Sheila Turner

Effectiveness of five different approaches in management of urinary tract infection: randomised controlled trial

Objective To assess the impact of different management strategies in urinary tract infections. Design Randomised controlled trial. Setting Primary care. Participants 309 non-pregnant women aged 18-70 presenting with suspected urinary tract infection. Intervention Patients were randomised to five management approaches: empirical antibiotics; empirical delayed (by 48 hours) antibiotics; or targeted antibiotics based on a symptom score (two or more of urine cloudiness, urine smell, nocturia, or dysuria), a dipstick result (nitrite or both leucocytes and blood), or a positive result on midstream urine analysis. Self help advice was controlled in each group. Main outcome measures Symptom severity (days 2 to 4) and duration, and use of antibiotics. Results Patients had 3.5 days of moderately bad symptoms if they took antibiotics immediately. There were no significant differences in duration or severity of symptoms (mean frequency of symptoms on a 0 to 6 scale: immediate antibiotics 2.15, midstream urine 2.08, dipstick 1.74, symptom score 1.77, delayed antibiotics 2.11; likelihood ratio test for the five groups P=0.177). There were differences in antibiotic use (immediate antibiotics 97%, midstream urine 81%, dipstick 80%, symptom score 90%, delayed antibiotics 77%; P=0.011) and in sending midstream urine samples (immediate antibiotics 23%, midstream urine 89%, dipstick 36%, symptom score 33%, delayed antibiotics 15%; P<0.001). Patients who waited at least 48 hours to start taking antibiotics reconsulted less (hazard ratio 0.57 (95% confidence interval 0.36 to 0.89), P=0.014) but on average had symptoms for 37% longer than those taking immediate antibiotics (incident rate ratio 1.37 (1.11 to 1.68), P=0.003), particularly the midstream urine group (73% longer, 22% to 140%; none of the other groups had more than 22% longer duration). Conclusion All management strategies achieve similar symptom control. There is no advantage in routinely sending midstream urine samples for testing, and antibiotics targeted with dipstick tests with a delayed prescription as backup, or empirical delayed prescription, can help to reduce antibiotic use. Study registration National Research Register N0484094184 ISRCTN: 03525333.

Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study

Objective To assess the natural course and the important predictors of severe symptoms in urinary tract infection and the effect of antibiotics and antibiotic resistance. Design Observational study. Setting Primary care. Participants 839 non-pregnant adult women aged 18-70 presenting with suspected urinary tract infection. Main outcome measure Duration and severity of symptoms. Results 684 women provided some information on symptoms; 511 had both laboratory results and complete symptom diaries. For women with infections sensitive to antibiotics, severe symptoms, rated as a moderately bad problem or worse, lasted 3.32 days on average. After adjustment for other predictors, moderately bad symptoms lasted 56% longer (incidence rate ratio 1.56, 95% confidence interval 1.22 to 1.99, P<0.001) in women with resistant infections; 62% longer (1.62, 1.13 to 2.31, P=0.008) when no antibiotics prescribed; and 33% longer (1.33, 1.14 to 1.56, P<0.001) in women with urethral syndrome. The duration of symptoms was shorter if the doctor was perceived to be positive about diagnosis and prognosis (continuous 7 point scale: 0.91, 0.84 to 0.99; P=0.021) and longer when the woman had frequent somatic symptoms (1.03, 1.01 to 1.05, P=0.002; for each symptom), a history of cystitis, urinary frequency, and more severe symptoms at baseline. Conclusion Antibiotic resistance and not prescribing antibiotics are associated with a greater than 50% increase in the duration of more severe symptoms in women with uncomplicated urinary tract infection. Women with a history of cystitis, frequent somatic symptoms (high somatisation), and severe symptoms at baseline can be given realistic advice that they are likely to have severe symptoms lasting longer than three days.

Women’s views about management and cause of urinary tract infection: qualitative interview study

Objectives To explore the views of women with urinary tract infection on the acceptability of different strategies for managing the infection, including delayed use of antibiotics, and the cause of infection. Design Qualitative interview study with semistructured one to one interviews within a randomised controlled trial of different management strategies. Analysis drew on some of the principles of constant comparison to generate key themes grounded in reported experiences and understandings. Setting Seven general practices across four counties in southern England. Participants 21 women presenting to general practices who were taking part in the larger trial. Results Women preferred not to take antibiotics and were open to alternative management approaches. With a strategy of “antibiotic delay” some women felt a lack of validation or that they were not listened to by their general practitioner. Women attributed urinary tract infection to lifestyle habits and behaviours, such as poor hygiene, general “negligence,” and even a “penalty of growing old.” Conclusion A clear acknowledgment of women’s triggers to consult is needed. If women are asked to delay taking antibiotics, the clinician must address the particular worries that women might have and explain the rationale for not using antibiotics immediately.

Cost effectiveness of management strategies for urinary tract infections: results from randomised controlled trial

Objective To assess the cost effectiveness of different management strategies for urinary tract infections. Design Cost effectiveness analysis alongside a randomised controlled trial with a one month follow-up. Setting Primary care. Participants 309 non-pregnant adult women aged 18-70 presenting with suspected urinary tract infection. Interventions Patients were randomised to five basic management approaches: empirical antibiotics, empirical delayed (by 48 hours) antibiotics, or targeted antibiotics based on either a high symptom score (two or more of urine cloudiness, smell, nocturia, dysuria), dipstick results (nitrite or leucocytes and blood), or receipt of a positive result on midstream urine analysis. Main outcome measure Duration of symptoms and cost of care. Results Management with targeted antibiotics with midstream urine analysis was more costly over the period of one month. Costs for the midstream urine analysis and dipstick management groups were £37 and £35, respectively; these compared with £31 for immediate antibiotics. Cost effectiveness acceptability curves suggested that if avoiding a day of moderately bad symptoms was valued at less than £10, then immediate antibiotics is likely to be the most cost effective strategy. For values over £10, targeted antibiotics with dipstick testing becomes the most cost effective strategy, though because of the uncertainty we can never be more than 70% certain that this strategy truly is the most cost effective. Conclusion Dipstick testing with targeted antibiotics is likely to be cost effective if the value of saving a day of moderately bad symptoms is £10 or more, but caution is required given the considerable uncertainty surrounding the estimates.

The health technology assessment adaptation toolkit: Description and use

OBJECTIVES Adapting health technology assessment (HTA) reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This article describes an instrument, the adaptation toolkit, which has been developed to aid in the process of adaptation of HTA reports. METHODS The toolkit was developed by a partnership of HTA agencies and networks from across Europe. The role of the toolkit is to guide the user through the process of selecting possible relevant material from these report(s), assessing the relevance, reliability, and transferability of the material, and adapting it for the desired context. RESULTS The adaptation toolkit has been developed, it comprises a collection of resources that help the user assess whether data and information in existing HTA reports should and could be adapted for their own setting. The toolkit contains two sections: a preliminary speedy sifting section and the main toolkit. The main toolkit includes five domains: (i) technology use and development, (ii) safety, (iii) effectiveness (including efficacy), (iv) economic evaluation, and (v) organizational aspects. Legal, ethical, and social aspects are beyond the scope of the toolkit. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. CONCLUSIONS The completed current version of the toolkit contains checklists and resources to aid in the adaptation of HTA reports. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf..

The journey from self-care to GP care: a qualitative interview study of women presenting with symptoms of urinary tract infection

BACKGROUND Urinary tract infection (UTI) is one of the commonest acute infections presenting to primary care. Little is known of womens experiences of UTI; self-care strategies and key triggers for their consulting behaviour are also little known. AIM To explore womens experiences of self-care and their journey to GP care, when faced with symptoms of a UTI. DESIGN OF STUDY Qualitative semi-structured interview study with women recruited to a larger UK trial of different management strategies for UTI. SETTING General practices across four counties in southern England. METHOD Twenty-one women were interviewed about the experiences they had prior to their GP visit, self-care strategies, and triggers for help seeking. Interviews were analysed thematically, using principles of analytic induction. RESULTS Women reported a process of evaluation, monitoring, re-evaluation, and, finally, consulting in order to meet their needs. Four key triggers for consulting were identified: failure to alleviate symptoms through self-care; symptom duration and escalation; impeding normal functioning and the fulfilment of social roles; and concern that it may be or become a serious illness. CONCLUSION Although UTI is often self-limiting, when taking patient histories and formulating their management strategies clinicians need to take into account womens often painful experience, their efforts to resolve symptoms prior to consulting, and their fears that the symptoms may indicate something more serious than a UTI.

The adaptation of health technology assessment reports: Identification of the need for, and development of, a toolkit to aid the process

OBJECTIVES Europe has many health technology assessment (HTA) agencies, each producing their own HTA reports. Adapting HTA reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This study aims to examine and understand the process of adaptation, and to develop a toolkit that would help the adaptation of reports produced by other countries. METHODS The methods used were a review of the literature; a survey of twenty-nine European HTA organizations, two rounds of a Delphi survey, a face-to-face meeting of twenty-one European network for Health Technology Assessment (EUnetHTA) representatives, iterative rounds of review, and two rounds of quality assurance testing (termed applicability testing). RESULTS Descriptions of previous examples of adaptation in the literature are sparse. Most respondents had previous experience in adapting reports, and all believed that adaptation was useful, and there was the ability to benefit from the use of a toolkit to aid in the process. EUnetHTA Partners developed and tested an adaptation toolkit. The toolkit is composed of a series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports. CONCLUSIONS Consensus of opinion from twenty-nine European organizations/networks has indicated that the adaptation of HTA reports would be desirable and beneficial. A toolkit was developed to help with the adaptation of HTA reports produced in other settings. This collection of resources is available for use by all HTA agencies and can be accessed at: http://www.eunethta.net/upload/WP5/EUnetHTA_HTA_Adaptation_Toolkit_October08.pdf.

Development of a toolkit and glossary to aid in the adaptation of health technology assessment (HTA) reports for use in different contexts.

OBJECTIVES To develop a health technology assessment (HTA) adaptation toolkit and glossary of adaptation terms for use by HTA agencies within EU member states to support them in adapting HTA reports written for other contexts. METHODS The toolkit and glossary were developed by a partnership of 28 HTA agencies and networks across Europe (EUnetHTA work package 5), led by the UK National Coordinating Centre for Health Technology Assessment (NCCHTA). Methods employed for the two resources were literature searching, a survey of adaptation experience, two rounds of a Delphi survey, meetings of the partnership and drawing on the expertise and experience of the partnership, two rounds of review, and two rounds of quality assurance testing. All partners were requested to provide input into each stage of development. RESULTS The resulting toolkit is a collection of resources, in the form of checklists of questions on relevance, reliability and transferability of data and information, and links to useful websites, that help the user assess whether data and information in existing HTA reports can be adapted for a different setting. The toolkit is designed for the adaptation of evidence synthesis rather than primary research. The accompanying glossary provides descriptions of meanings for HTA adaptation terms from HTA agencies across Europe. It seeks to highlight differences in the use and understanding of each word by HTA agencies. The toolkit and glossary are available for use by all HTA agencies and can be accessed via www.eunethta.net/. CONCLUSIONS These resources have been developed to help HTA agencies make better use of HTA reports produced elsewhere. They can be used by policy-makers and clinicians to aid in understanding HTA reports written for other contexts. The main implication of this work is that there is the potential for the adaptation of HTA reports and, if utilised, this should release resources to enable the development of further HTA reports. Recommendations for the further development of the toolkit include the potential to develop an interactive web-based version and to extend the toolkit to facilitate the adaptation of HTA reports on diagnostic testing and screening.

Impact of NIHR HTA Programme funded research on NICE clinical guidelines: a retrospective cohort

BackgroundIt is vitally important that there is a connection between health research and clinical practice. Indications as to the impact of the research on evidence-based practice and policy can be obtained by tracking the use of outputs of health research, especially its use in clinical guidelines (CGs). This study aims to assess the proportion of National Institute for Health and Care Excellence (NICE) CGs citing National Institute for Health Research Health Technology Assessment (NIHR HTA) studies and the impact of evidence from those studies on the included NICE CGs.MethodsThis is a retrospective cohort study assessing the proportion of NICE CGs from all NICE CGs issued between April 2001 and April 2012, which cited evidence from studies funded by the NIHR HTA Programme and the impact of those studies on the CGs as the primary and secondary outcome measures.ResultsOf the cohort of NICE CGs (n = 122), 3 (2%) CGs were based on previous NIHR HTA reports and would not have been issued in that form without those NIHR HTA studies, 90 (74%) included evidence from NIHR HTA studies, and 29 (24%) did not include evidence from NIHR HTA studies. The impact of NIHR HTA evidence on NICE CGs varied in the type and quantity of data used.ConclusionsFindings suggest that NIHR HTA funded research impacts on clinical guidance from NICE and hence is well connected to both clinical practice and policy.

The clinical relevance and newsworthiness of NIHR HTA-funded research: a cohort study

Objective To assess the clinical relevance and newsworthiness of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme funded reports. Study design Retrospective cohort study. Setting The cohort included 311 NIHR HTA Programme funded reports publishing in HTA in the period 1 January 2007–31 December 2012. The McMaster Online Rating of Evidence (MORE) system independently identified the clinical relevance and newsworthiness of NIHR HTA publications and non-NIHR HTA publications. The MORE system involves over 4000 physicians rating publications on a scale of relevance (the extent to which articles are relevant to practice) and a scale of newsworthiness (the extent to which articles contain news or something clinicians are unlikely to know). Main outcome measures The proportion of reports published in HTA meeting MORE inclusion criteria and mean average relevance and newsworthiness ratings were calculated and compared with publications from the same studies publishing outside HTA and non-NIHR HTA funded publications. Results 286/311 (92.0%) of NIHR HTA reports were assessed by MORE, of which 192 (67.1%) passed MORE criteria. The average clinical relevance rating for NIHR HTA reports was 5.48, statistically higher than the 5.32 rating for non-NIHR HTA publications (mean difference=0.16, 95% CI 0.04 to 0.29, p=0.01). Average newsworthiness ratings were similar between NIHR HTA reports and non-NIHR HTA publications (4.75 and 4.70, respectively; mean difference=0.05, 95% CI −0.18 to 0.07, p=0.402). NIHR HTA-funded original research reports were statistically higher for newsworthiness than reviews (5.05 compared with 4.64) (mean difference=0.41, 95% CI 0.18 to 0.64, p=0.001). Conclusions Funding research of clinical relevance is important in maximising the value of research investment. The NIHR HTA Programme is successful in funding projects that generate outputs of clinical relevance.