Robert J. Froud

A systematic review and meta-synthesis of the impact of low back pain on people's lives

BackgroundLow back pain (LBP) is a common and costly problem that many interpret within a biopsychosocial model. There is renewed concern that core-sets of outcome measures do not capture what is important. To inform debate about the coverage of back pain outcome measure core-sets, and to suggest areas worthy of exploration within healthcare consultations, we have synthesised the qualitative literature on the impact of low back pain on people’s lives.MethodsTwo reviewers searched CINAHL, Embase, PsycINFO, PEDro, and Medline, identifying qualitative studies of people’s experiences of non-specific LBP. Abstracted data were thematic coded and synthesised using a meta-ethnographic, and a meta-narrative approach.ResultsWe included 49 papers describing 42 studies. Patients are concerned with engagement in meaningful activities; but they also want to be believed and have their experiences and identity, as someone ‘doing battle’ with pain, validated. Patients seek diagnosis, treatment, and cure, but also reassurance of the absence of pathology. Some struggle to meet social expectations and obligations. When these are achieved, the credibility of their pain/disability claims can be jeopardised. Others withdraw, fearful of disapproval, or unable or unwilling to accommodate social demands. Patients generally seek to regain their pre-pain levels of health, and physical and emotional stability. After time, this can be perceived to become unrealistic and some adjust their expectations accordingly.ConclusionsThe social component of the biopsychosocial model is important to patients but not well represented in current core-sets of outcome measures. Clinicians should appreciate that the broader impact of low back pain includes social factors; this may be crucial to improving patients’ experiences of health care. Researchers should consider social factors to help develop a portfolio of more relevant outcome measures.

Adverse events and manual therapy: A systematic review

OBJECTIVE To explore the incidence and risk of adverse events with manual therapies. METHOD The main health electronic databases, plus those specific to allied medicine and manual therapy, were searched. Our inclusion criteria were: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. We performed a meta-analysis using incident estimates of proportions and random effects models. RESULTS Eight prospective cohort studies and 31 manual therapy RCTs were accepted. The incidence estimate of proportions for minor or moderate transient adverse events after manual therapy was approximately 41% (CI 95% 17-68%) in the cohort studies and 22% (CI 95% 11.1-36.2%) in the RCTs; for major adverse events approximately 0.13%. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham/passive/control interventions compared to manual therapy was similar, but for drug therapies greater (RR 0.05, CI 95% 0.01-0.20) and less with usual care (RR 1.91, CI 95% 1.39-2.64). CONCLUSIONS The risk of major adverse events with manual therapy is low, but around half manual therapy patients may experience minor to moderate adverse events after treatment. The relative risk of adverse events appears greater with drug therapy but less with usual care.

Reporting outcomes of back pain trials: A modified Delphi study

Background: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret.

The MAPS Reporting Statement for Studies Mapping onto Generic Preference-Based Outcome Measures: Explanation and Elaboration.

BackgroundThe process of “mapping” is increasingly being used to predict health utilities, for application within health economic evaluations, using data on other indicators or measures of health. Guidance for the reporting of mapping studies is currently lacking.ObjectiveThe overall objective of this research was to develop a checklist of essential items, which authors should consider when reporting mapping studies. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a checklist, which aims to promote complete and transparent reporting by researchers. This paper provides a detailed explanation and elaboration of the items contained within the MAPS statement.MethodsIn the absence of previously published reporting checklists or reporting guidance documents, a de novo list of reporting items and accompanying explanations was created. A two-round, modified Delphi survey, with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, was used to identify a list of essential reporting items from this larger list.ResultsFrom the initial de novo list of 29 candidate items, a set of 23 essential reporting items was developed. The items are presented numerically and categorised within six sections, namely, (i) title and abstract, (ii) introduction, (iii) methods, (iv) results, (v) discussion and (vi) other. For each item, we summarise the recommendation, illustrate it using an exemplar of good reporting practice identified from the published literature, and provide a detailed explanation to accompany the recommendation.ConclusionsIt is anticipated that the MAPS statement will promote clarity, transparency and completeness of reporting of mapping studies. It is targeted at researchers developing mapping algorithms, peer reviewers and editors involved in the manuscript review process for mapping studies, and the funders of the research. The MAPS working group plans to assess the need for an update of the reporting checklist in 5 years’ time.

Systematic review of randomized controlled trials of clinical prediction rules for physical therapy in low back pain

Study Design. Systematic review. Objective. To evaluate randomized controlled trials validating the effects of a clinical prediction rule for patients with non-specific low back pain (LBP). The outcomes of interest were any back pain or pain-related measures. Summary of Background Data. LBP is a common and costly condition. Interventions for back pain seem to have, at best, small to moderate mean beneficial effects. Identifying subgroups of patients who may respond better to certain treatments may help to improve clinical outcomes in back pain. The development of clinical prediction rules is an attempt to determine who will respond best to certain treatments. Methods. We conducted electronic searches of MEDLINE (1980–2009), EMBASE (1980–2009), PsycINFO (1980–2009), Allied and Complementary Medicine (1980–2009), PubMed (1980–2009), ISI Web of Knowledge (1980–2009), and the Cochrane Library (1980–2009). The reference lists of relevant articles were searched for further references. Results. We identified 1821 potential citations; 3 articles were included. The results from the available data do not support the use of clinical prediction rules in the management of non-specific LBP. Conclusion. There is a lack of good quality randomized controlled trials validating the effects of a clinical prediction rule for LBP. Furthermore, there is no agreement on appropriate methodology for the validation and impact analysis. The evidence for, and development of, the existing prediction rules is generally weak. Level of Evidence: 1

A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

BackgroundPrevious reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality.MethodsWe systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites.Results73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality.ConclusionsDespite international attempts to improve methods in cluster randomised trials, important quality limitations remain amongst these trials in residential facilities. Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement. Funding bodies and journals should promote statistician involvement and co-authorship in addition to adherence to CONSORT guidelines.

Using ROC curves to choose minimally important change thresholds when sensitivity and specificity are valued equally: the forgotten lesson of pythagoras. theoretical considerations and an example application of change in health status.

Background Receiver Operator Characteristic (ROC) curves are being used to identify Minimally Important Change (MIC) thresholds on scales that measure a change in health status. In quasi-continuous patient reported outcome measures, such as those that measure changes in chronic diseases with variable clinical trajectories, sensitivity and specificity are often valued equally. Notwithstanding methodologists agreeing that these should be valued equally, different approaches have been taken to estimating MIC thresholds using ROC curves. Aims and objectives We aimed to compare the different approaches used with a new approach, exploring the extent to which the methods choose different thresholds, and considering the effect of differences on conclusions in responder analyses. Methods Using graphical methods, hypothetical data, and data from a large randomised controlled trial of manual therapy for low back pain, we compared two existing approaches with a new approach that is based on the addition of the sums of squares of 1-sensitivity and 1-specificity. Results There can be divergence in the thresholds chosen by different estimators. The cut-point selected by different estimators is dependent on the relationship between the cut-points in ROC space and the different contours described by the estimators. In particular, asymmetry and the number of possible cut-points affects threshold selection. Conclusion Choice of MIC estimator is important. Different methods for choosing cut-points can lead to materially different MIC thresholds and thus affect results of responder analyses and trial conclusions. An estimator based on the smallest sum of squares of 1-sensitivity and 1-specificity is preferable when sensitivity and specificity are valued equally. Unlike other methods currently in use, the cut-point chosen by the sum of squares method always and efficiently chooses the cut-point closest to the top-left corner of ROC space, regardless of the shape of the ROC curve.

Quality of cluster randomized controlled trials in oral health: a systematic review of reports published between 2005 and 2009

OBJECTIVES To assess the quality of methods and reporting of recently published cluster randomized trials (CRTs) in oral health. METHODS We searched PubMed for CRTs that included at least one oral health-related outcome and were published from 2005 to 2009 inclusive. We developed a list of criteria for assessing trial quality and reporting. This was influenced largely by the extended CONSORT statement for CRTs but also included criteria suggested by other authors. We examined the extent to which trials were consistent with these criteria. RESULTS Twenty-three trials were included in the review. In 15 (65%) trials, clustering had been accounted for in sample size calculations, and in 18 (78%) authors had accounted for clustering in analysis. Intraclass correlation coefficients (ICCs) were reported for eight (35%) trials; the outcome assessor was reported as having been blinded to allocation in 12 (52%) trials; 17 (74%) described eligibility criteria at individual level, but only nine (39%) described such criteria at cluster level. Sixteen of 20 trials (80%), in which individuals were recruited, reported that individual informed consent was obtained. CONCLUSIONS These results suggest that the quality of recent CRTs in oral health is relatively high and appears to compare favourably with other fields. However, there remains room for improvement. Authors of future trials should endeavour to ensure sample size calculations and analyses properly account for clustering (and are reported as such), consider the potential for recruitment/identification bias at the design stage, describe the steps taken to avoid this in the final report and report observed ICCs and cluster-level eligibility criteria.

Cascade diagrams for depicting complex interventions in randomised trials

Clarity about how trial interventions are delivered is important for researchers and those who might want to use their results. A new graphical representation aims to help make complex interventions clearer

Primary outcome measure use in back pain trials may need radical reassessment.

BackgroundThe answers to patient reported outcome measures and global transition questions for back pain can be discordant. For example, the most commonly used outcome measure in back pain trials, the Roland Morris Disability Questionnaire (RMDQ), can show improvement even though participants say that their back pain is worse. This gives cause for concern as transition questions are used as anchors to estimate minimally important change (MIC) thresholds on patient reported outcome measures such as the RMDQ. We aimed to explore and compare what people with back pain think when they respond to a transition question and when they complete the RMDQ.MethodsWe purposively sampled people enrolled on a back pain randomised controlled trial who completed the RMDQ and two transition questions. One enquired about change in ability to perform tasks, the other about change in back pain. We sampled participants with discordance (in both directions), and participants with concordant scores. We explored participants’ thought processes using in-depth interviews.ResultsWe completed 35 in-depth interviews. People with discordant RMDQ change and transition question responses attend to different factors when responding to transition questions compared to people with concordant scores. In particular, those for whom the RMDQ change indicated greater improvement than transition questions, prioritised their pain ahead of functional disability. When completing the RMDQ, participants’ thought processes were comparatively more objective, and specific to each statement.ConclusionApproaches to primary outcome assessment in back pain needs re-assessment. The RMDQ may be unsuitable for use as a primary outcome measure since patients may not attend to thinking about their back pain when completing it: patients’ abilities to cope with tasks can be independent of the change in their back pain. Some participants who improve on the RMDQ consider themselves globally worse. As transition questions can be driven by pain and other physical factors, transition questions should not be used to anchor minimally important change thresholds on the RMDQ.