|
Reassurance after diagnostic testing with a low pretest probability of serious disease: systematic review and meta-analysis |
Rolfe A, Burton C |
|
|
CRD summary This well-conducted review concluded that diagnostic tests, for symptoms with a low risk of serious illness, did little to reassure patients, decrease their anxiety, or resolve their symptoms, but they could prevent some subsequent primary care visits. This conclusion reflects the results of the review and appears likely to be reliable. Authors' objectives To assess the impact of diagnostic tests in reassuring patients with a low probability of serious disease. Searching Six databases, including MEDLINE and PsycINFO, were searched for articles from inception to the end of 2011. Search terms were reported. References of relevant systematic reviews and identified studies were checked. There were no language restrictions, but studies had to be published in peer-reviewed journals. Study selection Randomised controlled trials (RCTs), which enrolled adults, aged at least 18 years, with symptoms indicating a low probability of serious disease, were eligible for inclusion. Trials had to evaluate initial diagnostic tests, such as types of imaging, endoscopy or cardiac testing, in primary or secondary care. Trials in tertiary care centres were excluded. Eligible comparators were usual care or empirical treatment (no initial testing); subsequent testing was permitted if symptoms persisted. Outcomes had to be illness concern, generalised or non-specific anxiety, change in original symptoms, or subsequent doctor visits; these had to be reported at baseline and completion. Included trials assessed a range of symptoms. Just over half enrolled patients with dyspepsia, who were investigated with endoscopy or radiography; other trials assessed back pain using radiography. Single trials used blood tests and electrocardiography (for chest pain), imaging (for headache), and continuous event recorders (for palpitations). All except two trials assessed recent rather than persistent symptoms. Most trials were conducted in primary care. Half were conducted in the UK, while others were carried out in the USA, Denmark, the Netherlands, Indonesia or Italy. There was considerable variation in the outcome measures. Two reviewers independently assessed the studies for inclusion in the review. Assessment of study quality Two reviewers independently assessed the trials, using the Cochrane Collaboration's risk of bias tool. This covered the generation of the randomisation sequence, allocation concealment, blinding of patients and investigators, incomplete outcome data, selective reporting of outcomes, and other sources of bias. Disagreements were resolved by consensus. Data extraction Data were extracted to permit the calculation of odds ratios or mean differences, with 95% confidence intervals. Two reviewers independently extracted the data using a prespecified form; disagreements were resolved by consensus. Methods of synthesis Pooled odds ratios or standardised mean differences, with 95% confidence intervals, were calculated using a random-effects meta-analysis. Heterogeneity was assessed using Ι² and where this was 50% or less, pooled estimates were presented. Odds ratios for the use of health care resources were converted to the number needed to investigate. Results of the review Fourteen RCTs, with 3,828 patients, were included in the review. Most trials were of moderate quality; only one reported blinded outcome assessment, and six had unclear randomisation and allocation concealment. Thirteen trials reported long-term data, with follow-up ranging from four to 18 months; follow-up rates ranged from 71% to 100%. The rates of subsequent testing, in control groups, ranged from 10% to 66% in endoscopy trials, and 1.5% to 13% in trials of other tests. There were no statistically significant differences between the groups in illness concern (OR 0.87, 95% CI 0.55 to 1.39; Ι²=0; three trials), anxiety (two trials), or symptoms (OR 0.99, 95% CI 0.85 to 1.15; Ι²=0; 10 trials) in the long-term. There was a trend towards anxiety being higher in the intervention groups (SMD 0.21, 95% CI -0.02 to 0.44; Ι²=0). Eleven trials reported subsequent primary care visits. Heterogeneity was high (Ι²=80%), but when a small trial and an old trial, predating modern treatment, were removed it was reduced (Ι²=33%) and a statistically significant reduction in visit rate was observed (OR 0.77, 95% CI 0.62 to 0.96; nine trials). In dyspepsia trials, the number needed to investigate was 16 (95% CI 8 to 100) and in back pain trials, the number needed to investigate was 26 (95% CI 15 to 155). Authors' conclusions Diagnostic tests, for symptoms with a low risk of serious illness, did little to reassure patients, decrease their anxiety, or resolve their symptoms, but they could reduce the number of subsequent primary care visits. CRD commentary This review addressed a clear question, supported by specific inclusion criteria. The search was thorough, but inclusion was restricted to published articles. The authors reported using methods to reduce bias and error at all stages of the review process. The trials were assessed for quality using appropriate criteria, and the results of the assessment were considered in the synthesis. The meta-analysis was appropriate, and the clinical and statistical variations between studies were taken into account. This was a well-conducted review and the authors' conclusions are likely to be reliable. Implications of the review for practice and research Practice: The authors stated that doctors and health care organisations should be aware of the limitations of the short-term reassurance provided by a negative result on a diagnostic test, and they should limit use of these tests to those that determine the patient's clinical management. Research: The authors stated that further research was needed to maximise the reassurance provided by medically necessary tests, and to develop safe strategies for managing patients, without testing, where an abnormal result is unlikely. They suggested that research should investigate whether reassurance should be targeted to particular patients. Funding Support received from the Chief Scientist Office of the Scottish Government, UK. Bibliographic details Rolfe A, Burton C. Reassurance after diagnostic testing with a low pretest probability of serious disease: systematic review and meta-analysis. JAMA Internal Medicine 2013; 173(6): 407-416 Indexing Status Subject indexing assigned by NLM MeSH Anxiety /diagnosis /etiology /physiopathology; Attitude to Health; Diagnostic Tests, Routine /psychology /statistics & Disease /psychology; Disease Management; Humans; Outcome Assessment (Health Care) /methods; Probability; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index; Sickness Impact Profile; Unnecessary Procedures /psychology; numerical data /utilization AccessionNumber 12013012308 Date bibliographic record published 27/02/2013 Date abstract record published 01/03/2013 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
|
|
|