Tilburg University
Health status and (health-related) quality of life in patients with fractures of the
extremities
van Son, Marleen
Publication date: 2015
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Citation for published version (APA):
van Son, M. (2015). Health status and (health-related) quality of life in patients with fractures of the extremities: Distal radius fractures and ankle fractures. Ridderprint.
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Health status and
quality of life
in patients with fractures of
the extremities:
Distal radius fractures and
ankle fractures
Marleen van Son
Health status and
quality of life
in patients with fractures of
the extremities:
Distal radius fractures and
ankle fractures
(health-related)
Health status and (health-related) quality of life in patients with fractures of the extremities: Distal radius fractures and ankle fractures
ISBN 978-94-6299-161-3
Cover design Maaike Algera, Tilburg, The Netherlands
Lay-out Maaike Algera, Tilburg, The Netherlands
Printing Drukkerij Ridderprint, Ridderkerk, The Netherlands
© Marleen A.C. van Son, Tilburg, The Netherlands.
Proefschrift
ter verkrijging van de graad van doctor aan Tilburg University op gezag van de rector magnificus, prof. dr. E.H.L. Aarts, in het openbaar te verdedigen ten overstaan van een door het college
voor promoties aangewezen commissie in de aula van de Universiteit op vrijdag 25 september 2015 om 14.15 uur
door
geboren op 14 juni 1987
Health status and (health-related) quality of life in
patients with fractures of the extremities:
Distal radius fractures and ankle fractures
Promotiecommissie
Promotores
Prof. dr. J.A. Roukema Prof. dr. J. de Vries
Copromotor
Dr. B.L. den Oudsten
Overige leden
Paranimfen
Contents
Chapter 1General introduction and outline of the dissertation
Chapter 2
Health status, health-related quality of life, and quality of life following ankle fractures: A systematic review
105
Chapter 3
Health status and (health-related) quality of life during the recovery of distal radius fractures: A systematic review
Chapter 4
Psychometric properties of the Short Musculoskeletal Function Assessment (SMFA) questionnaire in patients with a fracture of the upper or lower extremity
Chapter 5
The course of health status and (health-related) quality of life
following fracture of the lower extremity: A six months follow-up study
85
53
25
Chapter 6
The relationship between functional status, health status, and quality of life in patients with distal radius fractures
Chapter 7
Sociodemographic and clinical characteristics, trait anxiety, and health status as predictors of quality of life in patients with ankle fractures
223
Chapter 8
Trajectories in quality of life of patients with a fracture of the distal radius or ankle using latent class trajectory analysis: The relationship with sociodemographic, clinical, and psychological characteristics
Chapter 9
Health care utilization in patients with distal radius fractures and ankle fractures: The use of a self-report instrument
Chapter 1
Chapter 1 10 Chap ter 1
Epidemiology of fractures
of the extremities
Thirty-nine percent of the fractures that orthopedic surgeons encounter in clinical practice are fractures of the distal radius (DRF), metacarpus, and finger phalanges
(i.e., incidence 195.2, 130.3, and 107.3 fractures per 105 person-years respectively) 1.
The distal end of a bone is anatomically located farthest from the attachment of the limb to the body. The most common lower extremity fractures are situated at the proximal
femur or ankle (i.e., 129.4 and 100.8 fractures per 105 person-years respectively) 1.
The proximal end of the bone is situated towards the point where the limb is attached to the body. In Figure 1 the human skeleton is shown with also depicted the names of the
bones of the extremities 2.
Ankle fractures (AF) are mainly the result of substantial trauma sustained
during physical activity 3. The most common injury mechanism in DRF is a fall from a
standing position (i.e., ground level) on the outstretched hand 4. Two-third of the AF
are isolated malleolar fractures, while bi- (25%) and trimalleolar (7%) fractures are less
frequent 5. Aging of the population is now changing fracture epidemiology 1. While DRF
were traditionally considered as osteoporotic, bi- and trimallolar fractures are now
identified as predominantly osteoporotic as well 1. Osteoporosis, often referred to as
a silent disease 6, is defined by low bone mass and microarchitectural deterioration of
bone tissue. This leads to an increase in bone fragility 7.
Fracture classification
The Müller AO-classification of long bones is a widely used and accepted classification
system to categorize fractures 8. The AO-classification incorporates the anatomic
location of the fracture (i.e., the specific bone and bone segment) as well as severity of
morphological characteristics. To categorize AF, Weber 9, 10 and Lauge-Hansen 11 are two
other frequently applied classification systems. Weber is based solely on the anatomic location (i.e., the level of the fracture in the ankle joint) whereas Lauge-Hansen also incorporates the injury mechanism by identifying four fracture patterns of the ankle. Other systems that are used to classify DRF, besides the AO-classification, are Fernandez
12, Frykman 13, Melone 14, and the Universal classification system of Cooney 15. In our
Chap
ter 1
Figure 1. Human skeleton 2
Chapter 1 12
Chap
ter 1
Diagnostic procedure and
treatment in AF
The Ottawa ankle rules, including bony tenderness and inability of bear weight, assist emergency physicians in the identification of patients with a higher probability of fracture
in case of acute ankle injuries 16. These clinical decision rules prevent unnecessary
radiographic examination (i.e., anteroposterior X-ray and lateral X-ray) that is costly and
time consuming 17, 18.
AF are treated either nonoperatively or operatively with injury to the syndesmosis and dislocation of the bone as important indicators for operative treatment. During surgery, bone fragments are repositioned in their normal alignments (i.e., open reduction) and secured with screws and plates (i.e., internal fixation). The nonoperative approach of AF includes immobilization of the ankle with tape, a splint, or a cast up to six
weeks 19. No definitive conclusions can be drawn yet whether nonoperative or operative
treatments in general are superior regarding long-term functional and clinical outcomes
20. Therefore, the decision to treat a patient either nonoperatively or operatively is a
recurring topic of consideration in clinical practice.
Diagnostic procedure and
treatment in DRF
On clinical suspicion of a DRF, two X-rays are made of the wrist: a posteroanterior X-ray and a lateral view. Computed tomography is recommended in some intra-articular fractures and in complex or multi-fragmented fractures.
The nonoperative treatment of DRF is characterized with immobilization of the wrist in a cast for four to six weeks and closed reduction if necessary. Operative treatment is indicated if reposition was not successful and is also the first treatment of
choice with instable and comminuted DRF 21-23. A shift has been observed in the preferred
type of operative treatment from external fixation to internal fixation with plates 24, 25.
In a meta-analysis published in 2012, it was concluded that better functional outcomes were observed after internal fixation compared to external fixation, although external
Chap
ter 1
Outcomes in AF
Almost 80% of the patients have good to excellent results of their ankle one year after
operative treatment 27. However, after operatively treated AF, complications such as
infections (i.e., 1.8 to 8.6%), skin necrosis (i.e., 3%), and posttraumatic arthritis (i.e., 14%)
can occur 28, 29. In addition, almost half of the patients still reports stiffness, ankle swelling,
and pain one to five years after operative fixation of their AF 30, 31. Functional outcomes in
non-operatively treated patients are much less studied compared to operatively treated patients. An existing study indicates that an increase in age, a higher body mass index, an increase in distal fibular displacement, and a longer period of cast immobilization are
all predictors of worse physical functioning 46 months after non-operative treatment 32.
These functional impairments post-fracture can have severe consequences for patients’ daily life. Patients with AF need on average three months to return to their
work 33. However, AF can be a life-changing event for patients’ careers by losing their job
because of their injury 34. Moreover, patients experience difficulties returning to their
pre-injury sport levels 31 and 38% did not return to their pre-injury sporting activities
five years post-fracture 30. Sleep disturbance was reported by 19% of the patients three
months after AF 35. Six year post-fracture, fatigue (35%) and slowness (22%) attributed to
the initial injury are experienced by a substantial part of the patients 33.
Outcomes in DRF
The expected normal course of recovery in patients with a DRF is one of moderate pain and severe disability in the performance of activities one week after fracture, with significant improvement within three months. At six months, most patients experience
minimal pain and functional difficulties 36, 37. However, several short and long-term adverse
outcomes are reported as well in DRF. For example, complication rates of operatively
treated unstable DRF range from 22 to 48% 38-40. In addition, rates of secondary fracture
displacement after non-operatively treatment of mainly unstable or intra-articular DRF
are substantial: 28 to 64% 41-43. After cast removal, patients experience restricted forearm
and wrist motions and decreased grip strength 44. Moreover, patients with DRF loose on
average nine weeks from work 45. A severe type of fracture and high-energy trauma are
related to reduced functional outcome three to six months post-fracture. In addition, the variables older age and decreased bone mineral density were related to a delayed
functional recovery up to 12 months after DRF 46. Finally, the results of the injured wrist
of 21 percent of the patients were classified as fair or poor according to the Green and
Chapter 1 14
Chap
ter 1
Health status, health-related
quality of life, and quality of life
Thus, the impact of DRF and AF encompasses more than short term discomfort and can seriously affect patients’ lives in several areas for a long time. Research shows a discrepancy between radiological results and patient-reported outcomes in patients with
fractures 50-54. Therefore, patients’ well-being cannot be evaluated by the use of objective
parameters alone. The subjective experience of the patient should also be incorporated in the evaluation process post-fracture in order to provide a more comprehensive view on how these patients are doing. This could be performed by measuring patients’ health status (HS) and/or (health-related) quality of life (HR)QOL).
HS and (HR)QOL are related constructs but they cannot be directly equated. These three constructs have their multidimensionality in common, thereby covering
at least the physical, psychological, and social domain of patients’ lives 55-59. Therefore,
these constructs encompass more areas than only physical functioning (i.e., patients’
functional status (FS). However, HS is mainly a self-reported assessment of functioning 58
whereas (HR)QOL also includes how much patients are actually bothered by or satisfied with their levels of functioning and well-being (i.e., which is referred to as double
subjectivity 59). In addition, HRQOL is more narrowly defined than QOL, focusing on
those QOL components that are impacted by the disease 59. Patients with moderate to
serious disabilities can still report an excellent or good QOL. A high QOL against all odds,
i.e., the disability paradox 60, can be the result of reinterpretation of life after the patient
is adapted to the new condition.
Knowledge on the course of HS and (HR)QOL post-fracture could give patients some guidance on what to expect of their recovery. Besides the patients’ injury and its clinical characteristics, psychological variables as personality traits may influence patients’ course of QOL post-fracture. Obtaining better insights in these variables will help to identify subgroups of patients at risk who therefore need additional care and monitoring in clinical practice. However, generally psychological variables are not yet taken into account in studies on patients with DRF and AF. In the research areas of oncology and cardiology, personality characteristics are reasonably acknowledged
as important predictors of HS and (HR)QOL 61-64. Indications for this predictive role of
personality can also be found in studies on orthopedic patients undergoing arthroplasty
Chap
ter 1
trauma suggests that pain beliefs are related to HS/HRQOL 67, 68. Moreover, the use of
certain pain coping strategies have shown to influence recovery after whiplash injury
69. Eventually, patients’ QOL may be related to their health care utilization (HCU) and,
therefore, health care costs. Until now, not much is known about HCU and its indicators
in patients with AF and DRF 70.
Studies in this dissertation
The general aim of this dissertation was to evaluate patients’ HS and (HR)QOL following fracture of the upper or lower extremity, more specifically after DRF or AF. Therefore, data gathered in two studies were used and analyzed to meet this aim.
HS and (HR)QOL in patients with
fractures of the extremities
In the first study, patients with fractures of the upper or lower extremity were asked to report on their HS and (HR)QOL. These data were analyzed in chapters 4 and 5. Patients visiting the St. Elisabeth Hospital, Tilburg, The Netherlands, were asked to participate (November 2010-January 2012) within a few days after diagnosis. Inclusion criteria were an isolated unilateral fracture of the extremities inflicted by trauma and confirmed by X-ray, minimal age of 18 years old, and the capacity to self-report. The applied exclusion criteria were fractures due to diseases leading to weakness of the bone other than osteoporosis (e.g., cancer) or the presence of either severe psychopathology or serious physical comorbidity. Patients completed sets of questionnaires, including the Short
Function Musculoskeletal Function Assessment (SMFA) questionnaire 71, the World
Health Organization Quality of Life assessment instrument-Bref (WHOQOL-Bref) 72
and the RAND-36-item Health Survey 1.0 (RAND-36) 73, 74, at four time-points: time of
diagnosis asking about their pre-injury HS/(HR)QOL (Time-0retrospective), one week
Chapter 1 16
Chap
ter 1
HS and (HR)QOL in patients with
DRF and AF
Personality, pain coping and cognitions, and HCU were evaluated of patients with DRF or AF in addition to their HS, FS, and (HR)QOL (chapters 6, 7, 8 and 9). For this study, patients were recruited from two hospitals in the south of the Netherlands: the St. Elisabeth Hospital (January 2012-March 2015) and the TweeSteden Hospital, Tilburg (September 2012-March 2015). Within a few days after fracture diagnosis, patients were asked to participate in the study. Patients were eligible for participation if they had an isolated unilateral DRF or AF (i.e., that was inflicted by trauma and confirmed by X-ray) and were 18 years of age or older. Patients were excluded if they had more significant injuries besides their DRF or AF caused by the traumatic event, an incapacity to self-report, or severe psychopathology or serious physical comorbidity Patients received questionnaire
booklets at time of diagnosis regarding the pre-injury period (Time-0retrospective), three
Chap ter 1 Questionnaire Sociodemographic and clinical information DASH-DLV (only in patients with DRF) RAND-36 SMFA WHOQOL-Bref VAS PCCL NEO-FFI
Trait anxiety subscale (10 items) of STAI VAR Work absenteeism* HCU* Baseline X X X X X X X X X X 3 months follow-up X X X X X X X X 6 months follow-up X X X X X X X X 12 months follow-up X X X X X X X X 24 months follow-up X X X X X X X X
Abbreviations: DASH-DLV = Disabilities of the Arm, Shoulder, and Hand
questionnaire-Dutch Language Version; RAND-36 = RAND-36-item Health Survey 1.0; SMFA = Short Musculoskeletal Function Assessment questionnaire; WHOQOL-Bref = World Health Organization Quality of Life assessment instrument-Bref; VAS = Visual Analogue Scale; PCCL = Pain, Coping, and Cognition Questionnaire [Pijn, Coping, en CognitieLijst]; NEO-FFI = NEO-Five Factor Inventory; STAI = State-Trait Anxiety Inventory; VAR = Return-to-work questionnaire [Vragenlijst ArbeidsReïntegratie]; HCU = Health Care Utilization
Note: *Self-constructed questionnaires
Chapter 1 18
Chap
ter 1
Outline of the dissertation
Chap
ter 1
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Chap
Chapter 2
M.A.C. Van Son
J. De Vries
J.A. Roukema
B.L. Den Oudsten
Health status, health-related quality of life,
and quality of life following ankle fractures:
Chapter 2 26 Chap ter 2
Abstract
Introduction
The number of disabling short- and long term consequences after ankle fracture (AF) is high. Therefore, it is important to consider the health status (HS), health-related quality of life (HRQOL), and quality of life (QOL) of these patients. The aim of this study was to provide a systematic overview of studies on HS, HRQOL, and QOL in patients with AF. In addition, the conceptualization of HS, HRQOL, and QOL in these studies was evaluated.
Methods
A systematic literature search was conducted in Pubmed, Embase, The Cochrane Library, and PsycINFO (January 1976 to April 2012).
Results
Twenty-three studies were included of which almost half had a cross-sectional design. The assessment of HRQOL or QOL was an explicit objective in 17.4% of the studies. The SF-36 and SMFA were the instruments most often used and measure respectively HS and a combination of HS and HRQOL. However, they had been labelled as functional status. Inconclusive results were reported regarding the predictive value of age, sex, education level, alcohol use, smoking, fracture type, and the role of syndesmotic reduction with regard to HS and HRQOL. Also, inconclusive results were found comparing HS and HRQOL scores of patients with AF with norm population scores and regarding the course of HS and HRQOL over time. The additional value of early mobilization after AF was not confirmed.
Conclusions
There are few quality studies on HS and HRQOL following AF and results are inconclusive. Future studies should measure these important patient-reported outcomes, including QOL. The concepts HS and HRQOL are not applied in agreement with the content of the instruments and instruments are downgraded to assess functional status. The correct terminology should be used to warrant clear communication in the field.
Chap
ter 2
Introduction
Ankle fractures (AF) are lower extremity injuries often presented at Emergency Departments. The incidence rate of AF in Europe ranges between 101 and 107 fractures
per 105 person-years 1, 2. Under the age of 50, AF are most common in men, while above
the age of 50 women become dominant 2. The most common type of AF is the B1.1
and A1.2 lateral malleolar fracture according to the Orthopaedic Trauma Assocation
(AO/ATO) classification 3. AF are mainly caused by trauma as a consequence of physical
activity 2. Osteoporosis is of minor importance in these injuries 2.
The conservative treatment of cast immobilization of the ankle typically takes
up to six weeks 4-7. During this period patients are severely restricted in their activities of
daily living. An average of three months work absenteeism is usual 8. However, disabling
consequences of AF persist also long after treatment 9, 10 specifically when internal
fixation with osteosynthesis is needed 4-7. Fourteen months after an AF, full recovery is
reported by just 19% of the patients 11. After three years, half of the patients still report
symptoms like pain, stiffness, swelling, and instability of the ankle that prevent them to
return to their pre-injury activity level 12. Problems with basic activities as climbing stairs,
squatting, and running are common and one third of the patients is no longer able to
perform their preferred sports 8, 12.
The necessity to include the subjective experience of the patient in the evaluation of the recovery process after AF, in addition to the judgement of the treating physician, is warranted by two reasons. First, the high amount of short- and long-term consequences following AF has a profound and chronic impact on the daily life of the patient. Second, despite optimal radiographic results functional impairments are still present eight to
24 months after operation 10 influencing the patients’ being. Thus, patients’
well-being cannot be based on objective X-ray indices. Quality of life (QOL) encompasses the patients’ subjective evaluations of their well-being consisting of at least the physical,
psychological, and social domain 13. Therefore, QOL is a broad multidimensional concept.
It can be assessed with questions like: ‘How satisfied are you with your health?’ 14 or ‘How
much are you bothered by problems doing your usual work?’ 15 Health-related quality
of life (HRQOL) and health status (HS) are related but not equivalent concepts of QOL. The focus of HRQOL is on those QOL components that are impacted by the disease, i.e. the domains physical, psychological, and social. Thereby, this concept is more narrowly
Chapter 2 28
Chap
ter 2
merely an assessment of functioning whereas HRQOL focuses on subjective evaluation
of well-being 17. With questions like: ‘Does your health now limit you in these activities
e.g., lifting or carrying groceries, climbing one flight of stairs?’ 18, HS does not take into
consideration how much patients are bothered by their levels of functioning. This is illustrated by a complementary question of a QOL questionnaire: ‘How satisfied are
you with your ability to perform your daily living activities?’ 14 This question takes the
subjective evaluation of the patient into account.
This is the first systematic review with the focus on HS, HRQOL, and QOL in
patients with AF. Polinder et al. 19 presented a review on HS and HRQOL in general
trauma populations. Because they excluded trauma-specific studies, it is not possible to differentiate between subgroups of trauma patients. A second aim of this review was to evaluate the conceptualization of HS, HRQOL, and QOL in studies focusing on patients with AF. We compared the abovementioned definitions of HS, HRQOL, and QOL 13, 16, 17 with the description given in the included studies. In order to examine the conceptualization, the content of the used instruments was studied. In addition, we examined whether a distinction between HS, HRQOL or QOL was made.
Methods
Search strategy
A systematic literature search for the period 1976 to April 2012 was performed in Pubmed, Embase, The Cochrane Library, and PsycINFO. The search was build with a combination of key terms reflecting AF: ankle fracture*, “ankle joint”, “ankle injuries”, “fractures, bone” AND “lower extremity”. The search was further expanded with the key terms: “quality of life”, QOL, health-related quality of life, HRQOL, health status, HS, well-being, “recovery of function”, “disability evaluation”.
Selection criteria
The classification systems of Weber, Lauge-Hansen, and the AO/OTA are used to
categorize AF.20-23 The Weber classification system relates to the level of the fracture in the
ankle joint and is an anatomic classification 20, 21, whereas Lauge-Hansen indentifies four
fracture patterns and incorporates the injury mechanism 22. The AO/OTA classification
23 is an extension of the Weber classification taking also other features into account like
Chap
ter 2
Studies that met the following criteria were included for evaluation: (i) the study population consisted of patients with 44 type malleolar fractures according to the AO/ OTA classification system (Table 1), (ii) the study population consisted only of patients with AF or included an identifiable and separately analyzed subgroup of patients with AF, (iii) the study population existed of skeletally mature patients, (iv) the instruments (i.e., self-report or interview) used in the study measured HS, HRQOL or QOL according
to well-established definitions of HS 17, HRQOL 16, and QOL 13, (v) inferential statistics
are used and presented to analyze the data, (vi) the article was a full report published in English (no case report, editorial, poster text, letter, or review), and (vii) studies were published in peer-reviewed journals. Studies that were clearly affiliated with the condition of osteoporosis were excluded. We excluded studies with pilon fractures and
plafond fractures (i.e., 43 type distal fractures 23) because of the more complex nature of
these fractures. Reference lists of included studies were checked for studies that were not identified by the computerized search.
AO/OTA classification Type 44 malleolar
44-A infrasyndesmotic lesion
44-A1 isolated
44-A2 with fractured medial malleolus 44-A3 with posteromedial fracture
44-B transsyndesmotic fibular fracture
44-B1 isolated
44-B2 with medial lesion
44-BC with medial lesion and Volkmann’s fracture
44-C suprasyndesmotic lesion
44-C1 fibular diaphyseal fracture, simple
44-C2 fibular diaphyseal fracture, multifragmentary 44-C3 proximal fibular lesion
Chapter 2 30
Chap
ter 2
Data extraction
The combining of the computerized search results of the databases, and after removal of duplicate articles (n=232), resulted in a total of 1220 potentially relevant hits. The described inclusion criteria were applied to the title and abstract and 55 studies met the inclusion criteria. The full text for all the studies were obtained for more detailed inspection of which 20 actually met the inclusion criteria and were included in this review. If multiple reports were published on the same dataset, the article with the highest quality score was included. In case of equal quality, the most recent study was
included. Based on this criterion, one article was excluded 24. Through hand search, four
additional articles were found. Thus, a total of 23 articles were included. The flow chart of the study is shown in Figure 1.
Quality assessment
The methodological quality of the selected studies was independently assessed by two reviewers (MVS and BDO), using a modified version of an established checklist (Table
2) for systematic reviews on QOL 25-28. For each of the 18 items in the checklist, studies
could be assigned to one point if the criterion was met with the highest possible score of 18. If a particular criterion was not met or not (sufficiently) described, a zero was scored. Studies scoring 70% or more of the maximum score (i.e., ≥ 13 points) were considered to be of “high quality”. Studies scoring between 50% and 70% were labelled “moderate quality”, while the label “low quality’ was assigned to studies with scores lower than
Chap ter 2 The Cochrane Library N=86 PsycINFO N=36 Pubmed N=612 EmbaseN=718 Records screened N=1220
Full text articles assessed for eligibility N=55 Articles eligible N=20 Articles included N=19 Articles included in this review N=23 Total hits N=1452 Removed duplicates N=232 Records excluded based on title or abstract N=1165 Articles excluded after inspection based on criteria N=35 Articles included after a hand search N = 4 Articles excluded based on the same
sample population N=1
Chapter 2 32
Chap
ter 2
Table 2. Criteria list for assessing the methodological quality of studies among HS,
HRQOL, and QOL in patients with ankle fractures.
A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R.
Examining HS, HRQOL or QOL was a primary or secondary objective of the study A description is given of HS, HRQOL, and/or QOL by describing at least the three domains (i.e., physical, psychological, social) and/or the importance of the subjective experience of the patient is acknowledged.
A psychometrically sound measure of HS, HRQOL or QOL in fracture patients is used A reason is given for choosing this questionnaire
A distinction is made between HS, HRQOL or QOL
Study population
A description is present of at least two sociodemographic variables (e.g., age, sex, employment status, educational status)
A description is included of at least two clinical variables (e.g., Lauge-Hansen, Weber or AO/OTA classification, type of treatment)
Inclusion and/or exclusion criteria are provided
The study describes potential prognostic factors by using multivariate analyses or structural equation modelling (i.e, underlying associations between predictors in relation to outcome measures are examined).
Participation rates for patient groups are described (defined as the percentage of eligible patients who gave their informed consent) and have to be more than 75%
The ratio non-responders versus responders is given (defined as the ratio of patients who withdrew their informed consent), including reasons for withdrawal
Characteristics of responders were compared to non-responders to give information about the representativeness of the responders
Study design
The study sample is consisting of at least 75 patients (arbitrarily chosen)
The collection of data is prospectively gathered with at least two assessment points in time
The design is longitudinal (> 1 year)
The process of data collection is described (e.g., interview, self-report measurements) The loss to follow-up is described and is <20%
Results
The results are compared between two groups or more (e.g., healthy population, groups with different types of treatment, normative data)
HS, HRQOL or QOL assessment Positive if
Abbreviations: HS = Health status; QOL = Quality of life; HRQOL = Health-related quality of
Chap
ter 2
Results
Methodological quality
Table 3 provides an overview of the studies on HS and HRQOL in AF. Scoring the articles independently resulted in 3% disagreement between the two reviewers. These disagreements were discussed during a consensus meeting. Principally, the disagreements were on criterion B. The mean quality score was 6.7 (SD=1.8), which indicates an overall low quality of the articles. The quality scores ranged from 4 (low quality) to 12 (moderate quality). The following scoring criteria were most often not met or insufficiently described: a distinction is made between HS, HRQOL or QOL (criterion E: 100%), the ratio responders versus non-responders is given, including reasons for withdrawal (criterion K: 100%), characteristics of responders were compared to non-responders (criterion L: 95.7%), a psychometrically sound measure of HS, HRQOL or QOL is used (criterion C: 91.3%), participation rates for patient groups are described and these rates are exceeding 75% (criterion J: 91.3%), and the design is longitudinal (criterion O: 91.3%).
Study characteristics
Sample sizes ranged from 20 32 to 369 33 patients, with 8 (34.8%) studies 33-40 meeting
the criterion of at least 75 patients. Study samples typically existed of patients that had
been surgically treated for their AF (87%), with only three (13%) studies 38, 41, 42 that also
included patients with conservatively treated AF. More than half of the studies (52.2%) were prospective in nature. Only two of these (16.7%) studies had a follow-up of more
than one year 35, 43. Five studies were randomized controlled trials 36, 38, 44-46. Only four
(17.4%) studies described HRQOL 42, 43 or QOL 41, 47 as a primary or secondary objective
of their study.
Five different questionnaires were used to assess HS or HRQOL in patients with AF (Table 4). Frequently used questionnaires were the Short Form Health Survey-36
(SF-36), 18 applied in 12 (52.2%) studies 32, 35, 36, 42, 43, 45-51, and the Short Musculoskeletal
Function Assessment questionnaire (SMFA) 15 used in nine (39.1%) studies 33-35, 37, 39, 40, 50, 52,
53. However, the psychometric properties of these two measures were poorly examined
in fracture populations (Table 4), with only some research performed on patient cohorts
with hip fractures 54, 55 and tibial shaft fractures 56. Most studies applied only one HS
Chapter 2 34 Chap ter 2 Study Egol et al. 2010 34 Tejwani et al. 2010 35 Wikerøy et al. 2010 48 Davidovitch et al. 2009 33 Nilsson et al. 2009 36 Obremskey et al. 2009 37 Stufkens et al. 2009 49 Syndesmotic stabilization in addition to fixation (n=79) versus fixation alone (n=268)
Surgically treated trimalleolar fractures versus (n=54) surgically treated bimalleolar and unimalleolar AF (n=255)
Quadricortical syndesmotic fixation (n=23) versus
tricortical syndesmotic fixation (n=25); Posterior fracture fragment (n=12) versus absence of posterior fracture fragment (n=36)
<60 years old (n=313) versus ≥60 years
(n=56)
Physiotherapy training group (n=50) versus usual care (n=55)
Open reduction and internal fixation of unstable AF (n=49)
SER type IV AF with damaged deltoid ligament (n=17) versus SER type IV AF with intact deltoid ligament (n=19) P P CS P RCT P CS FU time in months*
Patient group Design*
Chap ter 2 Total score* 7 5 5 8 8 7 4
SMFA Dysfunction index scores were significantly worse at 6 and 12 months follow-up in patients who underwent syndesmotic stabilization (in addition to fixation) compared to patients who required fixation alone.
A significant difference at 1 year for the Dysfunction index of the SMFA was found for the trimalleolar group. SF-36 scores were not different, except for the subscales Vitality and Social functioning, which were significantly worse at 1 year in the trimalleolar group.
SF-36 scores were similar in the quadricortical group compared to the tricortical group. SF-36 scores were also similar in the group with a posterior fracture fragment compared to the group without a posterior fracture fragment.
SMFA scores improved in both age groups, returning to near baseline levels by 12 months. No significant differences in SMFA scores were found between the age groups at 3, 6 or 12 months.
SF-36 scores in the physiotherapy training group were not different from the usual care group at 6 and 12 month follow-up.
A significant improvement on all the Dysfunction scales of the SMFA was seen during the
first 2 months post-surgery. The plateau of improvement was reached 4 to 6 months after surgery. At 6 months, younger patients (≤49 years) had significantly better scores than the elderly (≥50 years) on the Function of the arm and hand, Daily activities, and Mobility scales. Patients with 44B fractures had significantly better Bother index scores than 44C fracture patients.
-Chapter 2 36 Chap ter 2 Study Anderson et al. 2008 51 Lin et al. 2008 38 Honigmann et al. 2007 44 Nilsson et al. 2007 47 Shah et al. 2007 57 Tejwani et al. 2007 39 Vioreanu et al. 2007 45 Egol et al. 2006 40
Operatively treated ankle fractures >65 years (n=25) and <65 years (n=46)
Manual therapy in addition to physiotherapy (n=46) versus physiotherapy alone (n=45)
Functional postoperative treatment without external stabilization (n=22, control group) versus postoperative stabilization in a vacuum orthesis (n=23, orthesis group) Surgically treated AF in patients ≥65 years (n=50)
Weber type B fractures (n=52) versus Weber type C fractures (n=17)
Bimalleolar fractures (n=163) versus lateral malleolar fractures with disruption of the deltoid ligament (n=103) Removable cast group (n=33) versus non-removable cast group (n=29) Surgically treated AF (n=198) CS RCT RCT P CS P RCT P FU time in months*
Patient group Design*
Chap ter 2 Total score* 6 9 8 8 5 7 5 7
The MCS of the SF-36 was significantly better in patients over 65 years compared to patients under 65 years. No differences were found with regard to the PCS of the SF-36 between those two groups.
AQoL scores improved over time in the treatment and control group. Manual therapy in addition to physiotherapy resulted not in better AQoL scores compared to physiotherapy alone. The effects of manual therapy did not depend on fracture severity.
At 6 weeks up, but not at 10 weeks follow-up, the SF-12 scores on the MCS in patients in the orthesis group were significantly higher compared to the control group. No differences were found in SF-12 scores between the two groups on the PCS.
SF-36 scores (Physical function, Physical role function, Emotional role function) in women with AF were significantly impaired at 6 months compared to population norms. At 12 month follow-up no differences were found. Men showed significantly better SF-36 scores in General Health at 12-month follow-up compared to normative data.
At 5 year follow-up, SF-12 scores were similar in Weber type B fractures compared to Weber type C fractures.
One year postoperatively, SMFA scores were significantly impaired in bimalleolar fractures compared to lateral malleolar fractures with medial ligamentous injury.
After 6 months, SF-36 scores were similar in the removable cast group compared to the non-removable cast group.
Chapter 2 38 Chap ter 2 Study Finnan et al. 2005 52 Weening et al. 2005 53 Bhandari et al. 2004 43 Lash et al. 2002 41 Obremskey et al. 2002 32
Open reduction and internal fixation in SER type IV AF (n=26)
Transsyndesmotic screw fixation (n=51)
Surgically treated Weber type B fractures (n=30)
AF (n=74)
Isolated, surgically treated AF (n=20) CS CS P CS P FU time in months*
Patient group Design*
-Chap ter 2 Total score* 6 6 12 8 5
At an average of 5 years, SMFA scores were only significantly impaired for the Mobility scale compared to the normative population. Less adequate radiographic reduction and post-traumatic arthritis were related to reduced SMFA scores (Daily activities, Mobility, Dysfunction index, Bother index).
At a mean of 18 month follow-up, SMFA scores were similar to US population norms. Accurate reduction of the syndesmosis accounted for 18% of the variation in SMFA Dysfunction index scores.
At 24 month follow-up, SF-36 scores were comparable with US population norms, except for the significantly impaired scores on the scales Physical function and Physical role function. Predictors of impaired scores on the PCS were smoking, a medial malleolar fracture, and lower levels of formal education. More alcohol use and older age were predictors of impaired scores on the SF-36 subscale Mental health.
Compared to a general population, patients had increased problems up to 21% on Mobility, Pain/ Discomfort, and Usual activities of the EQ-5D. Patients with poorer functional ankle outcome (measured by the OMA score) had significantly impaired EQ-5D scores.
-Chapter 2 40 Chap ter 2 Study Brown et al. 2001 50 Egol et al. 2000 46 Ponzer et al. 1999 42
Hardware-related ankle pain after ORIF (n=39) versus no pain after ORIF (n=87); Ankle pain and hardware removal (n=22) versus ankle pain but no hardware removal (n=17) Below-knee cast (n=28) versus functional brace with early movement (n=27 )
Weber type B fracture (n=41) CS RCT CS FU time in months*
Patient group Design*
Chap ter 2 Total score* 4 6 6
At mean follow-up of 27 months, patients with hardware-related ankle pain had significantly impaired SF-36 and SMFA scores (except Function of the arm and hand) compared to patients without pain. For the group with ankle pain, SF-36 and SMFA scores were similar in patients who had removed and who had not removed their hardware.
SF-36 subscores for General health perception and Vitality were significantly better in the functional brace group compared to the below-knee cast group after one year.
After two years, SF-36 subscores were significantly impaired for Physical functioning, Role limitations due to physical and emotional problems, Vitality, and Mental health compared to an average Swedish test population. Functional ankle outcome (measured by the OMA score) was significant positively related with SF-36 subscores. General conclusions J K L M N O P Q R H I + + -+ -+ + + + + +
-Abbreviations: QOL=Quality of life; HRQOL=Health-related quality of life; HS=Health status;
FU time=Follow-up time; P=Prospective study; CS=Cross-sectional study; RCT=Randomized Controlled Trial; AF=Ankle fracture; OCLT=Osteochondral lesions of the talus; SER=Supination-external rotation; ORIF=Open reduction and internal fixation; SMFA= Short Musculoskeletal Function Assessment questionnaire; SF-36=Short Form Health Survey-36; PCS=Physical Component Scale; MCS=Mental Component Scale; AQoL=Assessment of Quality of Life; SF-12=Short Form Health Survey-12; EQ-5D=European Quality of life instrument-5 dimensions; OMA-score=Olerud and Molander score
*Only the design, patient group, and general conclusions concerning HS or (HR)QOL are mentioned. In case of a prospective study, the follow-up time in months is presented. If the follow-up measurement is not standardized, the mean follow-up time and range are reported. The total score on the quality criteria is presented.
Chapter 2 42
Chap
ter 2
Age and sex were reported in 20 (87.0%) studies. In 20 (87.0%) studies a description was included of at least two clinical variables of interest. The type of AF according to the classifications of Lauge-Hansen, Danis-Weber or the AO/OTA were most often given (80.0%) in these studies.
The role of sociodemographic and
clinical factors in AF
From the eight studies that examined the role of sociodemographic and clinical factors in AF, five (62.5%) had a prospective follow-up design. Four prospective follow-up studies examined the role of age in HS and HRQOL in AF. The results are inconsistent. Three studies pointed out that younger age contributes to more rapid recovery regarding
HS and HRQOL three to six months after trauma 37, 40, 43. This age effect was no longer
present at 12 months 40, 43. However, Davidovitch et al. 33 found in the first six months
after surgery no predictive value of age. Some evidence is available that being female 47,
having a low level of formal education 43, and alcohol use 43 are predictive for impaired
HS after fracture.
Concerning smoking, one study found a negative relationship with HS 43 but
another did not found a relationship with HRQOL 40. Evidence of the predictive value
of type of fracture with regard to HS and HRQOL was inconclusive 40, 43. Associated
dislocation of the bone was not related to impaired HRQOL scores 40.
Cross-sectional studies pointed out that post-traumatic arthritis and ankle pain after internal fixation of the ankle with hardware, had a negative impact on HS
and HRQOL 50, 52. Less adequate reduction of the bone indicated by X-ray was related to
impaired SMFA scores 52. Older age was related to better HS (i.e., mental component
scores) two years after operation compared to younger patients 51.
Comparisons with norm populations
Several studies compared the scores of HS and HRQOL of patients with AF with existing
norm populations 32, 37, 41-43, 53. At six months, impaired SMFA Mobility scores were found
in patients with AF compared to general populations 37. The SF-36 domains Physical
functioning and Physical role function were still impaired two years after fracture
Chap
ter 2
Cross-sectional studies reported inconclusive results. Either deteriorating
effects on HS were detected two to five years after treatment 41, 42 or no impairments
were found in HRQOL at 18 months compared to population norms 53.
The course of HS and
HRQOL over time
The HS 32, 33, 37, 40, 43 and HRQOL 33, 40 of patients significantly improves from just after
surgery to two years after surgery. Most improvement in HS was made during the first
two months after the operation 37, except for the SF-36 domain General Health. Scores
on this domain were stable 32, 43. Two studies reported that HS and HRQOL returned to
values comparable with baseline levels within 12 months 33, 40. However, Obremskey et
al. 32 found the SF-36 domain Physical functioning still impaired at 20 months.
Type of fracture
Two studies detected six months to one year after the fracture differences between types of fractures regarding SF-36 domains Vitality and Social functioning and the SMFA Dysfunction and Bother index. At one to two year follow-up these differences
disappeared 35, 37. However, one prospective study found worse SMFA scores in patients
with bimalleolar fractures compared to patients with lateral malleolar fractures with
disruption of the deltoid ligament still after one year 39.
Cross-sectional studies confirm these inconsistent findings on the presence 49
and absence 57 of long-term differences in HS between varying types of fractures.
Syndesmotic injury in AF
Compared to patients with malleolar fixation, patients who underwent additional
syndesmotic stabilization with screws had an impaired HS after one year 34. A
cross-sectional study pointed out that HS after eight years is comparable between various syndesmotic fixation techniques (i.e., quadricortical screw fixation versus tricortical
screw fixation) 48. Achieving adequate reduction of the syndesmosis after screw fixation
Chapter 2 44 Chap ter 2
Outcome of movement
interventions after AF
The possible benefits of early mobilization and full weight bearing shortly after AF
are not confirmed by randomized controlled trials 36, 38, 44, 45. External stabilization in a
removable vacuum brace was followed by a better mental HS at six weeks follow-up compared to patients without external stabilization, but this effect disappeared at 10
weeks follow-up 44. Compared to usual care, a 12-week physiotherapy program had no
beneficial effects on HS after six to 12 months following AF 36. However, the authors
did not adjust the analyses for the fact that 76% of the patients in the control group had visited a physiotherapist on their own. Compared to physiotherapy, the addition of manual therapy to a physiotherapy program did not result in better HRQOL four to 24
weeks after cast removal 38.
Results of cross-sectional studies are inconsistent, describing either positive effects of early movement after one year in the SF-36 domains Vitality and General
health perception 46 or no effect of a removable cast compared to usual care 45.
Conceptualization of HS,
HRQOL, and QOL
All included studies used a HS or HRQOL instrument when we applied well-established
definitions of HS and HRQOL16, 17 to the content of the instruments (Table 4). However,
only four (17.4%) studies described in their objectives that the assessment of HRQOL or
QOL was a primary or secondary aim of their study 41-43, 47. In six (66.7%) of the studies
using the SMFA, the SMFA was referred to as measuring functional status or identifying
differences in function or functional outcome 33-35, 37, 40, 45. The SF-36 was labeled as a
functional status instrument in six (50.0%) of the studies that included the SF-36 32, 35,
36, 42, 47, 50. However, six (50.0%) studies reported that the SF-36 assessed QOL 36, 42, 43, 45, 47,
49. In five (21.8%) studies the concepts HS, HRQOL, and QOL were interchangeably used
within the article when referring to a single instrument 36, 42, 43, 47, 52. Four (17.4%) studies
did not define what their instruments measured and just used the terms SF-36 scores,
Chap
ter 2
tionnair
e
Generic or disease specific instrumen
t Studies in this r evie w tha t
used this instrumen
t Concep t measur ed Nr of items Nr of sub- scales Descrip tion sub sc ales Ps ychome tric pr operties in fr actur e popula tion t of e QoL) 58
opean Quality e ins
trumen t-5 Q-5D) 59 orm Health ve y-36 (SF-36) 18 orm Health ve y-12 (SF-12) 60 ele tal t tionnair e A) 15
Generic Generic Generic Generic Betw
een g
eneric
and disease specific (i.e., musculosk
ele tal conditions) 38 41 32, 35, 36, 42, 43, 45-50 44, 57 33-35, 37, 39, 40, 50, 52, 53 HR QOL HS HS HS HS and HRQOL 15 5 36 12 46 5 5 8 2 2 Illness, Independen t living , Social rela tionship s, Ph ysic al senses, Ps ychologic al w ell-being Mobility , Self -c ar e, Usual activities, P ain/disc om fort, An xie ty/depr ession
In addition: Visual Analogue Scale on self
-ra ted health Ph ysic al functioning , Social functioning , Ph ysic al r ole function, Emotional r ole function, Men
tal health, Vit
ality
,
Bodily pain, Gener
al health per cep tion Tw o o ver all sc ales: Ph ysic al Componen t Sc ale, Men tal Componen t Sc ale Ph ysic al Componen t Sc ale, Men tal Componen t Sc ale Dy sfunction Inde x, Bother Inde x The Dy sfunction inde x is theor etic ally divided in to f our ca teg
ories: Daily activities,
Emotional s
ta
tus, Function of the
arm and hand, Mobility
Not s tudied Proximal humer al fr actur es: 64 ICC .78, moder at e c ons truct v alidity , ceiling e ffect pr esen t Hip fr actur es: 54 Cr onbach’ s alpha
>.70, floor and ceiling e
ffects pr esen t, c ons truct v alidity , crit erion validity , and r esponsiv eness support ed Tibial sha ft fr actur es: 56 no floor and ceiling e ffects, r esponsiv eness and discrimina tiv e v alidity support ed Not s tudied Hip fr actur es: 55 g ood in ternal responsiv eness, accep table e xt ernal responsiv eness Tibial sha ft fr actur es: 56 ceiling eff ect pr esen t, r esponsiv eness and discrimina tiv e v alidity support ed* evia tions:
QOL = Quality of lif
e; HR
QOL = Health-r
ela
ted quality of Lif
e; HS = Health s ta tus; ICC = In tr a Class Coe fficien t; Nr = number In this s
tudy only the Dy
sfunction Inde x of the SMF A w as r eport ed. HS, HR QOL
, and QOL ques
tionnaires used in patien