Background and Purpose— The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS’s attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. Methods— A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957–2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selecti...

Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis.

Background: The SF-6D and EQ-5D are both preference-based measures of health. Empirical work is required to determine what the smallest change is in utility scores that can be regarded as important and whether this change in utility value is constant across measures and conditions. Objectives: To use distribution and anchor-based methods to determine and compare the minimally important difference (MID) for the SF-6D and EQ-5D for various datasets. Methods: The SF-6D is scored on a 0.29–1.00 scale and the EQ-5D on a −0.59–1.00 scale, with a score of 1.00 on both, indicating ‘full health’. Patients were followed for a period of time, then asked, using question 2 of the SF-36 as our anchor, if their general health is much better (5), somewhat better (4), stayed the same (3), somewhat worse (2) or much worse (1) compared to the last time they were assessed. We considered patients whose global rating score was 4 or 2 as having experienced some change equivalent to the MID. This paper describes and compares the MID and standardised response mean (SRM) for the SF-6D and EQ-5D from eight longitudinal studies in 11 patient groups that used both instruments. Results: From the 11 reviewed studies, the MID for the SF-6D ranged from 0.011 to 0.097, mean 0.041. The corresponding SRMs ranged from 0.12 to 0.87, mean 0.39 and were mainly in the ‘small to moderate’ range using Cohen’s criteria, supporting the MID results. The mean MID for the EQ-5D was 0.074 (range −0.011–0.140) and the SRMs ranged from −0.05 to 0.43, mean 0.24. The mean MID for the EQ-5D was almost double that of the mean MID for the SF-6D. Conclusions: There is evidence that the MID for these two utility measures are not equal and differ in absolute values. The EQ-5D scale has approximately twice the range of the SF-6D scale. Therefore, the estimates of the MID for each scale appear to be proportionally equivalent in the context of the range of utility scores for each scale. Further empirical work is required to see whether or not this holds true for other utility measures, patient groups and populations.

Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D.

Qualitative methods in psychology: A research guide

Basic concepts for qualitative research

Importance Describing the economic impact of childhood food allergy in the United States is important to guide public health policies. Objective To determine the economic impact of childhood food allergy in the United States and caregivers’ willingness to pay for food allergy treatment. Design, Setting, and Participants A cross-sectional survey was conducted from November 28, 2011, through January 26, 2012. A representative sample of 1643 US caregivers of a child with a current food allergy were recruited for participation. Main Outcomes and Measures Caregivers of children with food allergies were asked to quantify the direct medical, out-of-pocket, lost labor productivity, and related opportunity costs. As an alternative valuation approach, caregivers were asked their willingness to pay for an effective food allergy treatment. Results The overall economic cost of food allergy was estimated at $24.8 (95% CI, $20.6-$29.4) billion annually ($4184 per year per child). Direct medical costs were $4.3 (95% CI, $2.8-$6.3) billion annually, including clinician visits, emergency department visits, and hospitalizations. Costs borne by the family totaled $20.5 billion annually, including lost labor productivity, out-of-pocket, and opportunity costs. Lost labor productivity costs totaled $0.77 (95% CI, $0.53-$1.0) billion annually, accounting for caregiver time off work for medical visits. Out-of-pocket costs were $5.5 (95% CI, $4.7-$6.4) billion annually, with 31% stemming from the cost of special foods. Opportunity costs totaled $14.2 (95% CI, $10.5-$18.4) billion annually, relating to a caregiver needing to leave or change jobs. Caregivers reported a willingness to pay of $20.8 billion annually ($3504 per year per child) for food allergy treatment. Conclusions and Relevance Childhood food allergy results in significant direct medical costs for the US health care system and even larger costs for families with a food-allergic child.

https://jamanetwork.com/journals/jamapediatrics/articlepdf/1738764/poi130024.pdf

The economic impact of childhood food allergy in the United States.

Background Limited resources coupled with unlimited demand for healthcare mean that decisions have to be made regarding the allocation of scarce resources across competing interventions. Policy documents have advocated the importance of public views as one such criterion. In principle, the elicitation of public values represents a big step forward. However, for the exercise to be worthwhile, useful information must be obtained that is scientifically defensible, whilst decision-makers must be able and willing to use it. Aims and objectives The aim was to identify techniques that could be reasonably used to elicit public views on the provision of healthcare. Hence, the objectives were: (1) to identify research methods with the potential to take account of public views on the delivery of healthcare; (2) to identify criteria for assessing these methods; (3) to assess the methods identified according to the predefined criteria; (4) to assess the importance of public views vis-a-vis other criteria for setting priorities, as judged by a sample of decision-makers; (5) to make recommendations regarding the use of methods and future research. Methods A systematic literature review was carried out to identify methods for eliciting public views. Criteria currently used to evaluate such methods were identified. The methods identified were then evaluated according to predefined criteria. A questionnaire-based survey assessed the relative importance of public views vis-a-vis five other criteria for setting priorities: potential health gain; evidence of clinical effectiveness; budgetary impact; equity of access and health status inequalities; and quality of service. Two techniques were used: choice-based conjoint analysis and allocation of points technique. The questionnaire was sent to 143 participants. A subsample was followed up with a telephone interview. Results The methods identified were classified as quantitative or qualitative. RESULTS - QUANTITATIVE TECHNIQUES: Quantitative techniques, classified as ranking, rating or choice-based approaches, were evaluated according to eight criteria: validity; reproducibility; internal consistency; acceptability to respondents; cost (financial and administrative); theoretical basis; whether the technique offered a constrained choice; and whether the technique provided a strength of preference measure. Regarding ranking exercises, simple ranking exercises have proved popular, but their results are of limited use. The qualitative discriminant process has not been used to date in healthcare, but may be useful. Conjoint analysis ranking exercises did well against the above criteria. A number of rating scales were identified. The visual analogue scale has proved popular within the quality-adjusted life-year paradigm, but lacks constrained choice and may not measure strength of preference. However, conjoint analysis rating scales performed well. Methods identified for eliciting attitudes include Likert scales, the semantic differential technique, and the Guttman scale. These methods provide useful information, but do not consider strength of preference or the importance of different components within a total score. Satisfaction surveys have been frequently used to elicit public opinion. Researchers should ensure that they construct sensitive techniques, despite their limited use, or else use generic techniques where validity has already been established. Service quality (SERVQUAL) appears to be a potentially useful technique and its application should be researched. Three choice-based techniques with a limited application in healthcare are measure of value, the analytical hierarchical process and the allocation of points technique, while those more widely used, and which did well against the predefined criteria, include standard gamble, time trade-off, discrete choice conjoint analysis and willingness to pay. Little methodological work is currently available on the person trade-off. RESULTS - QUALITATIVE TECHNIQUES: Qualitative techniques were classified as either individual or group-based approaches. Individual approaches included one-to-one interviews, dyadic interviews, case study analyses, the Delphi technique and complaints procedures. Group-based methods included focus groups, concept mapping, citizens' juries, consensus panels, public meetings and nominal group techniques. Six assessment criteria were identified: validity; reliability; generalisability; objectivity; acceptability to respondents; and cost. Whilst all the methods have distinct strengths and weaknesses, there is a lot of ambiguity in the literature. Whether to use individual or group methods depends on the specific topic being discussed and the people being asked, but for both it is crucial that the interviewer/moderator remains as objective as possible. The most popular and widely used such methods were one-to-one interviews and focus groups. (ABSTRACT TRUNCATED)

C M Robb

Papers

Eliciting public preferences for healthcare: a systematic review of techniques.