Clinical Gastroenterology and Hepatology, Dec 1, 2022
BACKGROUND & AIMS Many of the reported adverse events in clinical trials of IBS are extra-int... more BACKGROUND & AIMS Many of the reported adverse events in clinical trials of IBS are extra-intestinal symptoms, which are typically assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment. METHODS The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome (IBS). Participants were randomized to receive double-blind peppermint oil (DBM), double-blind placebo (DBP), or treatment as usual (TAU). Extra-intestinal symptoms were assessed at baseline and end-of-study. RESULTS This analysis included 173 participants (30 in DBM, 72 in TAU, and 71 in DBP). At baseline, each group reported approximately five extra-intestinal symptoms per participant. The number of symptoms per participant decreased to an average of three by the end-of-study visit, and this change was statistically significant in all groups (p<0.001 for each group). When evaluating individual extra-intestinal symptoms, the majority of participants did not report new/worse symptoms. In fact, between the baseline assessment and the final assessment, the average symptom severity decreased significantly in all three groups (p<0.001,). CONCLUSIONS Our study suggests that participants with IBS often experience extra-intestinal symptoms at baseline and that these symptoms generally improve in severity over the course of a clinical trial, regardless of the treatment arm. Systematic assessment of extra-intestinal symptoms at the beginning of a clinical trial is necessary to determine more definitively whether these symptoms may be considered an adverse event attributable to a study medication.
American Journal of Lifestyle Medicine, Jun 20, 2023
The Transtheoretical Model of Change identifies key stages in behavior change, including a mainte... more The Transtheoretical Model of Change identifies key stages in behavior change, including a maintenance stage occurring when a behavior has been upheld for at least 6 months. Health and wellness coaching has demonstrated support for health behavior change, but maintenance of gains has received little attention. Our rapid systematic literature review characterizes both the research exploring sustained gains with health and wellness coaching and what is known about sustained gains after the completion of a health and wellness coaching engagement. Guided by The Cochrane Rapid Reviews Methods Group “Interim Guidance,” we drew 231 studies from the 2018 and 2020 Sforzo et al “Compendium of the health and wellness coaching literature,” and “Addendum…” appendices. Initial screening and coding for inclusion and exclusion criteria yielded 28 studies for data extraction. We examined studies across outcome categories (physiological, behavioral, psychological, and health risk assessment) to determine whether outcome measures were: not sustained; partially sustained; fully sustained; or improved from immediate post-intervention to a later follow-up period. Twenty-five of the 28 studies reviewed demonstrated partially, or fully, sustained or improved outcomes in one or more variables studied, with sustained gains demonstrated across outcome categories, strengthening confidence in HWC as a facilitator of lasting change.
Abstract : This project continues our work in the investigation of acupuncture as a treatment for... more Abstract : This project continues our work in the investigation of acupuncture as a treatment for the symptoms of Gulf War Illness. The goals of this current application are:1) Gather follow up data from our veteran participants (from our completed parent study The Effectiveness of Acupuncture in the Treatment Of Gulf War Illness W81XWH-09-2-0064) on current symptom levels and use of services to explore the long-term effects of an acupuncture treatment program, 2) Develop suggestions for how an acupuncture program may be implemented using the viewpoints of multiple stakeholders, 3) Develop a treatment manual for acupuncture practitioners explaining the most effective methods of treating the symptoms of GWI. As planned in the Statement of Work, we have completed the tasks: 1. Create program evaluation (follow up veteran survey) documents, 2. Train research assistant, and review goals with consultants, 3. Complete IRB Review, 4. Begin program evaluation with study subjects (in process), 5. Plan Program evaluation with multiple stakeholders (in process), 6. Start Delphi process.
ObjectivesCardiac rehabilitation (CR) programmes are standard of care for patients following a co... more ObjectivesCardiac rehabilitation (CR) programmes are standard of care for patients following a coronary event. While such exercise-based secondary prevention programme do offer benefits, they are used by less than 30% of eligible patients and attrition within these programmes is high. This project is a nested qualitative assessment of a pilot programme considering Tai Chi (TC) as an alternative to CR. We hypothesised that TC may overcome several key barriers to CR.MethodsA semistructured focus group agenda was used to assess three key domains of feasibility: (1) patients’ experiences, (2) reasons/barriers for not having attended CR and (3) any improvements in physical activity and other secondary outcomes (quality of life, weight, sleep). A thematic analysis was used to better understand the key concepts.ResultsThis high-risk group of patients reported that they enjoyed TC exercise, and felt confident and safe doing it. TC practice was reported to support other types of physical act...
Gulf War illness (GWI) is a chronic illness with no known validated biomarkers that affects the l... more Gulf War illness (GWI) is a chronic illness with no known validated biomarkers that affects the lives of hundreds of thousands of people. As a result, there is an urgent need for the development of an untargeted and unbiased method to distinguish GWI patients from non-GWI patients. We report on the application of laser-induced breakdown spectroscopy (LIBS) to distinguish blood plasma samples from a group of subjects with GWI and from subjects with chronic low back pain as controls. We initially obtained LIBS data from blood plasma samples of four GWI patients and four non-GWI patients. We used an analytical method based on taking the difference between a mean LIBS spectrum obtained with those of GWI patients from the mean LIBS spectrum of those of the control group, to generate a “difference” spectrum for our classification model. This model was cross-validated using different numbers of differential LIBS emission peaks. A subset of 17 of the 82 atomic and ionic transitions that pro...
Background There is increasing evidence suggesting that open-label placebo (OLP) is an effective ... more Background There is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients’ experiences with OLP, and no studies have directly compared patients’ experiences in double-blind placebo (DBP) conditions. Methods This study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS). We randomly selected 33 participants for interviews concerning their experiences in the parent trial. The data were qualitatively analyzed using an iterative immersion/crystallization approach. We then compared the qualitative interview data to the quantitative IBS severity data assessed during the parent trial, using a mixed methods approach. Results Two prominent interview themes were identified: (1) the participants’ feelings about their treatment allocation and (2) their reflections about the...
Clinical Gastroenterology and Hepatology, Dec 1, 2022
BACKGROUND & AIMS Many of the reported adverse events in clinical trials of IBS are extra-int... more BACKGROUND & AIMS Many of the reported adverse events in clinical trials of IBS are extra-intestinal symptoms, which are typically assessed by open-ended questions during the trial and not at baseline. This may lead to misattribution of some pre-existing symptoms as side effects to the treatment. METHODS The current study analyzed data from a 6-week clinical trial of irritable bowel syndrome (IBS). Participants were randomized to receive double-blind peppermint oil (DBM), double-blind placebo (DBP), or treatment as usual (TAU). Extra-intestinal symptoms were assessed at baseline and end-of-study. RESULTS This analysis included 173 participants (30 in DBM, 72 in TAU, and 71 in DBP). At baseline, each group reported approximately five extra-intestinal symptoms per participant. The number of symptoms per participant decreased to an average of three by the end-of-study visit, and this change was statistically significant in all groups (p<0.001 for each group). When evaluating individual extra-intestinal symptoms, the majority of participants did not report new/worse symptoms. In fact, between the baseline assessment and the final assessment, the average symptom severity decreased significantly in all three groups (p<0.001,). CONCLUSIONS Our study suggests that participants with IBS often experience extra-intestinal symptoms at baseline and that these symptoms generally improve in severity over the course of a clinical trial, regardless of the treatment arm. Systematic assessment of extra-intestinal symptoms at the beginning of a clinical trial is necessary to determine more definitively whether these symptoms may be considered an adverse event attributable to a study medication.
American Journal of Lifestyle Medicine, Jun 20, 2023
The Transtheoretical Model of Change identifies key stages in behavior change, including a mainte... more The Transtheoretical Model of Change identifies key stages in behavior change, including a maintenance stage occurring when a behavior has been upheld for at least 6 months. Health and wellness coaching has demonstrated support for health behavior change, but maintenance of gains has received little attention. Our rapid systematic literature review characterizes both the research exploring sustained gains with health and wellness coaching and what is known about sustained gains after the completion of a health and wellness coaching engagement. Guided by The Cochrane Rapid Reviews Methods Group “Interim Guidance,” we drew 231 studies from the 2018 and 2020 Sforzo et al “Compendium of the health and wellness coaching literature,” and “Addendum…” appendices. Initial screening and coding for inclusion and exclusion criteria yielded 28 studies for data extraction. We examined studies across outcome categories (physiological, behavioral, psychological, and health risk assessment) to determine whether outcome measures were: not sustained; partially sustained; fully sustained; or improved from immediate post-intervention to a later follow-up period. Twenty-five of the 28 studies reviewed demonstrated partially, or fully, sustained or improved outcomes in one or more variables studied, with sustained gains demonstrated across outcome categories, strengthening confidence in HWC as a facilitator of lasting change.
Abstract : This project continues our work in the investigation of acupuncture as a treatment for... more Abstract : This project continues our work in the investigation of acupuncture as a treatment for the symptoms of Gulf War Illness. The goals of this current application are:1) Gather follow up data from our veteran participants (from our completed parent study The Effectiveness of Acupuncture in the Treatment Of Gulf War Illness W81XWH-09-2-0064) on current symptom levels and use of services to explore the long-term effects of an acupuncture treatment program, 2) Develop suggestions for how an acupuncture program may be implemented using the viewpoints of multiple stakeholders, 3) Develop a treatment manual for acupuncture practitioners explaining the most effective methods of treating the symptoms of GWI. As planned in the Statement of Work, we have completed the tasks: 1. Create program evaluation (follow up veteran survey) documents, 2. Train research assistant, and review goals with consultants, 3. Complete IRB Review, 4. Begin program evaluation with study subjects (in process), 5. Plan Program evaluation with multiple stakeholders (in process), 6. Start Delphi process.
ObjectivesCardiac rehabilitation (CR) programmes are standard of care for patients following a co... more ObjectivesCardiac rehabilitation (CR) programmes are standard of care for patients following a coronary event. While such exercise-based secondary prevention programme do offer benefits, they are used by less than 30% of eligible patients and attrition within these programmes is high. This project is a nested qualitative assessment of a pilot programme considering Tai Chi (TC) as an alternative to CR. We hypothesised that TC may overcome several key barriers to CR.MethodsA semistructured focus group agenda was used to assess three key domains of feasibility: (1) patients’ experiences, (2) reasons/barriers for not having attended CR and (3) any improvements in physical activity and other secondary outcomes (quality of life, weight, sleep). A thematic analysis was used to better understand the key concepts.ResultsThis high-risk group of patients reported that they enjoyed TC exercise, and felt confident and safe doing it. TC practice was reported to support other types of physical act...
Gulf War illness (GWI) is a chronic illness with no known validated biomarkers that affects the l... more Gulf War illness (GWI) is a chronic illness with no known validated biomarkers that affects the lives of hundreds of thousands of people. As a result, there is an urgent need for the development of an untargeted and unbiased method to distinguish GWI patients from non-GWI patients. We report on the application of laser-induced breakdown spectroscopy (LIBS) to distinguish blood plasma samples from a group of subjects with GWI and from subjects with chronic low back pain as controls. We initially obtained LIBS data from blood plasma samples of four GWI patients and four non-GWI patients. We used an analytical method based on taking the difference between a mean LIBS spectrum obtained with those of GWI patients from the mean LIBS spectrum of those of the control group, to generate a “difference” spectrum for our classification model. This model was cross-validated using different numbers of differential LIBS emission peaks. A subset of 17 of the 82 atomic and ionic transitions that pro...
Background There is increasing evidence suggesting that open-label placebo (OLP) is an effective ... more Background There is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients’ experiences with OLP, and no studies have directly compared patients’ experiences in double-blind placebo (DBP) conditions. Methods This study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS). We randomly selected 33 participants for interviews concerning their experiences in the parent trial. The data were qualitatively analyzed using an iterative immersion/crystallization approach. We then compared the qualitative interview data to the quantitative IBS severity data assessed during the parent trial, using a mixed methods approach. Results Two prominent interview themes were identified: (1) the participants’ feelings about their treatment allocation and (2) their reflections about the...
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Papers by Lisa Conboy