Background: Mass anti-malarial administration has been proposed as a key component of the Plasmod... more Background: Mass anti-malarial administration has been proposed as a key component of the Plasmodium falci-parum malaria elimination strategy in the Greater Mekong sub-Region. Its effectiveness depends on high levels of coverage in the target population. This article explores the factors that influenced mass anti-malarial administration coverage within a clinical trial in Battambang Province, western Cambodia. Methods: Qualitative data were collected through semi-structured interviews and focus group discussions with villagers, in-depth interviews with study staff, trial drop-outs and refusers, and observations in the communities. Interviews were audio-recorded, transcribed and translated from Khmer to English for qualitative content analysis using QSR NVivo. Results: Malaria was an important health concern and villagers reported a demand for malaria treatment. This was in spite of a fall in incidence over the previous decade and a lack of familiarity with asymptomatic malaria. Participants generally understood the overall study aim and were familiar with study activities. Comprehension of the study rationale was however limited. After the first mass anti-malarial administration, seasonal health complaints that participants attributed to the anti-malarial as " side effects " contributed to a decrease of coverage in round two. Staff therefore adapted the community engagement approach, bringing to prominence local leaders in village meetings. This contributed to a subsequent increase in coverage. Conclusion: Future mass anti-malarial administration must consider seasonal disease patterns and the importance of local leaders taking prominent roles in community engagement. Further research is needed to investigate coverage in scenarios that more closely resemble implementation i.e. without participation incentives, blood sampling and free healthcare.
Journal of Chromatography B: Biomedical Sciences and Applications, 2000
A simple, sensitive and reproducible high-performance liquid chromatography (HPLC) method was dev... more A simple, sensitive and reproducible high-performance liquid chromatography (HPLC) method was developed for the determination of terazosin in human plasma. The method involves a one-step single solvent extraction procedure using dichloromethane with a 0.25 ml plasma sample. Recovery values were all greater than 90% over the concentration range 0.25–100 ng/ml. Terazosin was found to adsorb to glass or plastic tubes,
Background: Community engagement is increasingly promoted as a marker of good, ethical practice i... more Background: Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. Methods: In this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.
Authoritative international guidelines stipulate that for minors to participate in research, cons... more Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. These populations are under-represented in all types of clinical research. We propose that, for research with a prospect of direct benefit that has been approved by relevant ethics committees, the default position should be that minors who are able to provide valid consent and meet the following criteria should be able to consent for themselves regardless of age and whether they have reached majority: the minor must be competent and mature relative to the decision; their consent must be voluntary and they must be relatively ...
To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other th... more To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome. A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alpha-blockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment. Of the 43 patients ...
Background Emergence of artemisinin resistance in southeast Asia poses a serious threat to the gl... more Background Emergence of artemisinin resistance in southeast Asia poses a serious threat to the global control of Plasmodium falciparum malaria. Discovery of the K13 marker has transformed approaches to the monitoring of artemisinin resistance, allowing introduction of molecular surveillance in remote areas through analysis of DNA. We aimed to assess the spread of artemisinin-resistant P falciparum in Myanmar by determining the relative prevalence of P falciparum parasites carrying K13-propeller mutations.
BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) afflicts 2%-10% of adult m... more BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) afflicts 2%-10% of adult men. Available therapies offer little or no proven benefit. Because acupuncture represents an attractive "natural" therapy, we compared the efficacy of acupuncture to sham acupuncture for CP/CPPS. METHODS: Participants met US National Institutes of Health (NIH) consensus criteria for CP/CPPS, were aged Ն20 years old, and had a total score Ն15 on the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and symptoms for at least 3 of the preceding 6 months. They were randomized 1:1 to acupuncture or sham acupuncture. Treatment consisted of twice-weekly 30-minute sessions for 10 weeks (20 sessions total) without needle stimulation, herbs, or adjuvants. The primary response criterion was a 6-point decrease from baseline to week 10 in NIH-CPSI total score (range 0-43). RESULTS: Thirty-two (73%) of 44 participants responded in the acupuncture group compared with 21 (47%) of 45 sham group participants (relative risk 1.81, 95% confidence interval, 1.3-3.1, P ϭ .02). Long-term responses 24 weeks after completing therapy without additional treatment occurred in 14 (32%) of 44 acupuncture group participants and in 6 (13%) of 45 sham group participants (relative risk 2.39, 95% confidence interval, 1.0-5.6, P ϭ .04). CONCLUSIONS: After 10 weeks of treatment, acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms. Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture.
Little is known about how primary care physicians (PCPs) in Asia diagnose and manage prostatitis-... more Little is known about how primary care physicians (PCPs) in Asia diagnose and manage prostatitis-like symptoms. This study investigated the clinical diagnosis of and care provided for prostatitis-like symptoms by PCPs in a Malaysian population, and compared these findings to reports from other areas. All members of the Penang Private Medical Practitioners' Society were asked to complete a self-administered survey. Nonresponders were contacted after 3 weeks and received a telephone request after 6 weeks. Of the 786 practitioners contacted, 669 considered themselves to be PCPs, including 279 (42%) who responded to the survey. Adult males with prostatitis-like symptoms typically constitute <1% of the patients seen by PCPs. Most PCPs (72%) believe that prostatitis-like symptoms are caused by bacterial infection. 61% of PCPs base their diagnosis of prostatitis-like symptoms on clinical history, a physical examination and dipstick urinalysis. Standard management was to prescribe 1 or 2 courses of antimicrobials. Despite the 8.7% prevalence found in a previous survey in this population, prostatitis remains underdiagnosed in Malaysia. In contrast to many other clinical settings, urologists in Malaysia see a large proportion of newly diagnosed and treatment-naive prostatitis patients, providing an opportunity for clinical diagnostic and treatment studies.
Background: In response to calls to expand the scope of research ethics to address justice in glo... more Background: In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
Yoel Lubell and colleagues consider ethical and economic perspectives on mass drug administration... more Yoel Lubell and colleagues consider ethical and economic perspectives on mass drug administration of primaquine to limit transmission of P. falciparum malaria. Please see later in the article for the Editors' Summary.
Background: Existing evidence suggests that there is often limited understanding among participan... more Background: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial.
Objectives. To determine the prevalence, severity, and quality-of-life (QOL) impact of female low... more Objectives. To determine the prevalence, severity, and quality-of-life (QOL) impact of female lower urinary tract symptoms (FLUTS); to determine the patterns, reasons, and factors contributing to the women's treatment-seeking behavior; and to describe the relationship between the social demographic characteristics and FLUTS. Methods. A total of 2732 women older than 19 years of age were recruited by a series of FLUTS Awareness Campaigns held within Northern Malaysia from January to August 2004. Trained interviewers used surveys to collect information on social demographic characteristics, International Prostate Symptom Score, and King's Health Questionnaire to determine the prevalence, severity, QOL impact, treatment-seeking behavior, and risk factors of FLUTS. Results. The prevalence of FLUTS was 19.0% (n ϭ 519), with 88.6% having moderate and 11.4% severe FLUTS. Using the International Prostate Symptom Score QOL assessment index, 55.3% (n ϭ 287) scored 4 or greater. Using the King's Health Questionnaire, the most affected QOL domain was sleep/energy. The patterns of treatment-seeking behavior revealed that only 23.1% (n ϭ 120) of patients with FLUTS actively sought treatment. The major reason for those (76.9%) who failed to seek treatment was that they did not perceive FLUTS as a major health problem (29.1%). Factors that warranted treatment were the severity, bother, and QOL impact of FLUTS (all P Ͻ0.001), hematuria (P Ͻ0.001), age (P Ͻ0.005), parity, body mass index, and suprapubic pain (all P Ͻ0.05). The risk factors for FLUTS (defined as an odds ratio of 2 or more) included age 50 years or older, parity of 4 or more, illiteracy, postmenopausal status, and the presence of one or more concomitant chronic medical illness. Conclusions. Despite the high prevalence of FLUTS in Northern Malaysia (19.0%), many patients do not seek treatment, with ignorance being the major reason. UROLOGY 68: 751-758, 2006.
We review new data on the epidemiology of chronic prostatitis. These population-based studies use... more We review new data on the epidemiology of chronic prostatitis. These population-based studies used reasonable case-definitions to survey various populations from North America, Europe and Asia. Overall, 2-10% of adult men suffer from symptoms compatible with chronic prostatitis at any time and approximately 15% of men suffer from symptoms of prostatitis at some point in their lives. Other epidemiologic data suggest that chronic prostatitis may be associated with an increased risk for development of benign prostatic hyperplasia and prostate cancer. These data suggest that chronic prostatitis is an important international health care problem that merits increased priority from clinicians and researchers.
The objective of the study is to determine the short- and long-term utility of the Chinese, Malay... more The objective of the study is to determine the short- and long-term utility of the Chinese, Malay and English versions of the National Institutes of Health--Chronic Prostatitis Symptom Index (NIH-CPSI) in our ethnically diverse population. The NIH-CPSI was translated into Chinese and Malay, and then verified by back translation into English. Subjects included 100 new chronic prostatitis/chronic pelvic pain (CP/CPPS) patients, 71 new benign prostatic hyperplasia patients and 97 healthy individuals. Reliability was evaluated with test-retest reproducibility (TR) by calculating intraclass correlation coefficients (ICC). Internal consistency was evaluated by calculating Cronbach's alpha (alpha). Validity assessments included discriminant and construct validity. (Presented in the order of Chinese, Malay then English). ICC values for short-term (1 week) TR were 0.90, 0.80 and 0.89, while ICC values for long-term (14 weeks) TR were 0.54, 0.61 and 0.61. Cronbach's alpha values were 0.63, 0.62 and 0.57. The NIH-CPSI total score discriminated CP/CPPS patients (P<0.001) from the control groups with receiver operating curve values of 0.95, 0.98 and 0.94, respectively. Construct validity, reflected by the correlation coefficient values between the International Prostate Symptom Score and the NIH-CPSI of CP/CPPS patients were 0.72, 0.49 and 0.63 (all P<0.05). The Chinese, Malay and English versions of the NIH-CPSI each proved effective in our population. Short-term TR and discriminant validity were excellent for all three versions. However, long-term TR was only moderate, which might reflect variation in patients' perceptions of symptoms over time.
To determine the prevalence of chronic prostatitis/chronic pelvic pain syndrome (National Institu... more To determine the prevalence of chronic prostatitis/chronic pelvic pain syndrome (National Institutes of Health Category III prostatitis) in Penang, Malaysia and estimate the proportion of cases ascertained by population survey that met consensus clinical criteria for "chronic prostatitis." Methods. One percent of 20 to 50-year-old men in Penang, Malaysia were surveyed using the National Institutes of Health Chronic Prostatitis Symptom Index. A clinical evaluation that included lower urinary tract localization studies was recommended for symptomatic subjects who met the survey definition to identify bacterial prostatitis and other diagnoses that would exclude them from the consensus clinical definition for chronic prostatitis (Category III). Results. Of 3147 subjects surveyed, 275 (8.7%) met the survey criteria for chronic prostatitis. The prevalence of chronic prostatitis was 8.0% among Malays, 8.9% among non-Malays, and 16% among noncitizens (P ϭ 0.025). The prevalence increased with age: 6.3% in 20 to 30-year-old men, 8.9% in 31 to 40-year-old men, and 12.6% in 41 to 50-year-old men (P Ͻ0.001). Of 87 subjects evaluated clinically, 65 (75%) met the consensus clinical criteria for chronic prostatitis. Conclusions. Chronic prostatitis represents an important, international healthcare problem. A thorough clinical evaluation is necessary to verify that chronic prostatitis is indeed responsible for a patient's pelvic pain and lower urinary tract symptoms. UROLOGY 61: 60-64, 2003.
Objectives. To evaluate the initial, long-term, and durable response rates to terazosin, placebo,... more Objectives. To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome. Methods. A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alphablockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment. Results. Of the 43 patients in the terazosin group, 24 (56%) had an initial response compared with 14 (33%) of 43 subjects in the placebo group (P ϭ 0.03). Long-term responses were noted in 23 (56%) of 41 assessable subjects treated with terazosin initially compared with 12 (32%) of 38 assessable subjects treated with placebo (P ϭ 0.03). Of the nonresponders and initial responders with relapse, 7 (41%) of 17 subjects responded to terazosin compared with 7 (21%) of 34 given other treatment (P ϭ 0.12). Durable responses occurred in 18 (44%) of the 41 assessable patients treated initially with terazosin and in 6 (16%) of 38 treated initially with placebo (P ϭ 0.01). Conclusions. Patients treated with terazosin were more likely to have initial, long-term, and durable responses than those treated with placebo. UROLOGY 64: 881-886, 2004.
To examine the prevalence, characteristics, and impact of sexual dysfunction in our primary care ... more To examine the prevalence, characteristics, and impact of sexual dysfunction in our primary care referral population.
Background: There are very few drugs that prevent the relapse of Plasmodium vivax malaria in man.... more Background: There are very few drugs that prevent the relapse of Plasmodium vivax malaria in man. Tinidazole is a 5-nitroimidazole approved in the USA for the treatment of indications including amoebiasis and giardiasis. In the non-human primate relapsing Plasmodium cynomolgi/macaque malaria model, tinidazole cured one of six macaques studied with an apparent mild delay to relapse in the other five of 14-28 days compared to 11-12 days in controls. One study has demonstrated activity against P. vivax in man. Presented here are the results of a pilot phase II, randomized, open-label study conducted along the Thai-Myanmar border designed to evaluate the efficacy of tinidazole to prevent relapse of P. vivax when administered with chloroquine. Methods: This study utilized a modified triangular test sequential analysis which allows repeated statistical evaluation during the course of enrolment while maintaining a specified power and type 1 error and minimizing recruitment of subjects. Enrolment was to be halted when a pre-specified success/failure ratio was surpassed. The study was designed to have a 5% type 1 error and 90% power to show whether tinidazole would produce a relapse rate of less than 20% or greater than 45% through Day 63 of weekly follow-up after initiation of treatment and initial parasite clearance with 3 days of an oral weight based dosing of chloroquine and five days of 2 grams/ day of tinidazole.
Background: Mass anti-malarial administration has been proposed as a key component of the Plasmod... more Background: Mass anti-malarial administration has been proposed as a key component of the Plasmodium falci-parum malaria elimination strategy in the Greater Mekong sub-Region. Its effectiveness depends on high levels of coverage in the target population. This article explores the factors that influenced mass anti-malarial administration coverage within a clinical trial in Battambang Province, western Cambodia. Methods: Qualitative data were collected through semi-structured interviews and focus group discussions with villagers, in-depth interviews with study staff, trial drop-outs and refusers, and observations in the communities. Interviews were audio-recorded, transcribed and translated from Khmer to English for qualitative content analysis using QSR NVivo. Results: Malaria was an important health concern and villagers reported a demand for malaria treatment. This was in spite of a fall in incidence over the previous decade and a lack of familiarity with asymptomatic malaria. Participants generally understood the overall study aim and were familiar with study activities. Comprehension of the study rationale was however limited. After the first mass anti-malarial administration, seasonal health complaints that participants attributed to the anti-malarial as " side effects " contributed to a decrease of coverage in round two. Staff therefore adapted the community engagement approach, bringing to prominence local leaders in village meetings. This contributed to a subsequent increase in coverage. Conclusion: Future mass anti-malarial administration must consider seasonal disease patterns and the importance of local leaders taking prominent roles in community engagement. Further research is needed to investigate coverage in scenarios that more closely resemble implementation i.e. without participation incentives, blood sampling and free healthcare.
Journal of Chromatography B: Biomedical Sciences and Applications, 2000
A simple, sensitive and reproducible high-performance liquid chromatography (HPLC) method was dev... more A simple, sensitive and reproducible high-performance liquid chromatography (HPLC) method was developed for the determination of terazosin in human plasma. The method involves a one-step single solvent extraction procedure using dichloromethane with a 0.25 ml plasma sample. Recovery values were all greater than 90% over the concentration range 0.25–100 ng/ml. Terazosin was found to adsorb to glass or plastic tubes,
Background: Community engagement is increasingly promoted as a marker of good, ethical practice i... more Background: Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. Methods: In this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.
Authoritative international guidelines stipulate that for minors to participate in research, cons... more Authoritative international guidelines stipulate that for minors to participate in research, consent must be obtained from their parents or guardians. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. These populations are under-represented in all types of clinical research. We propose that, for research with a prospect of direct benefit that has been approved by relevant ethics committees, the default position should be that minors who are able to provide valid consent and meet the following criteria should be able to consent for themselves regardless of age and whether they have reached majority: the minor must be competent and mature relative to the decision; their consent must be voluntary and they must be relatively ...
To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other th... more To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome. A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alpha-blockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment. Of the 43 patients ...
Background Emergence of artemisinin resistance in southeast Asia poses a serious threat to the gl... more Background Emergence of artemisinin resistance in southeast Asia poses a serious threat to the global control of Plasmodium falciparum malaria. Discovery of the K13 marker has transformed approaches to the monitoring of artemisinin resistance, allowing introduction of molecular surveillance in remote areas through analysis of DNA. We aimed to assess the spread of artemisinin-resistant P falciparum in Myanmar by determining the relative prevalence of P falciparum parasites carrying K13-propeller mutations.
BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) afflicts 2%-10% of adult m... more BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) afflicts 2%-10% of adult men. Available therapies offer little or no proven benefit. Because acupuncture represents an attractive "natural" therapy, we compared the efficacy of acupuncture to sham acupuncture for CP/CPPS. METHODS: Participants met US National Institutes of Health (NIH) consensus criteria for CP/CPPS, were aged Ն20 years old, and had a total score Ն15 on the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and symptoms for at least 3 of the preceding 6 months. They were randomized 1:1 to acupuncture or sham acupuncture. Treatment consisted of twice-weekly 30-minute sessions for 10 weeks (20 sessions total) without needle stimulation, herbs, or adjuvants. The primary response criterion was a 6-point decrease from baseline to week 10 in NIH-CPSI total score (range 0-43). RESULTS: Thirty-two (73%) of 44 participants responded in the acupuncture group compared with 21 (47%) of 45 sham group participants (relative risk 1.81, 95% confidence interval, 1.3-3.1, P ϭ .02). Long-term responses 24 weeks after completing therapy without additional treatment occurred in 14 (32%) of 44 acupuncture group participants and in 6 (13%) of 45 sham group participants (relative risk 2.39, 95% confidence interval, 1.0-5.6, P ϭ .04). CONCLUSIONS: After 10 weeks of treatment, acupuncture proved almost twice as likely as sham treatment to improve CP/CPPS symptoms. Participants receiving acupuncture were 2.4-fold more likely to experience long-term benefit than were participants receiving sham acupuncture.
Little is known about how primary care physicians (PCPs) in Asia diagnose and manage prostatitis-... more Little is known about how primary care physicians (PCPs) in Asia diagnose and manage prostatitis-like symptoms. This study investigated the clinical diagnosis of and care provided for prostatitis-like symptoms by PCPs in a Malaysian population, and compared these findings to reports from other areas. All members of the Penang Private Medical Practitioners' Society were asked to complete a self-administered survey. Nonresponders were contacted after 3 weeks and received a telephone request after 6 weeks. Of the 786 practitioners contacted, 669 considered themselves to be PCPs, including 279 (42%) who responded to the survey. Adult males with prostatitis-like symptoms typically constitute <1% of the patients seen by PCPs. Most PCPs (72%) believe that prostatitis-like symptoms are caused by bacterial infection. 61% of PCPs base their diagnosis of prostatitis-like symptoms on clinical history, a physical examination and dipstick urinalysis. Standard management was to prescribe 1 or 2 courses of antimicrobials. Despite the 8.7% prevalence found in a previous survey in this population, prostatitis remains underdiagnosed in Malaysia. In contrast to many other clinical settings, urologists in Malaysia see a large proportion of newly diagnosed and treatment-naive prostatitis patients, providing an opportunity for clinical diagnostic and treatment studies.
Background: In response to calls to expand the scope of research ethics to address justice in glo... more Background: In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework-'research for health justice'-was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework.
Yoel Lubell and colleagues consider ethical and economic perspectives on mass drug administration... more Yoel Lubell and colleagues consider ethical and economic perspectives on mass drug administration of primaquine to limit transmission of P. falciparum malaria. Please see later in the article for the Editors' Summary.
Background: Existing evidence suggests that there is often limited understanding among participan... more Background: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial.
Objectives. To determine the prevalence, severity, and quality-of-life (QOL) impact of female low... more Objectives. To determine the prevalence, severity, and quality-of-life (QOL) impact of female lower urinary tract symptoms (FLUTS); to determine the patterns, reasons, and factors contributing to the women's treatment-seeking behavior; and to describe the relationship between the social demographic characteristics and FLUTS. Methods. A total of 2732 women older than 19 years of age were recruited by a series of FLUTS Awareness Campaigns held within Northern Malaysia from January to August 2004. Trained interviewers used surveys to collect information on social demographic characteristics, International Prostate Symptom Score, and King's Health Questionnaire to determine the prevalence, severity, QOL impact, treatment-seeking behavior, and risk factors of FLUTS. Results. The prevalence of FLUTS was 19.0% (n ϭ 519), with 88.6% having moderate and 11.4% severe FLUTS. Using the International Prostate Symptom Score QOL assessment index, 55.3% (n ϭ 287) scored 4 or greater. Using the King's Health Questionnaire, the most affected QOL domain was sleep/energy. The patterns of treatment-seeking behavior revealed that only 23.1% (n ϭ 120) of patients with FLUTS actively sought treatment. The major reason for those (76.9%) who failed to seek treatment was that they did not perceive FLUTS as a major health problem (29.1%). Factors that warranted treatment were the severity, bother, and QOL impact of FLUTS (all P Ͻ0.001), hematuria (P Ͻ0.001), age (P Ͻ0.005), parity, body mass index, and suprapubic pain (all P Ͻ0.05). The risk factors for FLUTS (defined as an odds ratio of 2 or more) included age 50 years or older, parity of 4 or more, illiteracy, postmenopausal status, and the presence of one or more concomitant chronic medical illness. Conclusions. Despite the high prevalence of FLUTS in Northern Malaysia (19.0%), many patients do not seek treatment, with ignorance being the major reason. UROLOGY 68: 751-758, 2006.
We review new data on the epidemiology of chronic prostatitis. These population-based studies use... more We review new data on the epidemiology of chronic prostatitis. These population-based studies used reasonable case-definitions to survey various populations from North America, Europe and Asia. Overall, 2-10% of adult men suffer from symptoms compatible with chronic prostatitis at any time and approximately 15% of men suffer from symptoms of prostatitis at some point in their lives. Other epidemiologic data suggest that chronic prostatitis may be associated with an increased risk for development of benign prostatic hyperplasia and prostate cancer. These data suggest that chronic prostatitis is an important international health care problem that merits increased priority from clinicians and researchers.
The objective of the study is to determine the short- and long-term utility of the Chinese, Malay... more The objective of the study is to determine the short- and long-term utility of the Chinese, Malay and English versions of the National Institutes of Health--Chronic Prostatitis Symptom Index (NIH-CPSI) in our ethnically diverse population. The NIH-CPSI was translated into Chinese and Malay, and then verified by back translation into English. Subjects included 100 new chronic prostatitis/chronic pelvic pain (CP/CPPS) patients, 71 new benign prostatic hyperplasia patients and 97 healthy individuals. Reliability was evaluated with test-retest reproducibility (TR) by calculating intraclass correlation coefficients (ICC). Internal consistency was evaluated by calculating Cronbach's alpha (alpha). Validity assessments included discriminant and construct validity. (Presented in the order of Chinese, Malay then English). ICC values for short-term (1 week) TR were 0.90, 0.80 and 0.89, while ICC values for long-term (14 weeks) TR were 0.54, 0.61 and 0.61. Cronbach's alpha values were 0.63, 0.62 and 0.57. The NIH-CPSI total score discriminated CP/CPPS patients (P<0.001) from the control groups with receiver operating curve values of 0.95, 0.98 and 0.94, respectively. Construct validity, reflected by the correlation coefficient values between the International Prostate Symptom Score and the NIH-CPSI of CP/CPPS patients were 0.72, 0.49 and 0.63 (all P<0.05). The Chinese, Malay and English versions of the NIH-CPSI each proved effective in our population. Short-term TR and discriminant validity were excellent for all three versions. However, long-term TR was only moderate, which might reflect variation in patients' perceptions of symptoms over time.
To determine the prevalence of chronic prostatitis/chronic pelvic pain syndrome (National Institu... more To determine the prevalence of chronic prostatitis/chronic pelvic pain syndrome (National Institutes of Health Category III prostatitis) in Penang, Malaysia and estimate the proportion of cases ascertained by population survey that met consensus clinical criteria for "chronic prostatitis." Methods. One percent of 20 to 50-year-old men in Penang, Malaysia were surveyed using the National Institutes of Health Chronic Prostatitis Symptom Index. A clinical evaluation that included lower urinary tract localization studies was recommended for symptomatic subjects who met the survey definition to identify bacterial prostatitis and other diagnoses that would exclude them from the consensus clinical definition for chronic prostatitis (Category III). Results. Of 3147 subjects surveyed, 275 (8.7%) met the survey criteria for chronic prostatitis. The prevalence of chronic prostatitis was 8.0% among Malays, 8.9% among non-Malays, and 16% among noncitizens (P ϭ 0.025). The prevalence increased with age: 6.3% in 20 to 30-year-old men, 8.9% in 31 to 40-year-old men, and 12.6% in 41 to 50-year-old men (P Ͻ0.001). Of 87 subjects evaluated clinically, 65 (75%) met the consensus clinical criteria for chronic prostatitis. Conclusions. Chronic prostatitis represents an important, international healthcare problem. A thorough clinical evaluation is necessary to verify that chronic prostatitis is indeed responsible for a patient's pelvic pain and lower urinary tract symptoms. UROLOGY 61: 60-64, 2003.
Objectives. To evaluate the initial, long-term, and durable response rates to terazosin, placebo,... more Objectives. To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome. Methods. A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alphablockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment. Results. Of the 43 patients in the terazosin group, 24 (56%) had an initial response compared with 14 (33%) of 43 subjects in the placebo group (P ϭ 0.03). Long-term responses were noted in 23 (56%) of 41 assessable subjects treated with terazosin initially compared with 12 (32%) of 38 assessable subjects treated with placebo (P ϭ 0.03). Of the nonresponders and initial responders with relapse, 7 (41%) of 17 subjects responded to terazosin compared with 7 (21%) of 34 given other treatment (P ϭ 0.12). Durable responses occurred in 18 (44%) of the 41 assessable patients treated initially with terazosin and in 6 (16%) of 38 treated initially with placebo (P ϭ 0.01). Conclusions. Patients treated with terazosin were more likely to have initial, long-term, and durable responses than those treated with placebo. UROLOGY 64: 881-886, 2004.
To examine the prevalence, characteristics, and impact of sexual dysfunction in our primary care ... more To examine the prevalence, characteristics, and impact of sexual dysfunction in our primary care referral population.
Background: There are very few drugs that prevent the relapse of Plasmodium vivax malaria in man.... more Background: There are very few drugs that prevent the relapse of Plasmodium vivax malaria in man. Tinidazole is a 5-nitroimidazole approved in the USA for the treatment of indications including amoebiasis and giardiasis. In the non-human primate relapsing Plasmodium cynomolgi/macaque malaria model, tinidazole cured one of six macaques studied with an apparent mild delay to relapse in the other five of 14-28 days compared to 11-12 days in controls. One study has demonstrated activity against P. vivax in man. Presented here are the results of a pilot phase II, randomized, open-label study conducted along the Thai-Myanmar border designed to evaluate the efficacy of tinidazole to prevent relapse of P. vivax when administered with chloroquine. Methods: This study utilized a modified triangular test sequential analysis which allows repeated statistical evaluation during the course of enrolment while maintaining a specified power and type 1 error and minimizing recruitment of subjects. Enrolment was to be halted when a pre-specified success/failure ratio was surpassed. The study was designed to have a 5% type 1 error and 90% power to show whether tinidazole would produce a relapse rate of less than 20% or greater than 45% through Day 63 of weekly follow-up after initiation of treatment and initial parasite clearance with 3 days of an oral weight based dosing of chloroquine and five days of 2 grams/ day of tinidazole.
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