Michael Francis Johnston

Evidence-based effect size estimation:An illustration using the case of acupuncture for cancer-related fatigue

BackgroundEstimating a realistic effect size is an important issue in the planning of clinical studies of complementary and alternative medicine therapies. When a minimally important difference is not available, researchers may estimate effect size using the published literature. This evidence-based effect size estimation may be used to produce a range of empirically-informed effect size and consequent sample size estimates. We provide an illustration of deriving plausible effect size ranges for a study of acupuncture in the relief of post-chemotherapy fatigue in breast cancer patients.MethodsA PubMed search identified three uncontrolled studies reporting the effect of acupuncture in relieving fatigue. A separate search identified five randomized controlled trials (RCTs) with a wait-list control of breast cancer patients receiving standard care that reported data on fatigue. We use these published data to produce best, average, and worst-case effect size estimates and related sample size estimates for a trial of acupuncture in the relief of cancer-related fatigue relative to a wait-list control receiving standard care.ResultsUse of evidence-based effect size estimation to calculate sample size requirements for a study of acupuncture in relieving fatigue in breast cancer survivors relative to a wait-list control receiving standard care suggests that an adequately-powered phase III randomized controlled trial comprised of two arms would require at least 101 subjects (52 per arm) if a strong effect is assumed for acupuncture and 235 (118 per arm) if a moderate effect is assumed.ConclusionEvidence-based effect size estimation helps justify assumptions in light of empirical evidence and can lead to more realistic sample size calculations, an outcome that would be of great benefit for the field of complementary and alternative medicine.

Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study.

BackgroundCancer-related fatigue (CRF) is a prominent clinical problem. There are calls for multi-modal interventions.MethodsWe assessed the feasibility of delivering patient education integrated with acupuncture for relief of CRF in a pilot randomized controlled trial (RCT) with breast cancer survivors using usual care as control. Social cognitive and integrative medicine theories guided integration of patient education with acupuncture into a coherent treatment protocol. The intervention consisted of two parts. First, patients were taught to improve self-care by optimizing exercise routines, improving nutrition, implementing some additional evidence-based cognitive behavioral techniques such as stress management in four weekly 50-minute sessions. Second, patients received eight weekly 50-minute acupuncture sessions. The pre-specified primary outcome, CRF, was assessed with the Brief Fatigue Inventory (BFI). Secondary outcomes included three dimensions of cognitive impairment assessed with the FACT-COGv2.ResultsDue to difficulties in recruitment, we tried several methods that led to the development of a tailored recruitment strategy: we enlisted oncologists into the core research team and recruited patients completing treatment from oncology waiting rooms. Compared to usual care control, the intervention was associated with a 2.38-point decline in fatigue as measured by the BFI (90% Confidence Interval from 0.586 to 5.014; p <0.10). Outcomes associated with cognitive dysfunction were not statistically significant.ConclusionsPatient education integrated with acupuncture had a very promising effect that warrants conducting a larger RCT to confirm findings. An effective recruitment strategy will be essential for the successful execution of a larger-scale trial.Trial registrationNCT00646633

HIV/AIDS in China: 1990–2001

China is facing a major crisis because of the increasing epidemics of HIV/AIDS and other sexually transmitted diseases (STDs). The purpose of this paper is to enhance understanding of the crisis by analyzing the capacity of Chinas health care system, its governmental HIV/AIDS policies, and the published literature on the epidemiology of HIV/AIDS during the period 1990–2001. HIV/AIDS and other STDs are rapidly increasing. The situation is urgent and requires comprehensive preventive actions. Chinas health care system is decentralized and underfunded, and access to treatment by the poor is seriously limited. There is a lag in public knowledge and in knowledge among health care workers about HIV/AIDS. The HIV/AIDS epidemic emerged initially in rural areas by means of intravenous drug use. Paid blood donors and blood recipients account for a significant portion of the persons infected by the HIV virus, especially in rural areas. Sexual risk behaviors in rural and urban areas are of increasing importance as a method of transmission of the virus.

Hyper-edges and multidimensional centrality

Abstract Many social transactions are supra-dyadic; they either involve more than two participants (buyer, seller, broker) or they involve important aspects of the interaction’s setting, tike its timing or its location. Standard network techniques do not adequately plumb these networks. Using the concept of a hypergraph [Berge, C. 1973, Graphs and Hypergraphs], this paper shows how the concept of network centrality can be adapted to supra-dyadic networks. Use of the technique is illustrated with data on attacks by inhabitants of Caribbean islands on Spanish settlements in the period 1509–1700.

The Potential of a Person-Centered Approach in Caring for Patients With Cancer: A Perspective From the UCLA Center for East-West Medicine

Background: Evolving patient preferences as well as an expanding evidence base for commonly used complementary and alternative medicine therapies for patients with cancer have led to inroads by integrative medicine into clinical oncology. Traditional Chinese medicine (TCM) has been used in conjunction with conventional biomedicine in the prevention and treatment of cancer in China for several decades. Methods: The authors, through select review of the existing literature and by drawing on clinical experience, describe a person-centered approach to care of patients with cancer that incorporates TCM concepts and techniques. Two cases are used to illustrate how this approach might address unmet needs and enhance quality of life for patients with cancer. Results: TCM’s emphasis on a comprehensive understanding of imbalance in various systems and resultant compromise of homeostatic reserve as well as its ability to treat them with distinctive therapeutic modalities can add unique value to the overall management of the patient with cancer. Conclusions: TCM can be used adjunctively to improve quality of life and functional status during a patient’s struggle with cancer. An approach integrating both medicines that is guided by scientific evidence, safety, and patient preferences has the potential to improve modern oncologic care.

Asthma outcome measures

Asthma is a common chronic disease with underlying inflammation of the airway. Advances in science have led to increased understanding of the heterogeneous nature of asthma and its complex mechanisms. Traditionally, asthma-practice guidelines have focused on optimizing lung function and the US FDA has required increases in lung function and reduction of exacerbation as primary outcomes in clinical trials of new asthma therapeutics. Improved lung function is a critical indicator of bronchodilator therapy, but the importance of long-term asthma control while maintained on controller medication is increasingly emphasized. The NIH asthma guidelines suggest the use of patient-reported outcomes, including health-related quality-of-life measures, to assess asthma control. Clinical practices and research studies concerning asthma can benefit from harmonizing the major outcome measures so that comparisons across studies can be made. In this article, we review common asthma outcome measures with a focus on recent efforts to harmonize outcomes for therapeutic clinical trials in asthma.

Acupuncture for Chemotherapy-Associated Cognitive Dysfunction: A Hypothesis-Generating Literature Review to Inform Clinical Advice

There is an emerging consensus that between one fifth and one half of breast cancer patients experience chemotherapy-associated cognitive dysfunction. Research shows that patients with cancer are often interested in acupuncture for symptom relief. A clinical question thus arises: What should physicians advise their patients regarding the use of acupuncture to alleviate or ameliorate chemotherapy-associated cognitive dysfunction? The authors review and synthesize 2 bodies of relevant research literature: (1) the developing literature on the etiology and nature of chemotherapy-associated cognitive dysfunction and (2) the literature concerning acupuncture for neurological diseases and psychological issues. There is evidence that acupuncture may be effectively used to manage a range of psychoneurological issues, some of which are similar to those experienced by patients with chemotherapy-associated cognitive dysfunction. The evidence of efficacy is more promising for psychological than neurological conditions. Given evidence of possible efficacy combined with evidence of demonstrated safety, we suggest that physicians should support patient decisions to use acupuncture services for chemotherapy-associated cognitive dysfunction, especially given the lack of proven alternatives.

Acupuncture and fatigue: Current basis for shared communication between breast cancer survivors and providers

IntroductionFatigue is the most common symptom reported by survivors of cancer. At present the medical community lacks evidence-based options for its management.Materials and methodsThis paper describes the rationale, current evidence, and research in progress as related to the use of acupuncture as a potential option.ResultsPreliminary evidence suggests that clinicians and cancer survivors may find benefit in considering acupuncture as an option for managing fatigue; this is especially appealing since acupuncture appears to be a safe medical technique. We draw upon our research and clinical experience to generate a description of considerations for patient and provider when thinking about acupuncture as an option for the management of fatigue in non-anemic, disease-free breast cancer survivors.Discussion/conclusionsResearch examining its relative effectiveness and potential for integration with other approaches is a logical next step if the results from RCTs are positive.Implications for cancer survivorsAcupuncture is not routinely considered in mainstream discussions of options for fatigue management. While future research will more clearly determine its relative effectiveness, given the present options available clinicians and breast cancer survivors may find benefit in considering and discussing acupuncture as an approach for managing persistent fatigue.

Scleroderma, stress and CAM utilization.

Scleroderma is an autoimmune disease influenced by interplay among genetic and environmental factors, of which one is stress. Complementary and alternative medicine (CAM) is frequently used to treat stress and those diseases in which stress has been implicated. Results are presented from a survey of patients with scleroderma. Respondents were a convenient sample of those attending a national conference in Las Vegas in 2002. Findings implicate stress in the onset, continuation and exacerbation of scleroderma. The implication is that CAM providers may be filling an important patient need in their provision of services that identify and treat stress and its related disorders.

Elderly patient refractory to multiple pain medications successfully treated with integrative East-West medicine

Background: Polypharmacy is a common and serious problem in the elderly today. Few solutions have been effective in reducing its incidence. Case summary: An 87-year-old female with a history of osteoarthritis and spinal stenosis presented with a five month history of severe right hip pain. She had been seen by multiple specialists and hospitalized many times. During these encounters, she was prescribed a long list of pain medications. However, these medications did not improve her pain and added to her risk of adverse drug events. After exhausting traditional Western medical therapies, she received a referral to the UCLA Center for East–West Medicine. There, clinicians treated her with a nonpharmacological integrative East-West medicine approach that included acupuncture, dry needling of trigger points, and education on self-acupressure. Her pain began improving and she was able to cut back on analgesic use under physician supervision. Ultimately, she improved to the point where she was able to discontinue all of her pain medications. Symptomatic relief was evidenced by improvement in health-related quality of life (HRQOL). Conclusions: This case study suggests that integrative East–West medicine may have the potential to reduce the incidence of polypharmacy in elderly patients presenting with pain conditions and improve their quality of life.