clinical prediction rules for physical therapy interventions - a systematic review

8/2/2019 Clinical Prediction Rules for Physical Therapy Interventions - A Systematic Review

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doi: 10.2522/ptj.20080239Originally published online December 18, 2008

2009; 89:114-124.PHYS THER.Jason M Beneciuk, Mark D Bishop and Steven Z GeorgeInterventions: A Systematic ReviewClinical Prediction Rules for Physical Therapy

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Clinical Prediction Rules forPhysical Therapy Interventions:A Systematic ReviewJason M Beneciuk, Mark D Bishop, Steven Z George

Background and Purpose. Clinical prediction rules (CPRs) involving physicaltherapy interventions have been published recently. The quality of the studies used

to develop the CPRs was not previously considered, a fact that has potential impli-cations for clinical applications and future research. The purpose of this systematicreview was to determine the quality of published CPRs developed for physicaltherapy interventions.

Methods. Relevant databases were searched up to June 2008. Studies wereincluded in this review if the explicit purpose was to develop a CPR for conditionscommonly treated by physical therapists. Validated CPRs were excluded from thisreview. Study quality was independently determined by 3 reviewers using standard18-item criteria for assessing the methodological quality of prognostic studies. Per-centage of agreement was calculated for each criterion, and the intraclass correlationcoefcient (ICC) was determined for overall quality scores.

Results. Ten studies met the inclusion criteria and were included in this review.Percentage of agreement for individual criteria ranged from 90% to 100%, and the ICCfor the overall quality score was .73 (95% condence interval .27.92). Criteriacommonly not met were adequate description of inclusion or exclusion criteria,inclusion of an inception cohort, adequate follow-up, masked assessments, sufcientsample sizes, and assessments of potential psychosocial factors. Quality scores for individual studies ranged from 48.2% to 74.0%.

Discussion and Conclusion. Validation studies are rarely reported in theliterature; therefore, CPRs derived from high-quality studies may have the bestpotential for use in clinical settings. Investigators planning future studies of physicaltherapy CPRs should consider including inception cohorts, using longer follow-up

times, performing masked assessments, recruiting larger sample sizes, and incorpo-rating psychological and psychosocial assessments.

JM Beneciuk, PT, DPT, FAAOMPT,is currently enrolled in the Reha-bilitation Sciences Doctoral Pro-gram (PhD), Department of Phys-

ical Therapy, University of Florida,PO Box 100154, Gainesville, FL32610-0154 (USA). Address allcorrespondence to Dr Beneciuk [email protected].

MD Bishop, PT, PhD, is AssistantProfessor, Department of PhysicalTherapy, University of Florida.

SZ George, PT, PhD, is AssistantProfessor, Department of PhysicalTherapy, Brooks Center for Reha-bilitation Studies, University of Florida. Mailing address: Depart-ment of Physical Therapy, Univer-sity of Florida, PO Box 100154,Gainesville, FL 32610-0154 (USA). Address all correspondence to Dr George at: [email protected].

[Beneciuk JM, Bishop MD, GeorgeSZ. Clinical prediction rules for physical therapy interventions: asystematic review. Phys Ther .2009;89:114124.]

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Clinical prediction rules (CPRs)(or clinical decision rules)have become popular in thephysical therapy literature. The in-tent of CPRs is to assist clinicians in

making a diagnosis, establishing aprognosis, or implementing an intervention. 1 Although it has been sug-gested that well-constructed CPRscan improve clinical decision mak-ing and practice, 2 there is a lack of consensus as to what constitutes amethodologically sound CPR, espe-cially in the derivation stage.

McGinn and colleagues 3 recom-mended a 3-step process in the development and testing of a CPR. Therst step involves the derivation of the CPR (derivation studies), and thesecond step involves the validationof the CPR (validation studies). Thethird step involves assessment of theimpact of the rule on clinical behav-ior, also referred to as an impactanalysis. For CPRs for physical ther-apy interventions, steps 2 and 3 arenot routinely performed. Although ithas been suggested that a validatedCPR can be applied in various set-

tings with condence in its accura-cy, 4 our impression is that most CPRsreported in the physical therapy lit-erature are derivation studies. Fur-thermore, the lapse in time before validation occurs can be extensive.This situation presents clinicians with the dilemma of whether they should incorporate the results of aderivation study into their clinicalpractice.

Our opinion is that the quality of aderivation study is one factor thatshould be considered before a CPR isimplemented into clinical practice.This interpretation can be difcult,however, because the quality of CPR derivation studies pertaining to interventions has not been reported. As-sessing the quality of derivation stud-ies has potential advantages for physical therapy practice and re-search. First, a quality assessment

will assist clinicians in deciding whether a given CPR is appropriatefor implementation into clinicalpractice. Second, a quality assess-ment will assist future researchers in

the design of high-quality studies for the development of new CPRs.

Therefore, the purpose of this sys-tematic review was to determine thequality of CPRs developed for interventions used by physical therapists.Studies were included in this review if the explicit purpose was to develop a CPR related to a specic in-tervention approach for conditionscommonly treated by physical thera-pists. Previously validated CPRs wereexcluded from this review becausethere is less debate over the clinicalapplication of validated CPRs 2 andbecause methodological concernsabout derivation studies are of lessconcern when a validation study hasbeen reported.

MethodData Sources and Searches A systematic review of relevant data-bases (PubMed, CINAHL, ProQuest,

and Academic Search Premier) fromtheir inception up to June 2008 re-sulted in the retrieval of 49 potentialpublications (Figure). The search strategy began with the lter pre-dict$ OR clinical$ OR outcome$ OR risk$. 5 In comparison with a goldstandard, 6 this lter has a sensitivity of 98.4% for retrieving CPRs from theliterature. 5 A second search strategy consisted of the key words clinicalprediction rule. The rst author ex-

amined reference lists from all se-lected publications to verify that nopertinent publications were missedduring the above-described searches.Studies were included in this review if the explicit purpose was to develop a CPR related to a specic in-tervention approach for conditionscommonly managed by physicaltherapists. Previously validated CPRs were excluded from this review.

Data Extraction and QualityAssessmentQuality scores were independently assigned to eligible studies by 3 reviewers using a modied version of a

list of criteria, reported by Kuijperset al, 7 for assessing the methodolog-ical quality of prognostic studies.These criteria were selected be-cause, in our experience, the physi-cal therapy literature has followed amodel that uses cohort designs for CPR derivation studies. Therefore,CPR derivation studies involvingphysical therapy interventions areappropriate for quality assessmenttools that are sensitive to method-ological issues that affect prognosticstudies. 8 Another reason why thesecriteria were appropriate for our purpose was that they were devel-oped by authors aware of issues re-lated to CPRs. Specically, Kuijperset al9 later reported a CPR for deter-mining the prognosis for patients with shoulder pain in general prac-tice settings.

The original list of criteria 7 was al-tered slightly by removing the crite-

rion related to the rate of response of potential study participants becausethis item is not commonly reportedin the physical therapy literature. Ad-ditionally, we added an importantcriterion by including masking of outcome assessors and treating clini-cians. 6,8 In our opinion, the resultingcriteria are similar to those that havebeen suggested for evaluating thequality of prognostic studies for pa-tients receiving physical therapy care 8 and are consistent with theprocess of evaluating prognostic variables. 10

The 18 criteria used to assess quality in this systematic review repre-sented 8 categories: study popula-tion, response information, follow-up, intervention, outcome, masking,prognostic factors, and data presen-tation. A description of each crite-rion is provided in the Appendix.

Clinical Prediction Rules for Physical Therapy Interventions

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The criteria could be scored as pos-itive, negative, or unclear. A positivescore indicated that the criterion was identied in the study and metspecic requirements consistent with a high-quality prognostic study. A negative score indicated that thecriterion was identied in the study but did not meet specic require-ments. A score of unclear meantthat the study provided insufcientinformation regarding that criterion.To obtain a conservative estimate of quality, negative and unclear ratings were collapsed when study quality was rated. A total quality score was

determined by adding positivescores, providing a potential high score of 18 (100%).

Ratings of individual studies to deter-mine quality scores were indepen-dently assigned by the 3 reviewersbefore a meeting on the interpreta-tion of the 18-item list of criteria(time 1). The meeting provided anopportunity for reviewers to assessagreement and discuss criteria thatresulted in high disagreement. In ad-dition, components for a given crite-rion that may have been overlookedby reviewers were claried. As ap-

propriate, a quality criterion was up-dated to reect an updated interpre-tation. For example, there weredifferences in opinion about whatconstituted a prospective study (cri-terion E). During the meeting, an op-erational denition for a prospectivestudy was approved. After the meet-ing, the 3 reviewers again indepen-dently assigned ratings (time 2), thistime using the nal guidelines provided in the Appendix.

Data Synthesis and AnalysisStatistical pooling of results was notperformed because of the obvious

Figure.Flow chart depicting search and selection process for clinical prediction rule (CPR).


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heterogeneity among studies in pop-ulations used, interventions applied,and outcome measures adminis-tered. Reliability analyses were per-formed with SPSS 15.0 for Windows*

and Excel.

Percentage of agreement was calculated for individual items.Negative and unclear ratings werecollapsed into one variable so thatratings could be dichotomized into 2categories. Interrater reliability wasreported for the total quality scoreby use of the intraclass correlationcoefcient (ICC [2,1]) and respec-tive 95% condence intervals (CI). 11

To determine a single overall quality score for an individual study (Tab. 1), each of the 3 reviewersscores for a particular study wereaveraged to account for the possibil-ity that interrater agreement was lessthan 100% after time 2. Therefore,the overall quality scores solely re-ect the results after time 2 ratings. As in other reviews using this scor-ing system, high-quality studies wereoperationally dened as those thathad average quality scores of greater than 60%. 7

ResultsThe initial search strategy yielded atotal of 4,080 publications. A major-ity of the publications did not meetthe criteria for review because they did not pertain to physical therapy interventions described in the Guideto Physical Therapist Practice .12 Af-ter titles were reviewed and dupli-cates were determined, 25 potentialpublications were further reviewed.Of these, 17 publications were ex-cluded on the basis of the followingcriteria: not intervention based(n 12), 9,1323 nonspecic interven-tion (n 3), 2426 and eventually vali-dated CPR (n 2). 27,28 Publications were excluded on the basis of thenonspecic intervention criterion

if they did not report on the resultsof a specic physical therapy intervention approach or used multidisci-plinary interventions. For example,methods consisting of various com-binations of physical therapy interventions that were not specically

described, such as exercises aimedat restoring neuromuscular controlat the shoulder, 26(pp12311232) or notdescribed in general, such as phys-iotherapy for shoulder pain, 24(p486) were grounds for exclusion. Grossand Battie 25 used a multidisciplinary approach that consisted of physicaltherapy, occupational therapy, exer-cise therapy (kinesiology), medicine,and psychology but that was not spe-cic to physical therapy alone; there-fore, their study was also excluded. Additionally, studies that potentially included interventions that were not within the scope of physical therapy practice were excluded. 26

The remaining 8 studies were in-cluded in this review. Two addi-tional publications were included af-ter a review of reference lists andrelated articles, resulting in the analysis of 10 publications in this review.

Five studies involved CPRs for re-sponses to spinal manipulation. 2933The other studies predicted re-sponses to lumbar stabilization, 34 hipmobilization, 35 patellar taping, 36multimodal interventions for cervi-cal radiculopathy, 37 and trigger point

therapy for headache 38 (Tab. 1).

Methodological CriteriaPercentage of agreement on ratingsof individual items ranged from 70%to 100%; items B, E, H, K, L, and Phad the lowest levels of agreement(70%86.7%) (Tabs. 2 and 3). After ameeting on the interpretation of the18-item list of criteria, percentage of agreement on ratings of individualitems ranged from 90% to 100%(Tabs. 2 and 3). Individual itemscommonly rated as low quality (ie,not meeting the criteria in greater than 50% of the studies) were items A, B, F, K, M, and R. Among theseitems, the inclusion of an inceptioncohort (item A), description of inclu-sion and exclusion criteria (item B),and follow-up of 6 months (item F) were met in 10% of the studies.The results indicated that for 6 items,all 3 reviewers were in absolute

* SPSS Inc, 233 S Wacker Dr, Chicago, IL60606. Microsoft Corp, One Microsoft Way, Red-mond, WA 98052-6399.

Table 1.Individual Clinical Prediction Rule (CPR) Studies and Mean Overall Quality Scores

CPR (Study)% Overall

Quality Score a

Stabilization exercise for low back pain (LBP) (Hicks et al 34 ) 74.0

Muscle trigger point therapy for chronic tension-type headache(Fernandez-de-las-Penas et al 38 )

72.2

Inability of people with LBP to show improvement with spinalmanipulation (Fritz et al 29 )

70.4

Thoracic spine manipulation for neck pain (Cleland et al 30 ) 68.5

Multimodal intervention for cervical radiculopathy (Cleland et al 37 ) 61.1

Cervical manipulation for neck pain (Tseng et al 31 ) 59.3

Physical therapist management of cervicogenic headache (Jull andStanton 32 )

55.5

Patellar taping for patellofemoral pain syndrome (Lesher et al 36 ) 55.5

Lumbopelvic manipulation for patellofemoral pain syndrome (Iversonet al 33 )

53.7

Hip mobilization for knee pain and clinical evidence of kneeosteoarthritis (Currier et al 35 )

48.2

a Mean of scores from all 3 reviewers after time 2.


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agreement that a given criterion wasmet across all studies reviewed (eg,all 3 reviewers were in absoluteagreement that item B was met in 3%of all studies reviewed) (Tab. 4).

Quality Score Absolute agreement among the 3 reviewers on overall quality scores wascalculated at time 1 (ICC .67, 95%CI .10.91) and after a meeting on

the interpretation of the 18-item listof criteria (time 2) (ICC .73, 95%CI .27.92) (Tabs. 2 and 3). Next, amean quality score was calculatedfor each reviewer (Tab. 1). At time 2,mean quality scores for individualstudies (X 11.13; 61.8%) rangedfrom 8.67 to 13.33 (48.2%74.0%).Five studies 29,30,34,37,38 were rated atgreater than 60% (range 61.1%74.0%). Four studies 3133,36 were

rated at 50% to 60% (range 53.7%59.3%), and one study 35 was rated atless than 50% (48.2%).

Discussion

The intent of this review was to ratethe methodological quality of CPR derivation studies reported in thephysical therapy literature. This is animportant issue because the quality of derivation studies for physicaltherapy interventions has not beensystematically considered. The lack of consideration of derivation studieshas important clinical and research implications. For example, CPR vali-dation studies often are not per-formed, a fact that makes the deci-sion to incorporate CPRs into clinicalpractice a potentially difcult one.One CPR has been validated in clin-ical settings with samples of patientssimilar to those included in the der-ivation study. 28 However, this CPR has not been validated in differentsettings with new groups of patientsand different intervention parame-ters. 39 On the basis of the results of this review, several CPRs may be ap-propriate for clinical applications in-

volving patients and clinical environ-ments similar to those used in theCPR derivation process. We ac-knowledge that the quality of a der-ivation study is only one aspect of clinical decision making for the useof a CPR. However, it is informationthat was not previously reported andtherefore might enhance clinical de-cision making. We used a quality score of greater than 60% as a cutoff score for a high-quality study, be-cause this threshold was used in aprevious review of prognosticstudies. 7

Studies that met this quality indexincluded CPRs for determining fac-tors associated with responses to sta-bilization exercises, 34 responses tomuscle trigger point therapy for tension-type headaches, 38 the inabil-ity of patients with low back pain toshow improvement with spinal ma-

Table 2.Interrater Reliability

Rating TimeIntraclass Correlation Coefcient

(95% Condence Interval)

Overall Quality Score

X (% a ) Range (% a )

1 .67 (.10.91) 11.47 (63.7) 715 (38.883.3)

2 .73 (.27.92) 11.13 (61.8) 714 (38.877.7)

a Overall quality score converted to percentage.

Table 3.Individual Item Percentage of Agreement

Item Description

% AgreementAmong All 3

Reviewers

Time 1Rating

Time 2Rating

A Inception cohort 90.0 90.0

B Inclusion/exclusion criteria 70.0 96.7

C Study population 93.3 93.3

D Nonresponders vs responders 90.0 90.0

E Prospective data collection 86.7 96.7

F Follow-up at 6 mo 100.0 100.0

G Dropouts/loss to follow-up of 20% 93.3 93.3

H Information on subjects completing study vs loss to follow-up/dropouts

83.3 90.0

I Intervention fully described/standardized 96.7 96.7

J Standardized assessment of relevant outcome crit eria 96.7 96.7

K Masking of outcome assessor and treating clinician 86.7 93.3

L Standardized assessment of subject characteristicsand potential clinical prognostic factors

83.3 96.7

M Standardized assessment of potential psychosocialprognostic factors

96.7 96.7

N Frequencies of most important outcome measures 90.0 90.0

O Frequencies of most important prognostic factors 96.7 96.7

P Appropriate analysis techniques 86.7 100.0

Q Prognostic model presented 93.3 93.3

R Sufcient numbers of subjects 90.0 90.0


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nipulation, 29 manipulation of thethoracic spine in patients diagnosed with mechanical neck pain, 30 and amultimodal intervention approach for cervical radiculopathy. 37 The

lower-quality studies included CPRsfor predicting favorable responses tocervical manipulation in patients with neck pain, 31 the managementof cervicogenic headache, 32 patellar taping, 36 lumbopelvic manipulationin patients with patellofemoral painsyndrome, 33 and hip mobilizationfor knee pain indicative of osteoar-thritis. 35 Quality scores can assist cli-nicians in deciding whether to usethese nonvalidated CPRs. However,quality scores are not a substitute for CPR validation studies. Validationstudies provide more-denitive infor-mation for clinical applications be-cause they are independent studiesof new subjects and involve a variety of clinicians and patients. 1,3,6,40

An important factor to consider for amethodologically sound CPR deriva-tion is the risk-to-benet ratio associ-ated with its application. Risk wasnot empirically assessed in the CPRs

considered in this review, a fact thatis not surprising given the status of the physical therapy literature. 41Clinical prediction rules were origi-nally developed in the medical pro-fession for decisions involvinghigher associated risks, such as thoseassociated with traumatic inju-ries. 4245 The risk associated with the interventions used in the CPRsconsidered in this review is believedto be minimal in comparison with the risk associated with emergency medicine. For example, consider therisk associated with the use of stabi-lization exercises for low back pain 34in comparison with the risk of notordering radiographs for traumaticinjuries. 4244 Failure to detect a frac-ture is associated with a risk higher than that associated with the use of stabilization exercises when thoseare not indicated. Unfortunately, thecurrent physical therapy literature

does not allow a quantitative consid-eration of the risk-to-benet ratio, soclinical decisions must be based onqualitative factors.

Individual items that received low-quality ratings were similar to previously suggested areas of meth-odological concern for CPR studies. 2,6,40 Specically, masking of outcome assessors and treating clini-cians (item K) did not occur in amajority of the studies reviewed.Masking of outcome assessors and

treating clinicians is important for limiting the measurement bias of po-tential predictor variables. 1,3,8 Addi-tional areas of concern identied inthis review included the use of aninception cohort and denition of the duration of symptoms in eligibil-ity criteria. To limit potential error inestablishing a prognosis, subjectsshould be enrolled in a commontime frame with regard to their cur-rent condition. 8 This criterion wasnot a component in a majority of thestudies used to develop CPRs. There-fore, samples used to develop CPRsmay lack homogeneity, thereby in-creasing the potential for bias in pre-dictor variables and outcomes. An-other area lacking in CPR derivationstudies published to date was thefollow-up period, which was sug-gested to be at least 6 months. Im-mediate effects were commonly re-ported; such immediate effects

might be benecial only in demon-strating evidence of responsiveness. 8

Longer follow-up times are neededto demonstrate valid clinical implica-tions for the use of a given interven-tion. Finally, an assessment of poten-tial psychosocial prognostic factors(item M) was commonly not in-cluded. Psychological factors, such as kinesophobia, catastrophizing,anxiety, and depression might havestrong inuences on outcomes re-lated to musculoskeletal condi-tions. 4649 Incorporating these fac-

tors into the development processhas important clinical implicationsfor future CPRs.

Limited sample sizes have been re-ported to be common methodologi-cal aws in CPR studies. 2 It has beensuggested that 10 to 15 subjects arerequired for each prospective pre-dictor variable in CPR studies. 50 Notmeeting this requirement may leadto inaccurate statistical results be-cause of overtting of regressionmodels. 50 It is important that our sample size determination was basedon the nal CPR model and not oninitial prospective variables. The re-sult was that only 40% of studies hadan adequate sample size, and this was a liberal estimate. If we hadelected to use initial prospective variables, then no studies wouldhave met the criterion for samplesize, a result suggesting that previ-

Table 4.Methodological Criteria Commonly Receiving Low Ratings

Item Description% Positive

Rating a

B Inclusion/exclusion criteria 3

A Inception cohort 10

F Follow-up at 6 mo 10

K Masking 27

R Sufcient numbers of subjects 40

M Standardized assessment of potential psychosocialprognostic factors

47

a Items for which all 3 reviewers agreed (absolute agreement) that a given criterion was met across the10 studies reviewed (eg, all 3 reviewers were in absolute agreement that item B was met in 3% of allstudies reviewed).


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ously noted concerns about smallsample sizes used in CPR derivationstudies are legitimate. We suggestthat future studies include larger sample sizes to account for deriva-

tion regression models in addition tothe nal, more parsimonious models.

Several limitations of this systematicreview should be considered in theinterpretation of the results. Al-though the results may be relevant tothe decision-making process for im-plementing a CPR in practice, our ndings should not be viewed asdenitive. Our data provide com-plementary information on which CPRs to use in clinical practice, butthe ultimate decision must be madein the context of a clinicians ex-perience and factors specic to theencounter with a patient. Thesefactors include, but are not limitedto, whether patients seen in clinicalpractice are similar to those enrolledin the respective CPR study and whether a quantitative assessment of the risk-to-benet ratio is available.

Another limitation is that the quality

criteria used in this review were developed for prognostic studies, notspecically for CPR derivation stud-ies involving interventions. Although these study designs are similar, theremay be subtle differences with re-gard to quality determinations. Thequality criteria used in this review did not include certain statistical el-ements that may have important im-plications for CPRs. For example, thecriteria did not include the consider-ation of a quantitative risk-to-benetanalysis, 41 reporting of potential pre-dictor variable reliability, 2,6 or re-porting of CIs 2,6 and effect sizes. 51Furthermore, the quality scores wereequally weighted so that the meth-odological importance of a category was equally distributed among all of the criteria. This decision was madebecause we did not have clear evi-dence to follow for weighting deci-sions. Another relevant issue is that

randomized designs have been sug-gested to be appropriate for CPR studies involving intervention selec-tion. 6,40 Although this may be true, itappears that the use of cohort stud-

ies is much more common in thephysical therapy literature, becauseonly one study included in this review used a randomized design. 32Therefore, future assessments of thequality of CPR derivation studiesshould include the development of astandardized rating system with amore-specic statistical criterion,consideration of weighting of quality scores on the basis of the method-ological importance of particular cat-egories, and the development of acriterion that is sensitive enough todetermine the overall quality of astudy design (such as distinguishingbetween cohort and randomizeddesigns).

There was substantial agreementamong the raters on individual itemsand overall quality scores; however,it is clear that agreement can be im-proved. Improvement can be accom-plished by providing quality criteria

more explicit than previously re-ported criteria, especially with re-gard to inception cohort, responders versus nonresponders, frequency of outcome measures, and sample sizedetermination. The reliability esti-mates were also imprecise (large95% CIs); we believe that this resultmay have been attributable to therelatively small number of studies in-cluded in this review. Additionally, we opted to collapse negative andunclear ratings, a strategy that may have inuenced the percentage of agreement among the reviewers.However, this decision to collapsethe data was made a priori and, evenif the data had not been collapsed,the overall quality scores would nothave been affected (Tab. 1). Thesescores considered only positive rat-ings because negative and unclear ratings were equally weighted as 0

when the overall quality scores weredetermined. 7

ConclusionThis systematic review provides im-

petus for future research. First, it re-inforces the importance and priority of performing validation studies.There are currently 10 CPR deriva-tion studies in the physical therapy literature that have not been vali-dated, and these studies vary greatly in overall quality. A glut of CPR der-ivation studies with various degreesof quality may only further confuseclinical practice, a result that is con-trary to the original intent of CPRs. Itis clear that follow-up validationstudies are a high priority for advanc-ing clinical practice. Second, the re-sults of this review provide a clear direction for investigators wishing toconduct high-quality CPR derivationstudies. In our opinion, the areas thatshould be a high priority for futurederivation studies aimed at CPR development are recruiting inceptioncohorts, performing masked assess-ments, including longer follow-uptimes, collecting larger sample sizes,

and incorporating psychological or psychosocial assessments.

All authors provided concept/idea/researchdesign and writing. Dr Beneciuk and Dr Bishop provided data collection. Dr Beneciukand Dr George provided data analysis. Dr George provided project management and fund procurement. Dr Bishop and Dr Georgeprovided consultation (including review of manuscript before submission).

Dr Beneciuk was supported by a NationalInstitutes of Health T-32 Neural Plasticity

Research Training Fellowship (grantT32HD043730). Dr Bishop and Dr Georgewere supported by grant R21 AT002796awarded to Dr George from the NationalInstitutes of Health/National Center for Complementary and Alternative Medicine.

This article was received August 7, 2008, and was accepted October 30, 2008.

DOI: 10.2522/ptj.20080239


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51 Cook C. Clinimetrics corner: use of effectsizes in describing data. J Man ManipTher. 2008;16:E54E57.


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Appendix.Eighteen-Item List of Criteria for Assessing the Methodological Quality of Studies a

A. Positive if subjects were identied at an early uniform point (inception cohort) in the course of the condition (rstepisode, with restriction to duration of symptoms mentioned, of their respective complaint or rst physical

therapyrelated intervention episode for their respective complaint).

B. Positive if criteria were formulated for at least age, duration of symptoms, and relevant comorbidities.

C. Positive if setting in which subjects were treated was described.

D. Positive if information was presented about subject or condition characteristics of responders and nonrespondersor if there was no selective response.

E. Positive if a prospective design was used (immediate or same-day follow-up was not considered prospective).

F. Positive if the follow-up period was 6 mo.

G. Positive if the total number of subjects was 80% at the last moment of nal follow-up compared with thenumber of subjects at baseline.

H. Positive if demographic or clinical information (subject or condition characteristics, such as age, sex, and other potential prognostic predictors) was presented for subjects completing the study and those lost to follow-up/ dropouts at the main moment of baseline outcome measurement, or no selective dropouts/lost to follow-up, or no dropouts/lost to follow-up.

I. Positive if the intervention subsequent to inclusion in a cohort was fully described or standardized (treatingclinicians had to adhere to a strict protocol and were not permitted to adjust the intervention on the basis of their independent decision-making processes).

J. Positive if standardized questionnaires or quantitative measurements of at least 1 of the following 5 outcomemeasures were used for each follow-up measurement: pain, general improvement, functional status, generalhealth status, or lost days of work.

K. Positive if masking of the outcome assessor and treating clinician was achieved. In studies in which self-administered questionnaires were used, masking of the outcome assessor portion of this criterion would beconsidered acceptable but would have no bearing on the treating clinician status.

L. Positive if standardized questionnaires or objective measurements were used at baseline for at least 4 of thefollowing 6 potential prognostic factors: age, sex, pain, functional status, duration of complaints, or physical work load.

M. Positive if standardized questionnaires or objective measurements were used at baseline for at least 1 of thefollowing 7 potential prognostic factors: depression, somatization, distress, fear-avoidance, coping strategies,anxiety, or psychosocial work-related factors (social support, psychological demands, and job decision latitude).

N. Positive if frequency, percentage, or mean, median, and standard deviation or condence interval were reportedfor the most important outcome measures.

O. Positive if frequency, percentage, or mean, median, and standard deviation or condence interval were reportedfor the most important prognostic factors.

(continued)


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Appendix.Continued

P. Positive if univariate crude estimates were provided for the association of a prognostic factor with outcome.

Q. Positive if an attempt was made to determine a set of prognostic factors with the highest prognostic value.

R. Positive if the number of cases in the multivariate analysis was at least 10 times the number of independent variables in the multivariate analysis (on the basis of the nal clinical prediction rule model, not the initialprospective variables).

a Criteria B, E, H, and R required consensus agreement or clarication before the second rating process, as follows: Bclarication regarding the inclusion of duration of symptoms; Econsensus agreement on the operational denition of a prospective design; Hclarication regarding information provided for dropouts/lost to follow-up; and Rclarication regarding the number of cases in the multivariate analysis being at least 10 times the number of independentvariables in the multivariate analysis (on the basis of the nal clinical prediction rule model).


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doi: 10.2522/ptj.20080239Originally published online December 18, 2008

2009; 89:114-124.PHYS THER.Jason M Beneciuk, Mark D Bishop and Steven Z GeorgeInterventions: A Systematic ReviewClinical Prediction Rules for Physical Therapy

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