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Abstract Objectives To explore the potential impacts of incorporating prebiopsy magnetic resonance imaging into primary care as a triage test within the prostate cancer diagnostic pathway. Subjects and methods Decision analytic modelling with decision trees was utilised for this early economic evaluation. A conceptual model was developed reflecting the common primary care routes to diagnosis for prostate cancer: opportunistic, asymptomatic prostate‐specific antigen (PSA) screening or symptomatic presentation. The use of multiparametric MRI (mpMRI) or biparametric MRI (bpMRI) as a primary care triage test following an elevated PSA result was evaluated. A health system perspective was adopted with a time horizon of 12 months. Health effects were expressed in terms of utilities drawn from the literature. The primary outcome was prostate cancer diagnosis. Evidence used to inform the model was drawn from published primary studies, systematic reviews, and secondary analyses of primary and secondary care datasets. Results Base case analysis showed that the PSA pathway was dominated by both mpMRI‐ and bpMRI‐based pathways for patients undergoing opportunistic screening and symptomatic assessment. bpMRI pathways had greater improvement in cost and utility than mpMRI pathways in both clinical scenarios. Significantly more MRI scans would be performed using the modelled approach (66 626 scans vs. 37 456 scans per 100 000 patients per annum), with fewer subsequent urgent suspected cancer referrals for both mpMRI (38% reduction for screening and symptomatic patients) and bpMRI (72% reduction for screening; 71% for symptomatic) pathways, and a small increase in number of missed cancer diagnoses. Deterministic sensitivity analyses, varying each parameter to its upper and lower 95% confidence intervals, showed no significant change in the dominance of the MRI‐based prostate cancer diagnostic pathways. Conclusion Using prostate MRI as a second‐level triage test for suspected prostate cancer in primary care could reduce health service costs without a detrimental effect on patient utility.

Abstract Background CA-125 testing is a recommended first line investigation for women presenting with possible symptoms of ovarian cancer in English primary care, to help determine whether further investigation for ovarian cancer is needed. It is currently not known how well the CA-125 test performs in ovarian cancer detection for patients from different ethnic groups. Methods A retrospective cohort study utilising English primary care data linked to the national cancer registry was undertaken. Women aged ≥ 40 years with a CA-125 test between 2010 and 2017 were included. Logistic regression predicted one-year ovarian cancer incidence by ethnicity, adjusting for age, deprivation status, and comorbidity score. The estimated incidence of ovarian cancer by CA-125 level was modelled for each ethnic group using restricted cubic splines. Results The diagnostic performance of CA-125 differed for women from different ethnicities. In an unadjusted analysis, predicted CA-125 levels for Asian and Black women were higher than White women at corresponding probabilities of ovarian cancer. The higher PPVs for White women compared to Asian or Black women were eliminated by inclusion of covariates. Conclusion The introduction of ethnicity-specific thresholds may increase the specificity and PPVs of CA-125 in ovarian cancer detection at the expense of sensitivity, particularly for Asian and Black women. As such, we cannot recommend the use of ethnicity-specific thresholds for CA-125.

Abstract Background Black men have higher prostate-specific antigen (PSA) levels and higher prostate cancer incidence and mortality than White men, while Asian men tend to have lower prostate cancer incidence and mortality than White men. Much of the evidence comes from the USA, and information from UK populations is limited. Methods This retrospective cohort study used data on patients registered at general practices in England contributing to the Clinical Practice Research Datalink (CPRD) Aurum dataset. Those eligible were men aged 40 and over with a record of ethnicity and a PSA test result recorded between 2010 and 2017 with no prior cancer diagnosis. The aim was to assess the incidence of prostate cancer following a raised PSA test result in men from different ethnic groups. Additionally, incidence of advanced prostate cancer was investigated. Cancer incidence was estimated from multi-level logistic regression models adjusting for potential confounding factors. Results 730,515 men with a PSA test were included (88.9% White). Black men and men with mixed ethnicity had higher PSA values, particularly for those aged above 60 years. In the year following a raised PSA result (using age-specific thresholds), Black men had the highest prostate cancer incidence at 24.7% (95% CI 23.3%, 26.2%); Asian men had the lowest at 13.4% (12.2%, 14.7%); incidence for White men was 19.8% (19.4%, 20.2%). The peak incidence of prostate cancer for all groups was in men aged 70–79. Incidence of prostate cancer diagnosed at an advanced stage was similar between Black and White men. Conclusions More prostate cancer was diagnosed in Black men with a raised PSA result, but rates of advanced prostate cancer were not higher in this group. In this large primary care-based cohort, the incidence of prostate cancer in men with elevated PSA levels increases with increasing age, even when using age-adjusted thresholds, with Black men significantly more likely to be diagnosed compared to White or Asian men. The incidence of advanced stage prostate cancer at diagnosis was similar for Black and White men with a raised PSA result, but lower for Asian men.

Objectives To investigate the role of comorbid chronic obstructive pulmonary disease (COPD) and symptom type on general practitioners’ (GP’s) symptom attribution and clinical decision-making in relation to lung cancer diagnosis.Design Vignette survey with a 2×2 mixed factorial design.Setting A nationwide online survey exploring clinical decision-making in primary care.Participants 109 GPs based in the United Kingdom (UK) who were registered as responders on Dynata (an online survey platform).Interventions GPs were presented with four vignettes which described a patient aged 75 with a smoking history presenting with worsening symptoms (either general or respiratory) and with or without a pre-existing diagnosis of COPD.Primary and secondary outcome measures GPs indicated the three most likely diagnoses (free-text) and selected four management approaches (20 pre-coded options). Attribution of symptoms to lung cancer and referral for urgent chest X-ray were primary outcomes. Alternative diagnoses and management approaches were explored as secondary outcomes. Multivariable mixed-effects logistic regression was used, including random intercepts for individual GPs.Results 422 vignettes were completed. There was no evidence for COPD status as a predictor of lung cancer attribution (OR=1.1, 95% CI=0.5–2.4, p=0.914). There was no evidence for COPD status as a predictor of urgent chest X-ray referral (OR=0.6, 95% CI=0.3–1.2, p=0.12) or as a predictor when in combination with symptom type (OR=0.9, 95% CI=0.5–1.8, p=0.767).Conclusions Lung cancer was identified as a possible diagnosis for persistent respiratory by only one out of five GPs, irrespective of the patients’ COPD status. Increasing awareness among GPs of the link between COPD and lung cancer may increase the propensity for performing chest X-rays and referral for diagnostic testing for symptomatic patients.

Background: Colorectal cancer is the second leading cause of cancer-related mortality in the UK and a significant contributor to morbidity and mortality worldwide. Early diagnosis provides opportunities for intervention and improved survival. Significant event analysis (SEA) is a well-established quality improvement method for learning from new cancer diagnoses. Aim: To provide additional insights into diagnostic processes for colorectal cancer and to identify areas for improvement in patient care pathways. Design & setting: Fifty-three general practices across Pennine Lancashire, England, submitted one or more SEA reports as part of an incentivised scheme. Method: A standardised data collection form was used to collate learning points and recommendations for improvements. In total, 161 reports were analysed using an inductive framework analysis approach. Results: There was an overarching theme of building vigilance and collaboration between and within general practices and secondary care. The following four main sub-themes were also identified: education; individualised and flexible care; ownership and continuity; and communication. Conclusion: These findings provide additional insights into colorectal cancer pathways from a primary care perspective. Practices should be supported in developing protocols for assessment and follow-up of patients with varying presentations. Screening and access to investigations are paramount for improving early diagnosis; however, a flexible diagnostic approach is required according to the individual circumstances of each patient.

Background Errors associated with failures in filing, actioning and communicating blood test results can lead to delayed and missed diagnoses and patient harm. This study aimed to audit how blood tests in primary care are filed, actioned and communicated in primary care, to identify areas for patient safety improvements.Methods UK primary care clinicians were recruited through the Primary Care Academic CollaboraTive (PACT). PACT members audited 50 recent sets of blood tests from their practice and retrospectively extracted data on blood test result coding, actioning and communication. PACT members received a practice report, showing their own results, benchmarked against other participating practices.Results PACT members from 57 general practices across all four UK nations collected data on 2572 patients who had blood tests in April 2021. In 89.9% (n=2311) they agreed with the initial clinician’s actioning of blood tests; 10.1% disagreed, either partially (7.1%) or fully (3.0%).In 44% of patients (n=1132) an action (eg, ‘make an appointment’) was specified by the filing clinician. This action was carried out in 89.7% (n=1015/1132) of cases; in 6.8% (n=77) the action was not carried out, in 3.5% (n=40) it was unclear. In the 117 cases where the test result had not been actioned 38% (n=45) were felt to be at low risk of harm, 1.7% (n=2) were at high risk of harm, 0.85% (n=1) came to harm.Overall, in 47% (n=1210) of patients there was no evidence in the electronic health records that results had been communicated. Out of 1176 patients with one or more abnormal results there was no evidence of test communication in 30.6% (n=360). There were large variations between practices in rates of actioning and communicating tests.Conclusion This research demonstrates variation in the way blood test results are actioned and communicated, with important patient safety implications.

Objective Our objective was to codesign, implement, evaluate acceptability and refine an optimised antenatal education session to improve birth preparedness.Design There were four distinct phases: codesign (focus groups and codesign workshops with parents and staff); implementation of intervention; evaluation (interviews, questionnaires, structured feedback forms) and systematic refinement.Setting The study was set in a single maternity unit with approximately 5500 births annually.Participants Postnatal and antenatal women/birthing people and birth partners were invited to participate in the intervention, and midwives were invited to deliver it. Both groups participated in feedback.Outcome measures We report on whether the optimised session is deliverable, acceptable, meets the needs of women/birthing people and partners, and explain how the intervention was refined with input from parents, clinicians and researchers.Results The codesign was undertaken by 35 women, partners and clinicians. Five midwives were trained and delivered 19 antenatal education (ACE) sessions to 142 women and 94 partners. 121 women and 33 birth partners completed the feedback questionnaire. Women/birthing people (79%) and birth partners (82%) felt more prepared after the class with most participants finding the content very helpful or helpful. Women/birthing people perceived classes were more useful and engaging than their partners. Interviews with 21 parents, a midwife focus group and a structured feedback form resulted in 38 recommended changes: 22 by parents, 5 by midwives and 11 by both. Suggested changes have been incorporated in the training resources to achieve an optimised intervention.Conclusions Engaging stakeholders (women and staff) in codesigning an evidence-informed curriculum resulted in an antenatal class designed to improve preparedness for birth, including assisted birth, that is acceptable to women and their birthing partners, and has been refined to address feedback and is deliverable within National Health Service resource constraints. A nationally mandated antenatal education curriculum is needed to ensure parents receive high-quality antenatal education that targets birth preparedness.

Objectives To explore and characterise maternity healthcare professionals’ (MHCPs) experience and practice of shared decision-making (SDM), to inform policy, research and practice development.Design Qualitative focus group study.Setting Large Maternity Unit in the Southwest of England.Participants MHCPs who give information relating to clinical procedures and pregnancy care relating to labour and birth and are directly involved in decision-making conversations were purposively sampled to ensure representation across MHCP groups.Data collection A semistructured topic guide was used.Data analysis Reflexive thematic analysis was undertaken.Results Seven focus groups were conducted, comprising a total of 24 participants (3–5 per group). Two themes were developed: contextualising decision-making and controversies in current decision-making. Contextual factors that influenced decision-making practices included lack of time and challenges faced in intrapartum care. MHCPs reported variation in how they approach decision-making conversations and asked for more training on how to consistently achieve SDM. There were communication challenges with women who did not speak English. Three controversies were explored: the role of prior clinical experience, the validity of informed consent when women were in pain and during life-threatening emergencies and instances where women declined medical advice.Conclusions We found that MHCPs are committed to SDM but need better support to deliver it. Structured processes including Core Information Sets, communication skills training and decision support aids may help to consistently deliver SDM in maternity care.

Abstract Background Global annual cancer incidence is forecast to rise to 27.5 M by 2040, a 62% increase from 2018. For most cancers, prevention and early detection are the most effective ways of reducing mortality. This study maps trials in cancer screening, prevention, and early diagnosis (SPED) to identify areas of unmet need and highlight research priorities. Methods A systematic mapping review was conducted to evaluate all clinical trials focused on cancer SPED, irrespective of tumour type. The National Cancer Research Institute (NCRI) portfolio, EMBASE, PubMed and Medline were searched for relevant papers published between 01/01/2007 and 01/04/2020. References were exported into Covidence software and double-screened. Data were extracted and mapped according to tumour site, geographical location, and intervention type. Results One hundred seventeen thousand seven hundred one abstracts were screened, 5157 full texts reviewed, and 2888 studies included. 1184 (52%) trials focussed on screening, 554 (24%) prevention, 442 (20%) early diagnosis, and 85 (4%) a combination. Colorectal, breast, and cervical cancer comprised 61% of all studies compared with 6.4% in lung and 1.8% in liver cancer. The latter two are responsible for 26.3% of global cancer deaths compared with 19.3% for the former three. Number of studies varied markedly according to geographical location; 88% were based in North America, Europe, or Asia. Conclusions This study shows clear disparities in the volume of research conducted across different tumour types and according to geographical location. These findings will help drive future research effort so that resources can be directed towards major challenges in cancer SPED.

BackgroundActive surveillance (AS) is a management option for men diagnosed with lower risk prostate cancer. There is wide variation in all aspects of AS internationally, from patient selection to investigations and follow-up intervals, and a lack of clear evidence on the optimal approach to AS. This study aimed to provide guidance for clinicians from an international panel of prostate cancer experts.MethodsA modified Delphi approach was undertaken, utilising two rounds of online questionnaires followed by a face-to-face workshop. Participants indicated their level of agreement with statements relating to patient selection for AS via online questionnaires on a 7-point Likert scale. Factors not achieving agreement were iteratively developed between the two rounds of questionnaires. Draft statements were presented at the face-to-face workshop for discussion and consensus building.Results12 prostate cancer experts (9 urologists, 2 academics, 1 radiation oncologist) participated in this study from a range of geographical regions (4 USA, 4 Europe, 4 Australia). Complete agreement on statements presented to the participants was 29.4% after Round One and 69.0% after Round Two. Following robust discussions at the face-to-face workshop, agreement was reached on the remaining statements. PSA, PSA density, Multiparametric MRI, and systematic biopsy (with or without targeted biopsy) were identified as minimum diagnostic tests required upon which to select patients to recommend AS as a treatment option for prostate cancer. Patient factors and clinical parameters that identified patients appropriate to potentially receive AS were agreed. Genetic and genomic testing was not recommended for use in clinical decision-making regarding AS.ConclusionsThe lack of consistency in the practice of AS for men with lower risk prostate cancer between and within countries was reflected in this modified Delphi study. There are, however, areas of common practice and agreement from which clinicians practicing in the current environment can use to inform their clinical practice to achieve the best outcomes for patients.

Context: Prebiopsy magnetic resonance imaging (MRI) of the prostate has been shown to increase the accuracy of the diagnosis of clinically significant prostate cancer. However, evidence is still evolving about how best to integrate prebiopsy MRI into the diagnostic pathway and for which patients, and whether MRI-based pathways are cost effective. Objective: This systematic review aimed to assess the evidence for the cost effectiveness of prebiopsy MRI-based prostate cancer diagnostic pathways. Evidence acquisition: INTERTASC search strategies were adapted and combined with terms for prostate cancer and MRI, and used to search a wide range of databases and registries covering medicine, allied health, clinical trials, and health economics. No limits were set on country, setting, or publication year. Included studies were full economic evaluations of prostate cancer diagnostic pathways with at least one strategy including prebiopsy MRI. Model-based studies were assessed using the Philips framework, and trial-based studies were assessed using the Critical Appraisal Skills Programme checklist. Evidence synthesis: A total of 6593 records were screened after removing duplicates, and eight full-text papers, reporting on seven studies (two model based) were included in this review. Included studies were judged to have a low-to-moderate risk of bias. All studies reported cost-effectiveness analyses based in high-income countries but had significant heterogeneity in diagnostic strategies, patient populations, treatment strategies, and model characteristics. Prebiopsy MRI-based pathways were cost effective compared with pathways relying on ultrasound-guided biopsy in all eight studies. Conclusions: Incorporation of prebiopsy MRI into prostate cancer diagnostic pathways is likely to be more cost effective in than that into pathways relying on prostate-specific antigen and ultrasound-guided biopsy. The optimal prostate cancer diagnostic pathway design and method of integrating prebiopsy MRI are not yet known. Variations between health care systems and diagnostic approaches necessitate further evaluation for a particular country or setting to know how best to apply prebiopsy MRI. Patient summary: In this report, we looked at studies that measured the health care costs and benefits and harms to patients of using prostate magnetic resonance imaging (MRI), to decide whether men need a prostate biopsy for possible prostate cancer. We found that using prostate MRI before biopsy is likely to be less costly for health care services and probably has better outcomes for patients being investigated for prostate cancer. It is still unclear what the best way to use prostate MRI is.

Background: Older housebound people are an under-researched group for whom achieving good primary health care can be resource intensive. Aims: To describe the characteristics and healthcare use of older (≥65 years) housebound people; explore clinician views on delivery of care to housebound people; and assess the feasibility of using a new network of healthcare professionals to deliver high quality research. Design & setting: Retrospective observational study of electronic GP records and clinician survey in England. Method: Clinical members of a new UK research network called the Primary care Academic CollaboraTive (PACT) will collect the data. For part A, around 20 GP practices will be recruited and clinicians will identify 20 housebound and 20 non-housebound people, matched by age and gender (around 400 total in each group). Anonymised data will be collected on characteristics (age, gender, ethnicity, deprivation decile), long-term conditions, prescribed medicines, quality of healthcare (via Quality Outcomes Framework targets), and continuity of care. Reports with benchmarked practice-level data will be provided to practices to identify areas for quality improvement and to enhance engagement. For part B, 2–4 clinicians will be recruited from around 50 practices in England (around 150 clinicians) to complete a survey about delivery of healthcare for housebound people. For part C, data will be collected to assess the feasibility of using the PACT network to deliver primary care research. Conclusion: Older housebound people are a neglected group both in terms of research and clinical care. Understanding the characteristics and use of primary healthcare of housebound people will help identify how to improve their care.

Abstract Background Sub-optimal medication adherence in pregnant women with chronic disease and pregnancy-related indications has the potential to adversely affect maternal and perinatal outcomes. Adherence to appropriate medications is advocated during and when planning pregnancy to reduce risk of adverse perinatal outcomes relating to chronic disease and pregnancy-related indications. We aimed to systematically identify effective interventions to promote medication adherence in women who are pregnant or planning to conceive and impact on perinatal, maternal disease-related and adherence outcomes. Methods Six bibliographic databases and two trial registries were searched from inception to 28th April 2022. We included quantitative studies evaluating medication adherence interventions in pregnant women and women planning pregnancy. Two reviewers selected studies and extracted data on study characteristics, outcomes, effectiveness, intervention description (TIDieR) and risk of bias (EPOC). Narrative synthesis was performed due to study population, intervention and outcome heterogeneity. Results Of 5614 citations, 13 were included. Five were RCTs, and eight non-randomised comparative studies. Participants had asthma (n = 2), HIV (n = 6), inflammatory bowel disease (IBD; n = 2), diabetes (n = 2) and risk of pre-eclampsia (n = 1). Interventions included education +/− counselling, financial incentives, text messaging, action plans, structured discussion and psychosocial support. One RCT found an effect of the tested intervention on self-reported antiretroviral adherence but not objective adherence. Clinical outcomes were not evaluated. Seven non-randomised comparative studies found an association between the tested intervention and at least one outcome of interest: four found an association between receiving the intervention and both improved clinical or perinatal outcomes and adherence in women with IBD, gestational diabetes mellitus (GDM), and asthma. One study in women with IBD reported an association between receiving the intervention and maternal outcomes but not for self-reported adherence. Two studies measured only adherence outcomes and reported an association between receiving the intervention and self-reported and/or objective adherence in women with HIV and risk of pre-eclampsia. All studies had high or unclear risk of bias. Intervention reporting was adequate for replication in two studies according to the TIDieR checklist. Conclusions There is a need for high-quality RCTs reporting replicable interventions to evaluate medication adherence interventions in pregnant women and those planning pregnancy. These should assess both clinical and adherence outcomes.

Key recommendations A combination of mifepristone and a prostaglandin preparation should usually be recommended as the first‐line intervention for induction of labour (Grade B). A single 200 milligram dose of mifepristone is appropriate for this indication, followed by: 24+0–24+6 weeks of gestation – 400 micrograms buccal/sublingual/vaginal/oral of misoprostol every 3 hours; 25+0–27+6 weeks of gestation – 200 micrograms buccal/sublingual/vaginal/oral of misoprostol every 4 hours; from 28+0 weeks of gestation – 25–50 micrograms vaginal every 4 hours, or 50–100 micrograms oral every 2 hours [Grade C]. There is insufficient evidence available to recommend a specific regimen of misoprostol for use at more than 28+0 weeks of gestation in women who have had a previous caesarean birth or transmural uterine scar [Grade D]. Women with more than two lower segment caesarean births or atypical scars should be advised that the safety of induction of labour is unknown [Grade D]. Staff should be educated in discussing mode of birth with bereaved parents. Vaginal birth is recommended for most women, but caesarean birth will need to be considered for some [Grade D]. A detailed informed discussion should be undertaken with parents of both physical and psychological aspects of a vaginal birth versus a caesarean birth [Grade C]. Parents should be cared for in an environment that provides adequate safety according to individual clinical circumstance, while meeting their needs to grieve and feel supported in doing so (GPP). Clinical and laboratory tests should be recommended to assess maternal wellbeing (including coagulopathy) and to determine the cause of fetal death, the chance of recurrence and possible means of avoiding future pregnancy complications [Grade D]. Parents should be advised that with full investigation (including postmortem and placental histology) a possible or probable cause can be found in up to three‐quarters of late intrauterine fetal deaths [Grade B]. All parents should be offered cytogenetic testing of their baby, which should be performed after written consent is given (GPP). Parents should be advised that postmortem examination can provide information that can sometimes be crucial to the management of future pregnancy [Grade B]. A single 200 milligram dose of mifepristone is appropriate for this indication, followed by: 24+0–24+6 weeks of gestation – 400 micrograms buccal/sublingual/vaginal/oral of misoprostol every 3 hours; 25+0–27+6 weeks of gestation – 200 micrograms buccal/sublingual/vaginal/oral of misoprostol every 4 hours; from 28+0 weeks of gestation – 25–50 micrograms vaginal every 4 hours, or 50–100 micrograms oral every 2 hours [Grade C]. [ABSTRACT FROM AUTHOR]

Background In primary care, health professionals use blood tests to investigate nonspecific presentations to inform referral decisions. Reference ranges for the commonly used blood tests in western countries were developed in predominately White populations, and so may perform differently when applied to non-White populations. Knowledge of ethnic variation in blood test results in healthy/general populations could help address ethnic inequalities in cancer referral for diagnosis and outcomes. Objective This systematic review explored evidence of ethnic differences in the distribution of selected blood test results among healthy/general populations to inform future research aimed at addressing inequalities in cancer diagnosis. Methods We searched PubMed and EMBASE to identify studies reporting measures of haemoglobin, MCV, calcium, albumin, platelet count, and CRP in nondiseased adults from at least 2 different ethnic groups. Two reviewers independently screened studies, completed data extraction and quality assessment using an adapted Newcastle-Ottawa scale. Participants were stratified into White, Black, Asian, Mixed, and Other groups. Data were synthesised narratively and meta-analyses were conducted where possible. Results A total of 47 papers were included. Black men and women have lower average values of haemoglobin, MCV, and albumin, and higher average values of CRP relative to their White counterparts. Additionally, Black men have lower average haemoglobin than Asian men, whereas Asian women have lower average CRP values when compared with White women. Conclusions There is evidence of ethnic differences in average values of haemoglobin, MCV, CRP, and albumin in healthy/general populations. Further research is needed to explore the reasons for these differences. Systematic review registration: CRD42021274580 [ABSTRACT FROM AUTHOR]

Abstract Background Prostate-specific antigen (PSA) is a commonly used test to detect prostate cancer. Attention has mostly focused on the use of PSA in screening asymptomatic patients, but the diagnostic accuracy of PSA for prostate cancer in patients with symptoms is less well understood. Methods A systematic database search was conducted of Medline, EMBASE, Web of Science, and the Cochrane library. Studies reporting the diagnostic accuracy of PSA for prostate cancer in patients with symptoms were included. Two investigators independently assessed the titles and abstracts of all database search hits and full texts of potentially relevant studies against the inclusion criteria, and data extracted into a proforma. Study quality was assessed using the QUADAS-2 tool by two investigators independently. Summary estimates of diagnostic accuracy were calculated with meta-analysis using bivariate mixed effects regression. Results Five hundred sixty-three search hits were assessed by title and abstract after de-duplication, with 75 full text papers reviewed. Nineteen studies met the inclusion criteria, 18 of which were conducted in secondary care settings with one from a screening study cohort. All studies used histology obtained by transrectal ultrasound-guided biopsy (TRUS) as a reference test; usually only for patients with elevated PSA or abnormal prostate examination. Pooled data from 14,489 patients found estimated sensitivity of PSA for prostate cancer was 0.93 (95% CI 0.88, 0.96) and specificity was 0.20 (95% CI 0.12, 0.33). The area under the hierarchical summary receiver operator characteristic curve was 0.72 (95% CI 0.68, 0.76). All studies were assessed as having a high risk of bias in at least one QUADAS-2 domain. Conclusions Currently available evidence suggests PSA is highly sensitive but poorly specific for prostate cancer detection in symptomatic patients. However, significant limitations in study design and reference test reduces the certainty of this estimate. There is very limited evidence for the performance of PSA in primary care, the healthcare setting where most PSA testing is performed.

BACKGROUND: Southern Asia has one of the highest burdens of neonatal mortality worldwide (26/1000 live births). Ensuring that women receive antenatal care from a skilled provider may play an important role in reducing this burden. OBJECTIVE: This study aimed to determine whether antenatal care received from a skilled provider could reduce neonatal mortality in Southern Asia by systematically reviewing existing evidence. STUDY DESIGN: Seven databases were searched (MEDLINE, Embase, Cochrane Library, CINAHL, PubMed, PsycINFO, and International Bibliography of the Social Sciences [IBSS]). The key words included: “neonatal mortality,” “antenatal care,” and “Southern Asia.” Nonrandomized comparative studies conducted in Southern Asia reporting on neonatal mortality in women who received antenatal care compared with those who did not were included. Two authors carried out the screening and data extraction. The Risk of Bias Assessment tool for Non-randomized Studies (RoBANS) was used to assess quality of studies. Results were reported using a random-effects model based on odds ratios with 95% confidence intervals. RESULTS: Four studies were included in a meta-analysis of adjusted results. The pooled odds ratio was 0.46 (95% confidence interval, 0.24 to 0.86) for neonatal deaths among women having at least 1 antenatal care visit during pregnancy compared with women having none. In the final meta-analysis, 16 studies could not be included because of lack of adjustment for confounders, highlighting the need for further higher-quality studies to evaluate the true impact. CONCLUSION: This review suggests that in Southern Asia, neonates born to women who received antenatal care have a lower risk of death in the neonatal period compared with neonates born to women who did not receive antenatal care. This should encourage health policy to strengthen antenatal care programs in Southern Asia.

BACKGROUND: Use of timely antenatal care has been identified as key to facilitating healthy pregnancies worldwide. Although considerable investment has been made to enhance maternal health services in Nepal, approximately one-third of women do not attend antenatal care until after the first trimester (late). These women miss out on the benefits of screening and interventions that are most effective in the first trimester. OBJECTIVE: This study aimed to identify the missed opportunities of women who do not attend antenatal care in the first trimester, and to explore some of the factors underlying late attendance and consider potential solutions for minimizing these missed opportunities in the future. STUDY DESIGN: This study was conducted in 3 hospitals in Nepal. Focus groups (n=18) with a total of 48 postnatal women and 49 staff members, and 10 individual interviews with stakeholders were conducted. Purposive sampling facilitated the obtainment of a full range of maternity experiences, staff categories, and stakeholder positions. Data were qualitative and analyzed using a thematic approach. RESULTS: Limited awareness among women of the importance of early antenatal care was reported as a key factor behind attendance only after the first trimester. The family and community were described as significant influencers in women's decision-making regarding the timing of antenatal care. The benefits of early ultrasound scanning and effective supplementation in pregnancy were the major missed opportunities. Increasing awareness, reducing cost, and enhancing interprofessional collaboration were suggested as potential methods for improving timely initiation of antenatal care. CONCLUSION: Limited awareness continues to drive late attendance to antenatal care after the first trimester. Investment in services in the first trimester and community health education campaigns are needed to improve this issue and enhance maternal and neonatal outcomes.

Background: The number of blood tests done in primary care has been increasing over the past 20 years. Some estimates suggest that up to one-quarter of these tests may not have been needed. This could lead to a cascade effect of further investigations, appointments, or referrals, as well as anxiety for patients, increased workload, and costs to the health service. To better understand the impact and sequelae of blood tests on patients, it is necessary to know why blood tests are requested and what is done with the results. Aim: To explore who orders blood tests and why, and how test results are actioned in primary care. Design & setting: Retrospective audit of electronic health records in general practices across the UK. Method: The Primary care Academic CollaboraTive (PACT), a UK-wide network of primary care health professionals, will be utilised to collect data from individual practices. PACT members will be asked to review the electronic health records of 50 patients who had recent blood tests in their practice, and manually extract anonymised data on who requested the test, the indication, the result, and subsequent actions. Data will also be collected from PACT members to assess the feasibility of the collaborative model. Conclusion: PACT offers a unique opportunity to extract clinical data which cannot otherwise be obtained. Understanding the indications for tests will help identify priority areas for research to optimise testing and patient safety in primary care.

Objectives This study aimed to understand and explore patient and general practitioner (GP) experiences of ‘traditional’ and ‘one-stop’ prostate cancer diagnostic pathways in England.Design Qualitative study using semi-structured interviews, analysed using inductive thematic analysisSetting Patients were recruited from National Health Service (NHS) Trusts in London and in Devon; GPs were recruited via National Institute for Health Research (NIHR) Clinical Research Networks. Interviews were conducted in person or via telephone.Participants Patients who had undergone a MRI scan of the prostate as part of their diagnostic work-up for possible prostate cancer, and GPs who had referred at least one patient for possible prostate cancer in the preceding 12 months.Results 22 patients (aged 47–80 years) and 10 GPs (6 female, aged 38–58 years) were interviewed. Patients described three key themes: cancer beliefs in relation to patient’s attitudes towards prostate cancer; communication with their GP and specialist having a significant impact on experience of the pathway and pathway experience being influenced by appointment and test burden. GP interview themes included: the challenges of dealing with imperfect information in the current pathway; managing uncertainty in identifying patients with possible prostate cancer and sharing this uncertainty with them, and other social, cultural and personal contextual influences.Conclusions Patients and GPs reported a range of experiences and views of the current prostate cancer diagnostic pathways in England. Patients valued ‘one-stop’ pathways integrating prostate MRI and diagnostic consultations with specialists over the more traditional approach of several hospital appointments. GPs remain uncertain how best to identify patients needing referral for urgent prostate cancer testing due to the lack of accurate triage and risk assessment strategies.

Background: Screening is not recommended for prostate cancer in the UK. Asymptomatic men aged ≥50 years can request a prostate-specific antigen (PSA) test following counselling on potential harms and benefits. There are areas of clinical uncertainty among GPs, resulting in the content and quality of counselling varying. Aim: To produce a consensus that can influence guidelines for UK primary care on the optimal use of the PSA test in asymptomatic men for early prostate cancer detection. Design and setting: Prostate Cancer UK facilitated a RAND/UCLA consensus. Method: Statements covering five topics were developed with a subgroup of experts. A panel of 15 experts in prostate cancer scored (round one) statements on a scale of one (strongly disagree) to nine (strongly agree). Panellists met to discuss statements before rescoring (round two). A lived experience panel of seven men scored a subset of statements with outcomes fed into the main panel. Results: Of the initial 94 statements reviewed by the expert panel, a final 48/85 (56%) achieved consensus. In the absence of screening, there was consensus on proactive approaches to initiate discussions about the PSA test with men who were at higher-than-average risk. Conclusion: Improvements in the prostate cancer diagnostic pathway may have reduced some of the harms associated with PSA testing; however, several areas of uncertainty remain in relation to screening, including optimal PSA thresholds for referral and intervals for retesting. There is consensus on proactive approaches to testing in higher-than-average risk groups. This should prompt a review of current guidelines. [ABSTRACT FROM AUTHOR]

Background: Magnetic resonance imaging (MRI) of the prostate is a new, more accurate, non-invasive test for prostate cancer diagnosis. Aim: To understand the acceptability of MRI for patients and GPs for prostate cancer diagnosis. Design and setting: Qualitative study of men who had undergone a prostate MRI for possible prostate cancer, and GPs who had referred at least one man for possible prostate cancer in the previous 12 months in West London and Devon. Method: Semi-structured interviews, conducted in person or via telephone, were audio-recorded and transcribed verbatim. Deductive thematic analysis was undertaken using Sekhon's Theoretical Framework of Acceptability, retrospectively for patients and prospectively for GPs. Results: Twenty-two men (12 from Devon, age range 47–80 years), two patients' partners, and 10 GPs (6 female, age range 36–55 years) were interviewed. Prostate MRI was broadly acceptable for most patient participants, and they reported that it was not a significant undertaking to complete the scan. GPs were more varied in their views on prostate MRI, with a broad spectrum of knowledge and understanding of prostate MRI. Some GPs expressed concerns about additional clinical responsibility and local availability of MRI if direct access to prostate MRI in primary care were to be introduced. Conclusion: Prostate MRI appears to be acceptable to patients. Some differences were found between patients in London and Devon, mainly around burden of testing and opportunity costs. Further exploration of GPs' knowledge and understanding of prostate MRI could inform future initiatives to widen access to diagnostic testing in primary care. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer is the second leading cause of cancer-related mortality in the UK and a significant contributor to morbidity and mortality worldwide. Early diagnosis provides opportunities for intervention and improved survival. Significant event analysis (SEA) is a well-established quality improvement method for learning from new cancer diagnoses. Aim: To provide additional insights into diagnostic processes for colorectal cancer and to identify areas for improvement in patient care pathways. Design & setting: Fifty-three general practices across Pennine Lancashire, England, submitted one or more SEA reports as part of an incentivised scheme. Method: A standardised data collection form was used to collate learning points and recommendations for improvements. In total, 161 reports were analysed using an inductive framework analysis approach. Results: There was an overarching theme of building vigilance and collaboration between and within general practices and secondary care. The following four main sub-themes were also identified: education; individualised and flexible care; ownership and continuity; and communication. Conclusion: These findings provide additional insights into colorectal cancer pathways from a primary care perspective. Practices should be supported in developing protocols for assessment and follow-up of patients with varying presentations. Screening and access to investigations are paramount for improving early diagnosis; however, a flexible diagnostic approach is required according to the individual circumstances of each patient. [ABSTRACT FROM AUTHOR]

Abstract Background Active surveillance (AS) is a management option for men diagnosed with lower risk prostate cancer. There is wide variation in all aspects of AS internationally, from patient selection to investigations and follow-up intervals, and a lack of clear evidence on the optimal approach to AS. This study aimed to provide guidance for clinicians from an international panel of prostate cancer experts. Methods A modified Delphi approach was undertaken, utilising two rounds of online questionnaires followed by a face-to-face workshop. Participants indicated their level of agreement with statements relating to patient selection for AS via online questionnaires on a 7-point Likert scale. Factors not achieving agreement were iteratively developed between the two rounds of questionnaires. Draft statements were presented at the face-to-face workshop for discussion and consensus building. Results 12 prostate cancer experts (9 urologists, 2 academics, 1 radiation oncologist) participated in this study from a range of geographical regions (4 USA, 4 Europe, 4 Australia). Complete agreement on statements presented to the participants was 29.4% after Round One and 69.0% after Round Two. Following robust discussions at the face-to-face workshop, agreement was reached on the remaining statements. PSA, PSA density, Multiparametric MRI, and systematic biopsy (with or without targeted biopsy) were identified as minimum diagnostic tests required upon which to select patients to recommend AS as a treatment option for prostate cancer. Patient factors and clinical parameters that identified patients appropriate to potentially receive AS were agreed. Genetic and genomic testing was not recommended for use in clinical decision-making regarding AS. Conclusions The lack of consistency in the practice of AS for men with lower risk prostate cancer between and within countries was reflected in this modified Delphi study. There are, however, areas of common practice and agreement from which clinicians practicing in the current environment can use to inform their clinical practice to achieve the best outcomes for patients.

Abstract Background Globally too many mothers and babies die during childbirth; 98% of maternal deaths are avoidable. Skilled clinicians can reduce these deaths; however, there is a world-wide shortage of maternity healthcare workers. Malawi has enough to deliver 20% of its maternity care. A motivating work environment is important for healthcare worker retention. To inform a future trial, we aimed to assess the feasibility of implementing a motivational intervention (Appreciative Inquiry) to improve the working lives of maternity healthcare workers and patient satisfaction in Malawi. Methods Three government hospitals participated over 1 year. Its effectiveness was assessed through: a monthly longitudinal survey of working life using psychometrically validated instruments (basic psychological needs, job satisfaction and work-related quality of life); a before and after questionnaire of patient satisfaction using a patient satisfaction tool validated in low-income settings with a maximum score of 80; and a qualitative template analysis encompassing ethnographic data, semi-structured interviews and focus groups with staff. Results The intervention was attended by all 145 eligible staff, who also participated in the longitudinal study. The general trend was an increase in the scores for each scale except for the basic psychological needs score in one site. Only one site demonstrated strong evidence for the intervention working in the work-related quality of life scales. Pre-intervention, 162 postnatal women completed the questionnaire; post-intervention, 191 postnatal women participated. Patient satisfaction rose in all three sites; referral hospital 4.41 rise (95% CI 1.89 to 6.95), district hospital 10.22 (95% CI 7.38 to 13.07) and community hospital 13.02 (95% CI 10.48 to 15.57). The qualitative data revealed that staff felt happier, that their skills (especially communication) had improved, behaviour had changed and systems had developed. Conclusions We have shown that it is possible to implement Appreciative Inquiry in government facilities in Malawi, which has the potential to change the way staff work and improve patient satisfaction. The mixed methods approach revealed important findings including the importance of staff relationships. We have identified clear implementation elements that will be important to measure in a future trial such as implementation fidelity and inter-personal relationship factors.

BACKGROUND: Maternal and neonatal mortality rates remain high in many economically underdeveloped countries, including Nepal, and good quality antenatal care can reduce adverse pregnancy outcomes. However, identifying how to best improve antenatal care can be challenging. OBJECTIVE: To identify the interventions that have been investigated in the antenatal period in Nepal for maternal or neonatal benefit. We wanted to understand their scale, location, cost, and effectiveness. STUDY DESIGN: Online bibliographic databases (Cochrane Central, MEDLINE, Embase, CINAHL Plus, British Nursing Index, PsycInfo, Allied and Complementary Medicine) and trial registries (ClinicalTrials.gov and the World Health Organization Clinical Trials Registry Platform) were searched from their inception till May 24, 2020. We included all studies reporting any maternal or neonatal outcome after an intervention in the antenatal period. We screened the studies and extracted the data in duplicate. A meta-analysis was not possible because of the heterogeneity of the interventions and outcomes, so we performed a narrative synthesis of the included studies. RESULTS: A total of 25 studies met our inclusion criteria. These studies showed a variety of approaches toward improving antenatal care (eg, educational programs, incentive schemes, micronutrient supplementation) in different settings (home, community, or hospital-based) and with a wide variety of outcomes. Less than a quarter of the studies were randomized controlled trials, and many were single-site or reported only short-term outcomes. All studies reported having made a positive impact on antenatal care in some way, but only 3 provided a cost-benefit analysis to support implementation. None of these studies focused on the most remote communities in Nepal. CONCLUSION: Our systematic review found good quality evidence that micronutrient supplementation and educational interventions can bring important clinical benefits. Iron and folic acid supplementation significantly reduces neonatal mortality and maternal anemia, whereas birth preparedness classes increase the uptake of antenatal and postnatal care, compliance with micronutrient supplementation, and awareness of the danger signs in pregnancy.

BACKGROUND: Maternal mortality in East Africa is high with a maternal mortality rate of 428 per 100,000 live births. Malawi, whilst comparing favourably to East Africa as a whole, continues to have a high maternal mortality rate (349 per 100,000 live births) despite it being reduced by 53% since 2000. To make further improvements in maternal healthcare, initiatives must be carefully targeted and evaluated to achieve maximum influence. The Malawian Government is committed to improving maternal health; however, to achieve this goal, the quality of care must be high. Furthermore, such a goal requires enough staff with appropriate training. There are not enough midwives in Malawi; therefore, focusing on staff working lives has the potential to improve care and retain staff within the system. OBJECTIVE: This study aimed to identify ways in which working lives of maternity healthcare workers could be enhanced to improve clinical care. STUDY DESIGN: We conducted a 1-year ethnographic study of 3 district-level hospitals in Malawi. Data were collected through observations and discussions with staff and analyzed iteratively. The ethnography focused on the interrelationships among staff as these relationships seemed most important to working lives. The field jottings were transcribed into electronic documents and analyzed using NVivo. The findings were discussed and developed with the research team, participants, and other researchers and healthcare workers in Malawi. To understand the data, we developed a conceptual model, “the social order of the hospital,” using Bourdieu's work on political sociology. The social order was composed of the social structure of the hospital (hierarchy), rules of the hospital (how staff in different staff groups behaved), and precedent (following the example of those before them). RESULTS: We used the social order to consider the different core areas that emerged from the data: processes, clinical care, relationships, and context. The Malawian system is underresourced with staff unable to provide high-quality care because of the lack of infrastructure and equipment. However, some processes hinder them on national and local level, for example staff rotations and poorly managed processes for labeling drugs. The staff are aware of the clinical care they should provide; however, they sometimes do not provide such care because they are working with the predefined system and they do not want to disrupt it. Within all of this, there are hierarchical relationships and a desire to move to the next level of the system to ensure a better life with more benefits and less direct clinical work. These elements interact to keep care at its most basic as disruption to the “usual” way of doing things is challenging and creates more work. CONCLUSION: To improve the working lives of the Malawian maternity staff, it is necessary to focus on improving the working culture, relationships, and environment. This may help the next generation of Malawian maternity staff to be happier at work and to better provide respectful, comprehensive, high-quality care to women.

Background Missed opportunities for diagnosing cancer cause patients harm and have been attributed to suboptimal use of tests and referral pathways in primary care. Primary care physician (PCP) factors have been suggested to affect decisions to investigate cancer, but their influence is poorly understood.Objective To synthesise evidence evaluating the influence of PCP factors on decisions to investigate symptoms of possible cancer.Methods We searched MEDLINE, Embase, Scopus, CINAHL and PsycINFO between January 1990 and March 2021 for relevant citations. Studies examining the effect or perceptions and experiences of PCP factors on use of tests and referrals for symptomatic patients with any cancer were included. PCP factors comprised personal characteristics and attributes of physicians in clinical practice.Data extraction and synthesis Critical appraisal and data extraction were undertaken independently by two authors. Due to study heterogeneity, data could not be statistically pooled. We, therefore, performed a narrative synthesis.Results 29 studies were included. Most studies were conducted in European countries. A total of 11 PCP factors were identified comprising modifiable and non-modifiable factors. Clinical judgement of symptoms as suspicious or 'alarm' prompted more investigations than non-alarm symptoms. ‘Gut feeling’ predicted a subsequent cancer diagnosis and was perceived to facilitate decisions to investigate non-specific symptoms as PCP experience increased. Female PCPs investigated cancer more than male PCPs. The effect of PCP age and years of experience on testing and referral decisions was inconclusive.Conclusions PCP interpretation of symptoms as higher risk facilitated testing and referral decisions for possible cancer. However, in the absence of 'alarm' symptoms or ‘gut feeling’, PCPs may not investigate cancer. PCPs require strategies for identifying patients with non-alarm and non-specific symptoms who need testing or referral.PROSPERO registration number CRD420191560515.

Background: Maternal Near Miss cases have similarities with those dying from such complications and so present an important opportunity to improve practice. This study was conducted to assess the prevalence of Maternal Near Miss events and identify the delays experienced. Methods: This was a facility-based cross-sectional study conducted in three tertiary referral hospitals from three provinces of Nepal. All the women surviving a near miss event during six months data collection period were included in the study. Results: There were 67 near miss cases, 7 maternal deaths, and 9158 live births in the study hospitals during the data collection period. This resulted in Maternal Near Miss ratio of 7.31/1000 live births and facility-based Maternal Mortality Ratio of 76/100,000 live births. Severe obstetric haemorrhage (54%) was the most frequent clinical cause of near miss, followed by hypertensive disorders (43%). At least one type of delay was experienced by 85% women. First delay occurred in 63% (42 of 67) cases, second delay occurred in 52% (33 of 62) cases and third delay occurred in 55% (37 of 67) cases. Conclusions: This study found out that all three delays were common among women experiencing maternal near miss event. Raising awareness regarding dangers signs, improving referral system and strengthening ability of health workers can help in reducing these delays. Keywords: Maternal near miss; MNM; Nepal; three delays