What to do about poor clinical performance in clinical trials

The performance of individual clinicians is being monitored as never before. Su Mason and colleagues discuss the implications of this for clinical trials and recommend what should happen if during a trial the performance of one clinician or one centre is identified as being particularly poor. Tom Treasure, a surgeon, wants the monitoring to be done fairly and to take account of the complexities of clinical practice; and Heather Goodare, a patient, wants to be told when things go wrong. The Department of Health in England has issued guidelines for research governance stating that healthcare organisations remain responsible for the quality of all aspects of patients' care whether or not some aspects of the care are part of a research study.1 We discuss how this obligation can be met in multicentre trials, given that data on the performance of clinicians are held by the trial management team, not by the host organisation

Bayes and health care research.

Bayes’ rule shows how one might rationally change one’s beliefs in the light of evidence. It is the foundation of a statistical method called Bayesianism. In health care research, Bayesianism has its advocates but the dominant statistical method is frequentism. There are at least two important philosophical differences between these methods. First, Bayesianism takes a subjectivist view of probability (i.e. that probability scores are statements of subjective belief, not objective fact) whilst frequentism takes an objectivist view. Second, Bayesianism is explicitly inductive (i.e. it shows how we may induce views about the world based on partial data from it) whereas frequentism is at least compatible with non-inductive views of scientific method, particularly the critical realism of Popper. Popper and others detail significant problems with induction. Frequentism’s apparent ability to avoid these, plus its ability to give a seemingly more scientific and objective take on probability, lies behind its philosophical appeal to health care researchers. However, there are also significant problems with frequentism, particularly its inability to assign probability scores to single events. Popper thus proposed an alternative objectivist view of probability, called propensity theory, which he allies to a theory of corroboration; but this too has significant problems, in particular, it may not successfully avoid induction. If this is so then Bayesianism might be philosophically the strongest of the statistical approaches. The article sets out a number of its philosophical and methodological attractions. Finally, it outlines a way in which critical realism and Bayesianism might work together. </p

The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy

OBJECTIVE: To compare the effects of laparoscopic hysterectomy and abdominal hysterectomy in the abdominal trial, and laparoscopic hysterectomy and vaginal hysterectomy in the vaginal trial. DESIGN: Two parallel, multicentre, randomised trials. Setting 28 UK centres and two South African centres. Participants 1380 women were recruited; 1346 had surgery; 937 were followed up at one year. PRIMARY OUTCOME: outcome Rate of major complications. RESULTS: In the abdominal trial laparoscopic hysterectomy was associated with a higher rate of major complications than abdominal hysterectomy (11.1% v 6.2%, P = 0.02; difference 4.9%, 95% confidence interval 0.9% to 9.1%) and the number needed to treat to harm was 20. Laparoscopic hysterectomy also took longer to perform (84 minutes v 50 minutes) but was less painful (visual analogue scale 3.51 v 3.88, P = 0.01) and resulted in a shorter stay in hospital after the operation (3 days v 4 days). Six weeks after the operation, laparoscopic hysterectomy was associated with less pain and better quality of life than abdominal hysterectomy (SF-12, body image scale, and sexual activity questionnaires). In the vaginal trial we found no evidence of a difference in major complication rates between laparoscopic hysterectomy and vaginal hysterectomy (9.8% v 9.5%, P = 0.92; difference 0.3%, − 5.2% to 5.8%), and the number needed to treat to harm was 333.We found no evidence of other differences between laparoscopic hysterectomy and vaginal hysterectomy except that laparoscopic hysterectomy took longer to perform (72 minutes v 39 minutes) and was associated with a higher rate of detecting unexpected pathology (16.4% v 4.8%, P = < 0.01). However, this trial was underpowered. CONCLUSIONS: Laparoscopic hysterectomy was associated with a significantly higher rate of major complications than abdominal hysterectomy. It also took longer to perform but was associated with less pain, quicker recovery, and better short term quality of life. The trial comparing vaginal hysterectomy with laparoscopic hysterectomy was underpowered and is inconclusive on the rate of major complications; however, vaginal hysterectomy took less time

Cross sectional study of performance indicators for English Primary Care Trusts: testing construct validity and identifying explanatory variables

BACKGROUND: The performance of Primary Care Trusts in England is assessed and published using a number of different performance indicators. Our study has two broad purposes. Firstly, to find out whether pairs of indicators that purport to measure similar aspects of quality are correlated (as would be expected if they are both valid measures of the same construct). Secondly, we wanted to find out whether broad (global) indicators correlated with any particular features of Primary Care Trusts, such as expenditure per capita. METHODS: Cross sectional quantitative analysis using data from six 2004/05 PCT performance indicators for 303 English Primary Care Trusts from four sources in the public domain: Star Rating, aggregated Quality and Outcomes Framework scores, Dr Foster mortality index, Dr Foster equity index (heart by-pass and hip replacements), NHS Litigation Authority Risk Management standards and Patient Satisfaction scores from the Star Ratings. Forward stepwise multiple regression analysis to determine the effect of Primary Care Trust characteristics on performance. RESULTS: Star Rating and Quality and Outcomes Framework total, both summary measures of global quality, were not correlated with each other (F = 0.66, p = 0.57). There were however positive correlations between Quality and Outcomes Framework total and patient satisfaction (r = 0.61, p < 0.001) and between screening/'additional services' indicators on the Star Ratings and Quality and Outcomes Framework (F = 24, p < 0.001). There was no correlation between different measures of access to services. Likewise we found no relationship between either Star Rating or Litigation Authority Standards and hospital mortality (F = 0.61, p = 0.61; F = 0.31, p = 0.73). CONCLUSION: Performance assessment in healthcare remains on the Government's agenda, with new core and developmental standards set to replace the Star Ratings in 2006. Yet the results of this analysis provide little evidence that the current indicators have sufficient construct validity to measure the underlying concept of quality, except when the specific area of screening is considered

Lay support for pregnant women with social risk: a randomised controlled trial

Objectives We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families. Design Prospective, pragmatic, individually randomised controlled trial. Setting 3 Maternity Trusts in West Midlands, UK. Participants Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded. Interventions POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms. Main outcome measures Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8–12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8–12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems. Results Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) −0.00, 95% CI (95% CI −0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD −0.79 (95% CI −1.56 to −0.02) was significantly better, although for all women recruited, no significant differences were seen (MD −0.59 (95% CI −1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD −0.30 (95% CI −0.61 to −0.00) p=0.05), and there were no differences in other secondary outcomes. Conclusions This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes

Variations in hospital standardised mortality ratios (HSMR) as a result of frequent readmissions

BACKGROUND: We investigated the impact that variations in the frequency of readmissions had upon a hospital's standardised mortality ratio (HSMR). An adapted HSMR model was used in the study. Our calculations were based on the admissions of 70 hospitals in The Netherlands during the years 2005 to 2009. METHODS: Through a retrospective analysis of routinely collected hospital data, we calculated standardised in-hospital mortality ratios both by hospital and by diagnostic group (H/SMRs) using two different models. The first was the Dutch 2010 model while the second was the same model but with an additional adjustment for the readmission frequency. We compared H/SMR outcomes and the corresponding quality metrics in order to test discrimination (c-statistics), calibration (Hosmer-Lemeshow) and explanatory power (pseudo-R2 statistic) for both models. RESULTS: The SMR outcomes for model 2 compared to model 1, varied between -39% and +110%. On the HSMR level these variations ranged from -12% to +11%. There was a substantial disagreement between the models with respect to significant death on the SMR level as well as the HSMR level (~ 20%). All quality metrics comparing both models were in favour of model 2. The susceptibility to adjustment for readmission increased for longer review periods. CONCLUSIONS: The 2010 HSMR model for the Netherlands was sensitive to adjustment for the frequency of readmissions. A model without this adjustment, as opposed to a model with the adjustment, produced substantially different HSMR outcomes. The uncertainty introduced by these differences exceeded the uncertainty indicated by the 95% confidence intervals. Therefore an adjustment for the frequency of readmissions should be considered in The Netherlands, since such a model showed more favourable quality metric characteristics compared to a model without such an adjustment. Other countries could well benefit from a similar adjustment to their models. A review period of the data collected over the last three years, at least, is advisable. (aut.ref.

Medical device procurement in low- and middle-income settings: protocol for a systematic review

Background: Medical device procurement processes for low- and middle-income countries (LMICs) are a poorly understood and researched topic. To support LMIC policy formulation in this area, international public health organizations and research institutions issue a large body of predominantly grey literature including guidelines, manuals and recommendations. We propose to undertake a systematic review to identify and explore the medical device procurement methodologies suggested within this and further literature. Procurement facilitators and barriers will be identified, and methodologies for medical device prioritization under resource constraints will be discussed. Methods/design: Searches of both bibliographic and grey literature will be conducted to identify documents relating to the procurement of medical devices in LMICs. Data will be extracted according to protocol on a number of pre-specified issues and variables. First, data relating to the specific settings described within the literature will be noted. Second, information relating to medical device procurement methodologies will be extracted, including prioritization of procurement under resource constraints, the use of evidence (e.g. cost-effectiveness evaluations, burden of disease data) as well as stakeholders participating in procurement processes. Information relating to prioritization methodologies will be extracted in the form of quotes or keywords, and analysis will include qualitative meta-summary. Narrative synthesis will be employed to analyse data otherwise extracted. The PRISMA guidelines for reporting will be followed. Discussion: The current review will identify recommended medical device procurement methodologies for LMICs. Prioritization methods for medical device acquisition will be explored. Relevant stakeholders, facilitators and barriers will be discussed. The review is aimed at both LMIC decision makers and the international research community and hopes to offer a first holistic conceptualization of this topic.sch_iih1. Perry L, Malkin R: Effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? Med Biol Eng Comput 2011, 49:719-722. 2. World Health Organization: Medical devices: Managing the Mismatch (An outcome of the Priority Medical Devices project). Geneva: World Health Organization; 2010. 3. World Health Organization: Local Production and Technology Transfer to Increase Access to Medical Devices: Addressing the barriers and challenges in low- and middle-income countries. Geneva: World Health Organization; 2012. 4. World Health Organization: Background paper 8: future public health needs: communalities and differences between high- and low-resource settings in Geneva. In Medical Devices: Managing the Mismatch (An outcome of the Priority Medical Devices Project). 2010. 5. Howitt P, Darzi A, Yang GZ, Ashrafian H, Atun R, Barlow J, Blakemore A, Bull AMJ, Car J, Conteh L, Cooke GS, Ford N, Gregson SJ, Kerr K, King D, Kulendran M, Malkin R, Majeed A, Matlin S, Merrified R, Penfolf H, Reid SD, Smith PC, Stevens MM, Templeton MR, Vincent C, Wilson E: Technologies for global health. Lancet 2012, 380:507-535. 6. National Institute of Health and Care Excellence: Guide to the Methods of Technology Appraisal 2013. 2013, [http://www.nice.org.uk/article/pmg9/ chapter/foreword] 7. World Health Organization: Background Paper 3: Clinical evidence for medical devices: regulatory processes focusing on Europe and the United States of America Geneva. In Medical Devices: Managing the Mismatch (An outcome of the Priority Medical Devices Project). 2010. 8. Australian Government Department of Health and Ageing: HTA policy framework. [http://www.health.gov.au/internet/hta/publishing.nsf/Content/ policy-1] 9. Canadian Health Technology Assessment Task Group: Health technology strategy 1. 0 final report. [http://www.who.int/medical_devices/ survey_resources/health_technology_national_policy_canada.pdf] 10. Fricke FU, Dauben HP: Health technology assessment: a perspective from Germany. Value Health 2009, 12(Suppl 2):S20-S27. 11. World Health Organization: Baseline Country Survey on Medical Devices. Geneva: World Health Organization; 2010. 12. UNAIDS & World Health Organization: Guidelines for Using HIV Testing Technologies in Surveillance. 2009. 13. Rieder HL, Van Deun A, Kam KM, Kim SJ, Chonde RM, Trbucq A, Urbanczik R: Priorities for Tuberculosis Bacteriology Services in Low-Income Countries. Paris: International Union Against Tuberculosis and Lung Disease; 2007. 14. World Health Organization: List of medical devices by health care facility: specialized hospital-diagnostic. 2010, [http://hinfo.humaninfo.ro/gsdl/ whoghp/documents/s17971en/s17971en.pdf] 15. World Health Organization: Background paper 1: a stepwise approach to identify gaps in medical devices (availability matrix and survey methodology), Geneva. In Medical Devices: Managing the Mismatch (An outcome of the Priority Medical Devices Project). 2010. 16. Baltussen R, Niessen L: Priority setting of health interventions: the need for multi-criteria decision analysis. Cost Eff Resour Alloc 2006, 4:14. 17. Glassman A, Chalkidou K, on behalf of the Center for Global Development Priority Setting Institutions for Global Health Working Group: Priority-Setting in Health Building institutions for smarter public spending. Washington: Center for Global Development; 2012. 18. Kapiriri L, Martin DK: A strategy to improve priority setting in developing countries. Health Care Anal 2007, 15:159-167. 19. 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Improving the health and welfare of people who live in slums

Summary In the first paper in this Series we assessed theoretical and empirical evidence and concluded that the health of people living in slums is a function not only of poverty but of intimately shared physical and social environments. In this paper we extend the theory of so-called neighbourhood effects. Slums offer high returns on investment because beneficial effects are shared across many people in densely populated neighbourhoods. Neighbourhood effects also help explain how and why the benefits of interventions vary between slum and non-slum spaces and between slums. We build on this spatial concept of slums to argue that, in all low-income and-middle-income countries, census tracts should henceforth be designated slum or non-slum both to inform local policy and as the basis for research surveys that build on censuses. We argue that slum health should be promoted as a topic of enquiry alongside poverty and health

The effects of laryngeal mask airway passage simulation training on the acquisition of undergraduate clinical skills: a randomised controlled trial

Background\ud Effective use of the laryngeal mask airway (LMA) requires learning proper insertion technique in normal patients undergoing routine surgical procedures. However, there is a move towards simulation training for learning practical clinical skills, such as LMA placement. The evidence linking different amounts of mannequin simulation training to the undergraduate clinical skill of LMA placement in real patients is limited. The purpose of this study was to compare the effectiveness in vivo of two LMA placement simulation courses of different durations. \ud \ud Methods\ud Medical students (n = 126) enrolled in a randomised controlled trial. Seventy-eight of these students completed the trial. The control group (n = 38) received brief mannequin training while the intervention group (n = 40) received additional more intensive mannequin training as part of which they repeated LMA insertion until they were proficient. The anaesthetists supervising LMA placements in real patients rated the participants' performance on assessment forms. Participants completed a self-assessment questionnaire. \ud \ud Results\ud Additional mannequin training was not associated with improved performance (37% of intervention participants received an overall placement rating of > 3/5 on their first patient compared to 48% of the control group, $X^2$ = 0.81, p = 0.37). The agreement between the participants and their instructors in terms of LMA placement success rates was poor to fair. Participants reported that mannequins were poor at mimicking reality. \ud \ud Conclusions\ud The results suggest that the value of extended mannequin simulation training in the case of LMA placement is limited. Educators considering simulation for the training of practical skills should reflect on the extent to which the in vitro simulation mimics the skill required and the degree of difficulty of the procedure. \ud \u