Is it "loud" enough?: A qualitative investigation of blunt use among African American young adults.

Heavy blunt use is common among young adult cannabis users, especially African Americans. This exploratory qualitative study aimed to examine how African American young adults understand, talk about and experience their blunt use. Semi-structured interviews were conducted with adults reporting daily or almost daily blunt use in the past month (N = 20; 75% male). Thematic analysis of the audio-recorded interviews revealed aspects of how blunts are described, made and used among heavy blunt users. The three emergent themes have implications for the assessment of cannabis use and intervention development for heavy blunt users.

Safety and efficacy of (+)-epicatechin in subjects with Friedreich's ataxia: A phase II, open-label, prospective study.

BACKGROUND: (+)-Epicatechin (EPI) induces mitochondrial biogenesis and antioxidant metabolism in muscle fibers and neurons. We aimed to evaluate safety and efficacy of (+)-EPI in pediatric subjects with Friedreich's ataxia (FRDA). METHODS: This was a phase II, open-label, baseline-controlled single-center trial including 10 participants ages 10 to 22 with confirmed FA diagnosis. (+)-EPI was administered orally at 75 mg/d for 24 weeks, with escalation to 150 mg/d at 12 weeks for subjects not showing improvement of neuromuscular, neurological or cardiac endpoints. Neurological endpoints were change from baseline in Friedreich's Ataxia Rating Scale (FARS) and 8-m timed walk. Cardiac endpoints were changes from baseline in left ventricular (LV) structure and function by cardiac magnetic resonance imaging (MRI) and echocardiogram, changes in cardiac electrophysiology, and changes in biomarkers for heart failure and hypertrophy. RESULTS: Mean FARS/modified (m)FARS scores showed nonstatistically significant improvement by both group and individual analysis. FARS/mFARS scores improved in 5/9 subjects (56%), 8-m walk in 3/9 (33%), 9-peg hole test in 6/10 (60%). LV mass index by cardiac MRI was significantly reduced at 12 weeks (P = .045), and was improved in 7/10 (70%) subjects at 24 weeks. Mean LV ejection fraction was increased at 24 weeks (P = .008) compared to baseline. Mean maximal septal thickness by echocardiography was increased at 24 weeks (P = .031). There were no serious adverse events. CONCLUSION: (+)-EPI was well tolerated over 24 weeks at up to 150 mg/d. Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes. SYNOPSIS: A (+)-epicatechin showed improvement of cardiac function, nonsignificant reduction of FARS/mFARS scores, and sustained significant upregulation of muscle-regeneration biomarker follistatin.

Methodological considerations for the design and implementation of a fully longitudinal mixed methods study.

Growing interest is evident in longitudinal mixed methods research, particularly fully longitudinal mixed methods designs in which both quantitative and qualitative data are collected concurrently for the duration of the study. Fully longitudinal mixed methods designs are particularly relevant for research on dynamic phenomena because of their ability to illuminate both quantitative and qualitative dimensions of change in real time as the phenomenon of interest changes. However, these are complex research designs and their data-intense nature makes them potentially burdensome for study participants, challenging for research teams, and costly for funding agencies. Despite growing use, the methodological literature on fully longitudinal mixed methods research is sparse and little guidance is available for researchers considering this approach. We address this gap by describing our experience with the design and implementation of a fully longitudinal mixed methods study of a dynamic phenomenon, namely, family caregiving during cancer treatment. We describe important questions and key decisions confronted while developing the research proposal, proactive strategies for study implementation, and implementation realities encountered while the study was in progress. On the basis of insights gained through real-world experience, we offer three guiding principles for researchers undertaking such a study. First, align the study design with the nature of the dynamics in the phenomenon of interest. Second, plan from the start when and how the integration of the longitudinal quantitative and qualitative data will occur. Third, employ implementation strategies that take into account the practical aspects of repeated contacts with study participants for an extended period.

Plantar Ulcers and Neuropathic Arthropathies: Associated Diseases, Polyneuropathy Correlates, and Risk Covariates.

OBJECTIVE: To evaluate the associated diseases, polyneuropathy correlates, and risk covariates of neuropathic plantar ulcers (PUs) and neuropathic arthropathies (NAs). DESIGN: The authors conducted a retrospective, observational study over 3.5 years of 69 patients with neuropathy, NA, or PU seen in a wound clinic who also had a comprehensive neurologic evaluation and neurophysiologic testing. Comparisons were made to a population representative cohort of patients with diabetes mellitus (DM; n = 259). RESULTS: Of the 69 wound clinic patients, 32 had PUs, 14 had NAs, and 23 had both. Of the 61 adequately assessed patients, 37 (61%) had DM, 22 (36%) had no known associated disease, and 2 (3%) had hereditary sensory and autonomic neuropathy. Of the 37 patients with DM, 35 had distal polyneuropathy, and 2 did not. In 22 patients with chronic idiopathic axonal polyneuropathy, 20 had distal polyneuropathy. CONCLUSIONS: Although DM was the disease most commonly associated with PUs and NAs, chronic hyperglycemia may not have been the major underlying risk factor. The major risk covariates are sensation loss from polyneuropathy, old age, obesity, repetitive foot injury, and inadequate foot care or treatment. Physicians and other healthcare providers can help by identifying patients at risk and instituting measures such as adequate foot care to decrease these risks.

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO).

BACKGROUND: Excessive haemorrhage at cesarean section requires donor (allogeneic) blood transfusion. Cell salvage may reduce this requirement. METHODS AND FINDINGS: We conducted a pragmatic randomised controlled trial (at 26 obstetric units; participants recruited from 4 June 2013 to 17 April 2016) of routine cell salvage use (intervention) versus current standard of care without routine salvage use (control) in cesarean section among women at risk of haemorrhage. Randomisation was stratified, using random permuted blocks of variable sizes. In an intention-to-treat analysis, we used multivariable models, adjusting for stratification variables and prognostic factors identified a priori, to compare rates of donor blood transfusion (primary outcome) and fetomaternal haemorrhage ≥2 ml in RhD-negative women with RhD-positive babies (a secondary outcome) between groups. Among 3,028 women randomised (2,990 analysed), 95.6% of 1,498 assigned to intervention had cell salvage deployed (50.8% had salvaged blood returned; mean 259.9 ml) versus 3.9% of 1,492 assigned to control. Donor blood transfusion rate was 3.5% in the control group versus 2.5% in the intervention group (adjusted odds ratio [OR] 0.65, 95% confidence interval [CI] 0.42 to 1.01, p = 0.056; adjusted risk difference -1.03, 95% CI -2.13 to 0.06). In a planned subgroup analysis, the transfusion rate was 4.6% in women assigned to control versus 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 2.2% versus 1.8% among elective cesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46). No case of amniotic fluid embolism was observed. The rate of fetomaternal haemorrhage was higher with the intervention (10.5% in the control group versus 25.6% in the intervention group, adjusted OR 5.63, 95% CI 1.43 to 22.14, p = 0.013). We are unable to comment on long-term antibody sensitisation effects. CONCLUSIONS: The overall reduction observed in donor blood transfusion associated with the routine use of cell salvage during cesarean section was not statistically significant. TRIAL REGISTRATION: This trial was prospectively registered on ISRCTN as trial number 66118656 and can be viewed on http://www.isrctn.com/ISRCTN66118656.

Short versus standard duration tourniquet use during Total Knee Replacement: A pilot study.

We performed a prospective, randomized, controlled trial to know whether a short duration of tourniquet application affects surgical time, post-operative swelling, pain, early rehabilitation and complications compared to standard use of tourniquet throughout the procedure. Sixty knees were randomized. There were no differences in terms of surgical time and pain experienced between the two groups. Patients in the short duration tourniquet group had significantly less thigh swelling (3.7±1.6 versus 4.8±2.35 p<0.01). There were no differences in the early rehabilitation between the groups. Soft tissue complications were higher in standard duration group. The use of tourniquet only during cementation of the implants reduces the thigh swelling and soft tissue complications associated with tourniquet use throughout the procedure.

Impact of brachial plexus birth injury on health-related quality of life in adulthood: a mixed methods survey study.

PURPOSE: To describe the scope and nature of health concerns, functional impairments, and quality of life issues among adults with brachial plexus birth injury (BPBI). METHODS: A mixed methods study was conducted by surveying two social media networks of adults with BPBI using a combination of closed-ended and open-ended questions regarding the role of BPBI on ones' health, function, and quality of life. Closed-ended responses were compared across ages and genders. Open-ended responses were qualitatively analyzed to expand upon the close-ended responses. RESULTS: Surveys were completed by 183 respondents (83% female, age range 20-87 years). BPBI was reported to impact hand and arm use in 80% of participants (including affected and unaffected limbs and bimanual tasks), overall health in 60% (predominantly pain), activity participation in 79% (predominantly activities of daily living and leisure), life roles in 76% (predominantly occupation and parenting), and overall quality of life in 73% (predominantly self-esteem, relationships, and appearance). Significantly more females than males reported other medical conditions and an impact on hand and arm use and life roles. No other responses varied by age or gender. CONCLUSIONS: BPBI affects many facets of health related quality of life in adulthood with variability among affected individuals.

Brachial plexus birth injury's scope of impact in adulthood is broad, covering every aspect of HRQoL.The focus of rehabilitation for brachial plexus birth injury (BPBI) through the lifespan should extend beyond improving physical musculoskeletal function and include comprehensive support for physical, emotional, social, and life role concerns.Brachial plexus birth injury's nature of impact in adulthood varies among individuals within each aspect of health-related quality of life.The variability of BPBI's impact in adulthood underscores the need for individualized, patient-centered assessment and rehabilitative care.

Barriers and Facilitators to Prevention and Care of COVID-19 Infection in Cincinnati Latinx Families: a Community-Based Convergent Mixed Methods Study.

BACKGROUND: Latinx populations have experienced disproportionately high case rates of COVID-19 across the USA. Latinx communities in non-traditional migration areas may experience greater baseline day-to-day challenges such as a lack of resources for immigrants and insufficient language services. These challenges may be exacerbated by the COVID-19 pandemic. OBJECTIVE: This article describes the results of an initial community health needs assessment to better understand the prevention and care of COVID-19 infection in the Cincinnati Latinx community. METHODS: We used convergent mixed methods to examine barriers and facilitators to COVID-19 prevention and care for those with infection. RESULTS: Latinx adults ≥ 18 years old completed 255 quantitative surveys and 17 qualitative interviews. Overarching mixed methods domains included knowledge, prevention, work, challenges, and treatment. Quantitative results largely reinforced qualitative results (confirmation). Certain quantitative and qualitative results, however, diverged and expanded insights related to caring for COVID-19 infection among Latinx adults (expansion). There were infrequent contradictions between quantitative and qualitative findings (discordance). Primary barriers for the Latinx community during the COVID-19 pandemic included insecurities in food, jobs, housing, and immigration. Key facilitators included having trusted messengers of health-related information. CONCLUSION: Public health interventions should be centered on community partnerships and the use of trusted messengers. Wraparound services (including resources for immigrants) are essential public health services. Close partnership with employers is essential as lack of sick leave and mask supplies were more frequent barriers than knowledge. These findings emerged from experiences during the COVID-19 pandemic but likely generalize to future public health crises.

Elevated pre-morbid weights in bulimic individuals are usually surpassed post-morbidly: implications for perpetuation of the disorder.

OBJECTIVE: To determine how often patients diagnosed with bulimia nervosa (BN) surpass their highest pre-morbid weight during the course of their disorder. METHOD: The weight histories of individuals with BN were determined using retrospective weight data (Study 1) and combined retrospective/prospective data (Study 2). RESULTS: Retrospective analyses indicated that 59.0% (n = 46) and 61.8% (n = 110), respectively, reported that their highest weight was reached after developing BN. In Study 2, 35.3% of participants superseded their highest pre-enrollment weights during 8 years of follow-up, and 71.6% reached a post-morbid highest weight before remission. Across studies, the primary difference between patients who did and did not reach their highest weight post-morbidly was that those who did had an earlier age of onset and longer duration of BN. DISCUSSION: Findings are discussed in terms of possible links between BN and weight-gain proneness, weight fluctuation across the course of BN, and implications for treating BN.

A Mixed Methods Study of Hearing Loss, Communication, and Social Engagement in a Group Care Setting for Older Adults.

Purpose: The purpose of this study is to characterize the communication needs of older adults in group care environments and understand the factors that foster engaged communication. Method: This mixed methods study provides an in-depth analysis of communication and engagement for older adults at two Program for All-inclusive Care for the Elderly (PACE) sites. Seventy-two PACE participants (M age = 74 years) completed a hearing test, cognitive screener (MOST™), the Institute of Medicine (IOM) Measures of Social and Behavioral Determinants of Health Questionnaire, and the UCLA Loneliness Scale. Using maximum variation sampling based on hearing status and UCLA Loneliness scores, 19 participants were invited to do (and 11 participants completed) one-on-one semi-structured interviews. In addition, 35 staff members participated in 5 focus groups. Field observations were interspersed throughout the data collection period. Results: Results suggest that communication challenges such as hearing loss, cognitive decline, and social isolation are highly prevalent in this convenience sample. Sixty-seven percent have at least a mild hearing loss in the better hearing ear. Eighty-two percent scored in the "very" or "most isolated" range of the IOM Measures of Social and Behavioral Determinants of Health questionnaire. The mean score on the MOST™ cognitive screener was 17.6, which is below the dementia screening cutoff score of 18 points. A thematic analysis of the qualitative data suggests that the PACE programs support socialization and engagement. A conceptual framework was developed by integrating quantitative and qualitative findings to recognize what contributes to meaningful interactions or engaged communication. Conclusion: Identifying communication challenges can enhance the benefits individuals can experience at care facilities and lessen the burden of the staff members trying to provide safe and effective care. In order to maximize the potential benefit of attending group-based day centers, the communication challenges and motivations of older adults need to be addressed.

Qualitative Findings for Supporting Newly Graduated Nurse and Teacher Sleep During Their First Year.

BACKGROUND: New graduate role transition for nurses and teachers is stressful. Poor adaptation may manifest as insomnia, which has implications for the new professionals, their employers, and the public served. This study examines factors that impact new graduate sleep, with the aim of identifying perceived helps and hindrances to sleep-during-transition. METHODS: Targeted content analysis of transcripts from a larger longitudinal mixed methods study comparing new graduate sleep during their first year of practice. Study participants (N = 21) answered questions in the final interview regarding the most positive and negative impact(s) on sleep during the transition year. Transcripts were analyzed and compared based on the new graduate sleep typology (i.e., Got Better, Got Worse, Stayed Varied) which emerged from the parent study. FINDINGS: Most participants, regardless of sleep type, identified a person/group as most positively impacting sleep. They identified work thoughts, stress/anxiety, people, work hours/sleep schedules, and environmental factors as negatively impacting sleep. Work thoughts and stress/anxiety were mentioned together and most frequently by participants in all three sleep types. CONCLUSION/APPLICATIONS TO PRACTICE: This study provided insight into new graduate nurse and teacher sleep during transition. Support persons and/or groups may be essential regardless of sleep type. Thought management/stress mitigation strategies and good sleep hygiene may also improve the sleep experiences of these new professionals. Occupational health nurses can support sleep-during-transition among new nurses and teachers by acting as sleep advocates. They may also identify a need for medical intervention and/or sleep specialists and should promote fatigue risk mitigating policies.

Applying mixed methods to pilot feasibility studies to inform intervention trials.

BACKGROUND: Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions. METHODS: We used an informal consensus-based process informed by key methodological resources and our team's complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research. RESULTS: We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data. CONCLUSIONS: By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials.

The anaesthetic management of caesarean section in the interventional radiology suite.

PURPOSE OF REVIEW: Interventional radiology has been used in the last decade for the management of major obstetric haemorrhage particularly when the placenta is pathologically adherent (accreta) or for postpartum haemorrhage when a bleeding vessel is suspected. This review describes the radiological, obstetric and anaesthetic interventions which are often carried out in the radiology suite. RECENT FINDINGS: The incidence of placenta accreta is increasing as the caesarean section rate rises. Pre-delivery diagnosis has been facilitated by the use of ultrasound and magnetic resonance imaging. The use of interventional radiology for elective caesarean sections with suspected placenta accreta is mainly restricted to larger centres and the evidence base for its use is currently weak. The actual location of the surgery remains controversial. Some centres with expertise perform the caesarean section in the radiology suite with obstetric, anaesthetic and neonatal teams in attendance. Robust communication is essential, especially when working in sites remote to the usual place of care. SUMMARY: This review describes the management of patients who are amenable to prophylactic or emergency radiological intervention for obstetric haemorrhage in the radiology suite. Controversy surrounds the optimum place for surgery and the most suitable mode of anaesthesia in these patients.

The Experience of Complex Pain Dynamics in Oncology Outpatients: A Longitudinal Qualitative Analysis.

BACKGROUND: Few qualitative studies of cancer patients' everyday experiences with pain exist within the large body of cancer pain research. Longitudinal qualitative studies are particularly sparse, and no studies have qualitatively described patients' pain experience over time during participation in a self-management intervention. OBJECTIVE: To longitudinally describe patients' pain experiences during a 10-week pain self-management intervention. METHODS: This qualitative study was embedded in a randomized controlled trial of a psychoeducational pain management intervention. The data consisted of transcribed audio recordings of each intervention session. An emergent, interpretive approach was used in this longitudinal qualitative analysis. RESULTS: Forty-two adult patients were included. The analysis revealed the strikingly dynamic nature of individual patient's pain experiences. Multiple facets of pain contributed to its dynamic nature, including pain in changing locations, co-occurring sources of pain, and varying patterns of pain intensity over time. For individual patients, the cumulative effect of these multiple facets resulted in a phenomenon we termed "complex pain dynamics." CONCLUSION: The results contribute to knowledge about the dynamic nature of cancer patients' pain experiences over a relatively short period. They suggest the need for a new paradigm for management of pain in cancer patients and raise questions about the interpretation of randomized controlled trial results in the absence of qualitative data. IMPLICATIONS FOR PRACTICE: Frequent assessments and reassessments of pain are needed in cancer patients with the ongoing development of highly individualized self-management strategies. A large repertoire of interventions is needed to effectively manage pain in cancer patients over time.

A Longitudinal Study of Predictors of Constipation Severity in Oncology Outpatients With Unrelieved Pain.

CONTEXT: Although constipation is a common symptom in oncology patients, it often goes unrecognized and untreated. In addition, little is known about characteristics associated with interindividual differences in constipation severity. OBJECTIVES: To describe prevalence, characteristics, and management of constipation; evaluate interindividual differences in constipation severity over 10 weeks; and identify demographic, clinical, and symptom characteristics associated with higher constipation severity scores. METHODS: In this prospective, longitudinal study, 175 oncology patients with unrelieved pain were recruited from eight outpatient cancer settings in the U.S. Patients completed demographic and symptom questionnaires at enrollment. Constipation severity was evaluated over 10 weeks using the Constipation Assessment Scale (CAS). Hierarchical linear modeling was used to identify characteristics associated with higher CAS scores. RESULTS: At enrollment, 70.1% of the patients reported constipation [i.e., CAS score of >2; mean CAS score: 3.72 (±3.11)]. While over the first week of the study patients used one to two constipation treatments per day, a large amount of interindividual variability was found in CAS scores. Higher percentage of days with no bowel movement, higher number of constipation treatments, higher state anxiety scores, and higher analgesic side effects scores were associated with higher CAS scores at enrollment. Higher percentage of days with no bowel movement was associated with interindividual differences in the trajectories of constipation. CONCLUSION: Our findings underscore the high prevalence of and large amount of interindividual variability in constipation severity. The characteristics associated with worse CAS scores can assist clinicians to identify high-risk patients and initiate prompt interventions.

Mixed methods grant applications in the health sciences: An analysis of reviewer comments.

Our aim was to understand how reviewers appraise mixed methods research by analyzing reviewer comments for grant applications submitted primarily to the National Institutes of Health. We requested scholars and consultants in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences to send us summary statements from their mixed methods grant applications and obtained 40 summary statements of funded (40%) and unfunded (60%) mixed methods grant applications. We conducted a document analysis using a coding rubric based on the NIH Best Practices for Mixed Methods Research in the Health Sciences and allowed inductive codes to emerge. Reviewers favorably appraised mixed methods applications demonstrating coherence among aims and research design elements, detailed methods, plans for mixed methods integration, and the use of theoretical models. Reviewers identified weaknesses in mixed methods applications that lacked methodological details or rationales, had a high participant burden, and failed to delineate investigator roles. Successful mixed methods applications convey assumptions behind the methods chosen to accomplish specific aims and clearly detail the procedures to be taken. Investigators planning to use mixed methods should remember that reviewers are looking for both points of view.

Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials.

It is common to undertake qualitative research alongside randomised controlled trials (RCTs) when evaluating complex interventions. Researchers tend to analyse these datasets one by one and then consider their findings separately within the discussion section of the final report, rarely integrating quantitative and qualitative data or findings, and missing opportunities to combine data in order to add rigour, enabling thorough and more complete analysis, provide credibility to results, and generate further important insights about the intervention under evaluation. This paper reports on a 2 day expert meeting funded by the United Kingdom Medical Research Council Hubs for Trials Methodology Research with the aims to identify current strengths and weaknesses in the integration of quantitative and qualitative methods in clinical trials, establish the next steps required to provide the trials community with guidance on the integration of mixed methods in RCTs and set-up a network of individuals, groups and organisations willing to collaborate on related methodological activity. We summarise integration techniques and go beyond previous publications by highlighting the potential value of integration using three examples that are specific to RCTs. We suggest that applying mixed methods integration techniques to data or findings from studies involving both RCTs and qualitative research can yield insights that might be useful for understanding variation in outcomes, the mechanism by which interventions have an impact, and identifying ways of tailoring therapy to patient preference and type. Given a general lack of examples and knowledge of these techniques, researchers and funders will need future guidance on how to undertake and appraise them.

Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial.

OBJECTIVES: To evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care. DESIGN: Model-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section. SETTING: 26 obstetric units in the UK. PARTICIPANTS: 3028 women at risk of haemorrhage recruited between June 2013 and April 2016. INTERVENTIONS: Cell salvage (intervention) versus routine care without salvage (control). PRIMARY OUTCOME MEASURES: Cost-effectiveness based on incremental cost per donor blood transfusion avoided. RESULTS: In the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses. CONCLUSIONS: The results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies. TRIAL REGISTRATION NUMBER: ISRCTN66118656.

Strategies to manage major obstetric haemorrhage.

PURPOSE OF REVIEW: Haemorrhage remains a cause of significant maternal morbidity and mortality. This review summarizes the prevention, management and treatment of obstetric haemorrhage and highlights recent advances and developments. RECENT FINDINGS: Postpartum haemorrhage is the most common cause of major obstetric haemorrhage and is usually due to uterine atony. Pharmacological treatment has not altered much in recent years with oxytocin and ergometrine remaining first-line options. Although controversy surrounds its advantages over other uterotonics, the use of misoprostol has been increasing, especially in resource-poor countries. Placenta accreta is becoming more common, a sequelae to the rising caesarean section rate. Interventional radiology may reduce blood loss in these cases. Uterine compression sutures, intrauterine tamponade balloons and cell salvage have all made their debut in the last decade. SUMMARY: Accurate diagnosis and appropriate management of obstetric haemorrhage can reduce maternal morbidity and mortality. This review outlines the current evidence.

A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial.

BACKGROUND: Caesarean section is associated with blood loss and maternal morbidity. Excessive blood loss requires transfusion of donor (allogeneic) blood, which is a finite resource. Cell salvage returns blood lost during surgery to the mother. It may avoid the need for donor blood transfusion, but reliable evidence of its effects is lacking. OBJECTIVES: To determine if routine use of cell salvage during caesarean section in mothers at risk of haemorrhage reduces the rates of blood transfusion and postpartum maternal morbidity, and is cost-effective, in comparison with standard practice without routine salvage use. DESIGN: Individually randomised controlled, multicentre trial with cost-effectiveness analysis. Treatment was not blinded. SETTING: A total of 26 UK obstetric units. PARTICIPANTS: Out of 3054 women recruited between June 2013 and April 2016, we randomly assigned 3028 women at risk of haemorrhage to cell salvage or routine care. Randomisation was stratified using random permuted blocks of variable sizes. Of these, 1672 had emergency and 1356 had elective caesareans. We excluded women for whom cell salvage or donor blood transfusion was contraindicated. INTERVENTIONS: Cell salvage (intervention) versus routine care without salvage (control). In the intervention group, salvage was set up in 95.6% of the women and, of these, 50.8% had salvaged blood returned. In the control group, 3.9% had salvage deployed. MAIN OUTCOME MEASURES: Primary - donor blood transfusion. Secondary - units of donor blood transfused, time to mobilisation, length of hospitalisation, mean fall in haemoglobin, fetomaternal haemorrhage (FMH) measured by Kleihauer-Betke test, and maternal fatigue. Analyses were adjusted for stratification factors and other factors that were believed to be prognostic a priori. Cost-effectiveness outcomes - costs of resources and service provision taking the UK NHS perspective. RESULTS: We analysed 1498 and 1492 participants in the intervention and control groups, respectively. Overall, the transfusion rate was 2.5% in the intervention group and 3.5% in the control group [adjusted odds ratio (OR) 0.65, 95% confidence interval (CI) 0.42 to 1.01; p = 0.056]. In a planned subgroup analysis, the transfusion rate was 3.0% in the intervention group and 4.6% in the control group among emergency caesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99), whereas it was 1.8% in the intervention group and 2.2% in the control group among elective caesareans (adjusted OR 0.83, 95% CI 0.38 to 1.83) (interaction p = 0.46, suggesting that the difference in effect between subgroups was not statistically significant). Secondary outcomes did not differ between groups, except for FMH, which was higher under salvage in rhesus D (RhD)-negative women with RhD-positive babies (25.6% vs. 10.5%, adjusted OR 5.63, 95% CI 1.43 to 22.14; p = 0.013). No case of amniotic fluid embolism was observed. The additional cost of routine cell salvage during caesarean was estimated, on average, at £8110 per donor blood transfusion avoided. CONCLUSIONS: The modest evidence for an effect of routine use of cell salvage during caesarean section on rates of donor blood transfusion was associated with increased FMH, which emphasises the need for adherence to guidance on anti-D prophylaxis. We are unable to comment on long-term antibody sensitisation effects. Based on the findings of this trial, cell salvage is unlikely to be considered cost-effective. FUTURE WORK: Research into risk of alloimmunisation among women exposed to cell salvage is needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66118656. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 2. See the NIHR Journals Library website for further project information.