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PUBLISHED: 24-09-2018
Exclusion criteria were if an instrument was 1). Key publications describing each instrument’s
clinician reported (therefore not a true PRO development are listed in Table 1.
instrument) or if they were specific for an Tables 2a and 3a give a summary of each
anatomical site other than the hand (for example, instrument’s adherence to the development and
of the elbow or shoulder). Also excluded were validation criteria set by the SAC7 and the FDA
articles reporting on a non-English instrument.14 guidelines.15 Tables 2b and 3b summarise the
Instruments that were developed specifically for domain analysis of the identified instruments.
a subpopulation such as children, the elderly or
Figure 1: Search strategy and results
workers compensation claimants were likewise
excluded.
Two reviewers independently screened titles
and abstracts for duplicates, discussed any
discrepancies and established consensus. The lead
author conducted the full text review and data
extraction. Identified instruments were appraised
according to their adherence to SAC 7 and the
United States Food and Drug Administration (FDA)
guidelines.15 The consensus-based standards for
the selection of health measurement instruments
(COSMIN)16 checklist was not used as synthesis
of measurement properties was not the primary
interest of this review but rather the methodology
used for PROM development.
Information regarding the development process
and psychometric evaluation of the PROMs was
extracted from the articles. The identified PROMs
that met the inclusion criteria were then analysed
for content. In the case where more than one
version of a tool was available, all versions were
PROMs=patient-reported outcome measures
included in the analysis to ensure a thorough QoL=quality of life
PRO=patient-reported outcome.
review. Guidelines for preferred reporting items
for systematic reviews and meta-analyses were
adhered to where pertinent.17
Results
The search resulted in 3,039 papers after the
removal of duplicates. Following screening of titles
and abstracts, 139 relevant papers underwent full
text review. A total of 87 articles met the inclusion
criteria, 20 instruments were identified as being
relevant to hand surgery. Further searching
identified another four eligible instruments. In
summary, 24 instruments were identified; 16
regional instruments (consisting of 10 upper
extremity and six hand/wrist instruments) and
eight condition specific instruments (see Figure
Table 1: Identified patient reported outcome instruments relevant to hand conditions and the key papers that
describe their development
Criteria DASH QD M2DASH POS-HA MAM16 MAM36 ULFI UEFI UEFI15 PROMIS MHQ BMHQ PRWHE HAT PEM MASS07
UEF
Item generation
Patient interviews • * • * •
Literature • • * • • * • • * * • * • • •
Expert opinion • • * • • * • * * • * • •
Item reduction
Expert opinion • • • • • • • • •
Item redundancy • • • • •
Endorsement frequencies • • • • • • • •
Missing data • • • •
Factor analysis • • • • • • •
Psychometric analysis
Acceptability • • • • • •
Internal consistency • • • • • • • • • • •
reliability
Interrater reliability
Test-retest reliability • • • • • • • • • • •
Responsiveness • • • • • • • •
Literature • • • •
Expert opinion • • • • •
Expert opinion •
Item redundancy • • • •
Endorsement frequencies • • •
Missing data • •
Factor analysis • • • •
Interrater reliability
Test-retest reliability • • • • • • •
Responsiveness • • • • • •
DASH QD M2 POS-HA MAM 16 MAM 36 ULFI UEFI UEFI 36 PROMIS MHQ BMHQ PRWHE HAT PEM MASS 07
DASH UEF
Physical functioning
Limitations of hand/wrist • • • • • •
Limitations of hand/digits • • • • •
Limitations of thumb • • • • •
Ability to work • • • • • • • • • •
Ability to travel • • • •
Symptoms
Pain issues • • • • • • • • •
Stiffness • • • • • •
Swelling • • • • • •
Weakness • • • • • •
Reduced ROM • • •
Insomnia • • • • • • • •
Change in appetite •
DASH QD M2 POS-HA MAM 16 MAM 36 ULFI UEFI UEFI 36 PROMIS MHQ BMHQ PRWHE HAT PEM MASS 07
DASH UEF
Health-related QOL
Inconvenience of medical/
hospital
Expectations • •
Psychological functioning
Avoidance of uncomfortable •
situations
Change in mood • • •
Body image
Self-consciousness • • • •
Sexual functioning • •
Psychological functioning
Self confidence / self esteem
Avoidance of uncomfortable
situations
Negative feelings about self
Change in mood • •
Body Image
Concerns regarding scarring
Self-consciousness
Satisfaction with hand •
appearance
Sexual functioning
Patient outcomes of surgery-hand/arm – POS–HA Michigan hand outcomes questionnaire – MHQ and
BMHQ
The POS–HA developed by Cano et al6 in 2004 is
the only instrument identified in this review that The MHQ developed in 1998 is a hand-specific
satisfies the gold-standard methodology of the outcomes instrument composed of 25 questions
SAC.7 This instrument includes a post-surgery to be answered for each hand and a further 12
component that asks the patient about their questions relating to both hands, totaling 62
satisfaction and whether expectations have been questions.46,47 These items are separated into six
met. However, the POS-HA does not employ IRT or domains: overall hand function, activities of daily
RA. Instruments that have been developed using living, pain, work performance, aesthetics and
IRT or RA include: the manual ability measure patient satisfaction with hand function. Each hand
(MAM–16, MAM–36)24,25 PROMIS physical function is evaluated separately and this is the only PROM
upper extremity or PROMIS PF–UE,28 and the upper identified that performs this analysis.46 The MHQ
extremity functional index (UEFI–15)13,27 however, has been developed using robust methodology,
these instruments are focussed mainly on function however, information regarding item reduction
and do not explore other domains as demonstrated is minimal in the literature. The psychometric
in Table 3a. validation of the MHQ has been thorough.30,46
The same developers produced the brief MHQ
Disabilities of the arm, shoulder and hand – DASH,
(BMHQ) in 2011.4 Item reduction was performed
QuickDASH and M2DASH
using a concept-retention technique that allows
The DASH, developed in 1996, is designed as a items that are deemed to be clinically relevant
brief, self-administered instrument that measures regardless of their statistical value. Two items were
upper extremity disability at the individual retained from each scale, resulting in 12 items in
level.18 Content was developed from literature the BMHQ. The items selected were chosen based
review, expert panels and existing scales.15,18 A on their correlation with the original MHQ score,
shorter version, the QuickDASH, was developed thus the psychometric properties of the original
in 2005 using concept retention methodology. MHQ are maintained. Unlike its forbearer, the
It has been reported that neither instrument is BMHQ does not differentiate between the hands.
specific to the upper limb, with the DASH unable
to reliably differentiate between upper and lower Patient-rated wrist evaluation—PRWE
limb pathology if completed by an individual The PRWE was developed in 1996 to measure
with pathology in both regions.43,44 The M2DASH the outcome following distal radius fracture.31 It
(Manchester-modified DASH), developed in 2008, was developed from a survey of wrist experts to
was designed to alleviate this issue by the retention determine the structure and content of the scale.
of items that are upper limb-specific.21,22 They identified the most important issues to be
pain, functional ability and patient satisfaction.31
Upper limb functional index—ULFI
The PRWE was modified to the PRWHE in 2004
The ULFI developed in 200626,45 is unique in that it by changing the word ‘wrist’ to ‘wrist/hand’
is composed of three sections including a patient- throughout the questionnaire.48
specific index and a visual analogue scale rating
overall status.
DASH is not specific for upper limb disability, as it with the implementation of condition-specific
has been shown to reflect lower limb and cervical instruments as a routine clinical measure is that,
spine pathology.21,44 in any given hand clinic, a whole suite of different
Since the development of the most commonly used questionnaires would be required, each with their
hand PROMS in the 1990s, there has been much own instructions, format and scoring systems. This
progress in the field of psychometrics. Classical test would simply not be practical in the majority of
theory (CTT) is based on the assumptions that: hand services.
compared to patient expectation and whether scales are being used but with the convenience and
the patient would recommend the operation to a clinical utility of a single PROM system.
friend with a similar issue. The MHQ has a cluster
of six questions exploring patient satisfaction with Disclosure
their hand function, motion, strength, pain and The authors have no financial or commercial
sensation. The PEM has three items that explore conflicts of interest to disclose.
patient satisfaction with hospital and their hand
References
and attempts to gauge whether the patient’s
1 B
lack N. Patient reported outcome measures could help
expectations have been met given their original transform healthcare. BMJ. 2013 Clinical research edi-
injury.33 This is something that the field of hand tion;346:f167.
surgery needs to establish a better understanding 2 P
orter ME, Larsson S, Lee TH. Standardizing patient out-
of so that we can improve the experience of hand comes measurement. New Engl J Med. 2016;374(6):504–06.
15 U
S Department of Health and Human Services Food and 28 H
ays RD, Spritzer KL, Amtmann D, Lai J-S, DeWitt EM,
Drug Administration Center for Drug Evaluation and Re- Rothrock N, DeWalt DA, Riley WT, Fries JF, Krishnan E.
search (CDER) Center for Biologics Evaluation and Research Upper-extremity and mobility subdomains from the pa-
(CBER) Center for Devices and Radiological Health (CDRH). tient-reported outcomes measurement information system
Guidance for industry: patient-reported outcome measures: (PROMIS) adult physical functioning item bank. Arch Phys
use in medical product development to support labeling Med Rehab. 2013;94(11):2291–296.
claims [PDF]. Washington, USA: Federal Government 2009. p
29 D
oring AC, Nota S, Hageman M, Ring DC. Measurement of
65132–33. Available from: https://www.fda.gov/downloads/
upper extremity disability using the patient-reported out-
drugs/guidances/ucm193282.pdf
comes measurement information system. J Hand Surg-Am.
16 Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford 2014;39(6):1160–165.
PW, Knol DL, Bouter LM, De Vet HC. The COSMIN check-
30 C
hung KC, Pillsbury MS, Walters MR, Hayward RA. Reliabili-
list for assessing the methodological quality of studies on
ty and validity testing of the Michigan hand outcomes ques-
measurement properties of health status measurement
tionnaire. J Hand Surg-Am. 1998;23(4):575–87.
instruments: an international Delphi study. Qual Life Res.
2010;19(4):539–49. 31 M
acDermid JC. Development of a scale for patient rating of
wrist pain and disability. J Hand Ther. 1996;9(2):178–83.
17 M
oher D, Liberati A, Tetzlaff J, Altman DG, Prisma G. Pre-
ferred reporting items for systematic reviews and meta-anal- 32 N
aidu SH, Panchik D, Chinchilli VM. Development and val-
yses: the PRISMA statement. Plos Med. 2009;6(7):e1000097. idation of the hand assessment tool. J Hand Ther. 2009 quiz
7;22(3):250–56.
18 H
udak PL, Amadio PC, Bombardier C, Beaton D, Cole D,
Davis A, Hawker G, Katz JN, Makela M, Marx RG. Develop- 33 M
acey AC, Burke FD. Outcomes of hand surgery. J Hand
ment of an upper extremity outcome measure: The DASH Surg.1995;20 B(6):841–55.
(disabilities of the arm, shoulder, and hand). Am J Ind Med. 34 A
lexander M, Franko OI, Makhni EC, Zurakowski D, Day CS.
1996;29(6):602–08. Validation of a modern activity hand survey with respect to
19 K
ennedy C, Beaton D, Solway S, McConnell S, Bombardier reliability, construct and criterion validity. J Hand Surg-Eur
C. Disabilities of the arm, shoulder and hand (DASH). The Vol. 2008;33(5):653–60.
DASH and QuickDASH outcome measure user’s manual. 3rd 35 M
ohan A, Vadher J, Ismail H, Warwick D. The Southamp-
ed. Toronto, Ontario: Institute for Work and Health; 2011. ton Dupuytren’s scoring scheme. J Plas Surg Hand Su.
20 B
eaton DE, Wright JG, Katz JN, Amadio P, Bombardier C, Cole 2014;48(1):28–33.
D, Davis A, Hudak P, Marx R, Hawker G, Makela M, Pun- 36 L
evine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG,
nett L. Development of the QuickDASH: comparison of three Fossel AH, Katz JN. A self-administered questionnaire
item-reduction approaches. J Bone Joint Surg. 2005 Series for the assessment of severity of symptoms and function-
a;87(5):1038–046. al status in carpal tunnel syndrome. J Bone Joint Surg Am.
21 K
han WS, Jain R, Dillon B, Clarke L, Fehily M, Ravenscroft 1993;75(11):1585–592.
M. The ‘M2 DASH’ – Manchester-modified disabilities of arm 37 A
troshi I, Lyren PE, Ornstein E, Gummesson C. The six-item
shoulder and hand score. Hand. 2008;3(3):240–44. CTS symptoms scale and palmar pain scale in carpal tunnel
22 K
han WS, Dillon B, Agarwal M, Fehily M, Ravenscroft M. The syndrome. J Hand Surg-Am. 2011;36(5):788–94.
validity, reliability, responsiveness, and bias of the Man- 38 M
assy-Westropp N, Ahern M, Krishnan J. A visual ana-
chester-modified disability of the arm, shoulder, and hand logue scale for assessment of the impact of rheumatoid ar-
score in hand injuries. Hand. 2009;4(4):362–67. thritis in the hand: validity and repeatability. J Hand Ther.
23 C
ano S, Browne J, Lamping D, Roberts A, McGrouther D, 2005;18(1):30–33.
Black N. The patient outcomes of surgery-hand/arm (POS– 39 B
ellamy N, Campbell J, Haraoui B, Buchbinder R, Hobby K,
HAnd/arm): A new patient-based outcome measure. J Hand Roth JH, MacDermid JC. Dimensionality and clinical impor-
Surg-Brit Eur. 2004;29(5):477–85. tance of pain and disability in hand osteoarthritis: develop-
24 Chen C, Granger C, Peimer C, Moy O, Wald S. Manual abil- ment of the Australian/Canadian (AUSCAN) osteoarthritis
ity measure (MAM–16): a preliminary report on a new pa- hand index. Osteoarthr Cartilage. 2002;10(11):855–62.
tient-centred and task-oriented outcome measure of hand 40 B
ellamy N, Campbell J, Haraoui B, Gerecz-Simon E, Buch-
function. J Hand Surg. 2005;30(2):207–16. binder R, Hobby K, MacDermid JC. Clinimetric properties of
25 C
hen CC, Bode RK. Psychometric validation of the manual the AUSCAN osteoarthritis hand index: an evaluation of re-
ability measure-36 (MAM–36) in patients with neurolog- liability, validity and responsiveness. Osteoarthr Cartilage.
ic and musculoskeletal disorders. Arch Phys Med Rehab. 2002;10(11):863–69.
2010;91(3):414–20. 41 B
ecker SJE, Teunis T, Ring D, Vranceanu AM. The tra-
26 G
abel CP, Michener LA, Burkett B, Neller A. The upper peziometacarpal arthrosis symptoms and disability ques-
limb functional index: development and determination tionnaire: development and preliminary validation. Hand
of reliability, validity, and responsiveness. J Hand Ther. 2016;11(2):197–205.
2006;19(3):328–49. 42 C
itron N, Hulme CE, Wardle N. A self-administered ques-
27 S
tratford PW. Development and initial validation of the up- tionnaire for basal osteoarthritis of the thumb. J Hand Surg-
per extremity functional index. Physioth Can. 2001;52:259–67. Eur Vol. 2007;32(5):524–28.
43 D
owrick AS, Gabbe BJ, Williamson OD, Cameron PA. Does 58 B
ogoch ER, Escott BG, Ronald K. Hand appearance as a pa-
the disabilities of the arm, shoulder and hand (DASH) scor- tient motivation for surgery and a determinant of satisfac-
ing system only measure disability due to injuries to the up- tion with metacarpophalangeal joint arthroplasty for rheu-
per limb? J Bone Joint Surg. 2006 Series B;88(4):524–27. matoid arthritis. J Hand Surg. 2011;36(6):1007–014.
44 H
uisstede BMA, Feleus A, Bierma-Zeinstra SM, Verhaar JA, 59 G
raham B. Defining and measuring patient satisfaction.
Koes BW. Is the disability of arm, shoulder, and hand ques- J Hand Surg. 2016;41(9):929–31.
tionnaire (DASH) also valid and responsive in patients with
60 P
enta M, Thonnard JL, Tesio L.ABILHAND: a Rasch-
neck complaints. Spine. 2009;34(4):E130–E8.
built measure of manual ability. Arch Phys Med Rehab.
45 G
abel CP, Michener LA, Melloh M, Burkett B. Modification of 1998;79(9):1038–042.
the upper limb functional index to a three-point response
improves clinimetric properties. J Hand Ther. 2010;23(1):41–
52.
46 C
hung BT, Morris SF. Reliability and internal validi-
ty of the Michigan hand questionnaire. Ann Plast Surg.
2014;73(4):385–89.
47 W
ehrli M, Hensler S, Schindele S, Herren DB, Marks M. Mea-
surement properties of the brief michigan hand outcomes
questionnaire in patients with Dupuytren contracture.
J Hand Surg-Am. 2016;41(9):896–902.
48 M
acDermid JC, Tottenham V. Responsiveness of the disabili-
ty of the arm, shoulder, and hand (DASH) and patient-rated
wrist/hand evaluation (PRWHE) in evaluating change after
hand therapy. J Hand Ther. 2004;17(1):18–23.
49 M
acey AC, Burke FD, Abbott K, Barton NJ, Bradbury E, Brad-
ley A, Bradley MJ, Brady O, Burt A, Brown P. Outcomes of
hand surgery. J Hand Surg-Brit Eur. 1995;20(6):841–55.
50 S
ambandam SN, Priyanka P, Gul A, Ilango B. Critical analysis
of outcome measures used in the assessment of carpal tun-
nel syndrome. Int Orthop. 2008;32(4):497–504.
51 C
ano SJ, Browne JP, Lamping DL, Roberts AHN, McGrouther
DA, Black NA. The patient outcomes of surgery-hand/arm
(POS–Hand/Arm): A new patient-based outcome measure. J
Hand Surg-Brit Eur. 2004;29B(5):477–85.
52 P
atrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML,
Molsen E, Ring L. Content validity—establishing and re-
porting the evidence in newly developed patient-reported
outcomes (PRO) instruments for medical product evalua-
tion: ISPOR PRO good research practices task force report:
part 1—eliciting concepts for a new PRO instrument. Value
Health. 2011;14(8):967–77.
53 F
ranchignoni F, Ferriero G, Giordano A, Sartorio F, Vercel-
li S, Brigatti E. Psychometric properties of QuickDASH–A
classical test theory and Rasch analysis study. Manual Ther.
2011;16(2):177–82.
54 B
raitmayer K, Dereskewitz C, Oberhauser C, Rudolf KD, Co-
enen M. Examination of the applicability of the disabilities
of the arm, shoulder and hand (DASH) questionnaire to pa-
tients with hand injuries and diseases using rasch analysis.
Patient. 2017;10(3):367–76.
55 K
amal RN, Hand Surgery Quality Consortium. Quality and
value in an evolving health care landscape. J Hand Surg.
2016;41(7):794–99.
56 P
ackham T, MacDermid JC. Measurement properties of the
patient-rated wrist and hand evaluation: rasch analysis of
responses from a traumatic hand injury population. J Hand
Ther. 2013 quiz 24;26(3):216–23.
57 J ohnson SP, Sebastin SJ, Rehim SA, Chung KC. The impor-
tance of hand appearance as a patient-reported outcome in
hand surgery. Plast Reconst Surg. 2015;3(11):e552.