CRITICALLY APPRAISED PAPER (CAP)

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1 CRITICALLY APPRAISED PAPER (CAP) Gruber, J. S., Bot, A. G. J., & Ring, D. (2014). A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger. Hand, 9(2), CLINICAL BOTTOM LINE There were no significant differences in final extensor lag between patients with mallet injury who did and did not use an orthosis at night. Four weeks of orthosis wear at night after 6 8 weeks of continuous orthosis wear for mallet finger did not lead to significantly greater distal interphalangeal (DIP) extension than no orthosis wear at night. Study outcomes could have been affected by inconsistent joint position, as described by the researchers (neutral to hyperextended). Details regarding orthosis design, total hours per day for wear of the orthosis, and presence of pain were omitted but might have affected treatment outcomes. Although participants were randomized, the rater was not blinded, and thus bias was introduced. RESEARCH OBJECTIVES Determine whether there was a difference in outcome between patients with an extension lag following 6 8 weeks of treatment for mallet injury who underwent an additional month of orthosis use at night and those who did not receive the additional treatment and identify predictors of extension lag, disability, and satisfaction. DESIGN TYPE AND LEVEL OF EVIDENCE Level I: The study was a prospective, randomized controlled trial with parallel groups and a pretest posttest design. This kind of study is considered the scientific standard in clinical research for establishing a cause and effect relationship (Portney & Watkins, 2009, p. 196). SAMPLE SELECTION Participants were selected from a single outpatient clinic, with intention to include an equal number of participants in the intervention group (night orthosis) and the comparison group (no night orthosis), by means of a 1:1 allocation ratio. After informed consent was obtained, patients were randomized through a spreadsheet random-number function. The researchers did not explain whether randomization procedures were concealed before assignment, nor did they indicate how patients were informed of the study. 1

2 Inclusion Criteria Inclusion criteria were (1) presence of mallet finger, (2) age 18 or older, (3) fluency in English, and (4) at least 6 weeks of continuous treatment with an orthosis or cast, with the DIP joint in extension or hyperextension, immediately prior to the start of the study. Exclusion Criteria Exclusion criteria included (1) presence of open lesions, (2) distal phalanx fractures that were untreated for 2 weeks or more after initial injury, and (3) fracture with dislocation of the distal phalanx. SAMPLE CHARACTERISTICS N = 51 #/% Male 34/67% #/% Female 17/33% Ethnicity No descriptive data were provided for ethnicity. Disease/disability diagnosis Tendinous or osseous mallet injury INTERVENTION AND CONTROL GROUPS Group 1 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Patients wore an orthosis at night to hold the DIP joint in extension. 25 The intervention took place at home. Patients applied the orthosis independently. Patients wore the orthosis at night. No definition of at night was provided. Patients wore the orthosis at night for 1 month after usual treatment for mallet injury (6 weeks of full-time orthosis use for osseous injury and 8 weeks of full-time orthosis use for tendon injury alone). Group 2 Brief description of the intervention How many participants in the group? Patients did not wear an orthosis at night to hold the DIP joint in extension. 26 2

3 Where did the intervention take place? Who delivered? How often? For how long? Not applicable Not applicable Not applicable Patients wore no orthosis after usual treatment for mallet injury (6 weeks of full-time orthosis use for osseous injury and 8 weeks of full-time orthosis use for tendon injury alone). The period of no orthosis wear lasted 4 weeks. Intervention Biases Check yes, no, or NR, and explain, if needed. Contamination: YES NO Comment: No member of the control group received intervention during the intervention period of the study. Cointervention: YES NO Comment: The treatment group received no additional intervention after the initial, nonexperimental treatment, other than use of the nighttime orthosis. Timing: YES Site: YES NO Comment: The follow-up period was variable. As such, the intervention period also might have varied, given that there was no indication that patients were told to stop wearing the orthosis at a given time, but only to return in 1 month. Follow-up was dependent on whether patients returned for an in-clinic visit (M = 5.7 weeks) or were contacted by telephone (M = 23 months). All patients were adults. Comment: The treatment group completed the intervention at home. It is assumed that the control group continued to live in their usual residence during the period of no intervention. Use of different therapists to provide intervention: YES NO Comment: The researchers indicated only that a custom, thermoplastic orthosis was fabricated, not who fabricated the orthosis. Patients self-applied the orthosis at night. 3

4 MEASURES AND OUTCOMES Measure 1 Name/type of Goniometry measure used What outcome is Extension lag of the DIP joint measured? Is the measure YES reliable? Although the researchers did not state how goniometric procedures were carried out, including placement technique and instrument selection, studies of reliability for goniometry in the DIP joint have demonstrated good to excellent inter- and intrarater reliability. Lewis, Fors, and Tharion (2010) established the reliability of goniometric measures of range of motion in the DIP joint in healthy participants; the intraclass correlation coefficient (ICC) for intrarater reliability ranged from.78 to.99, and the ICC for interrater reliability was.85 for active range of motion. Hamilton and Lachenbruch (1969) showed no statistical difference in intrarater reliability for lateral and posterior placement of the goniometer when the joint was in fixed position. Groth, VanDeven, Phillips, and Ehretsmann (2001) found interrater reliability to be higher with posterior placement (r =.99) compared with lateral placement (r =.86) across six raters. Is the measure YES valid? Studies support the validity of goniometric evaluation of range of motion in the interphalangeal joints; however, three studies have shown concurrent validity of goniometry of the shoulder (Triffitt, 1998; Tyler, Roy, Nicholas, & Gleim, 1999) and wrist (Wagner, 1993). Chapleau, Petit, and Rouleau (2011) found goniometric measures of the elbow to be valid, but measures of joint position on radiographs were more precise. When is the Goniometry was used as a pretest and posttest measure. measure used? Measure 2 Name/type of measure used Disabilities of the Arm, Shoulder and Hand (DASH) What outcome is measured? Patient-related report of ability to complete activities. Is the measure reliable? YES Beaton et al. (2001) found the DASH to have test retest reliability (ICC =.96). Is the measure valid? YES Beaton et al. (2001) reported on validity of the DASH. The researchers demonstrated that the DASH has discriminative and construct validity in patients with distal disorders. When is the measure used? The DASH was used at pretest and posttest. Measure 3 Name/type of measure used What outcome is measured? Pain Catastrophizing Scale (PSC) Catastrophic thinking related to pain (Sullivan, 2009, p. 4) 4

5 Is the measure reliable? YES The PSC has high internal consistency (Osman et al., 2000). Is the measure valid? YES The PSC possesses criterion-related, concurrent, and discriminative validity (Osman et al., 2000). When is the measure used? The PSC was used at pretesting only. Measure 4 Name/type of measure used Center for Epidemiological Studies Depression Scale (CES-D) What outcome is measured? Patient screening for symptomatology of depression Is the measure reliable? YES Interrater reliability for the CES-D is high (Shinar et al., 1986). Correlations between each item and the total test score ranged from moderate to high and were statistically significant for all but one item, which indicates internal consistency for most test items (Shinar et al., 1986). Is the measure valid? YES The CES-D has construct validity for patients following stroke; when scores for the CES- D were compared with other depression measures, including the Present State Examination, Hamilton Depression Scale, and Zung Depression Scale, correlation coefficients were statistically significant (Shinar et al., 1986). When is the measure used? The CES-D was used at pretesting only. Measure 5 Name/type of measure used Whitely Index What outcome is measured? Hypochondriacal worries and beliefs Is the measure reliable? YES Confirmed test retest reliability for general medicine outpatients (Speckens, Spinhoven, Sloekers, Bolk, & van Hemert, 1996). Is the measure valid? YES Test has concurrent and discriminative validity (Speckens et al., 1996). When is the measure used? The Whitely Index was used at pretesting only. 5

6 Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES NO Comment: With regard to measurement of extension lag, the researchers indicated that a trained research assistant not involved in the care of the patient obtained measures (p. 146). It is unclear whether the research assistant was blind to allocation of patients to the intervention or comparison group. Was there recall or memory bias? Check yes, no, or NR, and if yes, explain. YES Others (list and explain): Comment: The researchers did not discuss whether the participants who used an orthosis at night maintained a record of the incidence and duration of time per night that orthosis use occurred. Accordingly, participant recall or memory bias may be indicated, because participants recollections might have a wide variation in accuracy if there was no standardized method to track this information. The researchers did not indicate whether phone call follow-up to complete the DASH and ordinal scale for treatment satisfaction for participants who were unable to return for in-person follow-up was completed by the same or different persons. Therefore, interview bias could have been introduced during participant phone calls, given that interrater reliability or intrarater reliability might not have been established with the persons who completed participants scores by phone. RESULTS Residual lag was associated with initial extension lag (r =.43, p =.001), initial DIP flexion (r =.34, p =.014), follow-up DIP flexion (r =.39, p =.005), and age (r =.38, p =.006). Residual lag was not associated with patient satisfaction (r = p >.05). There were no differences in follow-up DASH scores (p =.67), treatment satisfaction (p =.48), and range of motion for DIP extension (p =.67) and flexion (p =.37) between the nighttime orthosis group and the no orthosis group. Patients previously discharged at the end of full-time orthosis wear did not maintain all of their extension. Effective treatment of mallet finger resulted in a slight extensor lag in most patients and a likely lag of 20 degrees or greater. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES Comment: The researchers conducted an a priori power analysis that indicated that a sample of 42 patients (21 in each group) would provide 80% statistical power (β =.20, α =.05) for a large effect size. Fifty-one participants were enrolled, of whom 20% were lost to follow-up. 6

7 Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES Comment: The researchers used the chi-square test to find the differences in categorical variables between the treatment groups (p. 146); the Fisher s exact test to compare the smoking status between the cohorts (p. 146); and independent t-tests to compare continuous variables (p. 146). Each of these tests is appropriate for the stated purpose (Portney & Watkins, 2009). The Pearson correlation was used to determine the correlation of continuous outcome variables with the final DASH score, satisfaction, and extensor lag. Independent t-tests and one-way ANOVA were employed for dichotomous and categorical variables, respectively (p. 146). Portney and Watkins (2009) supported the use of the Pearson product moment coefficient correlation when researchers are comparing continuous variables with underlying normal distribution (p. 528). Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES The statistics that answered the research question were discussed in the narrative and represented in table format. Was the percentage or number of participants who dropped out of the study reported? YES Yes: Ten of 51 patients, or 20%, dropped out of the study. Limitations What are the overall study limitations? The researchers used an intention-to-treat analysis through mean imputation for missing data (range of motion and DASH values). Given the small sample size and the fact that 20% did not return for follow-up, study outcomes might have differed if patients who did not return for range of motion measurements had larger differences in final extension lag than those who returned for follow-up. The study was powered to detect larger differences in extension lag but not smaller differences. Final extension lag averaged 14 degrees and correlated with extension lag at time of enrollment. However, the authors recognized that the extension lag values in this study were lower compared with other published reports. This suggests that the patients in this study may differ from other cohorts. Alternatively, this study included patients who had undergone 6 8 weeks of initial treatment, whereas other studies reported outcomes following the full continuum of intervention. Although the rater was a trained research assistant and reportedly was not involved in patient care, there was no indication that the rater was blind to treatment allocation. The orthosis was worn at night, but the researchers did not specify the number of hours per night or whether there was true homogeneity among the treatment group participants for orthosis-wear time. Additionally, the researchers did not indicate how adherence to wearing schedule was determined. 7

8 Farnebo and Chang (2013) suggested that patients with mallet injury and extension lag who also present with pain could benefit from continued orthosis use, yet their study did not indicate a recommended daily duration of wear. In this study, it seems that the researchers did not collect data on pain levels. Is it possible that a subset of patients with pain may benefit from nighttime use of an orthosis? Narrative reviews (Farnebo & Chang, 2013; Lin & Strauch, 2014) have suggested protocols for orthosis wear for mallet injuries, including positioning the DIP joint in neutral or hyperextension. In this study, the researchers indicated that patients were placed in an orthosis that held the DIP joint in a neutral or a slightly hyperextended (p. 146) position. It is unknown whether outcomes would have been different had everyone in this study been immobilized similarly. Patients in the intervention group were fitted with a custom-made thermoplastic nighttime orthosis. No further details were provided. It is unclear whether orthosis design makes a difference in outcomes following mallet injury. Two studies have suggested differences in failure rates between orthosis designs (Kinninmonth & Holburn, 1986; O Brien & Bailey, 2011), whereas other studies found no differences in outcomes between orthosis designs (Maitra & Dorani, 1993; Warren, Norris, & Fergusson, 1988). Further details of orthosis design or a picture of the orthosis used in this study would have clarified whether standardized treatment was truly provided across the group wearing an orthosis at night. CONCLUSIONS State the authors conclusions related to the research objectives. The results of this study indicate that supplemental use of an orthosis at night does not improve outcomes of mallet finger specific to extensor lag (following rupture of the terminal extensor tendon at the distal phalanx), satisfaction with treatment, or disability following tendon repair. Residual lags of 20 degrees or more are common, and patients with more severe initial extensor lags will likely experience worse final lags. References Beaton, D. E., Katz, J. N., Fossel, A. H., Wright, J. G., Tarasuk, V., & Bombardier, C. (2001). Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. Journal of Hand Therapy, 14(2), Chapleau, J., Petit, Y., & Rouleau, D. (2011). Validity of goniometric elbow measurements: Comparative study with a radiographic method. Clinical Orthopedics and Related Research, 469, Farnebo, S. & Chang, J. (2013). Practical management of tendon disorders in the hand. Plastic and Reconstructive Surgery, 132, 841e 851e. Groth, G. N., VanDeven, K. M., Phillips, E. C., & Ehretsmann, R. L. (2001). Goniometry of the proximal and distal interphalangeal joints, part II: Placement preferences, interrater reliability, and concurrent validity. Journal of Hand Therapy, 14(1),

9 Hamilton, G. F., & Lachenbruch, P. A. (1969). Reliability of goniometers in assessing finger joint angle. Physical Therapy, 49, Kinninmonth, A. W., & Holburn, F. A. (1986). A comparative controlled trial of a new perforated splint and a traditional splint in the treatment of mallet finger. Journal of Hand Surgery, 11(2), Lewis, E., Fors, L., & Tharion, W. J. (2010). Interrater and intrarater reliability of finger goniometric measurements. American Journal of Occupational Therapy, 64, Lin, J. D., & Strauch, R. J. (2014). Closed soft tissue extensor mechanism injuries (mallet, boutinniere, and sagittal band). Journal of Hand Surgery, 39, Maitra, A., & Dorani, B. (1993). The conservative treatment of mallet finger with a simple splint: A case report. Archives of Emergency Medicine, 10, O Brien, L. J., & Bailey, M. J. (2011). Single blind, prospective, randomized controlled trial comparing dorsal aluminum and custom thermoplastic splints to stack splints for acute mallet finger. Archives of Physical Medicine and Rehabilitation, 92, Osman, A., Barrios, F. X., Gutierrez, P. M., Kopper, B. A., Merrifield, T., & Grittmann, L. (2000). The Pain Catastrophizing Scale: Further psychometric evaluation with adult samples. Journal of Behavioral Medicine, 23, Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: Applications to practice (3rd ed.). Upper Saddle River, NJ: Pearson Prentice Hall. Shinar, D., Gross, C., Price, T., Banko, M., Bolduc, P., & Robinson, R. (1986). Screening for depression in stroke patients: The reliability and validity of the Center for Epidemiologic Studies Depression Scale. American Heart Association Stroke Journal 17, Speckens, A. E. M., Spinhoven, P., Sloekers, P. P. A., Bolk, J. H., & van Hemert, A. M. (1996). A validation study of the Whitely Index, the Illness Attitude Scales, and the Somatosensory Amplification Scale in general medicine and general practice patients. Journal of Psychosomatic Research, 40(1), Sullivan, M. J. L. (2009). The Pain Catastrophizing Scale: User manual. Retrieved from Triffitt, P. D. (1998). The relationship between motion of the shoulder and the stated ability to perform activities of daily living. Journal of Bone and Joint Surgery, 80(1), Tyler, T. F., Roy, T., Nicholas, S. J, & Gleim, G. W. (1999). Reliability and validity of a new method of measuring posterior shoulder tightness. Journal of Orthopaedic & Sports Physical Therapy, 29, Wagner, M. B. (1993). Assessment of hand function in Duchenne muscular dystrophy. Archives of Physical Medicine and Rehabilitation, 74, Warren, R. A., Norris, S. H., & Fergusson, D. C. (1988). Mallet finger: A trial of two splints. Journal of Hand Surgery, 13(2),

10 This work is based on the evidence-based literature review completed by Carly Sanders, MOTS, and Ginny Gibson, OTD, OTR/L, CHT, Faculty Advisor, Samuel Merritt University. CAP Worksheet adapted from Critical Review Form--Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 10