Andrew Lloyd

Inhaled corticosteroids for asthma: impact of practice level device switching on asthma control

BackgroundAs more inhaled corticosteroid (ICS) devices become available, there may be pressure for health-care providers to switch patients with asthma to cheaper inhaler devices. Our objective was to evaluate impact on asthma control of inhaler device switching without an accompanying consultation in general practice.MethodsThis 2-year retrospective matched cohort study used the UK General Practice Research Database to identify practices where ICS devices were changed without a consultation for ≥5 patients within 3 months. Patients 6–65 years of age from these practices whose ICS device was switched were individually matched with patients using the same ICS device who were not switched. Asthma control over 12 months after the switch was assessed using a composite measure including short-acting β-agonist and oral corticosteroid use, hospitalizations, and subsequent changes to therapy.ResultsA total of 824 patients from 55 practices had a device switch and could be matched. Over half (53%) of device switches were from dry powder to metered-dose inhalers. Fewer patients in switched than matched cohort experienced successful treatment based on the composite measure (20% vs. 34%) and more experienced unsuccessful treatment (51% vs. 38%). After adjusting for possible baseline confounding factors, the odds ratio for treatment success in the switched cohort compared with controls was 0.29 (95% confidence interval [CI], 0.19 to 0.44; p < 0.001) and for unsuccessful treatment was 1.92 (95% CI, 1.47 to 2.56; p < 0.001).ConclusionSwitching ICS devices without a consultation was associated with worsened asthma control and is therefore inadvisable.

The measurement of chronic pain and health-related quality of life following inguinal hernia repair: a review of the literature.

Background and methodsThis study reviews the existing literature examining chronic pain and health-related quality of life (HRQL) outcomes in hernia repair studies. A PubMed/Medline and Embase search was carried out to identify relevant papers. Studies meeting pre-specified inclusion/exclusion criteria were included and fully reviewed. Reference lists were scanned for additional studies. Only studies examining chronic (>3 months) post-operative inguinal hernia repair (IHR)-related pain were included in this review.Results and conclusionsTwenty-three studies were identified. The majority of studies used the visual analogue scale (VAS) for pain measurement and the Medical Outcomes Study Short-Form 36 (SF-36) for the measurement of HRQL. A reasonably consistent picture emerged from the literature, with the HRQL domains most often affected by pain (social functioning/mental health). Estimates of the prevalence of chronic pain and discomfort following IHR vary widely between studies. This is probably a reflection of the range of methods used for measuring pain, many of which do not have established psychometric properties. Our review suggests that a proportion of patients experience chronic pain and discomfort, which has a significant impact on HRQL. However, the current instruments used in the evaluation of chronic pain after IHR are not comparable and standardisation is required.

Health state utility scores in advanced non-small cell lung cancer.

BACKGROUND The aim of the study was to capture societal utility scores for health state descriptions of advanced, metastatic non-small cell lung cancer (NSCLC), as well as determine disutility associated with specific disease symptoms. METHODS NSCLC health states were produced based on an adaptation of existing health state descriptions for metastatic lung cancer. The health states were expanded to contrast disease state (responding disease and stable disease) and impact of specific severe symptoms (cough; dyspnoea; pain; or no additional severe symptoms). Interviews with five lung cancer clinicians were carried out to assess the content and face validity of the existing health states as descriptions specific to NSCLC. The interviews also sought to explore the impact of the disease symptoms of interest. The resulting health states were reviewed by two psychometric experts independently. The final health states were piloted in a conventional standard gamble interview which revealed no significant issues in interpretation or comprehension. In the main study, 101 members of the general public assessed their preference for each health state in a chained standard gamble (SG) interview and on a visual analogue scale (VAS) rating scale. All participants also completed the EQ-5D and a socio-demographic form. RESULTS The study sample was a relatively good match to the characteristics of the general public in England and Wales. A mixed model analysis revealed that age, gender, and HRQL were not significant predictors of utility, but a treatment response and each of the disease symptoms were. When adjusted to match census data, stable disease with no additional symptoms had a utility value of 0.626. Health state values declined by 0.069 with the addition of pain; 0.050 for dyspnoea; or 0.046 for cough. A treatment response would result in a utility gain of 0.086. CONCLUSIONS Members of the general public showed a preference for responding disease over stable disease and a stable health state with no additional symptoms over a stable health state with one of the three common NSCLC symptoms: cough, dyspnoea, and pain. The study highlights the value that society places on the avoidance of severe symptoms that some people with NSCLC can experience.

Health State Utility Scores for Cancer-Related Anemia through Societal and Patient Valuations

OBJECTIVES Fatigue is recognized as the most serious complication of chemotherapy for the majority of patients. This study aims to determine preferences and utility values for health state descriptions of anemia associated with cancer treatment. METHODS FACT-An clinical trial data were summarized to define health states associated with hemoglobin levels of 7.0-8.0, 8.0-9.0, 9.0-10.0, 10.0-10.5, 10.5-11.0, 11.0-12.0, and 12.0+ g/dL. Health state descriptions were reviewed by clinicians and two quality-of-life experts. Eighty-five members of the general public were asked to rate the health states using a visual analogue scale and standard gamble (SG). Twenty-six oncology patients were interviewed using the time trade-off (TTO). RESULTS The mean societal SG derived utility values showed a significant linear change from 0.583 +/- 0.067 (7-8 g/dL hemoglobin [Hb]) to 0.708 +/- 0.057 (12+ g/dL Hb). The patient TTO data ranged from 0.297 +/- 0.127 (7-8 g/dL Hb) to 0.611 +/- 0.092 (12+ g/dL Hb). CONCLUSIONS The health state utility scores from both groups show a decrement in line with worsening anemia. Furthermore, patients who have experienced cancer-related fatigue rate the more severe levels of anemia much lower than the general public.

A discrete choice experiment to determine patient preferences for injection devices in multiple sclerosis

Abstract Objective: Relapsing-remitting multiple sclerosis (MS) is usually managed with disease modifying drugs (DMDs), most commonly administered via self-injection. The aim of this study was to estimate the influence that different treatment-related attributes have for MS patients on their choice of MS DMD device. By establishing the relative importance of these characteristics for patients it should be possible to better understand the acceptability of a given device and to optimize the development of future devices. Methods: A discrete choice experiment (DCE) survey was developed on the basis of a review of published literature. Attributes identified for inclusion in the survey were: ease of use; comfort of use; presence of additional functions, needle visibility; practicality and efficacy. Choice sets were presented as pairs of hypothetical treatments based upon a fractional factorial design. One-hundred device-using MS patients completed the survey online. Analysis was conducted using a mixed-logit approach. Results: Analysis of the DCE data revealed that all attributes significantly predicted treatment choice. Efficacy exhibited the largest effect on treatment selection and this provided context for understanding the magnitude of impact for the other attributes. Reducing the discomfort associated with device use and eliminating the necessity for assembly or drug reconstitution were highly valued. The addition of reminder and time-stamping functions, improved needlestick injury prevention, and reduction in device size were secondary concerns but still deemed desirable. Conclusion: Efficacy is of primary importance to MS patients, but characteristics of drug delivery devices can play an important role in treatment decision-making. Not all device characteristics could be included, and results are based upon 100 participants only. Findings suggest there is significant potential value in developing self-injection devices that are not only efficacious but also convenient and comfortable to use. Reducing barriers to adherence could potentially translate into improved treatment outcomes for patients with MS.

One-to-one versus group setting for conducting computer-assisted TTO studies: Findings from pilot studies in England and the Netherlands

We compare two settings for administering time trade-off (TTO) tasks in computer-assisted interviews (one-to-one, interviewer-led versus group, self-complete) by examining the quality of the data generated in pilot studies undertaken in England and the Netherlands. The two studies used near-identical methods, except that in England, data were collected in one-to-one interviews with substantial amounts of interviewer assistance, whereas in the Netherlands, the computer aid was used as a self-completion tool in group interviews with lesser amounts of interviewer assistance. In total, 801 members of the general public (403 in England; 398 in the Netherlands) each completed five TTO valuations of EQ-5D-5L health states. Respondents in the Netherlands study showed a greater tendency to give ‘round number’ values such as 0 and 1 and to complete tasks using a minimal number of iterative steps. They also showed a greater tendency to skip the animated instructions that preceded the first task and to take into account assumptions that they were specifically asked not to take into account. When faced with a pair of health states in which one state dominated the other, respondents in the Netherlands study were more likely than those in the England study to give a higher value to the dominant health state. On the basis of these comparisons, we conclude that the one-to-one, interviewer-led setting is superior to the group, self-complete setting in terms of the quality of data generated and that the former is more suitable than the latter for TTO studies being used to value EQ-5D-5L.

Treatment preference, adherence and outcomes in patients with cancer: literature review and development of a theoretical model

Abstract Objective: A patient’s preference may guide their behavior and influence their willingness to take medication or undergo treatment affecting outcomes, such as health-related quality of life, or survival. The importance of understanding patient preferences within oncology is unclear and few adherence studies exist compared with other therapeutic areas. Research design and methods: This study was designed to review the literature regarding patient preferences, adherence and their link to outcomes specifically in the oncology setting and to propose a theoretical model. An in-depth review was conducted, using Embase, MEDLINE and Cochrane Library databases to search for published data examining patient preference, adherence and oncology-specific outcomes, from 1982–2012. Articles were reviewed independently by two authors and rated for relevance and quality. Information from high-quality articles and discussion with oncology and patient preference experts were used to identify associations between important individual concepts as a basis for a theoretical model. Results: In total, 1362 abstracts were identified. After removal of duplicates and initial review, 1269 were excluded and 93 reviewed in detail. Of these publications, 18 were deemed ‘high-quality’ and used to develop the final model. Variables associated with patient preference, adherence and outcome were identified. External variables included communication, treatment and mode of administration; patient beliefs and values were identified as cognitive variables; and adherence was attributed as a behavioral variable. Relationships between patient preference, adherence and clinical outcomes were established. Adverse events had a strong relationship with adherence; patient beliefs and values were identified as having a moderating effect on adherence. Adherence behavior had a direct relationship to outcomes. Conclusions: Improving our understanding of patient preference may improve clinical outcomes in oncology patients. Although the proposed theoretical model is limited, it provides a basis to develop testable hypotheses for the relationships between patient preference, adherence and outcomes specific to oncology.

Health state utilities for chronic lymphocytic leukemia: importance of prolonging progression-free survival

Abstract Chronic lymphocytic leukemia (CLL) is a largely incurable disease which affects patients’ health related quality of life (HRQL). Treatment is often initiated when symptoms affect HRQL, and patients can experience many rounds of treatment throughout their life. Therefore, the economic burden of CLL can be high. Utility or preference weights for health states reflect the value of HRQL of a given health state and range from 1 (full health) to 0 (dead) and below (negative values possible). Nine health states were developed representing different CLL treatment lines or disease stages. One hundred members of the UK general public valued each health state using the time trade-off methodology. Progression-free survival (PFS) without therapy (mean utility = 0.82) was the least burdensome, with relapsed lines of treatment (mean utility = 0.42) representing the greatest burden. The results underline the value in maintaining a state of PFS for as long as possible.

Willingness to Pay for Obesity Pharmacotherapy

Several treatments for obesity have received regulatory approval, but health insurers and other payers typically refuse to support access to them. Thus, patients are left to bear significant out‐of‐pocket costs for obesity pharmacotherapy. This study aimed to assess preferences and willingness to pay (WTP) for obesity medications among people seeking weight loss in the United States and United Kingdom. An online survey was developed based on literature review, clinician interviews, and profiles of available therapies. Participants indicated their preference for hypothetical treatments which varied by seven attributes: percentage of weight loss, long‐term health risk reduction, time to noticeable weight loss, delivery mode, side effects, lifestyle modification, and cost; 502 obese participants completed the survey (mean BMI 37.12 kg/m2 (±4.63); 73.5% female; 47.7 (±12.9) years of age). The participants deemed weight loss of >21 kg (United Kingdom) and >28 kg (United State) as “acceptable”. All treatment attributes were important (P < 0.001) except “time to noticeable weight loss.” The survey found that percentage weight loss was the most important factor for patients and a reduction in long‐term health risk was relatively less important. Patients were willing to pay £6.51/

Evaluation of psoriasis patients’ attitudes toward benefit–risk and therapeutic trade-offs in their choice of treatments

10.49 per month per percentage point of weight loss that a pharmacotherapy could provide. Participants also highly valued therapies that did not require substantial lifestyle modifications and were willing to pay £17.78/