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Martha Bayliss

    Martha Bayliss

    Additional file 1. Original survey items.
    Additional file 2. Supplementary tables and figures.
    Appendix 1. Work Productivity and Activity Impairment Questionnaire (WPAI). Appendix 2. Terms and Strings Used in Electronic Database Literature Searches. (DOCX 21 kb)
    Inclusion and Exclusion Criteria for Cognitive Interview Study. (DOCX 27 kb)
    In the first phase of research, we conducted in-depth, individual interviews among patients with UI due to IOAB to elicit symptoms of the condition and gather feedback on the initial PBD content. Patients completed the PBD and rated the... more
    In the first phase of research, we conducted in-depth, individual interviews among patients with UI due to IOAB to elicit symptoms of the condition and gather feedback on the initial PBD content. Patients completed the PBD and rated the relevance and understandability of concepts, words and pictures used. The PBD was revised based on this patient input. In a second phase, the revised PBD was evaluated for patients’ understanding of the content of the revised items, for the ease of completing the diary on a daily basis and for expressed willingness to complete the diary as required during the course of a clinical trial.
    Background Oral antipsychotic (AP) medications are frequently prescribed to people with bipolar I disorder (BD-I). A cross-sectional online survey examined the experiences of people living with BD-I with a history of recent AP use.... more
    Background Oral antipsychotic (AP) medications are frequently prescribed to people with bipolar I disorder (BD-I). A cross-sectional online survey examined the experiences of people living with BD-I with a history of recent AP use. Methods Adults with self-reported physician-diagnosed BD-I (N = 200) who received oral APs during the prior year completed a survey on AP-related experiences, including side effects and their perceived burden on social functioning, adherence, and work. Items also assessed preferences for trade-offs (balancing symptom management and side effects) when considering a hypothetical new AP. The perceived impact of specific, prevalent side effects on adherence, work, and preferences for a hypothetical AP were also examined. Analyses were descriptive. Results The survey sample had a mean age of 43.2 (SD = 12.4) years, was 60% female, and 31% nonwhite. Almost all participants (98%) had experienced AP side effects. Common self-reported side effects were feeling dro...
    Introduction:Previous research has reported broad deficits in health-related quality of life (HRQoL) in patients with immunoglobulin light chain (AL) amyloidosis. While research also shows improvements in HRQoL following treatment with... more
    Introduction:Previous research has reported broad deficits in health-related quality of life (HRQoL) in patients with immunoglobulin light chain (AL) amyloidosis. While research also shows improvements in HRQoL following treatment with high-dose melphalan and stem cell transplantation (SCT), little is known about whether changes in HRQoL corresponding to a hematologic complete response (CR) are indicative of clinically meaningful changes in functioning and well-being. The purpose of this analysis is to examine patterns of change in HRQoL among AL amyloidosis patients by achievement of hematologic CR following targeted treatment of plasma cell dyscrasia. Methods: Patients with AL amyloidosis were asked to complete the SF-36v1 Health Survey (SF-36v1) during clinic visits at the Amyloidosis Center at Boston University between 1994 and 2014. A complete case analytic sample (n=177) was created based on the following eligibility criteria: 1) patients with an SF-36v1 observation within 30 ...
    Introduction and Objective: AL amyloidosis (AL) is a rare, complex, and progressive disease in which an abnormal protein, amyloid, misfolds and deposits in organs. AL can affect one or many organs, such as the heart, kidneys, liver,... more
    Introduction and Objective: AL amyloidosis (AL) is a rare, complex, and progressive disease in which an abnormal protein, amyloid, misfolds and deposits in organs. AL can affect one or many organs, such as the heart, kidneys, liver, nervous system, and digestive tract, leading to organ dysfunction and death. AL symptoms and treatments are known to impact health-related quality of life (HRQoL), but little research has been conducted to establish which HRQoL concepts are relevant for AL patients before and during treatment. The objective of this study was to identify the most important HRQoL concepts to measure in clinical trials of AL patients through in-depth interviews with physicians and patients. Methods: This qualitative study was conducted from March to May 2015 through in-depth, 1-hour telephone interviews using a concept elicitation method and semistructured interview guides. In phase 1, interviews were conducted with three hematologists and one nephrologist on (a) journey to...
    This study examined the content validity of the SF-36v2® Health Survey (SF-36v2) in patients with AL amyloidosis using qualitative interviews with physicians and patients. The study included three distinct phases of qualitative research:... more
    This study examined the content validity of the SF-36v2® Health Survey (SF-36v2) in patients with AL amyloidosis using qualitative interviews with physicians and patients. The study included three distinct phases of qualitative research: concept elicitation interviews among physicians, concept elicitation interviews among patients, and cognitive debriefing interviews among patients. The concept elicitation interviews focused on areas of health-related quality of life that are affected by AL amyloidosis and may be affected by treatment, while patient cognitive debriefings aimed to confirm whether the SF-36v2 instructions, recall period, items, and response choices were comprehensive and understandable to AL amyloidosis patients. Physicians discussed the importance of measuring physical functioning, general health, mental/emotional health, sleep, fatigue, and work impact; though they also reported that they do not routinely use a standard Patient-Reported Outcome (PRO) measure of heal...
    This review is the first to evaluate the burden of ulcerative colitis [UC] on patients' quality of life by synthesizing data from studies comparing scores from the SF-36® Health Survey, a generic measure assessing eight... more
    This review is the first to evaluate the burden of ulcerative colitis [UC] on patients' quality of life by synthesizing data from studies comparing scores from the SF-36® Health Survey, a generic measure assessing eight quality-of-life domains, between UC patients and matched reference samples. A systematic review of the published literature identified articles reporting SF-36 domains or physical and mental component summary scores [PCS, MCS] from UC and reference samples. Burden of disease for each SF-36 domain was then summarized across studies by comparing weighted mean differences in scores between patient and reference samples with minimally important difference thresholds. Thirty articles met pre-specified inclusion criteria. SF-36 scores were extracted from five samples of patients with active disease, 11 samples with a mixture of disease activity, five samples of patients in clinical remission, and 13 samples of patients following proctocolectomy with ileostomy or ileal ...
    Little is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients' functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS)... more
    Little is known on the impact of emerging treatments for advanced melanoma (stages III and IV) on patients' functioning and well-being. The objective of this study was to describe the patient-reported treatment-related symptom (TRS) burden in advanced melanoma. Twenty-nine in-depth, qualitative interviews were conducted among adult patients with advanced melanoma in Canada using a semi-structured interview method. Interviews were transcribed verbatim, and key concepts were identified using a grounded theory analytic approach. The 29 patients reported 13 unique treatment journeys involving the following drug therapy categories: cytotoxic chemotherapies, CTLA-4 inhibitors, BRAF or MEK inhibitors, and PD-1 inhibitors. Patients typically underwent multiple treatment episodes over time. Common TRSs included nausea, fatigue, diarrhea or constipation, and skin rashes. Patients described these as impacting their physical functioning, ability to perform activities of daily living, social...
    Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of... more
    Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of interventions for migraine. The conceptual framework and items for a new patient-reported outcome (PRO) instrument, the Migraine Physical Function Impact Diary (MPFID), were developed using scientific methods recommended to ensure content validity of PRO instruments. The MPFID was developed to measure the impact of migraine on physical functioning based on themes raised in concept elicitation (CE) interviews (conducted previously) with adults with migraine. Cognitive interviews were conducted with adults with migraine to further explore content validity. The instrument was modified following an interim analysis of a first round of cognitive interviews, to assess comprehensiveness and clarity of items, instructions, and response options. Refinements we...
    Metastatic melanoma is a highly aggressive cancer, often striking in the prime of life. This study provides new information directly from advanced melanoma (stage III and IV) patients on how their disease impacts their health-related... more
    Metastatic melanoma is a highly aggressive cancer, often striking in the prime of life. This study provides new information directly from advanced melanoma (stage III and IV) patients on how their disease impacts their health-related quality of life (HRQL). Twenty-nine in-depth, qualitative interviews were conducted with adult patients with advanced melanoma in Canada. A semi-structured interview guide was used. Interviews were transcribed verbatim and key concepts were identified using a grounded theory analytic approach. Many patients' journeys began with the startling diagnosis of an invasive disease and a vastly shortened life expectancy. By the time they reached an advanced stage of melanoma, these patients' overall functioning and quality of life had been greatly diminished by this quickly progressing cancer. The impact was described in terms of physical pain and disability, emotional distress, diminished interactions with friends and family, and burden on caregivers. ...
    The objective of this study was to evaluate the measurement properties of the Migraine Physical Function Impact Diary (MPFID), a novel patient‐reported outcome (PRO) measure for assessing the impact of migraine on physical functioning.
    The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study... more
    The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application. For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice. Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple sc...
    Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical... more
    Sarilumab is a human monoclonal antibody directed against the alpha subunit of the interleukin-6 receptor complex. In the MOBILITY phase III randomized controlled trial (RCT), sarilumab + methotrexate (MTX) treatment resulted in clinical improvements at 24 weeks that were maintained at 52 weeks in adults with rheumatoid arthritis (RA), who have inadequate response to MTX (MTX-IR). These analyses indicate the effects of sarilumab + MTX versus placebo on patient-reported outcomes (PROs) in this RCT. Patients (n = 1197) were randomized to receive placebo, sarilumab 150 or 200 mg subcutaneously + MTX every 2 weeks for 52 weeks; after 16 weeks, patients without ≥20 % improvement from baseline in swollen or tender joint counts on two consecutive assessments were offered open-label treatment. PROs included patient global assessment of disease activity (PtGA), pain, health assessment questionnaire disability index (HAQ-DI), Short Form-36 Health Survey (SF-36), and functional assessment of c...
    ABSTRACT
    To compare the measurement properties of acute (one-week recall) and standard (four-week recall) versions of SF-36 Health Survey (SF-36) scale scores. SF-36 data collected from 142 participants (60% female, average age 39) in a clinical... more
    To compare the measurement properties of acute (one-week recall) and standard (four-week recall) versions of SF-36 Health Survey (SF-36) scale scores. SF-36 data collected from 142 participants (60% female, average age 39) in a clinical trial of an asthma medication: 74 patients randomized to the acute form and 68 to the standard. The SF-36 was self-administered at the time of a clinic visit (before clinical examination) to synchronize with clinical measures of disease severity at three different time points during the clinical trial: -2 weeks (two weeks before randomization to treatment), baseline (week 0 or randomization), and +4 weeks (four weeks after baseline). The acute form yielded high-quality data; scales conformed to the assumptions of the summated ratings method used to score the standard SF-36; and scales had good distributional properties, were reliable, and had a factor content similar to the standard. The data indicated that while the acute form was more sensitive tha...
    Although evidence of virologic elimination, normalization of serum alanine aminotransferase levels, and reduction in liver inflammation are the principal therapeutic outcome goals in chronic hepatitis C patients, improvement in... more
    Although evidence of virologic elimination, normalization of serum alanine aminotransferase levels, and reduction in liver inflammation are the principal therapeutic outcome goals in chronic hepatitis C patients, improvement in health-related quality of life (HQL) is also an important aspect of therapeutic outcome. In a recent report of chronic hepatitis C patients treated for 24 weeks with interferon, sustained virologic response (24 weeks post-treatment) was associated with improvement in HQL compared with nonresponse. We report on the relationship between sustained virologic response and Hepatitis Quality-of-Life Questionnaire (HQLQ) survey results of patients who relapsed after a previous course of interferon alfa who were subsequently treated with recombinant interferon alfa-2b (rIFN-alpha 2b) either alone or in combination with ribavirin. The HQLQ was administered at baseline, at treatment Weeks 12 and 24, and at follow-up Weeks 12 and 24. All patients received rIFN-alpha 2b 3...
    Physical component summary (PCS) and mental component summary (MCS) measures make it possible to reduce the number of statistical comparisons and thereby the role of chance in testing hypotheses about health outcomes. To test their... more
    Physical component summary (PCS) and mental component summary (MCS) measures make it possible to reduce the number of statistical comparisons and thereby the role of chance in testing hypotheses about health outcomes. To test their usefulness relative to a profile of eight scores, results were compared across 16 tests involving patients (N = 1,440) participating in the Medical Outcomes Study. Comparisons were made between groups known to differ at a point in time or to change over time in terms of age, diagnosis, severity of disease, comorbid conditions, acute symptoms, self-reported changes in health, and recovery from clinical depression. The relative validity (RV) of each measure was estimated by a comparison of statistical results with those for the best scales in the same tests. Differences in RV among scales from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were consistent with those in previous studies. One or both of the summary measures were significa...
    Primary care physicians are caring for increasing numbers of persons with comorbid chronic illness. Longitudinal information on health outcomes associated with specific chronic conditions may be particularly relevant in caring for these... more
    Primary care physicians are caring for increasing numbers of persons with comorbid chronic illness. Longitudinal information on health outcomes associated with specific chronic conditions may be particularly relevant in caring for these populations. Our objective was to assess the effect of certain comorbid conditions on physical well being over time in a population of persons with chronic medical conditions; and to compare these effects to that of hypertension alone. We conducted a secondary analysis of 4-year longitudinal data from the Medical Outcomes Study. A heterogeneous population of 1574 patients with either hypertension alone (referent) or one or more of the following conditions: diabetes, coronary artery disease, congestive heart failure, respiratory illness, musculoskeletal conditions and/or depression were recruited from primary and specialty (endocrinology, cardiology or mental health) practices within HMO and fee-for-service settings in three U.S. cities. We measured c...
    Abstract : Contents: A brief overview of adaptive testing; Estimation of latent trait status in adaptive testing procedures; Adaptive testing and the problem of classification; Applications of item characteristic curve theory to the... more
    Abstract : Contents: A brief overview of adaptive testing; Estimation of latent trait status in adaptive testing procedures; Adaptive testing and the problem of classification; Applications of item characteristic curve theory to the problem of test bias; Applications of adaptive testing in measuring achievement and performance.
    Background: Migraine headaches have been shown to have substantial personal and societal implications. Health-related quality of life (HRQOL) assessments of migraineurs have been used to monitor and evaluate patient- and population-based... more
    Background: Migraine headaches have been shown to have substantial personal and societal implications. Health-related quality of life (HRQOL) assessments of migraineurs have been used to monitor and evaluate patient- and population-based outcomes, and to evaluate effectiveness and responsiveness to treatment. In this paper, we test a new, even shorter generic health survey, the SF-8™ Health Survey (SF-8™), an alternate form that uses one question to measure each of the eight SF-36® Health Survey (SF-36®) domains, in a sub-sample of migraine sufferers. Methods: Data from 7557 participants surveyed via the Internet and mail were used to document the burden of migraine on HRQOL and to compare the relative burden of migraine with other chronic conditions using the SF-8. Results: Migraineurs' HRQOL is similar to those with congestive heart failure, hypertension and diabetes, and is better than those with depression. Migraine sufferers experience better physical health and worse ment...
    A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized... more
    A 69-item questionnaire measuring generic functioning and well-being and disease-specific health outcomes was developed and tested using the pre-treatment data from patients with chronic hepatitis C (CHC) participating in two randomized trials of interferon a-2b (n = 157). The questionnaire included all eight scales from the SF-36 and measures of nine other generic and disease-specific health concepts. Psychometric tests confirmed the assumptions underlying the construction and scoring of all generic and disease-specific scales. Cross-sectional tests of ‘known groups’ validity showed that CHC patients scored worse on the generic scales than patients with other chronic conditions and worse than a healthy general population. The generic and disease-specific scale scores were lower in the presence of physical findings of CHC, as hypothesized, but only the physical functioning and bodily pain scales were linked to cirrhosis or extreme alanine aminotransferase (ALT) ratios. This instrume...
    This paper presents a multi-method research project to develop a conceptual framework for measuring outcomes in studies of osteoporotic kyphosis. The research involved literature research and qualitative interviews among clinicians who... more
    This paper presents a multi-method research project to develop a conceptual framework for measuring outcomes in studies of osteoporotic kyphosis. The research involved literature research and qualitative interviews among clinicians who treat patients with kyphosis and among patients with the condition. Kyphosis due to at least one vertebral compression fracture is prevalent among osteoporotic patients, resulting in well-documented symptoms and impact on functioning and well-being. A three-part study led to development of a conceptual measurement framework for comprehensive assessment of symptoms, impact, and treatment benefit for kyphosis. A literature-based disease model (DM) was developed and tested with physicians (n = 10) and patients (n = 10), and FDA guidelines were used to develop a final disease model and a conceptual framework. The DM included signs, symptoms, causes/triggers, exacerbations, and functional status associated with kyphosis. The DM was largely confirmed, but physicians and patients added several concepts related to impact on functioning, and some concepts were not confirmed and removed from the DM. This study confirms the need for more comprehensive assessment of health outcomes in kyphosis, as most current studies omit key concepts.
    Background: Headache impact test (HIT™) is a precise, practical tool that quantifies the impact of headache on respondents' lives. It is the first widely-available dynamic health assessment (DynHA™). Applications of this brief,... more
    Background: Headache impact test (HIT™) is a precise, practical tool that quantifies the impact of headache on respondents' lives. It is the first widely-available dynamic health assessment (DynHA™). Applications of this brief, precise survey include population based screening for disabling headaches, tracking of individual patient scores over time, disease management programs and others. We use data from Internet HIT assessments

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