Standard Clinical Trial Research Articles

Computerized cognition assessment during acetylcholinesterase inhibitor treatment in Alzheimer’s disease

Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) has become a standard clinical trials outcome for cognition, but has been recognized as deficient in areas including coverage of cognitive domains, sensitivity and standardization. Computerized test batteries may address some of these issues. The cognitive drug research computerized assessment (CDR) system is validated in Alzheimer's disease (AD). This study was designed to further evaluate validity in relation to ADAS-Cog, mini mental state examination (MMSE) and cerebrospinal fluid (CSF) biomarkers and psychometric properties, in a population of Alzheimer's patients on stable anticholinesterase treatment. Patients completed cognition assessments, CSF and blood sampling at baseline and 6 months later. Data for 65 patients were evaluated. The CDR system demonstrated good psychometric properties in this population. Measures of psychomotor speed showed possible sensitivity to decline over 6 months. There are a number of methodological problems with current cognition assessment methodology for clinical trials. Computerized measures and in particular millisecond reaction time measures, may address many of these issues.

220 The Translational Laboratory Shared Services

The Translational Laboratory Shared Services (TLSS) established at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC) facilitates the preclinical studies (drug screening and in vivo animal models) and clinical development of novel, anticancer agents for patients with skin cancer such as melanoma, breast cancer, lung cancer, multiple myeloma, leukemia and lymphoma. The goals of TLSS are (1) to make preclinical in vitro and in vivo model expertise available to UMGCC members and facilitate translation of novel therapeutic concepts; (2) to add value to advanced preclinical developments of pharmaceutical companies and create a pipeline of new drugs for UMGCC's Phase I and II clinicians; and (3) to provide UMGCC clinicians with the means to perform early clinical trials and assessment of pharmacodynamic endpoints of molecularly targeted drugs. TLSS offers several in vitro assays: proliferation/cytotoxicity assays including MTT, XTT and WST-1 (mitochondrial function), SRB (total cellular protein), propidium iodide staining (total DNA content); proliferation/drug combination assays for single agents and the drug combination; tumor stem cell proliferation assays; in vivo nude mouse assays, including MTD and tissue collection, establishment of tumor xenograft mouse models, pharmacodynamic endpoints efficacy studies, establishment of cell lines from tumors. TLSS offers immunohistochemistry or immunofluorescence, Western blotting, Real time PCR, development of stably transfected cell lines, proteomic and genomic analyses before and after drug treatment. The clinical services include patient sensitivity testing; collection and processing of clinical materials (blood, bone marrow, tissue); development of Standard Operation Procedures (SOPs) and clinical trial protocol. Currently, several clinical Phase I and II trials, with a translational research initiative component, are ongoing. Some of them are sponsored by the National Cancer Institute (NCI). TLSS also provides these services to small biotechnology companies. Future plans for TLSS include services for researchers studying the HIV-1-related tumors such as Kaposi's sarcoma and B lymphoma.

Development and validation of a composite disease activity score for juvenile idiopathic arthritis

To develop and validate a composite disease activity score for juvenile idiopathic arthritis (JIA), the Juvenile Arthritis Disease Activity Score (JADAS). The JADAS includes 4 measures: physician global assessment of disease activity, parent/patient global assessment of well-being, active joint count, and erythrocyte sedimentation rate. These variables are part of the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30), Pedi 50, and Pedi 70 criteria for improvement. Validation analyses were conducted on >4,500 patients and included assessment of construct validity, discriminant validity, and responsiveness to change. Three versions of the JADAS were tested based on 71-joint (range 0-101), 27-joint (range 0-57), or 10-joint (range 0-40) counts. Statistical performances of the JADAS were compared with those of 2 rheumatoid arthritis composite scores, the Disease Activity Score in 28 joints (DAS28) and the Clinical Disease Activity Index (CDAI). The JADAS demonstrated good construct validity, yielding strong correlations with JIA activity measures not included in the score and moderate correlations with the Childhood Health Assessment Questionnaire. Correlations obtained for the 3 JADAS versions were comparable, but superior to those yielded by the DAS28 and CDAI. The area under the curve of the JADAS predicted long-term disease outcome, measured as radiographic progression over 3 years. In 2 clinical trials, the JADAS discriminated well between ACR Pedi 30, Pedi 50, and Pedi 70 response and revealed strong responsiveness to clinical change. The JADAS was found to be a valid instrument for assessment of disease activity in JIA and is potentially applicable in standard clinical care, observational studies, and clinical trials.

Should lifestyle modifications be promoted to prevent breast cancer?

Should lifestyle modifications be promoted to prevent breast cancer?

How do you judge relapse in Crohnʼs disease?

A relapse means worsening of an already diagnosed disease. The mechanism of a relapse is generally believed to follow the routes of the inflammatory cascade of the diseases, although much knowledge is lacking concerning modulation of these mechanisms during treatment. Moreover, the interpretation of a relapse is dependent on the individual situation and characteristics of the patient,1 on the quality of communication between patient and doctor, and the availability of diagnostic tools necessary for an objective judgment. Consequently, the recognition of a relapse and the degree of the relapse are based on the judgment of the patient and/or the doctor during situations that rely on both subjective impression and objective measures. The ultimate importance of the patient/doctor interaction in this setting is the consequence upon change of treatment, whereby the individual treatment schedule and experience related to side effects will have to be taken into consideration. To overcome the individual day-to-day variations and heterogeneity of factors influencing disease activity, clinical trials have included minimum requirements of activity for disease inclusion and relapse. It is therefore obvious that the basis of judgment from standardized clinical trial is different from the basis of judgment in clinical practice. Nevertheless, it is important to keep in mind that the common goal of these different situations is a solid basis for change of treatment.

Evaluation of phase II clinical trials of small molecule targeted inhibitors

14686 Background: Small molecule inhibitors, often cytostatic, pose challenges to phase (ph) II trial paradigms. Randomized ph II studies assessing rates and durations of disease stability, identification of markers for sensitivity and novel endpoints may be required for optimal evaluation. To identify how ph II studies have been conducted and to determine factors affecting trial outcome, we conducted a systemic evaluation of ph II trials of these agents. Methods: Medline search of ph II trials between 2000 to Oct 2007 was conducted. Inclusion criteria were single small molecule inhibitors of known targets, cancers excluding leukemia/lymphoma and in journals with impact factor ≥5. Publications were reviewed and following data were extracted: agent, tumor type, trial design, # patients, endpoint(s), correlative studies, clinical outcome, ph I activities, and whether agent proceeded to ph III. Results: Fifty six of 605 publications met the criteria. The 1° endpoints were response rate in 37 (66%), and progression-free or overall survival rate in 14 (25%). Seven (12.5%) did not have a clear description of statistics. Only 3 (5%) used randomized designs. Correlative studies were reported in 36 (64%). Ten evaluated small numbers of paired pre- post-treatment tumor biopsies, and 10 showed target inhibition or association of tumor characteristics with response. No studies were designed to specifically assess biomarkers as predictive markers. Two (4%) had a biomarker-defined study population. Ten (18%) met pre-determined primary endpoint goals. Among them, 3 (5%) proceeded to ph III and subsequently received FDA approval, 4 tested 2 FDA approved agents in selected patient populations with 2 follow-up ph III trials, and 3 tested novel agents in 3 tumor types without subsequent ph III trials. Conclusions: Most ph II studies of targeted agents used traditional endpoints and designs in histologically defined study populations. The success rates remain low. More studies are required to determine if randomized designs and incorporation of biomarker studies into ph II trials result in more successful ph III trials. Efforts should be made to define optimal design, study populations and biomarker studies for these agents and to improve standardized clinical trial reporting and quality of correlative studies. No significant financial relationships to disclose.

Rates of medial tibiofemoral joint space narrowing in osteoarthritis studies consistent despite methodological differences

Minimum tibiofemoral joint space width in the medial compartment (JSW) is the most well-established structural outcome measure for osteoarthritis (OA) of the knee. Its usefulness as a measure of therapeutic effectiveness in short-term studies is limited by the rate and variability of joint space narrowing (JSN) in the OA population. Microfocal radiography has been shown to improve reproducibility of JSW measurement compared to standard radiography, but measurement of magnification from microfocal knee films has been problematic, and JSN is yet to be investigated in a longitudinal microfocal study. To establish the effect on JSW reproducibility of a new method of magnification measurement in microfocal radiographs. To report on and compare rates of medial tibiofemoral JSN and their variations in the placebo arms of microfocal and standard radiographic clinical trials in OA, using fluoroscopic semi-flexed (SF) knee positioning. To place in the context of published estimates of rates of JSN from comparable studies. Using microfocal radiography, 36 patients were followed at a single centre for 2 years. Using standard radiography, 86 patients were followed for 1 year at a single centre, and 549 for 2 years in a multi-centre international study. Computerised JSW measurement was undertaken using enhanced and automated versions of existing algorithms. Rates of JSN were examined in the context of a review of published rates of JSN using a variety of techniques. Reproducibility of JSW measurement from microfocal radiographs was improved by the new magnification measurement. Rates of JSN were similar across the studies, but more variable when using standard radiography. The rates of JSN were also consistent with those from previously published investigations; all estimates since 2000, bar one, being consistent with the value 0.05 mm/year. Microfocal radiography using the new method lowered the variability of the rate of JSN, but the high cost and low availability of microfocal equipment remains a barrier to its more widespread use. The consistently low but highly variable rates of JSN seen in the review suggest that continued attempts to improve radiographic and mensural techniques are unlikely to significantly reduce required sample sizes.

Relationship of fMRI activation to clinical trial memory measures in Alzheimer disease

Functional MRI (fMRI) has shown promise as a tool to characterize altered brain function in Alzheimer disease (AD) and for use in proof of concept clinical trials. FMRI studies of subjects with AD have demonstrated altered hippocampal and neocortical activation while encoding novel stimuli compared to older controls. However, the relationship between fMRI activation and performance on standardized clinical trial memory measures has not been fully investigated. To determine whether patterns of activation during an associative-memory fMRI paradigm correlate with performance on memory measures used in AD clinical trials. Twenty-nine subjects with AD underwent neuropsychological testing, including the AD Assessment Scale (ADAS-Cog), and an associative-encoding fMRI paradigm. Scores were entered as regressors in SPM2 analyses of the differential fMRI activation to novel-vs-repeated (NvR) stimuli. To account for cerebral atrophy, native-space structure-function analyses were performed with subjects' high-resolution structural images. Performance on the ADAS-Cog verbal memory component, and the ADAS-Cog total score, correlated with NvR activation in left superior temporal (p = 0.0003; r = -0.51) and left prefrontal (p = 0.00001; r = -0.63) cortices. In a subgroup with more extensive neuropsychological testing (n = 14), performance on the Free and Cued Selective Reminding Test was correlated with activation in these same regions. fMRI activation remained correlated with performance even when accounting for atrophy. The relationship between functional MRI (fMRI) activation and standardized memory measures supports the potential use of fMRI to investigate regional mechanisms of treatment response in clinical trials of novel therapies for Alzheimer disease. .

Drug, Light Therapy Show Similar Efficacy in SAD

Back to table of contents Previous article Next article Clinical & Research NewsFull AccessDrug, Light Therapy Show Similar Efficacy in SADLynne LambergLynne LambergSearch for more papers by this authorPublished Online:2 Jun 2006https://doi.org/10.1176/pn.41.11.0025Light therapy and fluoxetine both induced remissions in about half of patients with winter seasonal affective disorder (SAD)—even those who were severely depressed, Canadian researchers found in a double-blind, randomized, controlled trial.Two-thirds of patients using either firstline treatment showed a clinical response, according to Raymond Lam, M.D., a professor of psychiatry and head of clinical neuroscience at the University of British Columbia, Vancouver. The results of the study, known as Can-SAD, were published in the May American Journal of Psychiatry.While light therapy worked a little faster than fluoxetine and triggered slightly fewer patient-reported adverse events in two-month trials, subjects tolerated both treatments well. Absent clear superiority for either light or fluoxetine, patient preference should guide treatment selection, the researchers suggested.“Patients often prefer light therapy, but physicians always wondered whether light was as good as drugs,” Lam told Psychiatric News.“ Now we have evidence to support the decision to use light as a first-choice treatment for patients with winter depression.”The researchers compared the two therapies in 96 adults with SAD at four centers over three winter seasons, 2000-2001 through 2002-2003. Their eight-week treatment protocol is the longest controlled light therapy study to date. It also is the first to run as long as the standard clinical trial for an antidepressant.All participants had moderate to severe depression, as indicated by the Structured Clinical Interview for DSM-IV and scores on Hamilton depression rating scales. None had previously used light therapy or fluoxetine. No subjects were currently taking other psychotropic medications, and none had engaged in formal psychotherapy for three months prior to the study or while participating in it.The researchers randomly assigned 48 eligible subjects to receive active light therapy plus placebo capsules, and 48 to receive placebo light therapy plus fluoxetine.Subjects on active light therapy received daily exposure to 10,000 lux light for 30 minutes as soon as possible after they awakened— the now-standard treatment. The placebo light therapy utilized dim light of only 100 lux on the same schedule. To minimize expectation bias, researchers told patients that the study aimed to examine different wavelengths of light without mentioning intensities.Subjects receiving active medication took 20 mg of fluoxetine in a single daily dose between 7 a.m. and 8 a.m. The identical placebo capsule taken at the same time of day had an inert filler.Board-certified psychiatrists, blinded to treatment assignments, assessed patient response using a variety of Hamilton depression scales. For the study, the researchers defined clinical response as a 50 percent or greater reduction in baseline in 24-item Hamilton depression scale scores at the last visit. They defined clinical remission as a clinical response plus a score of 8 or less.Researchers monitored adverse effects using a self-rated patient scale that assesses frequency and severity of 32 adverse events. This scale provides a broader and more systematic picture than spontaneous self-reports.Forty subjects in the active light treatment group and 40 in the active fluoxetine treatment group completed the study, with the majority improving in all measures over time. The response and remission rates for both active treatments were similar in magnitude to those reported in other placebo-controlled trials.Rates of many adverse events, despite intensive reporting, were lower than 5 percent for both light and fluoxetine treatment.At baseline, the researchers found no differences in expectations for light or drug between subjects assigned to either group. Overall, subjects had higher expectations for light over drug, although not for one light condition over the other.A grant from the Canadian Institutes of Health Research (CIHR) and a CIHR/Wyeth postdoctoral fellowship to one of the researchers funded the study. Up-lift Technologies supplied the light boxes.“The Can-SAD Study: A Randomized Controlled Trial of the Effectiveness of Light Therapy and Fluoxetine in Patients With Winter Seasonal Affective Disorder” is posted at<http://ajp.psychiatryonline.org/cgi/content/full/163/5/805>.▪ ISSUES NewArchived

Editorial: The placebo effect

Editorial: The placebo effect

Statin use in a “real-world” clinical setting: aggressive lipid lowering compared with usual care in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial

Clinical trials that incorporate elements of "real-world" experience are of great value to practicing physicians. Using a trial design adapted to approximate clinical settings, the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial compared a focused treatment strategy using atorvastatin with usual medical care. Patients eligible for study participation were predefined based on diagnosis codes for coronary heart disease from US managed care database records; 66% of these patients were taking lipid-lowering medications at study entry. In contrast to standard clinical trials, ALLIANCE maintained a real-world environment by limiting the interactions of investigators with patients after dose titration of aggressive treatment to a low-density lipoprotein (LDL) cholesterol goal < 80 mg/dL (2.1 mmol/L) or maximum atorvastatin dose of 80 mg/day. After 51.5 months of follow-up, the study showed that aggressive treatment with atorvastatin was associated with significantly lower LDL cholesterol levels (147 mg/dL [3.8 mmol/L] to 95 mg/dL [2.5 mmol/L]) over usual care (146 mg/dL [3.8 mmol/L] to 111 mg/dL [2.9 mmol/L]). This greater reduction in LDL cholesterol was accompanied by improved outcomes in the composite primary end point of cardiovascular events (-17% with atorvastatin vs. usual care; P = 0.02) and particularly in the end point of nonfatal myocardial infarction (-47% with atorvastatin vs. usual care; P = 0.0002). No safety difference was noted between the 2 treatment groups. These results indicate that usual-care treatment was not equivalent to targeted statin therapy, even in a trial conducted to minimize potential bias owing to traditional patient selection and trial design methods.

Unblinding of trial participants to their treatment allocation: lessons from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER)

The gold standard clinical trial design is the double-blind, randomized, controlled trial. No standard practice exists for the "unblinding" of trial participants and no legal obligation is placed on investigators to inform participants of their treatment allocation or study results at the end of a trial. Here we document our experiences of unblinding the 2520 Scottish participants in the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). The objectives of the PROSPER unblinding process were to provide all study participants with their study medication status and on-trial cholesterol levels and to respect the rights of participants not to be unblinded. It was considered imperative by the study executive that the blind was maintained until the presentation and publication of the results. Staff therefore remained "blinded" throughout the unblinding process. Inappropriate contact with the PROSPER participants was avoided by confirming their current vital status and health status. To coincide with the presentation of the PROSPER results, all participants, for whom it was deemed appropriate, were sent a summary of the results and were offered the opportunity to be advised of their treatment allocation and on-trial lipid profiles. The majority of participants opted for telephone unblinding. All primary care physicians who had patients randomised to the study were also sent a summary of the study results and sealed documents detailing the treatment allocation and lipid profiles for each patient. Relocated patients were traced and the information forwarded to their new primary care physicians. The dissemination of study results and treatment allocation to study participants is an integral part of the research process and should be included in the design of any clinical trial.

Behavioral Research and the Double‐Blind Placebo‐Controlled Methodology: Challenges in Applying the Biomedical Standard to Behavioral Headache Research

The randomized, double-blind, placebo-controlled experimental design has prevailed as the "gold standard" in biomedical research, intended to control potential bias in patient/group assignment, investigator allegiance, patient expectations, and nonspecific therapeutic effects. Properly executed, such designs ensure a study's internal validity and allow differential group outcomes to be attributed to the active treatment. These controlled trials generally yield more conservative outcomes than open trials and case reports and establish efficacy in pharmaceutical research. In meta-analytic reviews, studies are often assigned quality scores based in part on the degree to which they meet this scientific standard. Applying the biomedical research design standards for blinding and placebo control to clinical trials evaluating behavioral and other nonpharmacologic headache treatment nearly always is either infeasible or simply not possible. Only rarely is blinding meaningfully achievable in administration of behavioral or psychological therapies. Various "psychological placebo" control conditions have been forwarded in behavioral studies (eg, sham treatments, pseudomeditation), but these controls are incapable of emulating an inert control condition comparable to that of the pill placebo in pharmacologic research, and they are best reserved for studies examining the mechanisms whereby an intervention produces improvement. This article reviews the conceptual and procedural challenges in applying the standard pharmaceutical clinical trials research design to behavioral headache research as well as implications for meta-analyses across studies of various treatment modalities.

Good Review Practices: The First Step Forward for the Korea Food and Drug Administration

Good Review Practices (GRPs) are defined as drug regulatory reviewers’ adherence to pre-specified standards in terms of content and process. GRPs ensure the capture of important information in the review, enabling the standardization of reviews across divisions and disciplines, which results in consistent assessment over the drug development period. Although the Korea Food and Drug Administration has enacted many global standard clinical trial regulations since the late 1990s, it needs more transparent procedures, clearly documented and communicated to the sponsor, with agency wide commitments for recruiting and training quality reviewers. Therefore, establishing GRPs as review standards should be the first step for the Korea Food and Drug Administration. Additionally, third-party clinical review was proposed as an alternative to the current government-centered review system given the difficulty of hiring in-house clinical reviewers for the Korea Food and Drug Administration.

Clinical Trials With Complementary Therapies

As interest in complementary and alternative therapies grows, nurses can expect to be asked for advice regarding their use, but there are few clinical studies on which nurses can base their responses. Conducting research with complementary therapies is therefore important for nursing, but there are some pitfalls in doing research with these products, particularly if one is using standard clinical-trials methods. In this article, the authors outline some of those pitfalls based on their experience conducting a clinical trial to examine the effects of elk velvet antler on symptoms of rheumatoid arthritis. They discuss design issues related to justification, method, and ethics and explore some important regulatory issues of which nurses should be aware. Some recommendations are presented to help nurses engaging in such research to avoid problems that could interfere with the smooth conduct of their studies.

Use of computer-aided detection (CAD) tools in screening mammography: a multidisciplinary investigation

We summarise a set of analyses and studies conducted to assess the effects of the use of a computer-aided detection (CAD) tool in breast screening. We have used an interdisciplinary approach that combines: (a) statistical analyses inspired by reliability modelling in engineering; (b) experimental studies of decisions of mammography experts using the tool, interpreted in the light of human factors psychology; and (c) ethnographic observations of the use of the tool both in trial conditions and in everyday screening practice. Our investigations have shown patterns of human behaviour and effects of computer-based advice that would not have been revealed by a standard clinical trial approach. For example, we found that the negligible measured effect of CAD could be explained by a range of effects on experts' decisions, beneficial in some cases and detrimental in others. There is some evidence of the latter effects being due to the experts using the computer tool differently from the intentions of the developers. We integrate insights from the different pieces of evidence and highlight their implications for the design, evaluation and deployment of this sort of computer tool.

Physician remuneration in industry-sponsored clinical trials: the case for standardized clinical trial budgets.

Physicians who participate in clinical trials can contribute to the evidentiary base for practice and can offer their patients a chance to receive cutting-edge therapies and the close follow-up that often accompanies a trial protocol. As well, trial participation can benefit physicians themselves,

The Link Between Religion and Health: Psychoneuroimmunology and the Faith Factor

Back to table of contents Previous article Next article Book Forum: PsychoneuroimmunologyFull AccessThe Link Between Religion and Health: Psychoneuroimmunology and the Faith FactorWILLIAM R. YATES, M.D., WILLIAM R. YATESSearch for more papers by this author, M.D., Tulsa, Okla.Published Online:1 Mar 2004https://doi.org/10.1176/appi.ajp.161.3.586AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail This book contains 15 chapters written by national experts in a variety of disciplines. Most of the authors participated in a 1999 conference at Duke University to “review the effects of stress on the immune system and see how this knowledge might inform us about the religion-health relationship.”The number of studies supporting beneficial effects for religion on mental health, physical health, and mortality is growing, but no biological mechanism for such an effect has been proven. The editors propose that religion may have a beneficial effect on immune function through the neuroendocrine system’s modulation of the stress response. Several chapters address this hypothesis by examining neuroendocrine and immune function factors in cancer, autoimmune disorders, wound healing, HIV infection, and other infections. Although there are some studies supporting the editors’ hypothesis, clearly there is a long way to go.One of the important research issues addressed in this book is defining the multiple domains that exist under the umbrella of religion. Many early studies examined the role of religious denomination on health. Clearly, this categorization fails to recognize the complex features of religion and faith. The authors note that religious belief, religious behavior (i.e., frequency of church attendance), use of religion in coping, spirituality, and other features of religion may be related more directly to the beneficial effects of religion on health. Potentially important confounding issues, such as lower rates of smoking in church attenders, are also noted in this book. The authors review the psychometric issues involved in many of these religious domains and make specific recommendations for researchers who want to include religion as a descriptive variable.A final chapter summarizes the editors’ recommendation for an agenda for future research in the study of the effects of religion on health. They advocate a series of research projects, some classified as high priority and others classified as most practical. Some of the most practical studies would have a limited cost. For example, adding several measures of religiosity and several immune function markers to standard chemotherapy clinical trials could help examine the relationship between religion and immune response. The editors give additional examples of how “piggybacking” religion assessments may provide valuable information about the effect of religion on disease, health, and treatment response.I would recommend this book for clinical researchers interested in contributing to the study of the role of religion in psychiatry and medicine. Clinicians interested in the relationship between religion and health will also enjoy this summary of the current state of knowledge and glimpse into potential future research studies.Edited by Harold G. Koenig and Harvey Jay Cohen. New York, Oxford University Press, 2002, 304 pp., $35.00. FiguresReferencesCited byDetailsCited ByPeace and Conflict: Journal of Peace Psychology, Vol. 15, No. 4Spirituality in Nursing and Health-Related Literature22 June 2016 | Journal of Holistic Nursing, Vol. 25, No. 4Journal of Muslim Mental Health, Vol. 1, No. 2Peace and Conflict: Journal of Peace Psychology, Vol. 12, No. 3 Volume 161Issue 3 March 2004Pages 586-586 Metrics PDF download History Published online 1 March 2004 Published in print 1 March 2004

Modernity and Technology (review)

Misa, Thomas J., Philip Brey and Andrew Feenberg, eds. Modernity and Technology. MIT Press, 2003. Four of eleven papers in this collection perhaps can most usefully structure readings of this volume: David Hess and Arthur Mol describe evolving loci of (complementary or alternative medicine) and environmentalism, respectively; Johan Schot and Haider Khan, provide comparative, longer-term histories to understand these shifts. Together four prepare ground for what Ulrich Beck (a frequent reference) calls reflexive or second order modernization, and for how this differs from nineteenth century socialist or twentieth century social democratic and modernization theory. The editors and several contributors claim that they want to bridge gap between theories of modernity which they claim are not empirical or able to deal with micro level data, and histories of technology which are good at micro level contingencies but are not theoretical. The four papers mentioned demonstrate otherwise, and one is struck by how other papers fail to seriously engage with such traditional heuristics for dealing with the gap as contradictions between forces of production (technology) and relations of production (e.g. legal notions of property rights and public goods) in Marxist tradition (as Schot and Khan explore), alternative modernities in current development literature (as Schot, Murata, Hess, and Mol explore), systematic and increasing underdevelopment in 1970s literature on Africa and Latin America (and recent literature on foreign aid, NGOs, and failures of capacity building), dual economies, and so on, all of which intimately involve detailed and micro histories of many technologies. A number of papers cite Marx, Weber, Habermas, Beck, Giddens, and others, but systematically erase technological and historical contexts of their writing and heuristic concept formation. Having studied CAM for cancer patients (and spiritualist healing in Brazil), Hess is able to describe mainstreaming of CAM as a social movement, limited by testing, regulation, and licensing. Practitioners are in hospitals, but at a cost of (i) status deprivation to being auxiliaries like nurses or physical therapists, (ii) support mainly for therapies that complement conventional medicine, (iii) acceptance of those medicinals that meet both profitability and regulatory standards. CAM comes from many cultural backgrounds-U.S. chiropractic, Indian Ayurveda, Chinese acupuncture, Japanese macrobiotics, Central European anthrosophy-all contributing to a larger ecological-biological-health framework. CAM has spawned legislative reforms (access to care laws), has raised again value of retrospective cohort studies and best case series against gold standard (and expensive) clinical trial methods. Mol provides a parallel account of mainstreaming perspectives into industrial and capitalist social formations, using chemical industry as an index. He sketches four environmentalist frameworks, of which most robust seem to be neo-Marxist notion of crises producing contradictions within capitalism that militating towards new forces and relations of production; and similar but more Weberian notion of an emergent semi-autonomous sphere of ecological governance (1980s environmental ministries, regulations, monitoring, auditing, NGOs, and periodicals). The largest European chemical companies have introduced environmental management systems, with annual audits, certification, increasing expenditures on green RD PCV has been losing market share to PP and PE products. These pressures now have global reach. …

Challenges and Pitfalls in Clinical Trials of Treatments for Dry Eye

Clinical trials to evaluate the effectiveness of therapy for dry eye disease are challenging because of the nature of the disease, the multiple palliative methods used by patients to control their symptoms, and the potential limitations of the techniques available to evaluate therapeutic outcomes. This review identifies some of the pitfalls encountered in recent clinical trials in dry eye disease. The peculiarities of dry eye disease with respect to symptoms, signs, and pathophysiological changes are discussed. Potential problems that apply to all clinical trials, including patient selection, randomization in small populations, and assessment of the placebo effect, are presented with respect to dry eye clinical trials. Considerations regarding study design address inclusion/exclusion criteria and selection of outcome measures. Special attention is given to methods of symptom analysis, techniques of staining of the ocular surface, and grading systems for surface staining. Alternative methods to the standard clinical trial are mentioned to place them in perspective for overall evaluation of dry eye disease therapy. Finally, caveats are provided to encourage investigators to vigorously conduct future clinical trials in dry eye therapy.