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Research Design: Qualitative, Quantitative, and Mixed Methods Approaches

The goal of treatments for multiple sclerosis (MS) and other chronic neurological conditions that produce morbidity but have limited effect on mortality is to reduce disease impact on patients’ lives and to assure that interventions result in more good than harm. A measure of our success in reaching these goals can be made only with direct information from patients about how they experience the illness and the effects of treatments. Patient-derived data are increasingly accepted as an essential assessment domain in clinical research and treatment. Research shows that measures of patient perception and clinician-derived data are not redundant. ± 3 Observation of patient functioning in the clinic is not sufficient in itself since it has been determined that patient functioning in the artificial setting of the treatment center is not always duplicated at home. The approach to patient assessment that is considered relevant in monitoring the consequences of diseases and their treatments is known as `health-related quality of life’. Quality of life is one domain of health as defined by the World Health Organization (WHO). Health-related quality of life (HRQoL) is a discrete component of general quality of life. While general quality of life can be affected by many factors beyond the scope of health care including economic instability, civil unrest or poor environment, these have only an indirect relationship with HRQoL and are not included in its definition. While such factors as equal opportunity and social security are important to community health, these extend beyond the more immediate goal of treating the sick. This thinking led to the HRQoL definition: `Quality of life’ in clinical medicine represents the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient’. Although there is variation in terminology, this construct includes four broad domains: physical and occupational function, psychological function, social interaction and somatic sensation. Several operational characteristics of HRQoL assessment help to further define the construct. First and foremost, HRQoL is subjective. As Schipper and his colleagues explain `. . . in clinical medicine the ultimate observer of the experiment is not a dispassionate third party but a most intimately involved patient’. They note that since the goal of treatment is to minimize the manifest consequences of disease, HRQoL represents `the final common pathway of all the physiological, psychological and social inputs into the therapeutic process’. The second characteristic of HRQoL is that it is multifactorial. Having defined HRQoL as the integration of four domains, it is important to assure that patients’ daily experiences in each domain are explored in the questionnaire, albeit in a manner that is parsimonious and minimizes respondent burden. The third characteristic is self-administration: because HRQoL is subjective, there is concern that external administration would in some way influence patient report. The final characteristic is that HRQoL is time variable; it fluctuates. Progress in HRQoL assessment in research or clinical monitoring is evolutionary and, arguably, comparable to the increasing use of MRI and immunological markers in quantifying MS severity. Data derived from HRQoL measures are used for three general purposes. The first, most commonly used in research, is to classify or group patients by levels of disease severity. The second is to monitor for change in status that indicates a need for modifying the treatment plan or to predict the health of subjects at a future point in time. The third use is as an outcome variable in clinical research. HRQoL assessment is increasingly accepted as an outcome measure in MS research for disease-modifying treatments ± 11 and symptom management. ± 14 HRQoL assessment is less commonly used to monitor patient well-being as part of the usual process of care. This can be done routinely, in much the same way that upper and lower extremity monitoring is done using the NineHole Peg Test or Timed Twenty-five Foot Walk. However, challenges to using HRQoL monitoring in clinical practice are the limited availability of instruments proved to be sensitive to change in individual patients over time, easily interpreted by clinicians, accepted by patients as relevant, and that require limited time to complete. Quality of life researchers are actively engaged in improving the science of HRQoL interpretation at the individual level; it remains an emerging field. In this issue, Shawaryn describes a measure of illness intrusiveness that has good potential for use as an HRQoL screening instrument in the clinical setting. Her findings clearly demonstrate that the physical and cognitive aspects of MS affect HRQoL, each in different ways. Her findings hold for HRQoL as measured directly by the Multiple Sclerosis Quality of Life Inventory and indirectly, by the Illness Intrusiveness Rating Scale. This later measure has a number of benefits for clinical use including brevity, face validity, clinical relevance and patient acceptability. Even though there are not yet standard methods for determining when a change in this or other patient self-reported measures indicates a need to review or revise a patient’s treatment plan, these measures have an important use for physicians providing care to patients with MS and other chronic conditions. Routine use of such measures allows physicians to review, quickly and systematically, patient functioning and concerns and to help patients to become active participants in their care.

Health-related quality of life.

Changes in health policy have underlined the importance of evidence-based clinical practice and rigorous evaluation of patient-based outcomes. As patient-based outcome measurement is particularly important in treatment trials of multiple sclerosis, a number of disease-specific instruments have been developed recently. One limitation of these instruments is that none was developed using the standard psychometric approach of reducing a large item pool generated from people with multiple sclerosis. Consequently, an outcome measure for clinical trials of multiple sclerosis that is disease specific and combines patient perspective with rigorous psychometric methods will complement existing instruments. The aim of this study was to develop such a measure. Standard psychometric methods were used. A pool of 129 questionnaire items was generated from interviews with 30 people with multiple sclerosis, expert opinion and literature review. The questionnaire was administered by postal survey to 1530 people selected randomly from the Multiple Sclerosis Society membership database. Redundant items and those with limited measurement properties were removed. The remaining items (n = 41) were grouped into scales using factor analysis, and then refined to form the Multiple Sclerosis Impact Scale (MSIS-29), an instrument measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis. Five psychometric properties of the MSIS-29 (data quality, scaling assumptions, acceptability, reliability and validity) were examined in a separate postal survey of 1250 Multiple Sclerosis Society members. A preliminary responsiveness study of the MSIS-29 was undertaken in 55 people admitted for rehabilitation and intravenous steroid treatment of relapses. The MSIS-29 satisfied all psychometric criteria. Data quality was excellent, missing data were low (maximum 3.9%), item test-re-test reliability was high (r = 0.65-0.90) and scale scores could be generated for >98% of respondents. Item descriptive statistics, item convergent and discriminant validity, and factor analysis indicated that it was legitimate to generate scores for MSIS-29 scales by summing items. MSIS-29 scales showed good variability, small floor and ceiling effects, high internal consistency (Cronbach's alpha <or=0.91) and high test-re-test reliability (intraclass correlation <or=0.87). Correlations with other measures and the analysis of group differences provided evidence that the MSIS-29 measures the physical and psychological impact of multiple sclerosis. Effect sizes (physical scale = 0.82, psychological scale = 0.66) demonstrated preliminary evidence of good responsiveness. These results indicate the MSIS-29 is a clinically useful and scientifically sound patient-based outcome measure of the impact of multiple sclerosis suitable for clinical trials and epidemiological studies.

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The Multiple Sclerosis Impact Scale (MSIS-29)A new patient-based outcome measure

Objective: To improve, with the aid of psychometric analysis, the Balance Evaluation Systems Test (BESTest), a tool designed to analyse several postural control systems that may contribute to poor functional balance in adults. Methods: Performance of the BESTest was examined in a convenience sample of 115 consecutive adult patients with diverse neurological diagnoses and disease severity, referred to rehabilitation for balance disorders. Factor (both explorative and confirmatory) and Rasch analysis were used to process the data in order to produce a new, reduced and coherent balance measurement tool. Results: Factor analysis selected 24 out of the 36 original BESTest items likely to represent the unidimensional construct of “dynamic balance”. Rasch analysis was then used to: (i) improve the rating categories, and (ii) delete 10 items (misfitting or showing local dependency). The model consisting of the remaining 14 tasks was verified with confirmatory factor analysis to meet the stringent requirements of modern measurement. Conclusion: The new 14-item scale (dubbed mini-BESTest) focuses on dynamic balance, can be conducted in 10–15 min, and contains items belonging evenly to 4 of the 6 sections from the original BESTest. Further studies are needed to confirm the usefulness of the mini-BESTest in clinical settings.

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Using psychometric techniques to improve the balance evaluation systems test: the mini-bestest

Objective: To develop a patient-based measure of walking ability in MS. Methods: Twelve items describing the impact of MS on walking (12-Item MS Walking Scale [MSWS-12]) were generated from 30 patient interviews, expert opinion, and literature review. Preliminary psychometric evaluation (data quality, scaling assumptions, acceptability, reliability, validity) was undertaken in the data generated by 602 people from the MS Society membership database. Further psychometric evaluation (including comprehensive validity assessment, responsiveness, and relative efficiency) was conducted in two hospital-based samples: people with primary progressive MS (PPMS; n = 78) and people with relapses admitted for IV steroid treatment (n = 54). Results: In all samples, missing data were low (≤3.8%), item test–retest reproducibility was high (≥0.78), scaling assumptions were satisfied, and reliability was high (≥0.94). Correlations between the MSWS-12 and other scales were consistent with a priori hypotheses. The MSWS-12 (relative efficiency = 1.0) was more responsive than the Functional Assessment of Multiple Sclerosis mobility scale (0.72), the 36-Item Short Form Health Survey physical functioning scale (0.33), the Expanded Disability Status Scale (0.03), the 25-ft Timed Walk Test (0.44), and Guy’s Neurologic Disability Scale lower limb disability item (0.10). Conclusions: The MSWS-12 satisfies standard criteria as a reliable and valid patient-based measure of the impact of MS on walking. In these samples, the MSWS-12 was more responsive than other walking-based scales.

Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12).

Management of chronic post-partum pelvic girdle pain: evaluating effectiveness of combined physiotherapy and a dynamic elastomeric fabric orthosis

[Baert, I.; Eijnde, B. O.; Feys, P.] Univ Hasselt, Diepenbeek, Belgium. [Smedal, T.; Jones, K.] Haukeland Hosp, N-5021 Bergen, Norway. [Freeman, J.] Univ Plymouth, Plymouth PL4 8AA, Devon, England. [Dalgas, U.] Aarhus Univ, Aarhus, Denmark. [Romberg, A.] Masku Neurol Rehabil Ctr, Masku, Finland. [Kalron, A.] Chaim Sheba Med Ctr, IL-52621 Tel Hashomer, Israel. [Conyers, H.] Poole Hosp NHS Fdn Trust, Poole, Dorset, England. [Elorriaga, I.] Eugenia Epalza Rehabil Ctr, Bilbao, Spain. [Gebara, B.] Natl MS Ctr, Melsbroek, Belgium. [Gumse, J.] Helsinki MS Neuvela, Helsinki, Finland. [Heric, A.] MS Ctr Hakadal AS, Hakadal, Norway. [Jensen, E.] Danish MS Hosp Haslev & Ry, Haslev, Denmark. [Jensen, E.] Danish MS Hosp Haslev & Ry, Ry, Denmark. Rehabil Adn MS Ctr Overpelt, Overpelt, Belgium. [de Noordhout, B. M.] Ctr Neurol & Readaptat Fonct, Fraiture En Condroz, Belgium. [Martic, A.] Univ Med Ctr Ljubljana, Ljubljana, Slovenia. [Normann, B.] Kongsgaarden Physiotherapy AS, Nordland Hosp Trust, Bodo, Norway. [Rasova, K.] Charles Univ Prague, Prague, Czech Republic. [Santoyo Medina, C.] Hosp Dia Barcelona, CEMcat, Barcelona, Spain.

Jennifer Freeman

Papers

Management of chronic post-partum pelvic girdle pain: evaluating effectiveness of combined physiotherapy and a dynamic elastomeric fabric orthosis

Association of rehabilitation extent and content with change in walking in multiple sclerosis: a European multi-centre study

Exploring foot and ankle impairments affecting mobility and balance in stroke (FAiMiS study)

Balance Right in Multiple Sclerosis (BRiMS): Preliminary results of a randomised controlled feasibility trial.

Investigation for possible MS