trainees to experience it in protected situations and to develop effective technical and emotional responses. More empirical research is required to excavate this tacit supervisory practice and support its appropriate use in workplace learning to ensure both learning and safety.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"727 - 734"},"PeriodicalIF":0.0,"publicationDate":"2019-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009808","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48039914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do bedside whiteboards enhance communication in hospitals? An exploratory multimethod study of patient and nurse perspectives","authors":"Anupama Goyal, Hanna Glanzman, M. Quinn, Komalpreet Tur, Sweta Singh, S. Winter, Ashley Snyder, V. Chopra","doi":"10.1136/bmjqs-2019-010208","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-010208","url":null,"abstract":"Objective To understand patient and nurse views on usability, design, content, barriers and facilitators of hospital whiteboard utilisation in patient rooms. Design Multimethods study. Setting Adult medical-surgical units at a quaternary care academic centre. Participants Four hundred and thirty-eight adult patients admitted to inpatient units participated in bedside surveys. Two focus groups with a total of 13 nurses responsible for updating and maintaining the whiteboards were conducted. Results Most survey respondents were male (55%), ≥51 years of age (69%) and admitted to the hospital ≤4 times in the past 12 months (90%). Over 95% of patients found the whiteboard helpful and 92% read the information on the whiteboard frequently. Patients stated that nurses, not doctors, were the most frequent user of whiteboards (93% vs 9.4%, p<0.001, respectively). Patients indicated that the name of the team members (95%), current date (87%), upcoming tests/procedures (80%) and goals of care (63%) were most useful. While 60% of patients were aware that they could use the whiteboard for questions/comments for providers, those with ≥5 admissions in the past 12 months were significantly more likely to be aware of this aspect (p<0.001). In focus groups, nurses reported they maintained the content on the boards and cited lack of access to clinical information and limited use by doctors as barriers. Nurses suggested creating a curriculum to orient patients to whiteboards on admission, and educational programmes for physicians to increase whiteboard utilisation. Conclusion Bedside whiteboards are highly prevalent in hospitals. Orienting patients and their families to their purpose, encouraging daily use of the medium and nurse–physician engagement around this tool may help facilitate communication and information sharing.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":" ","pages":"1 - 2"},"PeriodicalIF":0.0,"publicationDate":"2019-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-010208","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47370571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inappropriate ED visits: patient responsibility or an attribution bias?","authors":"K. Chaiyachati, S. Kangovi","doi":"10.1136/bmjqs-2019-009729","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009729","url":null,"abstract":"The study by Naouri et al in this issue of BMJ Quality and Safety describes an ambitious, 24-hour cross-sectional physician survey and chart review of all the emergency departments (ED) in France to characterise the ‘inappropriateness’ of ED visits.1 The determination of inappropriateness for any given visit was based on (A) physician opinion, (B) physician determination of ambulatory care sensitivity, or (C) resource utilisation. Based on these measures, the authors concluded that between 13% and 27% of ED visits were inappropriate. Further, patients with supplemental public insurance (a proxy for the socioeconomic disadvantaged in France) were 15%–33% more likely to use the ED inappropriately.\u0000\u0000Naouri’s study is part of a growing body of literature that characterises ED use as inappropriate, avoidable, ambulatory care sensitive or preventable.2 3 While there is precedent and potential merit in classifying healthcare services based on their value,4 this trend raises some concerns—as the authors rightly conclude—when describing the use of EDs by disadvantaged populations.\u0000\u0000Determining the patient’s ED visit as inappropriate, without consideration of broader contextual factors, is an example of attribution bias: the tendency for people to overemphasise individual and personality-based explanations for behaviours while underemphasising situational explanations.5 We may blame patients for visiting the ED inappropriately, when in reality, healthcare systems are often designed to funnel patients towards …","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"441 - 442"},"PeriodicalIF":0.0,"publicationDate":"2019-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009729","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47613839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving end-of-rotation transitions of care among ICU patients","authors":"J. Denson, J. Knoeckel, S. Kjerengtroen, Rachel L. Johnson, B. McNair, O. Thornton, I. Douglas, M. Wechsler, R. Burke","doi":"10.1136/bmjqs-2019-009867","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009867","url":null,"abstract":"Background Hospitalised patients whose inpatient teams rotate off service experience increased mortality related to end-of-rotation care transitions, yet standardised handoff practices are lacking. Objective Develop and implement a multidisciplinary patient-centred handoff intervention to improve outcomes for patients who are critically ill during end-of-rotation transitions. Design, setting and participants Single-centre, controlled pilot study of medical intensive care unit (ICU) patients whose resident team was undergoing end-of-rotation transition at a university hospital from June 2017 to February 2018. Intervention A 4-item intervention was implemented over two study periods. Intervention 1 included: (1) in-person bedside handoff between teams rotating off and on service, (2) handoff checklist, (3) nursing involvement in handoff, and (4) 30 min education session. Intervention 2 included the additional option to conduct bedside handoff via videoconferencing. Main outcome measures Implementation was measured by repeated clinician surveys and direct observation. Patient outcomes included length of stay (LOS; ICU and hospital) and mortality (ICU, hospital and 30 days). Clinician perceptions were modelled over time using per cent positive responses in logistic regression. Patient outcomes were compared with matched control ‘transition’ patients from 1 year prior to implementation of the intervention. Results Among 270 transition patients, 46.3% were female with a mean age of 55.9 years. Mechanical ventilation (64.1%) and in-hospital death (27.6%) rates were prevalent. Despite high implementation rates—handoff participation (93.8%), checklist utilisation (75.0%), videoconferencing (62.5%), nursing involvement (75.0%)—the intervention did not significantly improve LOS or mortality. Multidisciplinary survey data revealed significant improvement in acceptability by nursing staff, while satisfaction significantly declined for resident physicians. Conclusions In this controlled pilot study, a structured ICU end-of-rotation care transition strategy was feasible to implement with high fidelity. While mortality and LOS were not affected in a pilot study with limited power, the pragmatic strategy of this intervention holds promise for future trials.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"250 - 259"},"PeriodicalIF":0.0,"publicationDate":"2019-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009867","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41660483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Obstetric care navigation: results of a quality improvement project to provide accompaniment to women for facility-based maternity care in rural Guatemala","authors":"Kirsten Austad, Michel Juarez, H. Shryer, Cristina Moratoya, P. Rohloff","doi":"10.1136/bmjqs-2019-009524","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009524","url":null,"abstract":"Background Many maternal and perinatal deaths in low-resource settings are preventable. Inadequate access to timely, quality care in maternity facilities drives poor outcomes, especially where women deliver at home with traditional birth attendants (TBA). Yet few solutions exist to support TBA-initiated referrals or address reasons patients frequently refuse facility care, such as disrespectful and abusive treatment. We hypothesised that deploying accompaniers—obstetric care navigators (OCN)—trained to provide integrated patient support would facilitate referrals from TBAs to public hospitals. Methods This project built on an existing collaboration with 41 TBAs who serve indigenous Maya villages in Guatemala’s Western Highlands, which provided baseline data for comparison. When TBAs detected pregnancy complications, families were offered OCN referral support. Implementation was guided by bimonthly meetings of the interdisciplinary quality improvement team where the OCN role was iteratively tailored. The primary process outcomes were referral volume, proportion of births receiving facility referral, and referral success rate, which were analysed using statistical process control methods. Results Over the 12-month pilot, TBAs attended 847 births. The median referral volume rose from 14 to 27.5, meeting criteria for special cause variation, without a decline in success rate. The proportion of births receiving facility-level care increased from 24±6% to 62±20% after OCN implementation. Hypertensive disorders of pregnancy and prolonged labour were the most common referral indications. The OCN role evolved to include a number of tasks, such as expediting emergency transportation and providing doula-like labour support. Conclusions OCN accompaniment increased the proportion of births under TBA care that received facility-level obstetric care. Results from this of obstetric care navigation suggest it is a feasible, patient-centred intervention to improve maternity care.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"169 - 178"},"PeriodicalIF":0.0,"publicationDate":"2019-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009524","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42726102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with inappropriate use of emergency departments: findings from a cross-sectional national study in France","authors":"D. Naouri, G. Ranchon, A. Vuagnat, Jeannot Schmidt, C. El Khoury, Y. Yordanov","doi":"10.1136/bmjqs-2019-009396","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-009396","url":null,"abstract":"Background Inappropriate visits to emergency departments (EDs) could represent from 20% to 40% of all visits. Inappropriate use is a burden on healthcare costs and increases the risk of ED overcrowding. The aim of this study was to explore socioeconomic and geographical determinants of inappropriate ED use in France. Method The French Emergency Survey was a nationwide cross-sectional survey conducted on June 11 2013, simultaneously in all EDs in France and covered characteristics of patients, EDs and counties. The survey included 48 711 patient questionnaires and 734 ED questionnaires. We focused on adult patients (≥15 years old). The appropriateness of the ED visit was assessed by three measures: caring physician appreciation of appropriateness (numeric scale), caring physician appreciation of whether or not the patient could have been managed by a general practitioner and ED resource utilisation. Descriptive statistics and multilevel logistic regression were used to examine determinants of inappropriate ED use, estimating adjusted ORs and 95% CIs. Results Among the 29 407 patients in our sample, depending on the measuring method, 13.5% to 27.4% ED visits were considered inappropriate. Regardless of the measure method used, likelihood of inappropriate use decreased with older age and distance from home to the ED >10 km. Not having a private supplementary health insurance, having universal supplementary health coverage and symptoms being several days old increased the likelihood of inappropriate use. Likelihood of inappropriate use was not associated with county medical density. Conclusion Inappropriate ED use appeared associated with socioeconomic vulnerability (such as not having supplementary health coverage or having universal coverage) but not with geographical characteristics. It makes us question the appropriateness of the concept of inappropriate ED use as it does not consider the distress experienced by the patient, and segments of society seem to have few other choices to access healthcare than the ED.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"449 - 464"},"PeriodicalIF":0.0,"publicationDate":"2019-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-009396","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47046634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenge of ensuring access to high-quality emergency surgical care for all","authors":"John W. Scott, J. Dimick","doi":"10.1136/bmjqs-2019-010219","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-010219","url":null,"abstract":"Emergency general surgery (EGS) encompasses a variety of common acute surgical conditions with high morbidity and mortality that often require timely delivery of resource-intensive care. In the UK, over 30 000 patients require an emergency laparotomy each year1 and a 2012 audit by the UK Emergency Laparotomy Network revealed a greater than 10-fold variation in mortality rates between hospitals.2 The wide variability in both processes of care and clinical outcomes make EGS a prime target for quality improvement (QI) programmes, whereby promotion of evidence-based practices associated with better outcomes have the potential to impact thousands of lives.\u0000\u0000The Enhanced Peri-Operative Care for High-risk patients (EPOCH) trial was designed to evaluate the impact of a national QI programme on survival after emergency abdominal surgery across 93 National Health Service (NHS) hospitals in the UK.1 In this trial, a care pathway consisting of 37 consensus-derived best practices was implemented at each hospital using a step-wedged trial design. Over the 85-week study period, the trial failed to demonstrate any significant improvements in mortality, length of stay or readmissions among adults undergoing open emergency abdominal procedures.3 When QI efforts aimed at sweeping practice change fail to improve outcomes, they may fail for one of two reasons. First, it may be a failure of implementing the required changes to existing practice. A trial …","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"613 - 614"},"PeriodicalIF":0.0,"publicationDate":"2019-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-010219","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47729357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Measuring low-value care: learning from the US experience measuring quality","authors":"L. Marcotte, Linnaea Schuttner, J. Liao","doi":"10.1136/bmjqs-2019-010191","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-010191","url":null,"abstract":"There is wide recognition that promoting healthcare value involves decreasing ‘low-value’ services—care without clinical benefit, little benefit compared with cost or disproportionate potential harm.1 While low-value care has been presumed to be a problem predominantly in the USA in the context of an expensive, fragmented, multipayer, fee-for-service system, recent evidence suggests low-value services are pervasive even in government-funded healthcare systems with universal coverage and interoperability.2 Accordingly, low-value care is garnering attention across the globe.3 \u0000\u0000In response, policymakers, insurers and individual healthcare systems must work together to create and track measures of low-value care. In the USA, a number of states have begun to use such measures to characterise low-value care delivered by healthcare provider organisations.4–6 Many of the existing measures have been derived from the national Choosing Wisely campaign7 with examples such as cervical cancer screening in women >65 years, preoperative testing in asymptomatic patients undergoing low-risk surgical procedures and diagnostic imaging for uncomplicated headache.8 More measures are likely to emerge amid the proliferation of value-based payment and care delivery reforms.\u0000\u0000While measuring low-value care is laudable and necessary, it is also challenging. Widely available data sources, such as claims, imperfectly capture clinical appropriateness of specific services. Measures should be valid and clearly define which facet(s) of value are being captured, and for which stakeholders. Engagement and collaboration between insurers and clinicians are needed to meaningfully implement these measures. Measures could create unintended consequences by prompting clinicians to focus disproportionately on measured services to the detriment of other aspects of care or select diagnostic coding aligned with a desired outcome. For example, a low-value care measure dissuading antibiotic prescribing in patients with acute bronchitis could drive clinicians to code more diagnoses as ‘upper respiratory tract infection’ …","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"154 - 156"},"PeriodicalIF":0.0,"publicationDate":"2019-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-010191","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43778711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative effectiveness of risk mitigation strategies to prevent fetal exposure to mycophenolate","authors":"A. Sarayani, Yasser Albogami, M. Elkhider, J. Hincapie-Castillo, B. Brumback, A. Winterstein","doi":"10.1136/bmjqs-2019-010098","DOIUrl":"https://doi.org/10.1136/bmjqs-2019-010098","url":null,"abstract":"Background In 2012, the US Food and Drug Administration approved a Risk Evaluation and Mitigation Strategy (REMS) programme including mandatory prescriber training and a patient/provider acknowledgement form to prevent fetal exposure to mycophenolate. Prior to the REMS, the teratogenic risk was solely mitigated via written information (black box warning, medication guide (MG period)). To date, there is no evidence on the effectiveness of the REMS. Methods We used a national private health insurance claims database to identify women aged 15–44 who filled ≥1 mycophenolate prescription. To compare fetal exposure during REMS with the MG period, we estimated the prevalence of pregnancy at treatment initiation in a pre/post comparison (analysis 1) and the rate of conception during treatment in a retrospective cohort study (analysis 2). Pregnancy episodes were measured based on diagnosis and procedure codes for pregnancy outcomes or prenatal screening. We used generalised estimating equation models with inverse probability of treatment weighting to calculate risk estimates. Results The adjusted proportion of existing pregnancy per 1000 treatment initiations was 1.7 (95% CI 1.0 to 2.9) vs 4.1 (95% CI 3.2 to 5.4) during the REMS and MG period. The adjusted prevalence ratio and prevalence difference were 0.42 (95% CI 0.24 to 0.74) and −2.4 (95% CI −3.8 to −1.0), respectively. In analysis 2, the adjusted rate of conception was 12.5 (95% CI 8.9 to 17.6) vs 12.9 (95% CI 9.9 to 16.9) per 1000 years of mycophenolate exposure time in the REMS versus MG periods. The adjusted risk ratio and risk difference were 0.97 (95% CI 0.63 to 1.49) and −0.4 (95% CI −5.9 to 5.0), respectively. Sensitivity analyses on the estimated conception date demonstrated robustness of our findings. Conclusion While the REMS programme achieved less pregnancies at treatment initiation, it failed to prevent the onset of pregnancy during treatment. Enhanced approaches to ensure effective contraception during treatment should be considered.","PeriodicalId":49653,"journal":{"name":"Quality & Safety in Health Care","volume":"29 1","pages":"636 - 644"},"PeriodicalIF":0.0,"publicationDate":"2019-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1136/bmjqs-2019-010098","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44473885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}