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Clinical prediction rules can assist clinicians to identify patients with low back pain who are likely to recover quickly with minimal treatment. There is a paucity of validated instruments to assist with this task. The accuracy of the rule (calibration and discrimination) was determined in a sample of 956 participants enrolled in a randomized controlled trial.
Clinical prediction rules can assist clinicians to identify patients with low back pain who are likely to recover quickly with minimal treatment. There is a paucity of validated instruments to assist with this task. The accuracy of the rule (calibration and discrimination) was determined in a sample of 956 participants enrolled in a randomized controlled trial.
Clinical prediction rules can assist clinicians to identify patients with low back pain who are likely to recover quickly with minimal treatment. There is a paucity of validated instruments to assist with this task. The accuracy of the rule (calibration and discrimination) was determined in a sample of 956 participants enrolled in a randomized controlled trial.
Predicting rapid recovery from acute low back pain based on
the intensity, duration and history of pain: A validation study C.M. Williams 1,2 , M.J. Hancock 3 , C.G. Maher 1 , J.H. McAuley 4 , C.W.C. Lin 1 , J. Latimer 1 1 The George Institute for Global Health, University of Sydney, NSW, Australia 2 Hunter Medical Research Institute and School of Medicine and Public Health, University of Newcastle, NSW, Australia 3 Faculty of Human Sciences, Macquarie University, Australia 4 Neuroscience Research Australia, Randwick, NSW, Australia Correspondence Christopher M. Williams E-mail: cwilliams@georgeinstitute.org.au Funding sources Drs Maher, Hancock and Latimer are investigators on a clinical trial evaluating the efcacy of paracetamol for acute low back pain (ACTRN126090000966291). This is an investigator initiated trial funded by Australias National Health and Medical Research Council (NHMRC). The trial medicines and supplementary funding are provided by GlaxoSmithKline. Drs Maher and Latimer hold research fellowships funded by the Australian Research Council. Conicts of interest There are no other conicts of interests. Accepted for publication 24 January 2014 doi:10.1002/j.1532-2149.2014.00467.x Abstract Background: Clinical prediction rules can assist clinicians to identify patients with low back pain (LBP) who are likely to recover quickly with minimal treatment; however, there is a paucity of validated instruments to assist with this task. Method: We performed a pre-planned external validation study to assess the generalizability of a simple 3-item clinical prediction rule developed to estimate the probability of recovery from acute LBP at certain time points. The accuracy of the rule (calibration and discrimination) was determined in a sample of 956 participants enrolled in a randomized controlled trial. Results: The calibration of the rule was reasonable in the new sample with predictions of recovery typically within 510% of observed recovery. Discriminative performance of the rule was poor to moderate and similar to that found in the development sample. Conclusions: The results suggest that the rule can be used to provide accurate information about expected recovery from acute LBP, within the rst few weeks of patients presenting to primary care. Impact analysis to determine if the rule inuences clinical behaviours and patient outcomes is required. 1. Introduction The prognosis of acute low back pain (LBP) is gener- ally regarded as favourable with simple treatments recommended as rst-line care (Koes et al., 2010). However, many patients presenting to care receive additional complex or expensive interventions initially (Chenot et al., 2008; Williams et al., 2010a), which provide little or no added benet (Hancock et al., 2007). This pattern of care is concerning as it results in increased costs of care and exposes patients to unnec- essary risks of adverse events (McGuirk et al., 2001; Minal et al., 2011). A challenge for clinicians treating patients with acute LBP is that while most recover quickly, some do not, and go on to develop persistent LBP (Menezes Costa et al., 2012; Itz et al., 2013). This uncertain prognosis may be a reason why many clinicians do not provide simple minimal care initially as recommended in international guidelines (Koes et al., 2010). If clini- cians were able to easily identify patients who are likely to recover rapidly, it may assist them to recom- mend simple minimal care with greater condence. Accurate information about the chance of recovery by certain time points may also help patients make informed choices. 2014 European Pain Federation - EFIC
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Clinical prediction rules (CPRs) can assist clinicians identify patients with a more or less favourable prog- nosis. In the LBP eld, most CPRs focus on predicting persistent pain (i.e. greater than 3 months) rather than rapid recovery (Hayden et al., 2010). Regardless of their scope, most of the CPRs for LBP have not under- gone external validation testing (Kent and Keating, 2008; Chouand Shekelle, 2010), whichis animportant prerequisite for their use in clinical practice. External validation testing assesses the accuracy of a CPR in different settings and patient populations to those in which it was developed (Altman and Royston, 2000). In external validation studies, the accuracy of a CPR should be measured in terms of calibration and dis- crimination (Altman and Royston, 2000). Calibration refers to how close the predicted probabilities or risks are to that observed, and discrimination refers to how well the CPRclassies those at high risk of the outcome compared with those at lower risk (Toll et al., 2008). One simple CPR developed by Hancock et al. (2009) aims to identify patients likely to recover rapidly from acute LBP. The original study assessed a range of base- line predictor variables including patient characteristics (e.g. gender, catastrophizing, fear-avoidance beliefs), features of the episode (e.g. duration, intensity) and clinical ndings (area of symptoms and lumbar seg- mental mobility) as predictors of rapid recovery. The results showed patients with lower than average initial pain intensity, shorter duration of symptoms and fewer previous episodes recovered more quickly than patients without these characteristics. For instance, in patients who had all three characteristics, the model predicted 53% probability of recovery at 1 week, 78% by 2 weeks and 98%by 4 weeks. Such information has the potential to help clinicians more condently rec- ommend simple minimal care as per guideline recom- mendations, in patients very likely to recover rapidly. However, to date, no external validation has been performed on the Hancock CPR. The aim of this pro- spective external validation study was to assess the generalizability of the Hancock CPR. 2. Methods 2.1 Study design This study uses data from a consecutive subset of participants enrolled in the paracetamol for low back pain (PACE) study (Williams et al., 2010b), which is a randomized controlled trial investigating the effectiveness of paracetamol for acute LBP. The validation study is based on the outcomes of par- ticipants from all groups enrolled in the trial between November 2009 and December 2011. The full trial methods have been published (Williams et al., 2010b). Ethical approval for the trial was granted by the University of Sydney Human Research Ethics Committee. The trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTN 12609000966291). 2.2 Setting and participants The methods of the development study (Hancock et al., 2009) and recruitment of the development sample (Hancock et al., 2007) have been published. In brief, the development sample is composed of 239 participants recruited by 19 general practitioners from 14 practices in Central West Sydney, Australia. These patients were enrolled in a random- ized controlled trial of diclofenac and/or spinal manipulation for acute LBP conducted in 20052006. The validation sample consisted of consecutive LBP patients recruited by 207 primary care clinicians (general practitioner, pharmacist or physiotherapist) in Greater Metropolitan Sydney, Austra- lia, to participate in the PACE study, a randomized controlled trial comparing paracetamol to placebo for acute LBP. Table 1 Whats already known about this topic? External validation testing of clinical prediction rules is an important prerequisite to recommending them for use in clinical practice. However, few pre- diction rules developed for low back pain have undergone this process. What does this study add? The prospective external validation study found a simple prediction rule was accurate to predict short-term recovery (within 4 weeks) from low back pain. Longer predictions (412 weeks) were less precise. Table 1 Key differences between development and validation studies. Study characteristic Development sample Validation sample Recruitment Setting GP (19) GP (157), Pharmacist (46) Physiotherapist (4) Geographic Central-West Sydney Greater Metropolitan Sydney Inclusion criteria Sciatica Excluded Included Regular paracetamol Included Excluded >moderate disability Included Not considered Treatments NSAIDs or manipulation Advice/paracetamol Data collection Face-to-face; phone interview Online survey; phone interview Time period 20052007 20092012 GP, general practitioner; NSAIDs, non-steroidal anti-inammatory drug. C.M. Williams et al. Validation of a prediction rule for low back pain 2014 European Pain Federation - EFIC
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details key methodological differences between the develop- ment and validation studies. Participants for each trial were consenting patients with a primary complaint of LBP less than 6 weeks in duration, with or without leg pain; with at least moderate intensity pain during the preceding 24 h (measured by an adaptation of item 7 of the Short Form-36); and who were pain free for at least 1 month before the onset of the current LBP episode. Patients were excluded if they were suspected of having a serious spinal pathology; were taking regular recommended doses of an analgesic; were pregnant or planning pregnancy during the treatment period (4 weeks); or had a contraindication paracetamol. Patients with a clinical diagnosis of sciatica were excluded from the study in which the development sample was drawn, whereas this criterion was not applied to the validation sample. For this validation study, all participants from the PACE cohort that had past the nal follow-up time point (12 weeks) at the time of analysis were included. No adjustment was made for treatment group as the primary trial was not completed and investigators remained blind to treatment allocation. Given the randomized design, equal numbers of participants from each treatment group are expected to be classied across the levels of the rule and therefore treatment effect consistent across the levels of the rule. 2.3 Outcomes and data collection The primary outcome sustained recovery from LBP was dened as a score of 0 or 1 out of 10 on a numerical pain rating scale for 7 consecutive days. Participants recorded pain scores in a daily pain diary until recovery, or for a maximum of 12 weeks. Outcome data were collected over the phone by a researcher blind to status on the prediction rule or tran- scribed directly by the participant into an online database. As the validation study was pre-planned in the design of the PACE study (Williams et al., 2010b) the prognostic vari- ables that comprised the prediction rule were the same as those used in the Hancock et al. study: baseline pain (7/10; numerical pain rating scale), duration of current symptoms (5 days), number of previous episodes of LBP (1). These variables and descriptive baseline data were collected during a telephone interview with each participant prior to random- ization, usually within 24 h following their initial consulta- tion with the recruiting clinician. This method of data collection was comparable with the development study. 2.4 Determining status on the prediction rule Status on the prediction rule was determined for each par- ticipant by calculating the number of predictors of recovery present. Participants were thus grouped into one of four strata representing their status on the prediction rule (0, 1, 2 or 3 features positive). No weighting of predictors was per- formed. This method of classication was retained from the development study whereby weighting of features did not add predictive value and simplicity of the rule was preferred for usability. 2.5 Statistical analysis and assessment of predictive accuracy The performance of the prediction rule was assessed by mea- suring the calibration and discrimination of the developed model at 1, 2, 4 and 12 weeks post randomization. Methods used for the model development have been published else- where and were not assessed in the current study (Hancock et al., 2009). Multivariate Cox regression was used to identify the nal variables included in the CPR. The development of the model was internally validated with re-sampling methods (Altman and Andersen, 1989; Hancock et al., 2009). Calibration of the rule was considered the most relevant measure of accuracy because the rules main aim was to provide information about the probability of recovery, based on a patients status on the rule. Calibration was assessed by comparing the proportion of participants predicted to recover (for each status level of the rule) to the observed (actual) proportion who recovered, at 1, 2, 4 and 12 weeks in the validation sample. Predicted recovery was based on sur- vival curves of the four strata produced after Cox regression. Observed recovery was calculated for each strata using the KaplanMeier procedure. We considered absolute differ- ences between predicted and actual probabilities of recovery of less than 5% to represent very good calibration, 510% moderate calibration and greater than 10% poor calibration. The discriminative ability of the prediction rule was evalu- ated by calculating the c-index (Harrell et al., 1984). A c-index of 1 represents a perfect model, were 0.5 indicates an uninformative model with discrimination no better than chance. We calculated the c-index for recovery at four time points; 1, 2, 4 and 12 weeks post randomization. Kaplan Meier survival curves were produced along with median recovery times for eachstratum. We also constructed stratum- specic likelihood ratios (LRs) to assess discrimination at each level of the rule. LRs were calculated for the outcome recov- ery at each time point. LRs were calculated by dividing the probability that a recovered patient has a score on the rule (e.g. three predictors present) by the probability that a non- recovered patient has the same score on the rule. Completeness of survival data was calculated using the completeness index (Clark et al., 2002). In the case of incom- plete data, censoring occurred at the last completed follow up if recovery had not been established. All analyses were performed in STATA version 12 (StataCorp, 2011). 3. Results 3.1 Study population Characteristics of patients in the validation and devel- opment samples were similar at baseline (Table 2) except patients in the validation sample were slightly older and had a greater number of previous episodes of LBP. Of the 956 participants included in the valida- tion study, 937 (99%) were followed until they had Validation of a prediction rule for low back pain C.M. Williams et al. 2014 European Pain Federation - EFIC
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recovered (82%) or were censored at the end of week 12 (Fig. 1). Completeness of survival data was esti- mated as 98.7%. Five participants were lost to follow up from day 1 and were censored at day 1. Another 14 participants had incomplete outcome data and were censored before week 2 (three participants) or week 12 (11 participants). Seven participants (0.7%) were excluded from the analyses because of missing predic- tors at baseline. Overall, there were 68 participants who had 0 pre- dictors, 348 had one predictor, 419 had two predictors, and 114 had three predictors. Of the 348 participants with one predictor and the 419 with two predictors present, the most common feature was pain (7/10; n = 238 and 357, respectively). 3.2 Accuracy of the rule Overall the calibration was very good to moderate as shown in Table 3 and Fig. 1. At week 1 observed prob- abilities of recovery were within 5% of predicted values for three of the four strata and within 10% for the other strata. At week 2, observed probabilities of recovery were within 5% of predicted values for one of the four strata and within 10% for the other three strata. At longer-term follow ups of 4 and 12 weeks, predicted and actual rates of recovery were less well Table 2 Baseline characteristics and predictors of development and vali- dation samples. Characteristic Development sample Validation sample Age (years) 40.7 (15.6) 44.5 (16.0) Female gender 105 (44%) 457 (46%) Disability (RM 24) 13.1 (5.4) 13.0 (5.5) Pain referral distal to knee 26 (11%) 206, (22%) Pain (010 NRS) 6.5 (1.7) 6.2 (1.9) Number of previous episodes 3.7 (6.4) 11.5 (79.1) Duration of current episode (days) 9.13 (9.31) 10.1 (10.0) Continuous variables are mean (standard deviation), categorical variables are n (%). RM24, 24 item Roland Morris Disability Questionnaire; NRS, numerical rating scale. Figure 1 Calibration plots for (A) weeks 1, (B) 2, (C) 4 and (D) 12 predicted versus observed recovery by number of predictors. Predicted and observed recoveries were within 510% difference for weeks 1 and 2, with slightly larger differences in weeks 4 and 12. 0 predic- tor is no predictor present; 1 predictor is any one of three predictors; 2 predictors is any two of three predictors; 3 predictors is all three predictors present. Predictors are: 7/10 (numerical pain rating scale), 5-day duration of current symptoms, number of previous epi- sodes of low back pain (LBP) 1. Recovery dened as 0 or 1 out of 10 on a pain rating scale for 7 consecutive days. Table 3 Calibration performance of the clinical prediction rule for each time point. Predictors present % recovered Week1 Week 2 Week 4 Week 12 Predicted Observed Predicted Observed Predicted Observed Predicted Observed 0 12.7 13.5 24.5 33.2 53.5 52.9 74.7 68.1 1 18.9 25.9 34.8 44.6 68.9 61.7 87.7 78.2 2 30 30.1 51.2 54 85.4 71.7 97.2 84.7 3 52.6 54.4 77.9 69.6 97.9 85.7 99.9 91.1 Number of patients at each level of the rule: 0 predictors (68), 1 predictor (348), 2 predictors (419), 3 predictors (114). C.M. Williams et al. Validation of a prediction rule for low back pain 2014 European Pain Federation - EFIC
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calibrated with observed rates being typically about 10% less than predicted rates (Fig. 1). There was a small reduction in the discriminative ability of the rule (e.g. at week 1 the discrimination reduced from 0.66 in the development sample to 0.65 in the validation sample). The c-index values for the rule in the validation sample are presented in Table 4. Stratum-specic LRs for each of the four time points presented in Table 4, and the survival curves with median survival times detailed in Fig. 2 demonstrate reasonable discriminative ability of the prediction rule in the validation sample. 4. Discussion 4.1 Principal ndings The performance of the prediction rule, when evalu- ated in a new independent patient dataset was reason- able, but this depended on the time frame for recovery. Calibration in the rst 2 weeks was very good or moderate with half of the observed values being within 5% of the predicted values, and the other half within 10%. At 4 and 12 weeks, calibration was less precise with observed values being typically about 10% less than predicted values. The discriminative ability of the rule, measured with the c-index, did not reduce signicantly in the validation sample; however, the overall discrimination was poor to moderate (e.g. at week 1, c-index = 0.65; LR3 = 2.74; differences in survival curves). 4.2 Strengths and limitations This study is of high quality and one of very few pre-planned validation studies to assess the accuracy of a previously developed clinical prediction rule for LBP in an external dataset (Kent and Keating, 2008). The intention to conduct the validation study has been published a priori (Williams et al., 2010b). We mea- sured critical aspects of accuracy (calibration and dis- crimination) and highlighted the relative importance of these measures based on how the rule would be used in clinical practice. The large data sample (n = 956) were captured prospectively during a high- quality multicentre trial and had a high rate of com- pleteness of follow up (99%). These data provide precise estimates from which to assess the perfor- mance of the prediction rule, and with only three predictor variables in the prediction rule, the study was sufciently powered for this purpose. These quali- ties are atypical in validation studies (Toll et al., 2008). There are some potential limitations to this study. First, we did not use a formal statistical test to assess the calibration of the observed and predicted values. Statistical tests such as the HosmerLemeshow test can be used for this purpose; however, in a large sample, Table 4 Discriminative performance of the clinical prediction rule for each time point. Predictors present LR (95%CI) Week 1 Week 2 Week 4 Week 12 0 0.36 (0.180.71) 0.48 (0.290.79) 0.52 (0.330.82) 0.48 (0.290.79) 1 0.80 (0.660.98) 0.77 (0.650.92) 0.74 (0.630.88) 0.77 (0.650.96) 2 0.99 (0.851.16) 1.13 (0.981.31) 1.18 (1.001.39) 1.21 (0.981.51) 3 2.74 (1.953.86) 2.24 (1.533.27) 2.77 (1.664.62) 2.43 (1.264.71) c-index 0.65 (0.60 0.70) 0.63 (0.580.67) 0.61 (0.570.64) 0.60 (0.560.64) Number of patients at each level of the rule: 0 predictors (68), 1 predictor (348), 2 predictors (419), 3 predictors (114). Figure 2 KaplanMeier recovery curves for each level of the clinical pre- diction rule (CPR) and median recovery time [number of days and 95% condence interval (CI) ]. Non-overlapping 95% CIs indicate signicant dif- ferences between strata. A logrank test for trend conrmed time to recovery was signicantly different and ordered by status on the CPR (p < 0.0001). 0 predictor is no predictor present; 1 predictor is any one of three predictors; 2 predictors is any two of three predictors; and 3 pre- dictors is all three predictors present. Predictors are: 7/10 (numerical pain rating scale), 5 days duration of current symptoms, number of previous episodes of low back pain (LBP) 1. Recovery dened as 0 or 1 out of 10 on a pain rating scale for 7 consecutive days. Validation of a prediction rule for low back pain C.M. Williams et al. 2014 European Pain Federation - EFIC
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this test will detect even small clinically insignicant differences between predicted and observed events. (McGeechan et al., 2008) Rather, we used arbitrary cut-offs of <5%, and less than 10% to describe our ndings as we considered the absolute difference between predicted and observed events to be more important than statistical signicance. Second, despite many key differences from the development study, this validation study is not a true independent valida- tion as some investigators were involved in the devel- opment study. Third, a clinically relevant comparison of predictive utility would be to compare the predic- tive ability of the rule to a clinicians subjective judge- ment of prognosis. While the development study found results in favour of the rule, the available data did not allow this comparison in the validation study. Finally, while in the development study, a wide range of potential psychosocial predictors were evalu- ated, none remained in the nal model. While the current study did not assess the validity of this nding from the development study, it is possible that psycho- social inuences on predicting rapid recovery are far less important than for predicting chronicity. Impor- tantly the current study aimed to validate the rule exactly as developed in the original study. 4.3 Comparison with previous research An initial step to comparing our results with previous studies is to assess the overall recovery rates across the whole sample. We observed a faster rate of recovery compared with other studies, and overall recovery by 12 weeks was higher. In our sample, 50% of partici- pants had recovered by 2 weeks, 65% by 4 weeks and 80% by 12 weeks. Others have typically found a median recovery time of 612 weeks and fewer patients recover overall (Menezes Costa et al., 2012). A possible reason for this is that unlike our study, it is unclear if participants of these studies received guideline-recommended treatments. The speed of recovery in our sample is similar to that of the devel- opment study, which also applied guideline- recommended rst-line care to all participants. This suggests the prediction rule would be ideally applied to patients provided with care in that context. To our knowledge, the Hancock prediction rule is the only instrument that provides probability for recovery from acute LBP at different time points within 12 weeks of symptom onset; and so, comparing the performance of calibration is not possible. Our nding of only poor to moderate discriminative per- formance at 12 weeks, however, is comparable with or slightly inferior to the few other prognostic rules for LBP that have undergone validation. The area under the curve (AUC) of the Orebro Musculoskeletal Pain Screening Questionnaire (Maher and Grotle, 2009) ranges from 0.62 to 0.75 for persistent pain and from 0.68 to 0.83 for persistent disability. (Hockings et al., 2008) A recent meta-analysis of the Orebro Question- naire revealed high heterogeneity and consequently weak to moderate predictive value (sensitivity 0.59, specicity 0.77 and AUC 0.64; Sattelmayer et al., 2012). Early validation of the STarT Back Screening Tool revealed that at 6 months, the tool predicts well between patients at low/medium risk of disability and high risk of disability (+LR 5.51, 95% condence interval 3.309.28; Hill et al., 2008). However, a rea- sonable predictive performance was not replicated in a broader validation sample (Fritz et al., 2011). A key difference between these instruments and the Hancock rule is that the other rules aim to identify risk of persistent symptoms, rather than likely rapid recov- ery. While the ability of these instruments to classify patients into different risk proles is comparable or slightly superior, the other instruments are typically much longer to complete and aim to predict non- recovery post 3 months rather than provide estimates of time to recovery within 3 months. Probability of outcome has been suggested as the more useful prog- nostic information for clinicians and their patients (Toll et al., 2008), and is arguably the case for acute LBP. 4.4 Interpretation of ndings The key aim of the prediction rule investigated was to provide clinicians and patients with additional infor- mation about a patient recovery from acute LBP. The rule may help in shared decision making about the need for (or to withhold) additional interventions beyond simple cheap rst-line care of advice and simple analgesics for acute LBP. The prognosis of LBP is widely reported to be favourable, yet many patients continue to receive complex and expensive interven- tions. The data from this study may help increase the number of patients who elect for minimal care, when presented with the probability of rapid recovery within the rst 4 weeks. For example, patients with three positive features on the CPR can be advised that with simple recommended treatments using the more conservative estimates from the validation study 7 in 10 people with these characteristics recover in 2 weeks (i.e. 70% chance of recovery within 2 weeks) and nearly 9 in 10 people (85%) recover by 4 weeks (Table 2). In our opinion, there is no threshold value (probability of recovery) at which minimal care is C.M. Williams et al. Validation of a prediction rule for low back pain 2014 European Pain Federation - EFIC
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clearly indicated; however, we believe data presented in this manner can be used easily by individual patients and clinicians to make more informed deci- sions about the required care for an episode of acute back pain. The current study demonstrates that the simple pre- diction rule generalized reasonably well to a new population. This validation study utilized different cli- nicians from a wider primary care setting (e.g. general practice, physiotherapy and pharmacy), and the trial interventions were different. In the development sample, patients with sciatica or radicular symptoms were excluded, whereas in the validation sample they were not. Consequently, there was a higher preva- lence of leg pain in the validation sample. As both studies recruited people with acute LBP who were seeking care, the prediction rule should only be con- sidered validated in this population. In contrast, patients with chronic LBP have been shown to have different predictors of prognosis, and for these patients, the rule may not be useful. 4.5 Future direction The presented clinical prediction rule will only be be valuable if shown to help in treatment decision making between patients and clinicians. Future studies should evaluate the impact of the prediction rule; to determine the utility of the rule, if it changes the number of patients who receive interventions beyond those recommended for rst-line care, and whether it inuences clinical outcomes or patient sat- isfaction with the process and outcome of care. Con- tinued validation in other geographical areas should also be considered where updating the rule with the addition of other variables may prove benecial in other countries with different health-care processes. For instance others have suggested psychological factors play an important role in predicting outcomes in similar cohorts (Grotle et al., 2005, 2007). 4.6 Conclusion We assessed the generalizability of a simple prediction rule that aimed to identify recovery in patients with acute LBP. The performance of the prediction rule, when evaluated in a new independent patient dataset, was found to be acceptable for predicting recovery. The prediction rule may help clinicians and patients make informed decisions about treatment with greater condence about the likely prognosis. Author contributions All authors made substantial contributions to conception and design, acquisition of data. C.W., M.H. and C.M. lead data analysis and interpretation of data. All authors were involved in drafting the paper or its critical appraisal for important content. All authors approved the nal the version to be published. References Altman, D., Andersen, P. (1989). 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