Shoulder-specific disability measures showed acceptable construct validity and responsiveness

doi:10.1016/j.jclinepi.2009.03.023

Journal of Clinical Epidemiology

Volume 63, Issue 2, February 2010, Pages 163-170

https://doi.org/10.1016/j.jclinepi.2009.03.023 Get rights and content

Abstract

Objective

To compare the construct validity and responsiveness of the Shoulder Pain and Disability Index (SPADI), Croft Index, and disabilities of the arm, shoulder, and hand (DASH) for patients with adhesive capsulitis and to compare these with pain on a visual analog scale, the Health Assessment Questionnaire, and the problem-elicitation technique.

Study Design and Setting

Two randomized double-blind placebo-controlled trials of interventions for adhesive capsulitis were performed. Both trials recruited patients from community-based physiotherapy practices. Responsiveness at 3 weeks postbaseline was assessed using four responsiveness parameters and three external criteria for improvement.

Results

Correlations between the shoulder-specific measures ranged from 0.55 to 0.65 at baseline and 0.49–0.55 for the 3-week change scores. Greater responsiveness was seen for the SPADI. The effect size for the SPADI ranged from 1.20 to 1.64, for the Croft Index from 0.87 to 1.21, and for the DASH from 0.55 to 0.83. Rankings were similar across the four responsiveness parameters and the three external criteria for improvement. Correlations between the shoulder-specific and generic measures for baseline and 3-week change scores were lower than those among the shoulder-specific measures (range: 0.17–0.60).

Conclusion

The shoulder-specific disability measures showed acceptable construct validity and responsiveness with a small but consistent overall advantage for the SPADI.

Introduction

What is new?

The key finding of this study

•
The shoulder-specific disability measures (SPADI, Croft Index, and DASH) demonstrated adequate construct validity for patients with adhesive capsulitis.
•
The pain visual analog score was the best performing generic measure in terms of responsiveness for this patient group.
•
What this adds to what was known. The lower correlations between the PET score and other measures suggest that it may measure factors important to patients but not picked up with fixed-item questionnaires. The SPADI appeared to be preferable to the other fixed-item shoulder-specific indices but may perform differently in other patient populations and settings.
•
What is the implication, what should change now. We recommend including at least one specific and one generic measure of outcome in clinical trials of shoulder disorders.

The shoulder-specific disability measures, namely Shoulder Pain and Disability Index (SPADI), Croft Index, and disabilities of the arm, shoulder, and hand (DASH), demonstrated adequate construct validity for patients with adhesive capsulitis. The lower correlations between the problem elicitation technique (PET) score and all the other measures suggest that the PET may measure factors important to patients but not picked up with fixed-item questionnaires. In terms of overall responsiveness, the SPADI performed better for most responsiveness indices than the Croft Index and the DASH.

The pain visual analog score was the best performing generic measure in terms of responsiveness for this patient group. The SPADI appeared to be preferable to the other fixed-item shoulder-specific indices but may perform differently in other patient populations and settings. We recommend including at least one specific and one generic measure of outcome in clinical trials of shoulder disorders.

Appropriate assessment of outcome is essential in determining the effectiveness of interventions in research and clinical practice. Pain, range of movement, and disability have been the most commonly used endpoints in clinical trials for shoulder disorders [1], [2], [3], [4], but choice of an assessment tool will be motivated by the psychometric properties of the instrument, such as reliability, construct validity, responsiveness, and ease of use. Michener and Leggin [5] compared 11 self-report shoulder-specific disability measures that had been assessed as reliable, valid, and responsive. All measures met minimum criteria and were judged to have adequate measurement properties but there was considerable variation between them.

In the context of a clinical trial, a responsive instrument should be able to distinguish differing treatment effects among interventions of differing efficacy, and highly responsive scales are preferred over lesser ones so that studies can be performed with fewer participants. The specific focus of shoulder-disability measures makes them potentially more responsive than arthritis-specific or generic health status measures for measuring shoulder disability. This has been demonstrated for the Shoulder Pain and Disability Index (SPADI) [6] in relation to the sickness impact profile [7] and to the Short Form-36 [8], but few studies have compared the responsiveness of different shoulder-specific disability measures [9], [10].

To study the responsiveness of an outcome measure, it is necessary to specify what constitutes improvement, to identify a group that shows improvement over time and to select the statistical indices for measuring responsiveness [11], [12], [13]. Different methods have been used [14] and prior studies have reported variable results by using different responsiveness indices [13], [14], [15].

The purpose of this study was to compare the construct validity and responsiveness of three fixed-item shoulder-specific disability indices: the SPADI [6], the Croft Index [16], and the DASH [17]. Three generic measures were included to allow for comparisons with the shoulder-specific measures: the problem-elicitation technique (PET), a patient preference disability questionnaire [18], [19]; overall pain intensity measured on a visual analog scale (VAS); and the arthritis-specific Health Assessment Questionnaire (HAQ) [20]. These measures were all used in two randomized double-blind placebo-controlled trials of interventions for adhesive capsulitis: arthrographic shoulder joint distension with saline and steroid [21] and short-course oral prednisolone [22].

We examined the robustness of the responsiveness estimates using four different responsiveness indices and three different external criteria for improvement. It was hypothesized that the shoulder-specific outcome measures would be highly correlated with each other and would have similar responsiveness for similar criteria of improvement. Correlation between the shoulder-specific and generic outcomes was expected to be lower because of the different focus of these questionnaires.

Section snippets

Methods

This analysis was based on data from two randomized double-blind placebo-controlled trials of interventions for patients with adhesive capsulitis. One trial investigated the efficacy of arthrographic joint distension [21]. The second investigated the efficacy of a short course of oral prednisolone [22]. Both trials showed a significant treatment effect at 3 weeks.

Detailed reports of the trials have been published elsewhere [21], [22]. Briefly, eligible participants for both trials were aged 18

Patient characteristics and responses

The baseline characteristics of the 95 patients (46 from the arthrographic joint distension trial and 49 from the oral prednisolone trial) are shown in Table 3. Over three-quarters of the patients were females and 10 had had symptoms for more than 1 year. After 3 weeks, 36 patients reported a marked improvement, 25 a moderate improvement, 17 no change, 13 a moderate worsening, and one patient reported a marked worsening.

At baseline, the mean score for the outcome measures, on a 1–100 scale, was

Discussion

The three shoulder-specific disability measures demonstrated adequate construct validity as indicated by their substantial or high baseline correlations. The lower correlations between the generic outcome measures suggest that these tools measure different aspects of the patient's pain, function, and disability. The PET score, in particular, may measure factors important to patients that are not picked up with fixed-item questionnaires. Correlations between the change scores at 3 weeks and

Acknowledgments

Jan Lucas Hoving and Henrica CW de Vet contributed to a preliminary draft of this report.

References (35)

G.J. van der Heijden et al.
Shoulder disability questionnaire design and responsiveness of a functional status measure
Journal of Clinical Epidemiology
(2000)
L.A. Michener et al.
A review of self-report scales for the assessment of functional limitation and disability of the shoulder
J Hand Ther
(2001)
D. Beaton et al.
Assessing the reliability and responsiveness of 5 shoulder questionnaires
J Shoulder Elbow Surg
(1998)
D.E. Beaton et al.
A taxonomy for responsiveness
J Clin Epidemiol
(2001)
J.G. Wright et al.
A comparison of different indices of responsiveness
J Clin Epidemiol
(1997)
G. Stucki et al.
Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis
J Clin Epidemiol
(1995)
J.L. Hoving et al.
Validity of the neck disability index, Northwick Park neck pain questionnaire, and problem elicitation technique for measuring disability associated with whiplash-associated disorders
Pain
(2003)
B. Burnand et al.
Indexes and boundaries for “quantitative significance” in statistical decisions
J Clin Epidemiol
(1990)
G. Guyatt et al.
Measuring change over time: assessing the usefulness of evaluative instruments
J Chronic Dis
(1987)
R.A. Deyo et al.
Assessing the responsiveness of functional scales to clinical change: an analogy to diagnostic test performance
J Chronic Dis
(1986)

S. Green et al.

Interventions for shoulder pain

Cochrane Database Syst Rev

(2000)

R. Buchbinder et al.

Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised double-blind placebo-controlled trial

Ann Rheum Dis

(2004)

D.A. van der Windt et al.

The responsiveness of the Shoulder Disability Questionnaire

Ann Rheum Dis

(1998)

J.W. Williams et al.

Measuring shoulder function with the Shoulder Pain and Disability Index

J Rheumatol

(1995)

S.L. Heald et al.

The shoulder pain and disability index: the construct validity and responsiveness of a region-specific disability measure

Phys Ther

(1997)

D.E. Beaton et al.

Measuring function of the shoulder. A cross-sectional comparison of five questionnaires

J Bone Joint Surg

(1996)

M. Skutek et al.

Outcome analysis following open rotator cuff repair. Early effectiveness validated using four different shoulder assessment scales

Arch Orthop Trauma Surg

(2000)

Cited by (58)

Improving Efficiency of Patient-Reported Outcome Collection: Application of Computerized Adaptive Testing to DASH and QuickDASH Outcome Scores
2021, Journal of Hand Surgery
Patient-reported outcome measures assess health status and treatment outcomes in orthopedic care, but they may burden patients with lengthy questionnaires. Predictive models using machine learning, known as computerized adaptive testing (CAT), offer a potential solution. This study evaluates the ability of CAT to improve efficiency of the 30-item Disabilities of the Arm, Shoulder, and Hand (DASH) and 11-item QuickDASH questionnaires.
A total of 2,860 DASH and 27,355 QuickDASH respondents were included in the analysis. The CAT system was retrospectively applied to each set of patient responses stored on the instrument to calculate a CAT-specific score for all DASH and QuickDASH entries. The accuracy of the CAT scores, viewed in the context of the minimal clinically important difference for both patient-reported outcome measures (DASH, 12; QuickDASH, 9), was determined through descriptive statistics, Pearson correlation coefficient, intraclass correlation coefficient, and distribution of scores and score differences.
The CAT model required an average of 15.3 questions to be answered for the DASH and 5.8 questions for the QuickDASH, representing a 49% and 47% decrease in question burden, respectively. Mean CAT score was the same for DASH and 0.1 points lower for QuickDASH with similar SDs (DASH, 12.9 ± 19.8 vs 12.9 ± 19.9; QuickDASH, 32.7 ± 24.7 vs 32.6 ± 24.6). Pearson coefficients (DASH, 0.99; QuickDASH, 0.98) and intraclass correlation coefficients (DASH, 1.0; QuickDASH, 0.98) indicated strong agreement between scores. The difference between the CAT and full score was less than the minimal clinically important difference in 99% of cases for DASH and approximately 95% of cases for QuickDASH.
The application of CAT to DASH and QuickDASH surveys demonstrated an ability to lessen the response burden with negligible effect on score integrity.
In the case of DASH and QuickDASH, CAT is an appropriate alternative to full questionnaire implementation for patient outcome score collection.
Cross-cultural adaptation, reliability, and validity of the Italian version of the Shoulder Disability Questionnaire
2020, Musculoskeletal Science and Practice
Citation Excerpt :
Our study is the first assessing construct validity using an a-priori hypothesis testing approach, as the COSMIN initiative (Mokkink et al., 2010) suggests. Previous studies supported construct validity of the tool with high correlations noted between its original version with the DASH (rs = 0.65), the Visual Analogue Scale for pain (rs = 0.60) (Staples et al., 2009), as well as between the Korean version with the Shoulder Pain and Disability Index (rs = 0.72) and the NPRS (rs = 0.65) (Choi et al., 2015). This study presented several limitations to be discussed.
The Shoulder Disability Questionnaire (SDQ) demonstrated promising psychometric properties, but currently there is no evidence of an Italian version.
To cross-culturally adapt the Italian version of the SDQ (SDQ-I) and to explore its psychometric properties in patients with non-specific shoulder pain (SP).
The SDQ-I was translated according to international guidelines and administered to 105 patients with SP. The SDQ-I scores were compared with Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Numerical Pain Rating Scale (NPRS), and 36-item Short Form Health Survey (SF-36). Structural validity (Exploratory Factor Analysis [EFA]), internal consistency (Cronbach's alpha), test-retest reliability (Intraclass Correlation Coefficient [ICC]), measurement error (Standard Error of the Measurement [SEM], Minimal Detectable Change [MDC]), and construct validity (hypothesis testing with correlation of the DASH, NPRS, and SF-36) were explored.
The EFA identified two subscales (activity and participation-psychosocial factors). The internal consistency was supported for activity (α = 0.78), but not for participation-psychosocial subscales (α = 0.45). Both subscales demonstrated high test-retest reliability (ICC = 0.97 [95%CI = 0.96–0.98] and ICC = 0.95 [95%CI = 0.93–0.97]), a SEM of 5.8% and 7.0%, and a MDC of 15% and 19% for the first and second subscale, respectively. Construct validity was satisfactory, as >75% of the expected correlations were met for each subscale.
The SDQ-I was successfully cross-cultural adapted into Italian and proved to be valid for patients with non-specific SP, but its reliability should be further assessed, as internal consistency of the participation-psychosocial subscale showed some psychometric flaws. Further research is needed to refine the instrument.
Construct validity of the Patient-Rated Wrist and Hand Evaluation questionnaire (PRWHE) for nerve repair in the hand
2019, Musculoskeletal Science and Practice
Many tools have been described for outcome assessment after nerve repair. The Patient-Rated Wrist and Hand Evaluation (PRWHE) have been shown to be valid for several hand conditions.
To explore the construct validity of the PRWHE in comparison to cold intolerance, pain and dysfunction questionnaires; the Rosén score and its subcomponents; and threshold sensibility, dynamometry and dexterity tests for nerve repair of the hand.
Clinical measurement.
Construct validity was analysed through Pearson's correlation coefficient in a convenience sample of 32 adult patients after long-term median and ulnar nerve repair.
The PRWHE total score was highly to moderately associated with the Disability of Arm, Shoulder and Hand (r = 0.83), Cold Intolerance Symptom Severity (r = −0.60) and McGill's Pain (r = 0.58) questionnaires. In addition, it was correlated to motor (r = −0.55) and sensor subdomains (r = −0.56) of the Rosén score. Substantial to high associations were found for the motor, sensory impairment and dexterity test.
The PRWHE was shown to be valid, based on construct validity, for patients with nerve repair of the hand.
Effectiveness of Nonsurgical Interventions for Managing Adhesive Capsulitis in Patients With Diabetes: A Systematic Review
2019, Archives of Physical Medicine and Rehabilitation
This systematic review evaluated the effectiveness of nonsurgical interventions for managing adhesive capsulitis (AC) in patients with diabetes on pain, function, and range of motion.
MEDLINE and other databases were searched for studies published in the last 20 years.
Randomized controlled trials (RCTs) that assessed AC in people with diabetes and implemented 1 or a combination of physiotherapeutic interventions, corticosteroids, and manipulation under anesthesia (MUA) were eligible for inclusion.
The Cochrane Risk of Bias was used by 2 independent raters who met to achieve consensus. The quality of trials was assessed using Grading of Recommendations, Assessment, Development and Evaluations. Data extracted from the eligible studies included study design, participant characteristics and duration of symptoms, type of intervention, outcome measures, follow-up intervals, and research findings.
Because of the lack of similar interventions, a narrative synthesis was conducted, and meta-analyses were not performed. The effect sizes or between-group differences of the interventions were reported. A total of 8 RCTs met the inclusion criteria: 4 addressed physiotherapeutic interventions, 3 corticosteroid injections, and 1 MUA. The effect sizes for physiotherapeutic interventions were 0.8-2.0, 0.9-2.0, and 1.0 for ROM, function, and pain, respectively, with the largest effect size (2.0) being reported for joint mobilization plus exercises. The effect sizes for corticosteroids were 0.2-0.5 and 0.1 for ROM and pain. The between-group improvement for MUA was 5.6 points on Constant Shoulder Score.
Low-quality evidence suggests large effects of joint mobilization plus exercises on AC in people with diabetes, although confidence in this conclusion is limited due to the high risk of bias. Even weaker support was available for corticosteroid and MUA. Future high-quality RCTs are needed to determine the best intervention for managing AC in patients with diabetes.
Quality of life and functional capacity of patients with adhesive capsulitis: identifying risk factors associated to better outcomes after treatment with nerve blocking
2017, Revista Brasileira de Reumatologia
Os objetivos deste estudo foram avaliar a qualidade de vida e a capacidade funcional de pacientes com capsulite adesiva no início e no fim do procedimento de bloqueio de nervo e identificar fatores de risco associados a melhores desfechos após o tratamento.
Fez‐se um estudo de coorte prospectiva. Os critérios de inclusão foram sinais clínicos de capsulite adesiva e alterações da doença nos exames de imagem do ombro. Administrou‐se a forma abreviada do questionário World Health Organization Quality of Life e o questionário Disabilities of the Arm, Shoulder and Hand no início e no fim do tratamento. Foi usada uma pontuação de 55 pontos ou mais no índice de Constant para descontinuar o tratamento. Usou‐se o teste de Wilcoxon para amostras pareadas. Aplicou‐se a análise de regressão múltipla de Poisson com variáveis de exposição com p < 0,20 na análise univariada. Usou‐se a qualidade de vida satisfatória e a melhor capacidade funcional como desfechos. O nível de significância foi de 5%.
Avaliaram‐se 43 pacientes. Na comparação entre os valores medianos no início e no fim do tratamento (Domínio Físico: 46,43 a 67,86; Domínio Psicológico: 66,67 a 79,17; Domínio Social: 66,67 a 75; Domínio Ambiental: 62,5 a 68,75; DASH: 64,16 a 38,33), o p foi < 0,05. O envelhecimento (Físico/Psicológico/DASH), a maior escolaridade (Físico/Ambiental/DASH), a menor gravidade (apenas Físico) e a menor quantidade de bloqueios de nervo (apenas Psicológico) foram fatores de risco independentes.
A qualidade de vida e a capacidade funcional dos pacientes melhoram no fim do procedimento. Pacientes mais idosos e uma maior escolaridade são os fatores de risco associados à qualidade de vida satisfatória e à melhor capacidade funcional depois do tratamento com bloqueio de nervo
The objectives of this study were to assess the quality of life and functional capacity of adhesive capsulitis patients at the beginning and end of procedure and to identify risk factors associated to better outcomes after treatment with nerve blocking.
A prospective cohort study was performed. Inclusion criteria were clinical signs of adhesive capsulitis and disease changes on shoulder imaging exams. The short form of World Health Organization Quality of life and Disabilities of the Arm, Shoulder and Hand questionnaires were administered at the beginning and end of treatment. A score of 55 points or more on the Constant index was used for discontinuation of treatment. We used the Wilcoxon test for paired samples. Multiple regression analysis of Poisson was carried out using exposure variables with p <0.20 in the univariate analysis and the satisfactory quality of life and better functional capability as outcomes. The significance level was 5%.
43 patients were evaluated. For the comparison between medians values at the beginning and end of treatment (Physical Domain: 46.43‐67.86; Psychologic Domain: 66.67‐79.17; Social Domain: 66.67‐75; Environment Domain: 62.5‐68.75; DASH: 64.16‐38.33), p was <0.05. Aging (Physical/Psychologic/DASH), higher educational level (Physical/Environment/DASH), less severity (only Physical) and fewer nerve blocking (only Psychologic) were these independent risk factors.
Quality of life and functional capacity of the patients improve at the end of procedure. Older patients and higher education levels are the risk factors most associated to satisfactory quality of life and better functional capacity after treatment with nerve blocking.
Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial
2020, The Lancet
Citation Excerpt :
The primary endpoint was 12 months after randomisation. Secondary patient-reported outcome measures were the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH)23 score, as a further region-specific measure of response to treatment;24 health-related quality of life using the 5-level version of the EuroQOL 5-Dimension questionnaire;25 the Numeric Rating Scale for pain;26 and the perceived extent of recovery measured by a single visual analogue scale (VAS) ranging from 0 (no need to seek further treatment) to 100 (definite need). The VAS for treatment recovery was purposefully designed for the study with input from patients and clinicians.
Manipulation under anaesthesia and arthroscopic capsular release are costly and invasive treatments for frozen shoulder, but their effectiveness remains uncertain. We compared these two surgical interventions with early structured physiotherapy plus steroid injection.
In this multicentre, pragmatic, three-arm, superiority randomised trial, patients referred to secondary care for treatment of primary frozen shoulder were recruited from 35 hospital sites in the UK. Participants were adults (≥18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation (≥50%) in the affected shoulder. Participants were randomly assigned (2:2:1) to receive manipulation under anaesthesia, arthroscopic capsular release, or early structured physiotherapy. In manipulation under anaesthesia, the surgeon manipulated the affected shoulder to stretch and tear the tight capsule while the participant was under general anaesthesia, supplemented by a steroid injection. Arthroscopic capsular release, also done under general anaesthesia, involved surgically dividing the contracted anterior capsule in the rotator interval, followed by manipulation, with optional steroid injection. Both forms of surgery were followed by postprocedural physiotherapy. Early structured physiotherapy involved mobilisation techniques and a graduated home exercise programme supplemented by a steroid injection. Both early structured physiotherapy and postprocedural physiotherapy involved 12 sessions during up to 12 weeks. The primary outcome was the Oxford Shoulder Score (OSS; 0–48) at 12 months after randomisation, analysed by initial randomisation group. We sought a target difference of 5 OSS points between physiotherapy and either form of surgery, or 4 points between manipulation and capsular release. The trial registration is ISRCTN48804508.
Between April 1, 2015, and Dec 31, 2017, we screened 914 patients, of whom 503 (55%) were randomly assigned. At 12 months, OSS data were available for 189 (94%) of 201 participants assigned to manipulation (mean estimate 38·3 points, 95% CI 36·9 to 39·7), 191 (94%) of 203 participants assigned to capsular release (40·3 points, 38·9 to 41·7), and 93 (94%) of 99 participants assigned to physiotherapy (37·2 points, 35·3 to 39·2). The mean group differences were 2·01 points (0·10 to 3·91) between the capsular release and manipulation groups, 3·06 points (0·71 to 5·41) between capsular release and physiotherapy, and 1·05 points (–1·28 to 3·39) between manipulation and physiotherapy. Eight serious adverse events were reported with capsular release and two with manipulation. At a willingness-to-pay threshold of £20 000 per quality-adjusted life-year, manipulation under anaesthesia had the highest probability of being cost-effective (0·8632, compared with 0·1366 for physiotherapy and 0·0002 for capsular release).
All mean differences on the assessment of shoulder pain and function (OSS) at the primary endpoint of 12 months were less than the target differences. Therefore, none of the three interventions were clinically superior. Arthoscopic capsular release carried higher risks, and manipulation under anaesthesia was the most cost-effective.
The National Institute for Health Research Health Technology Assessment programme.

View all citing articles on Scopus

View full text

Original ArticleShoulder-specific disability measures showed acceptable construct validity and responsiveness

Abstract

Objective

Study Design and Setting

Results

Conclusion

Introduction

Section snippets

Methods

Patient characteristics and responses

Discussion

Acknowledgments

Journal of Clinical Epidemiology

J Hand Ther

J Shoulder Elbow Surg

J Clin Epidemiol

J Clin Epidemiol

J Clin Epidemiol

Pain

J Clin Epidemiol

J Chronic Dis

J Chronic Dis

Interventions for shoulder pain

Cochrane Database Syst Rev

Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised double-blind placebo-controlled trial

Ann Rheum Dis

The responsiveness of the Shoulder Disability Questionnaire

Ann Rheum Dis

Measuring shoulder function with the Shoulder Pain and Disability Index

J Rheumatol

The shoulder pain and disability index: the construct validity and responsiveness of a region-specific disability measure

Phys Ther

Measuring function of the shoulder. A cross-sectional comparison of five questionnaires

J Bone Joint Surg

Outcome analysis following open rotator cuff repair. Early effectiveness validated using four different shoulder assessment scales

Arch Orthop Trauma Surg

Original Article
Shoulder-specific disability measures showed acceptable construct validity and responsiveness