Quality of Life Research

, Volume 18, Issue 3, pp 313–333 | Cite as

Evaluation of the methodological quality of systematic reviews of health status measurement instruments

  • Lidwine B. Mokkink
  • Caroline B. Terwee
  • Paul W. Stratford
  • Jordi Alonso
  • Donald L. Patrick
  • Ingrid Riphagen
  • Dirk L. Knol
  • Lex M. Bouter
  • Henrica C. W. de Vet
Open Access
Article

Abstract

A systematic review of measurement properties of health-status instruments is a tool for evaluating the quality of instruments. Our aim was to appraise the quality of the review process, to describe how authors assess the methodological quality of primary studies of measurement properties, and to describe how authors evaluate results of the studies. Literature searches were performed in three databases. One hundred and forty-eight reviews were included. The purpose of included reviews was to identify health status instruments used in an evaluative application and to report on the measurement properties of these instruments. Two independent reviewers selected the articles and extracted the data. Reviews were often of low quality: 22% of the reviews used one database, the search strategy was often poorly described, and in many cases it was not reported whether article selection (75%) and data extraction (71%) was done by two independent reviewers. In 11 reviews the methodological quality of the primary studies was evaluated for all measurement properties, and of these 11 reviews only 7 evaluated the results. Methods to evaluate the quality of the primary studies and the results differed widely. The poor quality of reviews hampers evidence-based selection of instruments. Guidelines for conducting and reporting systematic reviews of measurement properties should be developed.

Keywords

Systematic review Measurement properties Methodological quality Health status 

Introduction

Thousands of health status measurement instruments are used in research and clinical practice, and there are often many instruments for one single concept. Researchers, doctors, and policy-makers use the results obtained by instruments for further research, evidence-based patient care, guideline development, and evidence-based policy making.

The choice of an instrument depends on several factors, one of the most important being the measurement properties. The decision in favor of an instrument may have important consequences. Marshall et al. [1] showed that in schizophrenia trials authors were more likely to report that treatment was superior to control when an unpublished instrument was used in the comparison, rather than a published instrument. Furthermore, the selection of instruments with good measurement properties will lead to the detection of smaller treatment effects, or more power to draw stronger conclusions, and therefore to better interpretation of study results. In other words, if the measurement error of an instrument is small in relation to its minimal important change (MIC), one will be able to conduct clinical trials with relatively small sample sizes [2].

A systematic review of measurement properties critically appraises and compares the content and measurement properties of all instruments measuring a certain construct. High-quality systematic reviews of measurement properties provide evidence for the selection of the best instruments. The methodological quality of such a review should be thoroughly appraised in order to be confident that the design, conduct, analysis, and interpretation of the review was adequate, and to reveal any possible bias that might influence its conclusions. In general the critical appraisal of a systematic review consists of five steps: (1) reporting of relevant descriptive information, e.g., the target population, concept of interest, and the number of studies or instruments included, (2) appraisal of the quality of the review process, (3) appraisal of the methods used by the authors of reviews to assess the methodological quality of the primary studies included in the review, (4) appraisal of the results of the primary studies, and (5) a synthesis of the above mentioned data (steps 3 and 4) to come to an overall conclusion for each instrument.

Existing guidelines for the appraisal of systematic reviews of clinical trials (e.g., Cochrane Collaboration [3] or AMSTAR [4]) or diagnostic studies [5, 6] can be used to appraise the quality of the systematic review process (step 2). These guidelines contain items on the quality of the search strategy [4], article selection and data extraction [3, 7, 8], and inclusion and exclusion criteria [6]. The methodological quality of systematic reviews of measurement properties has not been systematically assessed yet.

Authors of reviews should appraise the methodological quality and results of the primary studies [3] (steps 3 and 4). Accepted guidelines are available to appraise the methodological quality of clinical trials (e.g., Delphi List [9]) or diagnostic studies (QUADAS [10]). Several guidelines have been developed to appraise the methodological quality of studies on measurement properties [e.g., 11, 12, 13]. It is unknown which of these guidelines are used most often in systematic reviews of measurement properties.

It was our aim (1) to find all existing systematic reviews of measurement properties, (2) to appraise the quality of the review process of these reviews, (3) to describe if and how the authors of reviews assessed the methodological quality of the primary studies included in these reviews, (4) to describe if and how the authors of reviews evaluated the results of the primary studies, and (5) to describe if authors of reviews synthesized the above-mentioned data (steps 3 and 4) to come to an overall conclusion regarding the quality of each instrument.

Methods

Identification of reviews

To identify systematic reviews of measurement properties, we searched PubMed (up to March 2007), EMBASE (up to March 2007), and PsycINFO (up to June 2005). The full search strategies can be found in Appendix 1. Additional articles were identified by manually searching references from the retrieved articles and the authors’ own literature.

We included articles that
  • Claimed to be “systematic reviews”

  • Aimed to identify all available health status measurement instruments in a particular population, as stated by the author

  • Concern health status measurement instruments that have been applied in an evaluative situation, i.e., instruments aimed to measure changes in health status over time in a longitudinal study

  • Aimed to report on or evaluate the measurement properties of the measurement instruments

Based on guidelines for systematic reviews of back and neck pain trials [8], we considered a review to be systematic if at least one search in an electronic database was performed. We considered the following concepts to represent “health status” based on the model of Wilson and Cleary [14]: biological and physiological processes, symptoms, functional status (i.e., both physical functioning and psychosocial functioning), or general health perceptions. We consider health-related quality of life (HR-QoL) as general health perception, and we excluded overall QoL. We excluded reviews that focused only on instruments applied in a discriminative situation, because these reviews are likely to have missed instruments that were used only in evaluative applications. We also excluded reviews that focused on instruments with a diagnostic or screening, or prognostic purpose.

Our aim was to find reviews that intended to find all available instruments for measuring a particular construct. We therefore excluded reviews of only one, or only the most commonly used instruments, or reviews that only included randomized clinical trials (RCTs). Reviews of RCTs very likely do not include all instruments that measure the construct of interest. Reviews that only described the instruments (e.g., format) were excluded. Only reviews written in English were included.

To determine the eligibility of the articles, two authors (L.M. and C.T.) independently reviewed title and abstract of every record retrieved from the searches. Full articles were retrieved for further assessment when the abstract suggested that the study might meet the inclusion criteria. Disagreements were resolved through consensus. A third reviewer (H.V.) was consulted in case of persisting disagreement.

Data extraction

Two authors (L.M. and C.T.) independently extracted data on (1) descriptive information, (2) the quality of the review process, (3) if and how the authors of reviews assessed the methodological quality of the primary studies included in the review, (4) if and how the results of the primary studies were evaluated and compared, and (5) if authors of reviews synthesized data to come to an overall conclusion on the quality of each instrument. Note that we only critically appraise the review process, and we simply describe if and how authors of reviews evaluate primary studies. A standard data extraction form was used (Appendix 2).

Descriptive information on reviews

Descriptive information that we extracted included year of publication, description of the health status concept of interest, study population of interest, number of health status instruments included, and type of health status instruments, i.e., patient-reported outcomes (PROs), proxy-reported outcomes or non-PROs. PRO was defined as a measurement of any aspect of a patient’s health status that comes directly from the patient, i.e., without the interpretation of the patient’s responses by a physician or anyone else [15]. Modes of data collection in PRO instruments include interviewer-administered instruments, self-administered instruments, computer-administered instruments or interactively administered instruments [16]. Proxy-reported outcomes include any endpoint obtained from a proxy, such as parent-assessed ratings measuring health-related quality of life in childhood acute lymphoblastic leukaemia (ALL) [17], or reports of a caregiver measuring pain in nonverbal older adults with advanced dementia [18]. Non-PROs are instruments that are based on other sources than patient or proxy reports, such as performance-based instruments [19], or clinical ratings, for example, to measure the severity of asthma in preschool children [20]. Finally, we extracted which measurement properties were reported in each review, and how they were reported, i.e., whether the exact results were reported or only the references to the publications.

Appraisal of the review process

To appraise the quality of the review process, we recorded whether the search strategy was described, which databases were searched, whether article selection and data extraction were performed by at least two persons, and whether inclusion and exclusion criteria for primary studies were described.

Description of the assessment of the methodological quality of primary studies

To describe if and how the methodological quality of the primary studies was assessed by the authors of the reviews, we recorded whether the methodological quality of each primary study was evaluated, i.e., if standards were applied to the primary studies. Standards refer to the study design and statistical analyses. An example of a standard for reliability is “rating ‘+’, when an intraclass correlation coefficient (ICC) was used.” If one or more standards were applied, we recorded for which measurement properties standards were applied, which standards were applied, and whether they were described completely, i.e., were reproducible.

Description of the evaluation of the results of primary studies

To describe if and how the results of the primary studies were assessed by the authors of the reviews, we recorded whether they applied criteria of adequacy for what constitutes good measurement properties. An example is “ICC should be at least 0.70.” We recorded whether the results were evaluated and, if so, for which measurement properties, which criteria were applied, and whether they were completely described, i.e., were reproducible.

Description of synthesizing the methodological quality and the results

We furthermore documented two characteristics regarding whether or not authors of reviews formulated an overall conclusion for each instrument: we recorded whether authors gave a total score for the quality of each health status instrument, and we recorded whether some order of importance of the measurement properties was taken into account when giving a total score (see also Appendix 2).

Results

Identification of reviews

The searches yielded 7,779 records. We included 148 systematic reviews of measurement properties (Fig. 1). Most of the excluded articles did not meet the inclusion criteria of being a systematic review of measurement properties of all available health status instruments; for example, we excluded reviews of only a selection of existing instruments, reviews of health status instruments used only in randomized clinical trials (RCTs), and reviews in which measurement properties were not reported or evaluated.
Fig. 1

Flowchart of selection process of systematic reviews of measurement properties

Publication of systematic reviews of measurement properties has increased from less than one review per year in the 1990s up to 31 in 2005 (Fig. 2). The decrease in the number of reviews published in 2006 is possibly due to a delay in the recording of articles in PubMed and EMBASE. The concepts of interest in the included systematic reviews were general health perceptions (43%), functional status (21%), symptoms (17%), and biological and physiological processes (5%). The other reviews (14%) focused on a combination of these concepts. The reviews focused on a variety of populations, such as children, general population or patient populations with specific diseases, such as cerebral palsy or multiple sclerosis, or disease groups, such as cancer, neurological diseases or rheumatic disorders. Information about the study population and the number and type of instruments included in each review is presented in Table 1.
Fig. 2

Number of systematic reviews of measurement properties published per year up to March 2007

Table 1

Descriptive information of the included systematic reviews of measurement properties

Reference

Population

Health status concept

Year of publication

PROa

Proxyb

Non-PROc

Number of instr.d

General health perception

Pickard [17]

Childhood acute lymphoblastic leukemia (ALL)

HR-QoL (health-related quality of life)

2004

Yes

Yes

Yes

20

Eiser [51]

Children

QoL (quality of life)

2001

Yes

Yes

No

43

Pal [52]

Children

Health status

1996

Yes

Yes

Yes

9

Schmidt [53]

Children and adolescents

HR-QoL

2002

Yes

Yes

No

16

Davis [54]

Children (0–12 years)

HR-QoL and QoL

2006

Yes

Yes

Yes

38

Hunter [55]

Children and adolescents

Mental health

1996

Yes

Yes

Yes

19

Brouwer [56]

Children with otitis media (0–18 years)

HR-QoL

2005

No

Yes

Yes

15

Haywood [57]

People aged 60 years and over

HR-QoL

2005

Yes

Yes

No

18

Haywood [39]

Older people aged 60 years and over

HR-QoL

2005

Yes

Yes

No

15

Haywood [58]

Older people

HR-QoL

2006

Yes

Yes

No

45

Hollifield [59]

Refugees

Health status (mental and physical), trauma, quality of care, and diagnostic

2002

Yes

No

No

12

Haywood [60]

Ankylosing spondylitis (AS)

Health or HR-QoL

2005

Yes

No

No

15

Namjoshi [61]

Bipolar disorder

HR-QoL

2001

Yes

No

No

14

Michalak [62]

Bipolar disorder

HR-QoL

2005

Yes

No

No

8

Okamoto [63]

Breast cancer

QoL

2003

Yes

No

No

11

Edwards [64]

Caregivers of patients with cancer

QoL

2002

Yes

No

No

4

Ringash [65]

Head and neck cancer

Disease-specific HR-QoL

2001

Yes

No

No

11

Van Korlaar [66]

Chronic venous disease

QoL

2003

Yes

No

No

16

Neelakantan [35]

Women with chronic pelvic pain

HR-QoL

2004

Yes

No

No

30

Riemsma [67]

Cognitive impairment due to acquired brain injury

General health status

2001

Yes

Yes

No

34

Jones [68]

Common chronic, benign gynecologic conditions

HR-QoL

2002

Yes

No

No

14

Ettema [69]

Dementia

QoL

2005

Yes

Yes

Yes

17

Salek [31]

Dementia/Alzheimer’s

QoL

1998

Yes

Yes

No

9

Walker [32]

Dementia/Alzheimer’s

QoL

1998

Yes

Yes

Yes

19

De Tiedra [70]

Dermatology

HR-QoL

1998

Yes

No

No

23

Garratt [71]

Diabetes mellitus (type 1 and 2)

Disease-specific HR-QoL

2002

Yes

No

No

9

Luscombe [72]

Diabetes mellitus type 2

HR-QoL

2000

Yes

No

No

31

Cagney [73]

End-stage renal disease (ESRD)

QoL

2000

Yes

No

No

53

Edgell [74]

End-stage renal disease (ESRD) patients

HR-QoL

1996

Yes

No

Yes

16

Kline [75]

Epilepsy and antiepileptic drug (AED) treatment

Condition specific HR-QoL

1998

Yes

No

No

4

Leone [76]

Epilepsy (adults)

HR-QoL

2005

Yes

No

No

45

Szende [77]

Hemophilia

HR-QoL and health status

2003

Yes

No

No

19

De Kleijn [78]

Hemophilia (age >16 years)

Health status: body structure, body function, activities

2002

Yes

No

Yes

34

De Boer [27]

HIV infected

HR-QoL

1995

Yes

No

No

12

Clayson [79]

HIV/AIDS

HR-QoL

2006

Yes

No

No

34

Bonomi [80]

Acute, chronic, and cancer pain

QoL, utility instruments

2000

Yes

No

No

18

Symonds [81]

Incontinency

HR-QoL

2003

Yes

No

No

10

Pallis [82]

Inflammatory bowel disease (IBD)

HR-QoL

2000

Yes

No

?

12

Cummins [83]

Intellectual disability

QoL

1997

Yes

No

No

13

Garratt [84]

Knee problems

Health and QoL

2004

Yes

No

No

16

Zanoli [85]

Lumbar disorders

HR-QoL

2000

Yes

No

No

92

Clark [86]

Menorrhagia

QoL

2002

Yes

No

No

30

Van Nieuwen-huizen [87]

Mental illness (severe)

QoL

1997

Yes

Yes

Yes

11

Lehman [88]

Mental illnesses (severe and persistent)

QoL

1996

Yes

No

No

10

Gruenewald [24]

Multiple sclerosis (severe)

HR-QoL

2004

Yes

Yes

No

23

Marinus [89]

Parkinson’s disease

QoL

2002

Yes

No

No

4

Heffernan [90]

Three degenerative neurological conditions: multiple sclerosis (MS), Parkinson’s disease, and motor neuron disease (MND)

Disease-specific health status

2005

Yes

No

No

16

Jørstad [91]

Population over 50 years who had not suffered a stroke or Parkinson’s disease, or had undergone a lower limb amputation

Fall-related psychological outcome measures

2005

Yes

No

?

26

Rannard [92]

Primary biliary cirrhosis (PBC)

HR-QoL

2004

Yes

No

Yes

20

De Korte [93]

Psoriasis

QoL

2002

Yes

No

No

6

Lewis [94]

Psoriasis

HR-QoL

2005

Yes

No

No

14

Hallin [95]

Spinal cord injury (SCI)

QoL

2000

Yes

No

No

14

Matza [96]

Stress urinary incontinence or overactive bladder (OAB)

Condition-specific HR-QoL

2004

Yes

No

?

16

Golomb [46]

Stroke

HR-QoL including functioning and well-being

2001

Yes

No

No

32

Buck [97]

Stroke

QoL

2000

Yes

No

No

25

Drake [26]

Total knee arthroplasty (TKA)

Global patient rating scales

1994

No

No

Yes

34

Prasad [98]

Working adults

Health-related work outcomes

2004

Yes

No

No

12

Lofland [99]

Various

Health-related loss in work productivity

2004

Yes

No

No

11

De Boer [34]

Vision impairments

Vision-related QoL

2004

Yes

No

No

31

Lundström [100]

Sight-threatening eye disease

HR-QoL/vision-related QoL

2006

Yes

No

No

16

Tripop [101]

Glaucoma

HR-QoL

2005

Yes

No

No

10

Franic [102]

Voice disorders

QoL

2005

Yes

No

No

9

Morley [103]

Chronic rhinosinusitis (patients undergoing endoscopic sinus surgery for)

HR-QoL

2006

Yes

No

No

20

Watt [104]

Benign thyroid disorders

HR-QoL

2006

Yes

No

No

6

Functional status (physical and psychosocial)

Ketelaar [105]

Children with cerebral palsy

Disability

1998

No

No

Yes

17

Boyce [106]

Children with cerebral palsy

Motor performance or quality of movement

1991

No

No

Yes

10

Buffart [107]

Children with congenital (unilateral) transverse or longitudinal reduction deficiencies of the upper limb

Arm/hand functioning

2006

Yes

Yes

Yes

23

Pakulis [108]

Adolescent sarcoma patients (bone tumor)

Physical functioning

2005

Yes

No

Yes

7

Moore [109]

English-speaking adult population

Functional living skills

2006

No

No

Yes

31

Arrington [21]

Chronic medical or general populations

Sexual function

2004

Yes

No

No

57

MacKnight [110]

Community-dwelling elderly

Performance-based mobility

1995

No

No

Yes

41

Wind [111]

Healthy and disabled subjects

Functional capacity

2005

Yes

No

Yes

27

Ramaker [25]

Parkinson’s disease

Impairment and disability

2002

No

No

Yes

11

Mannerkorpi [112]

Fibromyalgia syndrome (FMS)

Functional limitations and disability

1997

Yes

No

Yes

15

Grotle [28]

Low back pain

Functional status and disability

2004

Yes

No

No

36

Millard [113]

Chronic pain

Pain-related disability

1997

Yes

No

No

35

Dowrick [114]

Musculoskeletal disorders of the upper extremity/orthopaedic trauma population (e.g., fracture or dislocation)

Functional outcomes

2005

Yes

No

Yes

7

Law [29]

Occupational therapy

Functional ability in activities of daily living (ADL)

1989

Yes

No

Yes

13

Terwee [19]

Osteoarthritis of the hip or knee

Physical function

2006

No

No

Yes

26

Dziedzic [115]

Osteoarthritis of the hand

Hand disability/functional disability

2005

Yes

No

No

5

Swinkels [116]

Rheumatic disorders

Personal care disabilities

2005

Yes

No

No

19

Swinkels [117]

Patients with rheumatic disorders

Impairments in functions

2005

Yes

No

Yes

49

Swinkels [118]

Rheumatic disorders

Impairment

2005

Yes

No

Yes

42

Swinkels [119]

Rheumatoid arthritis

Disabilities in gait and gait-related activities

2004

Yes

No

No

61

McKibbin [120]

Seriously mentally ill, schizophrenia

Functioning

2004

No

No

Yes

8

Keskula [121]

Shoulder conditions (athletes)

Functional limitations and disability

2001

Yes

No

Yes

9

Michener [122]

Shoulder dysfunction

Functional limitations and disability

2001

Yes

No

No

11

Bot [41]

Shoulder or shoulder-upper limb problems

Shoulder disability

2004

Yes

No

No

16

Salerno [123]

Disorders of the neck and upper extremity (mild to moderate)

Functional status

2002

Yes

No

No

13

Chong [124]

Stroke

Instrumental activities of daily living (IADL)

1995

Yes

No

Yes

4

Croarkin [125]

Stroke

Upper extremity motor function tests

2004

No

No

Yes

9

McGee [126]

Cardiac rehabilitation

Psychological outcome: depression, anxiety, and other negative affective states

1999

Yes

No

?

13

Sakzewski [127]

Children with cerebral palsy (5–13 years)

Participation

2007

Yes

Yes

Yes

7

Morris [128]

Children with cerebral palsy (5–15 years)

Activity performance and participation as defined by ICF

2005

Yes

Yes

No

7

Eadie [129]

Speech-language pathology

Communicative (functioning) participation

2006

Yes

No

No

6

Symptoms

Brooks [130]

Adolescents

(Diagnose or measure) anxiety symptoms

2003

Yes

Yes

Yes

9

Duhn [131]

Infants

Pain assessment

2004

No

Yes

Yes

35

Ramelet [132]

Children (0–3 years)

Pain

2004

No

?

Yes

28

Stinson [133]

Children and adolescents

Pain

2006

Yes

No

No

7

Eccleston [134]

Adolescents (11–18 years)

(Impact of) pain

2005

Yes

Yes

No

43

Birken [135]

Preschool children (0–6 years)

Clinical asthma severity

2004

No

No

Yes

10

Linder [136]

Children with cancer (0–18 years)

Physical symptoms

2005

Yes

Yes

Yes

23

Stover [137]

Children less than 6 years old

PTSD symptoms and diagnostic measures

2005

Yes

Yes

Yes

7

Devine [138]

Adults

Sleep dysfunction

2005

Yes

No

Yes

22

Kirkova [139]

Adult cancer patients

Cancer symptoms

2006

Yes

Yes

Yes

21

Vadaparampil [140]

Adults with hereditary breast, ovarian, and colon cancer

Psychological factors (depression, anxiety or distress)

2005

Yes

No

No

11

Van Herk [141]

Older adults with severe cognitive impairments or communication difficulties

Pain

2007

No

No

Yes

13

Stolee [142]

Cognitively impaired older persons

Pain

2005

Yes

No

Yes

30

Zwakhalen [143]

Elderly people with dementia

Pain

2006

No

No

Yes

12

Herr [144]

Nonverbal older adults with dementia

Pain

2006

No

No

Yes

10

Smith [18]

Nonverbal older adults with advanced dementia

Pain

2005

No

Yes

Yes

7

Schofield [145]

Adults with cognitive impairment

Pain

2005

Yes

Yes

Yes

9

Schuurmans [146]

Delirium

Delirium (symptom severity)

2003

Yes

No

Yes

8

Stanghellini [22]

Gastro-oesophageal reflux disease (GERD)

Symptom scales

2004

Yes

No

Yes

20

Fraser [147]

Gastro-oesophageal reflux disease (GERD) or dyspepsia

Frequency or severity of GERD or dyspepsia symptoms

2005

Yes

No

No

26

Bouchard [148]

Panic, panic disorders, agoraphobia

Aspects of panic attacks or panic disorder

1997

Yes

No

No

14

Dorman [36]

Patients in palliative care

Breathlessness

2007

Yes

?

?

29

Bausewein [149]

Chronic conditions such as OPD, cancer, chronic heart failure, and motor neuron disease

Breathlessness

2007

Yes

No

Yes

33

Dittner [150]

Various

Fatigue

2004

Yes

No

?

30

Mota [151]

Adults

Fatigue

2006

Yes

No

No

18

Biological and physiological processes

Van der Windt [20]

Preschool children (0–5 years)

Clinical scores for acute asthma

1994

No

No

Yes

8

Moreau [152]

Low back pain

Isometric back extension endurance

2001

No

No

Yes

6

Charman [153]

Atopic eczema

Disease-specific objective skin examination scales (severity)

2000

No

No

Yes

13

Sun [154]

Osteoarthritis of hip and knee joints

Clinical rating systems

1997

Yes

No

Yes

45

Innes [155]

General population/occupational therapy

Grip strength

1999

No

No

Yes

13

Kettler [156]

People with cervical and lumbar disc and facet joint degeneration

Grading systems

2006

No

No

Yes

42

Hudson [157]

Systemic sclerosis

Disease activity in systemic sclerosis

2007

No

No

Yes

3

Combination

Daker-White [33]

General population

Sexual function, satisfaction or quality of life

2002

Yes

No

No

23

Cremeens [158]

Children (3–8 years)

QoL, self-esteem, self-concept, and mental health measures

2006

Yes

No

No

53

Hayes [159]

Critical care survivors

Impairment, functional status, and HR-QoL outcome measures

2000

Yes

No

Yes

36

Pietronbon [160]

Various

Neck pain or dysfunction

2002

Yes

No

No

5

Linder [161]

Acute sinusitis

HR-QoL and symptom scores

2003

Yes

No

No

21

Hearn [162]

Cancer (advanced)

Outcome measures

1997

Yes

Yes

Yes

12

Eechaute [42]

Chronic ankle instability

Patient-assessed instruments

2007

Yes

No

No

3

Dorey [38]

Erectile dysfunction

Outcome measure

2002

Yes

Yes

Yes

26

Veenhof [30]

Hip and/or knee OA

Pain, physical function, and patient global assessment

2006

Yes

No

No

32

Razvi [163]

Hypothyroidism (adult)

Symptoms, health status, and QoL

2005

Yes

No

Yes

9

Bijkerk [164]

Inflammatory bowel syndrome (IBS)

HR-QoL or symptoms

2003

Yes

No

?

10

Haywood [165]

Lateral ligament injury of the ankle

Multi-item measures of health outcome

2004

Yes

No

Yes

9

Costa [43]

Low back pain

Outcome measures

2007

Yes

No

No

15

Poolsup [166]

Mania

Global rating scales and symptom rating scales

1999

Yes

No

Yes

13

Platz [23]

Spasticity

Clinical phenomena, function (ability to perform an activity independently)

2005

Yes

No

Yes

37

D’Olhaberria-gue [167]

Stroke

Neurological examination; deficit or handicap and disability

1996

No

No

Yes

14

Van Tuijl [40]

Tetraplegics

Upper extremity tests: strength tests, functional tests, and ADL tests

2002

Yes

No

Yes

24

Margolis [168]

Visually impairments

Vision-specific HR-QOL or functioning or impact

2002

Yes

No

No

22

Ashcroft [169]

Psoriasis

Clinical outcome measures to evaluate severity of psoriasis and its response to treatment

1999

Yes

No

Yes

7

Avery [37]

Urinary and anal incontinence and vaginal and pelvic problems

QoL and symptoms

2007

Yes

No

No

23

Bialocerkowski [170]

Wrist complaints

Wrist outcome instruments, performance or function

2000

Yes

No

Yes

32

ICF International Classification of Functioning, Disability and Health, PTSD Post-traumatic stress disorder

aPatient-reported outcomes

bProxy-reported outcomes

cNon-patient-reported outcomes, such as clinical ratings and performance-based outcomes

dNumber of instruments included in the systematic review

Appraisal of the review process

Table 2 shows the results of the quality assessment of the review process of the systematic reviews with regard to the description of the search strategy, the databases used, the article selection and data extraction, and the description of inclusion and exclusion criteria. In 84% of the reviews the authors described the search strategy in some way. This varied from describing only the most important keywords to reporting the full search strategy, including MeSH terms and text words for each database. The search strategies were often limited. For example, only MeSH headings were used, and no free text words [21, 22]; or only a few synonyms were used, for example, only “measur* or assess*”; words such as “question*”, “self-report”, “test”, “scale”, “outcome” or “interview” were not used [23]. In some reviews only the text words “psychometrics” [24] or “clinimetrics” [25] were used. Furthermore, the use of truncation was poorly described in most reviews. Finally, in quite a few reviews (14%) the time period during which the databases were searched, and some reviews (7%) searched a period of only 10 years or less was not specified.
Table 2

Assessment of the quality of the review process of systematic reviews of measurement properties

Search strategy described

    Yes

84%

    No

16%

Number of databases used

    1

22%

    2

20%

    3

16%

    4

17%

    >4

24%

    Unclear

2%

Databases used

    PubMed

93%

    PsycINFO

40%

    CINAHL

39%

    EMBASE

35%

    Cochrane library

16%

Selection of articles performed by at least two reviewers

    Yes

22%

    No

3%

    Unclear

75%

Data extraction performed by at least two reviewers

    Yes

25%

    No

4%

    Unclear

71%

Inclusion and exclusion criteria of primary studies described

    Yes

72%

    No

28%

Description of the assessment of the methodological quality of the primary studies and evaluation of the results

In 44% (= 65/148) of the reviews the methodological quality of the included studies was not assessed and the results were not appraised, but only reported, i.e., steps 3 and 4 were omitted.

Of these reviews, 32% (= 21/65) only reported references of the primary studies and not the results; 38% (= 25/65) reported the results, 28% (= 18/65) reported partly results and partly references, and 2% (= 1/65) stated that no studies of measurement properties were found for any of the included instruments [26]. References were mainly reported for validity, and results for reliability.

In 56% (= 83/148) of the reviews the methodological quality of the included studies was (partly) assessed by the authors of the reviews and (some of) the results were evaluated, i.e., standards and/or criteria of adequacy were applied to one or more measurement properties (steps 3 and 4). In 53% (= 44/83) of these reviews (some) standards as well as criteria of adequacy were applied. In 46% (= 38/83) of these reviews only (some) criteria of adequacy were applied, and in one review only standards were applied.

Often a limited number of standards and/or criteria of adequacy were applied; for example, in some cases only a standard and a criterion for internal consistency were used [27]. Eleven reviews described and applied a complete set of standards, i.e., fully described and reproducible standards of reliability, validity, and responsiveness. Twelve reviews described and applied a complete set of criteria of adequacy, i.e., fully described and reproducible criteria of adequacy of reliability, validity, and responsiveness. In seven reviews both a complete set of standards and a complete set of criteria of adequacy were described and applied.

In Table 3 we summarize the standards and criteria of adequacy used by the authors of the reviews. Standards were most often applied for reliability (use of an ICC), internal consistency (use of Cronbach’s alpha), and construct validity (confirming hypotheses). Criteria of adequacy were most often applied for reliability (e.g., ICC >0.70) and for internal consistency (Cronbach’s alpha >0.70). Standards and criteria of adequacy for measurement error and interpretability were rarely used. Few authors of reviews mentioned that the use of Pearson’s correlation coefficients was not adequate to measure reliability [19, 28, 29]. Only two reviews gave an exact number as a minimum of the sample size (i.e., at least 50) for reliability [19, 30] and two reviews required that the sample size for reliability must be “reasonably large” [31, 32]. Criteria for construct validity varied from qualitative criteria such as “hypotheses confirmed” to quantitative criteria such as “r ≥ 0.40.” Standards given for responsiveness included confirming hypotheses, effect sizes or standardized response mean or other methods.
Table 3

Summary of standards and criteria of adequacy applied in the systematic reviews of measurement properties

Internal consistency

Standardsa (23×b)

Criteria of adequacyc (45×)

    Cronbach’s alpha (18×)

    KR-20 (2×), kappa (1×)

    Cronbach’s alpha is calculated for either the whole scale or for subscales depending on the outcome of the factor analysis (5×)

    Rasch analysis (2×)

    Rating system not specified (2×)

    Alpha > 0.70 (26×)

    Alpha < 0.90 (9×), or not too high (1×)

    Alpha > 0.80 (3×)

    Alpha > 0.95 (2×)

    Range (e.g., 0.00–0.39 low; 0.40–0.59 moderate; 0.60–0.79 moderately high; 0.80–1.0 high, or alpha < 0.70 questionable; 0.71–0.80 moderate; >0.80 good) (10×)

    Distinction between cut-off score for group level and clinical use (2×)

    Rating system not specified (2×)

Reliability

Standards (29×)

Criteria of adequacy (57×)

    ICC: (18×)

    Kappa (10×)

    Correlation coefficient (e.g., Pearson’s or Spearman) (11×)

    Correlation not adequate (3×)

    Time interval mentioned (3×)

    Other measures, e.g., MDC, CV, Kendall’s tau, t-test, Goodman-Kruskall gamma, odds ratio, percentage agreement (7×)

    Rating system not specified (7×)

    ICC > 0.70 (19×)

    ICC between 0.70 and 0.90 (7×)

ICC > 0.50 (1×), >0.60 (2×), >0.75 (2×), >0.80 (3×), >0.90 (7×)

    Lower limit ICC > 0.60 (1×)

    Range ICC, kappa or r (18×)

    Distinction between, e.g., test-retest reliability and interrater reliability or discriminative versus evaluative use (3×)

    Minimum sample size (3×)

    Rating system not specified (13×)

    Example: Test-retest reliability: ICC < 0.6; ±ICC 0.6–0.8; +ICC > 0.8; Interobserver reliability: ICC < 0.5; ±ICC 0.5–0.7; +ICC > 0.7.

Measurement error

Standards (6×)

Criteria of adequacy (4×)

    Bland & Altman 95% LoA (5×)

    SEM (5×)

    Kappa (3×)

    MDC (1×)

    SDD/SDC (2×)

    Rating system not specified (3×)

    LoA or SDC < M(C)IC (1×)

Validity

Standards (6×)

Criteria of adequacy (13×)

    Rating system not specified (3×)

    Rating system not specified (12×)

    Correlation between 0.4 and 0.8 (1×)

Content validity

Standards and/or criteria of adequacy (21×)

    Involvement of patients (7×)

    Judgement by reviewer (3×)

    Involvement of experts (4×)

    Examining the literature (2×)

    Statistical procedure (e.g., impact method, principal component analysis) (4×)

    Rating system not specified (3×)

Construct validity

Standards (26×)

Criteria of adequacy (28×)

    Confirming hypotheses (11×)

    Calculation of correlation (8×)

    Distinction between different forms of validity (e.g., convergent validity, divergent validity, known group validity) (6×)

    Rating system not specified (3×)

    Range (e.g., Cohen’s criteria or other, e.g., 0–0.39, 0.4–0.59, 0.6–0.79, 0.8–1.0) (11×)

    Hypotheses confirmed (7×)

    One cut-off point (e.g., r ≥ 0.40, or specified for, e.g., convergent validity, discriminant validity, known groups validity) (5×)

    Rating system not specified (3×)

    Other (e.g., number of populations validated) (2×)

Criterion validity

Standards (4×)

Criteria of adequacy (8×)

    Correlation of percentage agreement between instrument and “gold standard” (4×)

    Magnitude of the coefficients is hypothesis dependent (1×)

    Range (for correlations, kappa, or ES/SRM, e.g., “0.00–0.39 low; 0.40–0.59 moderate; 0.60–0.79 moderately high; 0.80–1.0 high,” or “high ≥ 90%, κ > 0.60, r > 0.75; moderate ≥ 70%, κ ≥ 0.40, r ≥ 0.50; low < 70%, κ < 0.40, r < 0.50” (5×)

    Significant correlations (1×)

    Rating system not specified (2×)

Responsiveness

Standards (17×)

Criteria of adequacy (26×)

    “Adequate measure” used, e.g., ES, SRM (7×)

    Confirming hypotheses (6×)

    Calculating change scores (3×)

    Other measures, e.g., ROC curves (1×), Guyatt index of responsiveness (1×), relative efficacy (1×), Student’s t-test/Wilcoxon’s test (1×)

    Rating system not specified (5×)

    Range or cut-off point for ES or SRM (11×)

    Hypotheses testing (5×)

    Significant difference (2×)

    ROC curve (1×)

    Intervention of known efficacy (1×)

    Rating system not specified (9×)

Interpretability

Standards and/or criteria of adequacy (7×)

    Presenting MIC/MCIC (4×)

    Presenting mean and SDs (e.g., for different subgroups, or before and after treatment) (4×)

    Rating system not specified (1×)

MDC minimal detectable change, CV coefficient of variation, LoA limits of agreement, SEM standard error of measurement, SDD/SDC smallest detectable difference/change, M(C)IC minimal (clinically) important change, ES effect size, SRM standardized response mean

aStandards refer to the study design and statistical analyses

bNumber of reviews in which the standard/criterion is mentioned

cCriteria of adequacy refer to what constitutes good measurement properties

Description of synthesizing methodological quality and results

In 7% (= 10/148) of the systematic reviews a total score was given for the quality of each instrument, and in 5% (= 8/148) of the systematic reviews an order of importance of measurement properties was taken into account when making the quality assessment. There was no agreement among the reviews regarding which property was most important. Some considered content validity as most important [33, 34, 35], while others considered construct validity [36], responsiveness [29, 36] or validity and reliability [37] as the most important measurement properties.

The reviews frequently used rating systems to indicate whether a standard or a criterion of adequacy was met. Different rating systems were used. An example of a nonspecified rating system is “0 = no numerical results reported; + = weak evidence; ++ = adequate evidence; +++ = good evidence” [38, 39, 40]. An example of a rating system in which the standard and the criterion are combined is “+ adequate design & method (i.e. factor analysis and Cronbach’s alpha), and alpha is between 0.70 and 0.90; ± doubtful method used (no factor analysis); − inadequate internal consistency (alpha <0.70); ? no information found on internal consistency” [30, 41, 42].

Discussion

It was our aim to identify all systematic reviews of measurement properties, to appraise the quality of the review process, and to describe whether the authors of the reviews appraised the methodological quality and results of the primary studies. We observed an increase in published systematic reviews of measurement properties in the last few years. Information required to assess the quality of the review process is often poorly described. More than half of the authors of the reviews evaluated neither the methodological quality of the primary studies nor the results of these studies. The reviews that did evaluate methodological quality and results used different standards and criteria of adequacy.

We attempted to use transparent and reproducible methods. However, because of the considerable variation in design, performance, and data presentation of the included reviews, some degree of judgement in appraising the quality of the systematic reviews and describing the standards and criteria was unavoidable.

We identified three major aspects: a lack of methodological quality of systematic reviews of measurement properties, i.e., low quality of search strategy, a lack of good reporting of the methods used to perform the systematic review, and a lack of use of standards and criteria of adequacy to assess the methodological quality of the primary studies.

Appraisal of the review process

Firstly, the quality and reporting of the search strategy was often poor. It was obvious that search strategies were often too narrow and that many systematic reviews were likely to be incomplete; for example, Costa et al. [43] found 17 primary studies on the Roland Morris Disability Questionnaire (RDQ) by using a search strategy consisting of several terms for low back pain with the terms “questionnaire(s) OR outcome measure(s) OR index OR scale”. However, a simple PubMed search “Roland AND (responsive* OR sensitiv*)” resulted in 11 additional responsiveness studies of the RDQ that were not included in the review. Furthermore, the review of Costa was limited to a time period from January 2001 to July 2007. With our simple PubMed search described above, we found another 12 responsiveness studies of the RDQ before 2001.

We recommend that the search strategy consist of terms describing the concept to be measured, terms describing the population of interest, and terms describing the type of instruments of interest, such as questionnaire, performance-based measure, etc. For each of these parts a comprehensive list of possible synonyms should be used, preferably drawn up in cooperation with a clinical librarian. Platz et al. [23] published a systematic review that aimed to characterize clinical assessment methods for spasticity and/or functional consequences in clinical patient populations at risk to suffer from spasticity. Their search strategy was adequate. They started with search terms for the construct (i.e., spas*, hyperton* or reflex*), secondly they used terms for the type of instrument (i.e., measure* or assess*) and thirdly terms for the population of interest (i.e., stroke or CVA or multiple sclerosis or MS or spinal cord injury or SCI or cerebral palsy or CP). Additionally, we recommend not to limit the search to a specific time period.

In many search strategies the focus is on finding all health status instruments, without focusing on finding all studies of measurement properties of these instruments. An additional search strategy, including the names of the instruments, is often needed to find all these studies. In our experience these studies of measurement properties do not always contain terms of measurement properties such as “reliability,” “validity,” and “responsiveness” in the title, abstract or keywords. Furthermore, the large variety in terms of measurement properties used in the literature makes it difficult to design a sensitive search strategy. The use of a methodological search filter with terms for measurement properties will inevitably result in missing studies and should therefore be discouraged. This is in line with what is known about the performance of other methodological search filters, e.g., for finding diagnostic studies [44]. In 21% of the reviews only one database was used. In guidelines for systematic reviews of clinical trials [3, 8] and observational studies [45] it is suggested that limiting a search to a single database will not provide a thorough summary of the existing literature.

Secondly, there is a lack of adequate reporting of the methods used in the systematic reviews of measurement properties. Because of this, it is difficult to assess the methodological quality of the reviews. It was often unclear if things were not done (e.g., data extraction performed by at least two independent reviewers) or if they were not reported. For example, Law and Letts clearly described that the data extraction was performed by two people, but they did not describe if the article selection was also performed by two people [29]. As we only used information from the published reviews and did not contact authors to ask for additional information, it is possible that we may have slightly underrated the quality of the reviews. However, we believe that our article clearly shows the need for guidelines for assessing the quality of systematic reviews of measurement properties and guidelines for reporting on these reviews.

Description of the assessment of the methodological quality of primary studies and the evaluation of the results of primary studies

Thirdly, more than half of the reviews did not evaluate either the methodological quality of the primary studies (step 3), or the results of these studies (step 4), i.e., standards for the appropriateness of the study design and statistical analyses, and criteria for what constitutes good measurement properties were often not applied; for example, Golomb et al. [46] published a review on health-related quality-of-life measures in stroke. They provided definitions of the measurement properties and adequately described the results of the measurement properties for each of the available measurement instruments, but they did not apply a priori determined standards to the methods used to assess the measurement properties, or criteria of adequacy to the results of those studies.

In our opinion it is important to assess the methodological quality of included primary studies in order to decrease the risk of bias in the review. Considering the large variety of methods used to evaluate the methodological quality of the individual studies, there is a need for guidance. Within this guidance more attention should be paid to techniques based on item response theory (IRT). IRT has many advantages over classical test theory; for example, shorter questionnaires with equal or even better reliability can be developed [47]. Furthermore, the ability scores are test independent [48], and scores obtained on different instruments measuring the same construct can be linked, so that they are comparable [49]. We think that standards and criteria of adequacy are most likely to be widely used when consensus is reached among international experts about the preferred standards and criteria of adequacy. We therefore started the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative with the aim to draw up a consensus-based checklist for the evaluation of the methodological quality of studies on measurement properties [50].

Conclusion

A systematic review of measurement properties is a useful tool for evaluating the quality of an instrument, or for interpreting results based on an instrument. In the last few years the number of such systematic reviews published has increased enormously every year. However, the methodological quality of these reviews leaves much to be desired and should be improved. We feel it is essential to develop guidelines for the assessment of the methodological quality of systematic reviews of measurement properties. This includes guidelines for the review process, guidelines to assess the methodological quality of the studies that evaluate measurement properties, and guidelines for criteria of adequacy for good measurement properties.

Notes

Acknowledgements

This study is financially supported by the EMGO Institute, VU University Medical Center, Amsterdam, and the Anna Foundation, Leiden, The Netherlands. These funding organizations did not play any role in the study design, data collection, data analysis, data interpretation or publication.

Conflict of interest

The authors of this review, except IR, are all members of the Steering Committee of the COSMIN study.

Open Access

This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

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Copyright information

© The Author(s) 2009

Authors and Affiliations

  • Lidwine B. Mokkink
    • 1
  • Caroline B. Terwee
    • 1
  • Paul W. Stratford
    • 2
  • Jordi Alonso
    • 3
    • 4
  • Donald L. Patrick
    • 5
  • Ingrid Riphagen
    • 6
    • 7
  • Dirk L. Knol
    • 1
  • Lex M. Bouter
    • 1
    • 8
  • Henrica C. W. de Vet
    • 1
  1. 1.Department of Epidemiology and BiostatisticsEMGO Institute for Health and Care Research, VU University Medical CenterAmsterdamThe Netherlands
  2. 2.School of Rehabilitation Science and Department of Clinical Epidemiology and BiostatisticsMcMaster UniversityHamiltonCanada
  3. 3.Health Services Research UnitInstitut Municipal d’Investigacio Medica (IMIM-Hospital del Mar)BarcelonaSpain
  4. 4.CIBER en Epidemiología y Salud Pública (CIBERESP)BarcelonaSpain
  5. 5.Department of Health ServicesUniversity of WashingtonSeattleUSA
  6. 6.Unit of Applied Clinical Research, Faculty of MedicineNorwegian University of Science and Technology (NTNU)TrondheimNorway
  7. 7.University LibraryVU University Medical CenterAmsterdamThe Netherlands
  8. 8.Executive Board of VU University AmsterdamAmsterdamThe Netherlands

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