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SPINE Volume 38, Number 9, pp 762–769 2013, Lippincott Williams & Wilkins LITERATURE REVIEW Systematic Review of Randomized Controlled Trials of Clinical Prediction Rules for Physical Therapy in Low Back Pain Shilpa Patel , C. Psychol , * Tim Friede , PhD , † Robert Froud , PhD , ‡ § David W. Evans , PhD , * and Martin Underwood , MD * Study Design. Systematic review. Conclusion. There is a lack of good quality randomized controlled Objective. To evaluate randomized controlled trials validating the trials validating the effects of a clinical prediction rule for LBP. effects of a clinical prediction rule for patients with non-specifi c low Furthermore, there is no agreement on appropriate methodology back pain (LBP). The outcomes of interest were any back pain or for the validation and impact analysis. The evidence for, and pain-related measures. development of, the existing prediction rules is generally weak. Summary of Background Data. LBP is a common and costly Key words: clinical prediction rules condition. Interventions for back pain seem to have, at best, small to predictors of response to treatment systematic review. moderate mean benefi cial effects. Identifying subgroups of patients Level of Evidence: 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. Low back pain (LBP) is a common and costly condi- tion. 1 , 2 Effective interventions for LBP have, at best, Methods. We conducted electronic searches of MEDLINE (1980– small to moderate effects, when averaged over popula- 2009), EMBASE (1980–2009), PsycINFO (1980–2009), Allied and tions. 3 – 6 The true potential value of these interventions might Complementary Medicine (1980–2009), PubMed (1980–2009), have been underestimated because most trials encompass all ISI Web of Knowledge (1980–2009), and the Cochrane Library people with non-specifi c LBP as a single group, assuming (1980–2009). The reference lists of relevant articles were searched homogeneity. 7 – 11 for further references. The identifi cation of subgroups is an important research Results. We identifi ed 1821 potential citations; 3 articles were priority. 8 , 12 , 13 There is growing interest in the development and included. The results from the available data do not support the use use of clinical prediction rules (CPRs) in the physical ther- of clinical prediction rules in the management of non-specifi c LBP. apy literature, where focus has been on using such rules to determine who will best respond to a given intervention. 14 – 18 It is likely that outcomes will be improved if subgroups of patients with LBP could be identifi ed and better matched to From the * University of Warwick, Warwick Clinical Trials Unit, Warwick Medical School, Coventry, United Kingdom † Department of Medical treatment. 19 , 20 Statistics, University Medical Centre Göttingen, Göttingen, Germany Clinical prediction rules are defi ned as: ‡ Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United … the process by which combinations of clinical Kingdom ; and § University College of Health Sciences, Campus Kristiania, fi ndings that have been statistically demonstrated to be meaningful predictors of a condition or outcome of Acknowledgment date: May 9, 2012. First revision date: October 24, 2012. Acceptance date: October 25, 2012. interest are used to categorize a heterogeneous group of The manuscript submitted does not contain information about medical patients into subgroups based on a shared likelihood of device(s)/drug(s). the presence of that condition or outcome. 7 This project benefi ted from facilities funded through Birmingham Science City Translational Medicine Clinical Research and infrastructure Trials platform, CPRs can be useful in determining prognosis, assessing the with support from Advantage West Midlands. likelihood of the presence or absence of a condition, and to Relevant fi nancial activities outside the submitted work: consultancy, stock/ help classify patients into groups more likely to benefi t from stock options, travel/accommodations/meeting expenses. treatment. Strictly speaking the latter is not covered by the Address correspondence and reprint requests to Shilpa Patel, University of defi nition given above, but for the purpose of this review we Warwick, Clinical Trials Unit, Warwick Medical School, Gibbet Hill Road, Coventry, CV4 7AL, West Midlands, United Kingdom; E-mail: shilpa.patel@ take a wider view. They can help with screening patients to decide when further investigations are likely or unlikely to DOI: 10.1097/BRS.0b013e31827b158f yield meaningful fi ndings. 21 – 23 www.spinejournal.com Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
BRS205361.indd 762 BRS205361.indd 762

LITERATURE REVIEW Systematic Review of RCTs • Patel et al Developing a CPR should be a 3-step process of deriva- tion, validation, and impact analysis. 24 – 26 During the deriva-tion stage, it is important to identify known individual predic-tors of response to treatment. For validation, external validity should be examined by applying the rule to different settings, patients, and clinicians before generalizing. 26 , 27 Unfortunately, validation studies are rarely reported in the literature. 28 If these tools are well-designed and validated in appropriate populations, they will have the potential to identify those patients most likely to benefi t from a particular treatment, which in turn will help improve clinical decision making and practice. 29 There is currently considerable interest in review-ing the literature on CPRs for back pain. This largely focuses on synthesizing the outcomes of the original studies. If, how-ever, the underpinning research methods used are not robust, little weight can be given to the conclusions. Here, we report a systematic review evaluating validation studies of CPRs for patients with LBP using randomized controlled trials (RCTs). Our outcomes of interest were any back pain or pain-related measures. We provide a methodological and statistical cri-tique of the included articles, different to articles already pub-lished in this area. MATERIALS AND METHODS
Inclusion Criteria
Figure 1. Describes the study selection process for the systematic
We included RCTs that validated the effects of a CPR. We defi ned a CPR as any clinical tool with various components drawn from the history, examination, and laboratory tests used to inform treatment choices. We included studies of the management of LBP were assessed for inclusion in this non-specifi c LBP, that is, we excluded studies concerned with diagnosis and management of malignancy, infection, fracture, or infl ammatory disorders ( e.g., ankylosing spondylitis). Tri- Inclusion Process
als were of interventions to treat LBP of any duration with Two reviewers independently reviewed titles and abstracts outcomes of pain, disability, and psychological distress. The of citations identifi ed from the electronic searches ( Figure 1 ). age of participants in trials was restricted to adults (18 yr We found that the inter-observer reliability for screening titles or older). Only articles published in English were included. and abstracts was poor; we therefore used a third reviewer Studies described as RCTs that did not allow the performance to screen all titles and abstracts. The third reviewer screened of the CPR to be assessed using random allocation were the titles and abstracts and developed a list of the potentially excluded. We excluded studies of surgical techniques and der- included articles. These were compared with those selected ivation studies (studies prospectively examining the predictive by reviewers 1 and 2. Those that matched were included and ability of selected variables for a CPR). those that did not were discussed by all 3 reviewers to reach a consensus. The agreed upon full articles were obtained and Search Strategy
reviewed by 2 reviewers. SP and RF independently extracted We searched the following electronic databases from 1980 to data and assessed the quality of each article. We extracted 2009: MEDLINE, EMBASE, PsycINFO, AMED, PubMed, data on the derivation and composition of the CPR tested, the ISI Web of Knowledge, and the Cochrane Library. We used treatments being compared, and the study design ( Table 1 ). MeSH (Medical Subject Heading) terms to identify articles All disagreements over data extraction and quality assessment containing material relevant to "back pain" and "low back were resolved by means of discussion. pain." We combined these using Boolean operators with key-word terms "subgroup" or "subgroups" or "classifi cation" Quality Assessment
or "criteria" or "diagnostic criteria" or "rule" or "rules" We used the Pincus 31 quality assessment tool for studies of or "decision rules" or "prediction rule" or "clinical predic- treatment moderators. Each study was assessed for quality tors." Databases were limited to RCTs. We also searched independently by 2 reviewers. Studies that met all 5 criteria reference lists of relevant articles for further citations. The were classifi ed as providing confi rmatory evidence, those validation studies included in a recent review of CPRs for complying with criteria 3, 4, and 5 were classifi ed as providing Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
BRS205361.indd 763 BRS205361.indd 763 LITERATURE REVIEW Systematic Review of RCTs • Patel et al exploratory evidence. All other studies were classifi ed as pro- a preplanned analysis of data from an attention-controlled viding insuffi cient evidence ( Table 2 ). trial of spinal manipulation therapy. After collection of base-line data, participants were randomized to one of 4 groups. Participants were assessed on the 5 criteria to determine sta- We identifi ed 1821 citations for possible inclusion from bib- tus on the prediction rule. A researcher who was blinded to liographic searches. We obtained 35 full texts for detailed allocation collected data on 2 of the 5 criteria, the treating inspection. Following examination and discussion, 32 articles physiotherapist collected data on the remaining 3 criteria. The were excluded, 27 articles were not validating the effects of authors conducted a 3-way interaction between a patient's a prediction rule, 3 presented results from mixed samples, 1 status on the rule, treatment group, and time, which was not study was not randomized, and 1 study recruited some partic- statistically signifi cant at the 5% level. The authors concluded ipants under the age of 18 years. Subsequently, 3 studies were no clinically worthwhile interaction effects between treatment included in this systematic review ( Table 1 ). Statistical pooling group and status on the rule for either pain or disability at any of the data was not performed because of the small number of studies found as well as heterogeneity in the interventions applied, outcome measures collected, and populations from Critique of Included Articles
which samples were drawn. Brennan et al 32 adopted a pragmatic approach to treatment Brennan et al 32 reported a 3-armed trial of manipulation, progression, patients moved to the second subacute stage if stabilization, and exercise. The CPR used was on the basis they achieved a predefi ned reduction in their Oswestry Dis- of work by Fritz et al . 33 They examined the inter-rater reli- ability Index score. For these patients the therapist could ability of individual examination items for a classifi cation select only those treatments permitted based on the patient's decision-making algorithm. At baseline history and physical original treatment group. Therapists were permitted to use examination, data were collected before randomizing patients their own clinical judgment to determine exercise dosage for to one of the 3 treatments. After completion of the study, the individual patients. Although this is more representative of baseline signs and symptoms were used by 2 physical thera- normal clinical practice, it is diffi cult to determine confound- pists to decide which subgroup the patient fi tted and a third ing factors that may have an effect on response to treatment. therapist was consulted if agreement could not be reached. Statistically, comparing those that are classifi ed as matched Patients were then classifi ed as "matched" (if they received with those that are unmatched is likely to produce larger the treatment that matched their subgroup classifi cation) or effects than if comparing those randomized with the different "unmatched" (if they received a treatment different to their treatments because some participants will receive the correct subgroup classifi cation). The results were analyzed using a treatment by chance. A closer inspection reveals that the sta- 3-way interaction between randomized treatment, classifi - tistical analysis used by Brennan seems not to have included cation, and time that was found to be signifi cant, whereas a test for an interaction between all subgroups and treatment, both the 2-way interaction between randomized treatment making it diffi cult to conclude which subgroup of patients and time and that between classifi cation subgroup and time would respond best to which treatment. In addition quality were not statistically signifi cant. The authors reported greater assessment of this article provided inconclusive evidence. change in the Oswestry Disability Questionnaire for matched In the analysis conducted by Childs et al , 14 the authors do subjects than unmatched both at 4-week and 1-year follow- test for a 3-way interaction between CPR, treatment group, and time and concluded a positive effective for the CPR. Childs et al 14 used a CPR in a 2-arm trial of spinal manipu- However, the CPR has been criticized as comprising of items lation and exercise. The rule had previously been developed in that would ordinarily be associated with a favorable prog- a prospective cohort study with a small sample of participants nosis, 35 , 36 which challenges the usefulness of such a rule in from an army medical center. 17 The prediction rule identifi ed clinical practice. Despite their positive result we think that the patients with LBP who had a good prognosis when treated methods used to develop this rule are not robust and the items with spinal manipulation, based on 5 clinical factors. Data on included in the rule select those that would get better ordinar- these 5 factors were collected at baseline by a physical therapist ily. The quality assessment of this article provided inconclu- blind to the participant's treatment group. Those participants who met 4 or more of the 5 criteria were classifi ed as posi- Hancock et al , 34 when independently assessing the fi ndings tive and therefore likely to respond to manipulation. Those reported by Childs et al , 14 found no signifi cant interactions classifi ed with 3 or fewer positive criteria were classifi ed as between the treatment group and status on the rule for either negative. The authors tested for a 3-way interaction between pain or disability. They found that a positive status on the rule patients' status on the rule, treatment group, and time. The predicted better prognosis regardless of treatment received for authors concluded that those positive on the prediction rule pain and disability at 2 and 12 weeks. Importantly, because that received a form of lumbosacral spinal manipulation had Hancock et al 34 did not fi nd a difference between interven- the greatest treatment benefi t at 4- and 6-month follow-up. tion and control treatments, it would be unlikely that there Hancock et al 34 evaluated the spinal manipulation rule used would be an important interaction between CPR and treat- by Childs et al 14 to assess generalizibility of setting and sample ment group unless it was hypothesized the intervention was of patients receiving spinal manipulation. They carried out harmful for at least some individuals. These results do not www.spinejournal.com Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
BRS205361.indd 764 BRS205361.indd 764 LITERATURE REVIEW Systematic Review of RCTs • Patel et al (Continued hed for both short- fi cation and time sig- vement in pain and ve on the rule and ve status on rule ay inter fi cant. 4 wk treatment ved for pain and dis- fi cant. Greater c uthors Results and Con-
A
randomized treatment, classi ni in OSW in matc unmatc and long-term follo 2 w signi effect 0.4 status on rule, treatment group, and time signi cant. P the rule that recei nal manipulation had great impro disability at 1 and 4 wk and 6- mo follo positi got exer on the rule and recei spinal manipulation treatment group, clini- cal prediction rule status and time not signi for pain or disability signi between treatment group and status on rule for either pain or disability Positi predicted better prognosis regardless of treatment recei ability at 2 and 12 wk Measure and
after baseline assessment. Long-term follo 1 yr A ther blinded to the patients' status on the rule repeated the history and ph examination 1 and 4 wk after randomization. 6-mo follo up question- naire scale) and disability (RMDQ) at 1, 2, 4, and 12 wk OSW at 1 wk.
diction Rule
are of the patients'w fi cation based on Details of Clinical Pre-
data w sify them into one of 3 groups: manipulation, speci lization (classi based on previous w by F pists blind to the treat- ment group assignment. If agreement w reac w the basis of the 5 criteria for spinal manipula- tion (Flynn randomization, ther were not instructed in the rules criteria and were una status on the rule. completion of the trial an examiner blinded to the patients treatment assign- ment determined patients status on the rule using baseline data (positi 4/5 criteria met, negati = Childs manipulation clinical prediction rule initially dev Patients were examined on Treatments Being Com-
vs exer stabilization lation plus an exer progr exer gr diclofenac vs PL SMT & diclofenac vs AT SMT & PL diclofenac vs AT SMT & diclofenac 4-arm trial aphics, RMDQ , catastro- dardized ph examination. Demogr data, current pain intensity modi standardized ph nation. Demo- gr bod assess symptoms, current pain intensity and w last 24 hr modi history FABQ phizing, self- statement, coping self-statement, numerical pain rating scale, patient speci functional scale.
History and stan- Setting and In- clusion Criteria
Patients aged 18 to 65 yr LBP of with or without referr lo and an OSW score of with facili- ties within the US Air Patients aged 18 to 60 yr with or without referr lo and an OSW score of at least 30% Patients with LBP of pain between the 12th rib and buttoc crease causing moder and moder disability Clinics in Utah.
Primary care.
Summary of the Included Studies
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BRS205361.indd 765 BRS205361.indd 765 LITERATURE REVIEW Systematic Review of RCTs • Patel et al support the wider use of the Childs rule and we agree that this conclusion is supported by the analysis of results from the Hancock trial. Quality Assessment
The differences in fi ndings between Hancock et al 34 and Childs et al 14 can be attributed to a variation on the type and application of spinal manipulation, the setting, and the patient population. More specifi cally, the spinal manipulation delivered in both studies was not the same. Hancock et al 34 reported baseline pain and disability scores between the spi-nal manipulation groups and placebo group, and these were small and not statistically signifi cant. Therefore, testing for an interaction effect may be misleading. This was the only trial uthors Results and Con-
, spinal manipulati providing exploratory evidence. DISCUSSION
In this review, we focused on evaluating validation studies of CPRs for LBP using RCTs. We have therefore not included studies looking specifi cally at the derivation of rules. Two systematic reviews, published after we had completed our Measure and
review, support our conclusions. The fi rst, examined the ionnaire; PL, placebo; SMT validity of CPRs and concluded that derivation studies were mainly of high quality, whereas the cross-sectional validation studies were weak, limiting application of the rules in clinical practice. 37 The second, a more recent review of CPRs for the management of LBP conclude the current evidence does not support the clinical application of these rules. 30 Our fi ndings diction Rule
add to this work by demonstrating that the evidence from ran-domized trials validating CPRs for non-specifi c LBP is weak. Details of Clinical Pre-
Only 3 articles met our inclusion criteria, 2 of which were small studies with a total sample of less than 150 patients. , Roland and Morris Disability Quest In all cases, the prediction rule had been developed in small selected populations compromising external validity. Even the largest of these studies (Hancock et al , 25 n = 239) is likely to be too small to validate a CPR adequately, and thus their Treatments Being Com-
westry; RMDQ negative fi ndings are unlikely to be robust due to the possibil- ity of type II error; indeed one of the challenges to performing interaction tests is having adequate statistical power. After completing the work for this review, the results of the STarT back trial, a well conducted RCT of subgrouping and targeted treatment for patients with LBP, which achieved rule. Resear blinded to treat- ment allocation collected data on 2 items (F w and dur current episode). Treating ther collected data on the remain 3 cri- teria in the initial assessment a positive result, were published. 38 This trial would not have met our inclusion criteria as the actual subgrouping tool was not being tested but rather the targeted treatments were being tested. To test the targeting tool the trial design would need to randomize patients to receive the "tool" versus "no tool," voidance Belief Questionnaire; OSWA with those receiving the tool being allocated to treatment and those without being randomly assigned to treatment. This trial design would allow for the statistical comparison of tool versus no tool, giving a better indication of the tools ability to subgroup patients to targeted treatments. Setting and In-
A systematic review by Haskins et al 30 excluded the article by Brennan et al , 32 in which a classifi cation approach was used. We have included this article in our review as we have used a slightly different defi nition of CPRs that allows trials using classifi cation and categorization to be included. We have excluded the article by Cleland et al, 39 which was included in LBP indicates lo this recent review because the authors only included patients www.spinejournal.com Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
BRS205361.indd 766 BRS205361.indd 766 LITERATURE REVIEW Systematic Review of RCTs • Patel et al TABLE 2. Methodological Quality of Included Articles
Question
1. Was the subgroup analysis specifi ed a priori ? Preplanned secondary analysis 2. Was the selection of subgroup factors for analysis Yes—based on work Yes-–based on work Yes—independent evaluation of theory/evidence driven? by Fritz et al 32 by Flynn et al 16 work by Childs et al 14 whose rule was based on Flynn et al 17 3. Were subgroup factors measured prior to 4. Were subgroup factors measured by adequate (reliable and valid) measurements, appropriate for the target population? 5. Does the analysis contain an explicit test of the interaction between moderator and treatment? positive on the CPR, therefore not allowing for the rule to be studies have been of high quality, 37 our review, as well as pre- validated appropriately. vious reviews, have found the quality of validation studies to Kent et al 40 conclude that treatments targeted to subgroups have been poor. 28 , 37 may be effective; however, the results of the studies need to be In a perspective article, Hancock et al 25 make a number of interpreted with caution. In their review they include a trial by useful suggestions for future work on predictors of response Long et al , 41 which we have excluded from our review because to treatment which could also be applied to validation of a the authors include patients only with a directional preference CPR. Alternatively, a CPR could be validated as the interven- and exclude those without, therefore not allowing the clini- tion in a RCT. Any such trials are likely to need very large cal prediction rule to be tested appropriately. The discussions numbers of subjects. The effect size for main treatment effects within the review by Kent et al 11 focus on the effect sizes of the in current positive LBP pain trials are typically small to mod- included trials and signifi cance of this. In our article we focus erate. Any interaction effect is unlikely to be greater than the on the authors ability to test a clinical prediction rule effec- main treatment effect; indeed if it was, it would suggest that tively in a RCT. We present a methodological and statistical for a substantial group of people the intervention was likely critique, different than that presented by Kent et al . 11 to have no positive effect or for an identifi able group to make The development of the CPRs tested in these studies lacked their condition worse. Thus, as a rule of thumb, trials at least methodological rigor. 37 It remains unclear as to which candi- 4 times the size of current large trials of LBP treatments; per- date domains should be included in a prediction rule for LBP. haps 2000 to 3000 participants will be needed to validate It seems that identifi cation of such domains, or indeed con- CPRs satisfactorily. 42 cluding that such domains cannot be identifi ed will require Ideally, it would be better to have CPRs that can be applied a substantial study with an a priori design. To develop a to a varied range of clinical decisions, but this is unlikely. rule that enables clinicians to choose between interventions, CPRs would be useful in LBP as the treatment effects cur- the developmental work of derivation and validation needs to rently seen in populations remain small; this is probably, at be thoroughly designed and systematically validated. least in part, due to the heterogeneity of the un-subgrouped The methodology for quality assessing studies of CPRs back pain population. In the physical therapy literature there is poorly developed. We used a tool developed for a differ- are currently 10 prediction rule derivation studies that have ent study of moderators. 31 Based on these criteria only one not been validated. 28 Notwithstanding this, authors continue of the included studies provides exploratory evidence, none to cite the effective management of LBP using CPR. 43 , 44 fall within the remit of confi rmatory evidence ( Table 2 ). The There is a need for future well-designed validation studies focus of this review was to critique the statistical methods of these rules to enable better matching of patients to treat- used for the testing of a CPR. Therefore, we did not provide ment that in turn may lead to better patient outcomes and any extensive data on the quality of the underpinning trial. less health care usage and thus cost to the health care system. If we had found an apparently robust evaluation of a CPR The task of developing, validating, and testing such CPRs on which changes in clinical practice might be based, then it should not be underestimated. It is diffi cult to justify the very would be very important to know the quality of the trials by large cost entailed in taking one CPR through full testing conventional measures. to inform just one treatment choice, therefore our research At present, we do not know if the disappointing perfor- efforts and our funders' resources may be better directed in mance of CPRs in RCTs is because inappropriate rules have alternative directions. However, we warn against the applica- been tested, the trials have been poorly designed, underpow- tion of CPRs without suffi cient evidence because patients in ered, or indeed whether it is impossible to develop CPRs need of treatment may be denied treatments that they might that are fi t for this purpose. Although most of the derivation have benefi ted from. Copyright 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
BRS205361.indd 767 BRS205361.indd 767 LITERATURE REVIEW Systematic Review of RCTs • Patel et al 17. Flynn T , Fritz J , Whitman J , et al. A clinical prediction rule for ➢ Key Points
classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation Spine 2002 ; 27 : Identifying subgroups of patients with LBP who can 18. Iverson CA , Sutlive TG , Crowell MS , et al. Lumbopelvic manipu- be better matched to treatments might help to im- lation for the treatment of patients with patellofemoral pain syn- prove clinical outcomes. drome: development of a clinical prediction rule . J Orthop Sports The existing evidence for CPRs is weak. Despite this, Phys Ther 2008 ; 38 : 297 – 309 . 19. Froud R , Eldridge S , Lall R , et al. Estimating the number needed prediction rules are still being promoted in the physi- to treat from continuous outcomes in randomised controlled trials: cal therapy literature. methodological challenges and worked example using data from There is a need for well-designed validation studies the UK Back Pain Exercise and Manipulation (BEAM) trial . BMC of CPRs to enable progression to clinical implementa- Med Res Methodol 2009 ; 9 : 35 . 20. Kraemer HC , Frank E , Kupfer DJ . Moderators of treatment outcomes: clinical, research, and policy importance 21. Bachmann LM , Kolb E , Koller MT , et al. Accuracy of Ottawa ankle Acknowledgment
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