Unsatisfactory colposcopy: clinical decision-making in conditions of uncertainty.

BACKGROUND: Unsatisfactory colposcopy, where the cells of interest are not visible in women with a positive cervical screening test, is a common area of clinical uncertainty due to the lack of clear evidence and guidance. Colposcopists' opinions and experiences are likely to have a significant influence on service provision and the development of national policy. The aim of this study was to analyse decision-making when applied to women with unsatisfactory colposcopy. METHODS: A multi-centre qualitative study utilizing a series of focus groups in an English healthcare region. Sampling aimed to ensure heterogeneity of experience and healthcare provider demographics. A topic guide covered a range of clinical and cytological variables and was compiled by the researchers and three expert Colposcopists. Using an iterative approach, thematic analysis was selected as the most appropriate method to identify factors affecting decision-making. RESULTS: Twenty-three Colposcopists from four units participated. The decision to treat was easier in women with high-grade cytology and high risk women with low-grade cytology such as heavy smokers, poor attenders, older women, those who had completed their families and women opting for treatment. Where decision-making was more complex, intuition and a multi-disciplinary approach were used to guide management. Areas of dissonance, which are affected by paucity of evidence and emotive factors, included cytological collection device, clinical setting and length of conservative follow-up and depth of excision in women at high risk of treatment-related morbidity. CONCLUSIONS: Anxiety of missing a cancer deters long-term cytological follow-up, resulting in heterogeneity of care and higher than anticipated excisional treatments in women with low-grade screening and unsatisfactory colposcopy. In areas of clinical uncertainty when decisions are dominated by affect, clinical guidance can reduce the difficulty and anxiety of decision-making.

Glutamine supplementation in cystic fibrosis: A randomized placebo-controlled trial.

RATIONALE: Pulmonary infection and malnutrition in cystic fibrosis are associated with decreased survival. Glutamine has a possible anti-microbial effect, with a specific impact against Pseudomonas aeruginosa. We aimed to test the hypothesis that oral glutamine supplementation (21 g/day) for 8 weeks in adults with cystic fibrosis would decrease pulmonary inflammation and improve clinical status. METHODS: The study design was a randomized double-blind placebo-controlled study design with an iso-nitrogenous placebo. The primary analysis was intention to treat, and the primary outcome was change in induced sputum neutrophils. RESULTS: Thirty-nine individuals were recruited and thirty-six completed the study. Glutamine supplementation had no impact on any of the outcome measures in the intention-to-treat analysis. In the per protocol analysis, glutamine supplementation was associated with an increase in induced sputum neutrophils (P = 0.046), total cells (P = 0.03), and in Pseudomonas isolation agar colony forming units (P = 0.04) compared to placebo. CONCLUSIONS: There was no effect of glutamine supplementation on markers of pulmonary inflammation in the intention-to-treat analysis.

Pseudomonas aeruginosa quorum sensing molecules correlate with clinical status in cystic fibrosis.

Pseudomonas aeruginosa produces quorum sensing signal molecules that are potential biomarkers for infection.A prospective study of 60 cystic fibrosis patients with chronic P. aeruginosa, who required intravenous antibiotics for pulmonary exacerbations, was undertaken. Clinical measurements and biological samples were obtained at the start and end of the treatment period. Additional data were available for 29 of these patients when they were clinically stable.Cross-sectionally, quorum sensing signal molecules were detectable in the sputum, plasma and urine of 86%, 75% and 83% patients, respectively. They were positively correlated between the three biofluids. Positive correlations were observed for most quorum sensing signal molecules in sputum, plasma and urine, with quantitative measures of pulmonary P. aeruginosa load at the start of a pulmonary exacerbation. Plasma concentrations of 2-nonyl-4-hydroxy-quinoline (NHQ) were significantly higher at the start of a pulmonary exacerbation compared to clinical stability (p<0.01). Following the administration of systemic antibiotics, plasma 2-heptyl-4-hydroxyquinoline (p=0.02) and NHQ concentrations (p<0.01) decreased significantly.In conclusion, quorum sensing signal molecules are detectable in cystic fibrosis patients with pulmonary P. aeruginosa infection and are positively correlated with quantitative measures of P. aeruginosa. NHQ correlates with clinical status and has potential as a novel biomarker for P. aeruginosa infection.

Using data and quality monitoring to enhance maternity outcomes: a qualitative study of risk managers' perspectives.

INTRODUCTION: Risk management is a core part of healthcare practice, especially within maternity services, where litigation and societal costs are high. There has been little investigation into the experiences and opinions of those staff directly involved in risk management: lead obstetricians and specialist risk midwives, who are ideally placed to identify how current implementation of risk management strategies can be improved. METHODS: A qualitative study of consultant-led maternity units in an English region. Semistructured interviews were conducted with the obstetric and midwifery risk management leads for each unit. We explored their approach to risk management, particularly their opinions regarding quality monitoring and related barriers/issues. Interviews were recorded, transcribed and thematically analysed. RESULTS: Twenty-seven staff from 12/15 maternity units participated. Key issues identified included: concern for the accuracy and validity of their local data, potential difficulties related to data collation, the negative impact of external interference by national regulatory bodies on local clinical priorities, the influence of the local culture of the maternity unit on levels of engagement in the risk management process, and scepticism about the value of benchmarking of maternity units without adjustment for population characteristics. CONCLUSIONS: Local maternity risk managers may provide valuable, clinically relevant insights into current issues in clinical data monitoring. Improvements should focus on the accuracy and ease of data collation with a need for an agreed maternity indicators set, populated from validated databases, and not reliant on data collection systems that distract clinicians from patient activity and quality improvement. It is clear that working relationships between risk managers, their own clinical teams and external national bodies require improvement and alignment. Further discussion regarding benchmarking between maternity units is required prior to implementation. These findings are likely to be relevant to other clinical specialties.

Development of maternity dashboards across a UK health region; current practice, continuing problems.

OBJECTIVE: To assess the development of local clinical dashboards in line with UK national guidance and to identify ongoing issues being faced by maternity units, across an entire health region, in developing quality assurance systems. STUDY DESIGN: A mixed-methods study involving all consultant-led maternity units in the South West of England Strategic Health Authority region (SWSHA). An electronic survey, followed by semi-structured interviews with the lead obstetrician and risk management midwife (or equivalent) of each maternity unit, to investigate methods employed to monitor outcomes locally, particularly the development of tools including maternity dashboards. Interviews were audio recorded, transcribed and thematically analysed to identify conceptual categories and themes. RESULTS: 12/15 eligible consultant-led maternity units participated in the study and 10/12 (83%) of these used a dashboard. There was an excessive number of non-standard indicators used by the maternity units, with 352 different quality indicators (QIs), covering 37 different indicator categories, with up to 39 different definitions for one particular QI. Issues identified were: an excess of indicators, disproportionate time taken to produce the dashboard, uncertainty surrounding thresholds for alert within the dashboards and a desire for more guidance and standardisation of indicators, and their use. CONCLUSIONS: Following recommendation by the Royal College of Obstetricians and Gynaecologists, maternity dashboards have been widely adopted by maternity units across the SWSHA to provide a local quality assurance system. There is, however, wide variation in both the quality indicators monitored and their definition. There is an urgent requirement for a national and international core set of maternity QIs. Further guidance is also required to inform alert thresholds for adverse outcomes. These perinatal data are collected electronically, and automating the production of a standardised dashboard is both possible and desirable.

Target renal damage: the microvascular associations of increased aortic stiffness in patients with COPD.

BACKGROUND: Although renal impairment has been described in COPD, there is opportunity to evaluate further to determine nature and consider optimal management. Increased aortic stiffness, as seen in COPD, leads to reduced buffering of pulsatile flow. We hypothesised that urinary albumin creatinine ratio (UACR) would reflect glomerular damage related to aortic stiffness. METHODS: Patients with COPD and controls underwent spirometry, blood pressure, arterial stiffness - aortic pulse wave velocity (PWV) and provided a spot urine sample for UACR, with other renal biomarkers measured. RESULTS: The UACR was increased in patients (n = 52): 0.80 mg/mmol compared to controls (n = 34): 0.46 mg/mmol, p < 0.05. Aortic PWV was related to log10 UACR in all subjects (r = 0.426, p < 0.001) and COPD patients alone. Aortic PWV was a significant variable for UACR with oxygen saturations, after accounting for potential confounders. Eight subjects (7 patients) reached a defined clinical microalbuminuria threshold, with aortic PWV greater in these patients compared to those patients without, although albuminuria is a continuum. Proximal tubular damage biomarkers, unlike the glomerular marker, were not different between patients and controls. CONCLUSIONS: There is glomerular damage in patients with COPD evidenced by increased UACR, related to increased aortic stiffness. Besides the macrovascular prognostic implications of increased aortic stiffness, the microvascular state in COPD management should be considered.

Intrapartum care quality indicators: a systematic approach for achieving consensus.

OBJECTIVE: To identify published maternity intrapartum quality indicators and rationalise them to a core set. STUDY DESIGN: Prospective qualitative consensus group exercise. A literature search identified sets of intrapartum quality indicators in the English language. These were rationalised to a shortlist using criteria adapted from 'The Good Clinical Indicator Guide'. An expert panel from key UK professions and organisations utilised a modified Delphi process to devise a final agreed set of intrapartum quality indicators that are specific, measurable, modifiable and relevant to clinical practice. Each indicator was rated in two rounds of web-based surveys, followed by a final face-to-face meeting of the panel. RESULTS: 290 clinical indicators were identified within 96 clinical categories with up to 18 different definitions. After rationalisation, 10 core and 24 additional quality indicators entered the Delphi process. A final panel of 12 indicators was defined. CONCLUSIONS: By using a simple Delphi process we have defined a set of broad clinical quality indicators that provide a comprehensive coverage of labour and delivery outcomes. We believe that this pragmatic portfolio will be useful for many wishing to develop performance monitoring and maternity dashboard systems.