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The problem of measurement error in modelling the effect of compliance in a randomized trial

STATISTICS IN MEDICINE 1999年第21期18卷 2863-2877页

作者： Dunn, G Univ Manchester Sch Epidemiol & Hlth Sci Biostat Grp Hlth Care Trials Unit Manchester M13 9PT Lancs England

This paper explores the implications of measurement error in the analysis of compliance-response relationships in data from randomized trials. Given that compliance measures are rarely, if ever, error-free indicators of exposure it is argued that both the designs for the collection of compliance data and the statistical models for their resulting analysis should be changed to take the possibility of measurement error into account. An analysis which ignores measurement error in the compliance measurements will provide biased estimates of compliance-response relationships. Provided that one has two or more indicators of compliance for each subject, more appropriate models can be fitted using covariance structure modelling software. If one wishes to explore interactions from repeated measures data on both compliance and response then it is also important that one recognizes that the response measures are also error-prone and that they too are dealt with appropriately. Copyright (C) 1999 John Whey & Sons, Ltd.

关键词：计算机模拟线性模型模型统计学病人依从/统计学和数值数据随机对照试验(主题)/统计学和数值数据人类

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Consequences and determinants of adherence to antiretroviral medication: results from Adult AIDS Clinical Trials Group protocol 370

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ANTIVIRAL THERAPY 2002年第3期7卷 185-193页

作者： Ickovics, JR Cameron, A Zackin, R Bassett, R Chesney, M Johnson, VA Kuritzkes, DR Yale Univ Sch Med Dept Epidemiol & Publ Hlth New Haven CT 06510 USA Yale Ctr Interdisciplinary Res AIDS New Haven CT USA Harvard Univ Sch Publ Hlth Ctr Biostat AIDS Res Boston MA 02115 USA Univ Calif San Francisco Ctr AIDS Prevent Studies San Francisco CA 94143 USA Univ Alabama Birmingham Med Sch Birmingham Birmingham AL USA Vet Affairs Med Ctr Birmingham AL USA Univ Colorado Hlth Serv Ctr Div Infect Dis Denver CO 80202 USA

Objectives: (1) To document rates and patterns of adherence from enrollment until week 24 of an AIDS clinical trial;(2) to examine the association of adherence to clinical end-points including plasma HIV-1 RNA level and CD4 cell count;and (3) to identify predictors of adherence from clinical, behavioural, psychosocial and demographic factors. Design: Sub-study of a multicentre, randomised, open-label, comparison-control led trial;21 collaborating units of the Adult AIDS Clinical Trials Group. Observational, prospective analysis. Methods: Ninety-three subjects with baseline plasma HIV-1 RNA levels >500 copies/ml, who completed clinical assessment, plasma HIV-1 RNA titres and CD4 cell counts at study entry, weeks 2, 4 and every 4 weeks thereafter until week 24. All patients were anti retroviral-experienced but were naive to non-nucleoside reverse transcriptase inhibitors and protease inhibitors. Self-reported adherence to antiretroviral therapies prescribed as part of the trial was assessed every 4 weeks from trial, week 4 until week 24. Results: Average adherence was high, with 63%, of subjects reporting >95% adherence across the trial. However, there was a significant decline in adherence over time on trial. After controlling for potential confounding variables, patients who were less than 95% adherent to medications were 3.5-times more likely to have treatment failure (HIV-1 RNA >50 copies/ml) than subjects with adherence rates of 95-100%. The strongest predictor of adherence was adverse clinical events (for example, dermatological, gastrointestinal symptoms): patients with adverse events were 12.8-times less likely to have 95-100% adherence. Other clinical, demographic, psychosocial and behavioural factors were also significant predictors of adherence. Conclusions: Adherence influences virological outcome even in AIDS clinical trials where overall adherence rates are high and should therefore be monitored in future trials. Intervention may be warranted to enhance

关键词：抗HIV药/治疗应用 CD4淋巴细胞计数 HIV/遗传学 HIV/免疫学 HIV/分离和提纯 HIV感染/药物疗法 HIV感染/免疫学 HIV感染/心理学 HIV感染/病毒学健康知识态度实践病人依从/统计学和数值数据 RNA 病毒/血液时间因素治疗失败成年人女(雌)性人类男(雄)性

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Adherence to antiretroviral therapy by pregnant women infected with human immunodeficiency virus: A pharmacy claims-based analysis

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OBSTETRICS AND GYNECOLOGY 2000年第2期95卷 167-173页

作者： Laine, C Newschaffer, CJ Zhang, DZ Cosler, L Hauck, WW Turner, BJ Thomas Jefferson Univ Jefferson Med Coll Div Gen Internal Med Ctr Res Med Educ & Hlth Care Philadelphia PA 19107 USA Thomas Jefferson Univ Jefferson Med Coll Biostat Sect Div Clin Pharmacol Philadelphia PA 19107 USA New York State Dept Hlth Albany NY USA

Objective: To assess adherence to antiretroviral therapy with the use of Medicaid pharmacy claims data for human immunodeficiency virus (HIV)-infected pregnant women and to identify associated maternal and health care factors. Methods: We retrospectively studied a cohort of 2714 HIV-infected women in New York State who delivered live infants from 1993-96;Among 682 women prescribed antiretroviral therapy in the last two trimesters, we studied 549 who started therapy more than 2 months before delivery. Adherence was defined as adequate if the supplied drug covered at least 80% of the days from the first prescription in the last two trimesters until delivery. Multivariable analyses were used to examine associations between maternal and health care factors and adherence. Results: Only 34.2% of 549 subjects had at least 80% adherence based on pharmacy data, a rate that remained stable over time. The adjusted odds ratios (ORs) of adherence for black (OR 0.47, 95% confidence interval [CI] 0.30, 0.75) and Hispanic (OR 0.49, 95% CI 0.29, 0.82) women were nearly 50% lower than for white women. The OR of adherence was 0.32 (95% CI 0.12, 0.90) for teenagers compared with women aged 25-29 years and 0.56 (95% CI 0.34, 0.92) for women in New York City versus those residing elsewhere. Women on antiretroviral therapy before pregnancy were more likely to adhere (OR 1.55, 95% CI 1.02, 2.35). Conclusion: Teenagers, women of minority groups, and women living in New York City had greater risks of poor antiretroviral adherence, whereas women already prescribed antiretrovirals before pregnancy had better adherence. Our conservative pharmacy data-based measure showed that most HIV -infected women adhered poorly and adherence did not improve over the 4-year study. (C) 2000 by The American College of Obstetricians and Gynecologists.

关键词：非洲裔美国人年龄因素抗HIV药/治疗应用队列研究置信区间 HIV感染/药物疗法 HIV感染/人种学西班牙裔美国人保险索赔审核/统计学和数值数据 Medicaid/统计学和数值数据少数民族多元分析纽约/流行病学比值比病人依从/人种学病人依从/统计学和数值数据药学服务/经济学药学服务/统计学和数值数据妊娠并发症感染性/药物疗法妊娠并发症感染性/人种学回顾性研究美国市区人口妇女卫生青少年成年人女(雌)性人类妊娠

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The impact of reminder letters on attendance for breast cancer screening

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IRISH JOURNAL OF MEDICAL SCIENCE 1999年第1期168卷 29-32页

作者： Hayes, C O'Herlihy, B Hynes, M Johnson, Z Dr Steevens Hosp Dept Publ Hlth Eastern Hlth Board Dublin 8 Ireland

Obejective - The aims of this investigation was to analyse the response to second and third postal invitations from a group of patients previously invited for mammographic screening and to identify any demographic differences between responders and non-responders Subjects - The subjects were females aged 50-64 yr resident in 6 adjacent District Electoral Divisions (DEDs) in North Dublin where screening had not been carried out prior to the study. Method - Non-responders to an invitation for screening were re-invited by computer-generated letter to attend for screening 6 weeks after issue of the first invitation and a final invitation was issued at 12 weeks. Data sources used for the project register were the Eastern Health Board General Medical Services data base (GMS), Voluntary Health Insurance Board (VHI) data and self-registration. Results - There were 1,310 females in the target age group who were eligible for screening. The response rate to the first invitation was 60.7 per cent. Issue of second invitation increased the rate by 17.9 per cent. A third invitation increased the response rate by a further 7.6 per cent, Those with private medical insurance were more likely to respond to the first and third invitations. The was no difference in response rate to the second invitation for those with and without private insurance. Women aged 55-64 were more likely to respond to first, second or third invitations than those aged less than 55 yr, Conclusions - Issue of second mailed invitations to women in the target age for mammography screening is cost-effective and should be incorporated into routine policy. Response to third invitations is not cost-effective.

关键词：乳腺肿瘤/预防和控制爱尔兰普查/方法普查/组织和管理病人依从/统计学和数值数据试点项目提醒者系统女(雌)性人类中年人

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Sulfonylurea pharmacotherapy regimen adherence in a medicaid population: Influence of age, gender, and race

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DIABETES EDUCATOR 1999年第4期25卷 531-+页

作者： Sclar, DL Robison, LM Skaer, TL Dickson, WM Kozma, CM Reeder, CE Washington State Univ Pharmacoecon & Pharmacoepidemiol Res Unit Coll Pharm Pullman WA 99164 USA Washington State Univ Program Stat Pullman WA 99164 USA Pullman Mem Hosp Pullman WA USA Univ S Carolina Coll Pharm Ctr Pharmaceut Econ Columbia SC 29208 USA

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Management of suicide attempts in Italy and Sweden - A comparison of services offered to consecutive samples of suicide attempters

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GENERAL HOSPITAL PSYCHIATRY 2000年第6期22卷 432-436页

作者： Runeson, B Scocco, P DeLeo, D Meneghel, G Wasserman, D Karolinska Inst St Gorans Hosp Dept Clin Neurosci Sect Psychiat S-11281 Stockholm Sweden Univ Padua Dept Neurol & Psychiat Sci WHO Collaborating Ctr Res & Training Suicide Prev Padua Italy Griffith Univ Brisbane Qld 4111 Australia Karolinska Inst Natl Inst Psychosocial Med Natl Swedish Ctr Suicide Res & Prevent Mental Ill Stockholm Sweden Karolinska Inst WHO Collaborating Ctr Stockholm Sweden

The aim of the study was to compare the management of suicide attempts by patients in Sweden and Italy with a view to providing a perspective on differences in treatment. Two consecutive samples of suicide attempters from Huddinge (n=97) and Padua (n=100) were studied in trans of sociodemographic characteristics previous care, referral, medical and psychiatric care, hospitalization, aftercare and short-term compliance. In Italian somatic management of acute suicidal crises, there are more physicians specializing in anesthesia or internal medicine working in ambulances and emergency wards, and there is a heavier emphasis on somatic care. Swedish management procedures seem to entail more medical examinations and biohumoral tests. Moreover, the procedures at the Swedish hospital give priority to early psychiatric intervention, and admission to psychiatric inpatient care is more frequent. However, it is not normal practice in emergency psychiatric care at either of the centers for specialists to serve in the immediate liaison consultation. There are differences in assessment and treatment between the two countries that may provide a perspective on their procedures, implying that current procedures for managing patients belonging to groups identified as "high-risk" in terms of suicide may be modified. (C) 2000 Elsevier Science Inc.

关键词：出院后医疗/组织和管理急诊室精神病/组织和管理住院/统计学和数值数据意大利精神卫生服务/组织和管理病人依从/心理学病人依从/统计学和数值数据精神病学/组织和管理卫生保健质量转诊和会诊/组织和管理社会经济因素自杀未遂/预防和控制自杀未遂/心理学自杀未遂/统计学和数值数据瑞典青少年成年人老年人老年人 80以上女(雌)性人类男(雄)性中年人

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How to improve the uptake of influenza vaccination in older persons at risk

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IRISH JOURNAL OF MEDICAL SCIENCE 1999年第2期168卷 107-108页

作者： Igoe, G Bedford, D Howell, F Collins, S The Surgery Deerpark Virgina Cavan North Ireland

A study was carried out to ascertain if those older persons at risk from influenza in Ireland would respond to a personalised invitation to attend for vaccination. Of the 193 patients invited to attend for vaccination, 126 (65.3 per cent) presented for vaccination. This rose to 142 (73.6 per cent) after a reminder letter was went oat. In the year previous to the study only 80 (41.5 per cent) of the same cohort of patients were vaccinated. This study has demonstrated how a simple invitation for influenza vaccination can dramatically improve the uptake rates.

关键词：队列研究置信区间健康调查流感疫苗/投药和剂量流感人/预防和控制爱尔兰比值比病人依从/统计学和数值数据危险性评估接种/方法接种/统计学和数值数据老年人女(雌)性人类男(雄)性

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Medical counterbioterrorism: The response to provide anthrax prophylaxis to New York City US postal service employees

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ANNALS OF EMERGENCY MEDICINE 2003年第4期41卷 441-446页

作者： Partridge, R Alexander, J Lawrence, T Suner, S Brown Univ Sch Med Rhode Isl Hosp Injury Prevent CtrDept Emergency Med Providence RI 02912 USA Maine Med Ctr Dept Emergency Med Portland ME 04102 USA Univ Vermont Coll Med Dept Surg Burlington VT USA Rhode Isl Dept Hlth Emergency Med Serv Children Providence RI 02908 USA Off Emergency Preparedness Dept Hlth & Human Serv Rockville MD USA

Study objective: We describe and analyze a recent rapid deployment of disaster medical assistance teams and other government agencies to provide medical screening and anthrax prophylaxis to New York City US Postal Service employees potentially exposed to letters contaminated with anthrax spores. Methods: A description of the response effort is presented. Data were collected on standardized forms and included the numbers of postal employees screened and offered antibiotic prophylaxis, as well as the numbers of patients seen per worker hour by various medical professionals. Results: One hundred members of 5 disaster medical assistance teams and other health professionals were deployed to New York City within 18 hours of activation. Over a 68-hour period, 7,076 patients were evaluated, representing all postal employees in the 6 major postal facilities in New York believed to be at risk for anthrax exposure. Of the total, 2,452 patients were seen during the first 24 hours, 3,875 during the second 24 hours, and the remaining 749 during the last 20 hours of operations. An average of 161 employees were screened per hour. The antibiotic most commonly dispensed was ciprofloxacin, followed by doxycycline and amoxicillin. Conclusion: The deployment of disaster medical assistance teams and other agencies to New York City to provide prophylaxis against inhalation anthrax to US Postal Service employees provides lessons for a rapid, efficient, and effective response to acts of bioterrorism. This deployment might also serve as a scaleable model for future events requiring medical prophylaxis.

关键词：炭疽/预防和控制抗菌药/治疗应用生物恐怖/预防和控制救灾计划/组织和管理效率组织预测卫生服务研究普查/组织和管理模型组织管理纽约市职业卫生服务/组织和管理病人依从/心理学病人依从/统计学和数值数据人员配备和时间安排/组织和管理邮政转诊和会诊/组织和管理回顾性研究危险因素时间因素工作负荷量人类

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Time to patient discontinuation of antihypertensive drugs in different classes

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AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY 2000年第1期57卷 51-54页

作者： Benson, S Vance-Bryan, K Raddatz, J Express Scripts Inc Pharmacotherapy Specialist Cardiol Plymouth MN USA Express Scripts Inc Pharmacotherapy Specialist Infect Dis Plymouth MN USA Express Scripts Inc Pharmacotherapy Assessment & Dis Management Plymouth MN USA

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Patient compliance and effect of orthopaedic shoes

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PROSTHETICS AND ORTHOTICS INTERNATIONAL 1999年第1期23卷 59-62页

作者： Philipsen, AB Ellitsgaard, N Krogsgaard, MR Sonne-Holm, S Hvidovre Univ Hosp Dept Orthopaed Surg DK-2650 Hvidovre Denmark

Orthopaedic shoes are individually handmade after a prescription from an orthopaedic surgeon, hence relatively expensive. Bad compliance is mentioned in the literature but not investigated. In order to evaluate patient compliance and the effect of orthopaedic shoes, 85 patients who were prescribed orthopaedic shoes at the authors' department during a 3 year period received a questionnaire concerning relief of symptoms and daily use of the shoes. The answers from 74 patients were correlated to the prescription procedure and the degree of medical follow-up. Only 60 of 74 patients used their shoes. Some 51 patients had some benefit while 23 had no effect or even worse symptoms. Some patients even used their shoes despite no symptomatic relief. However, patients who felt they were well informed about the purpose and function of their shoes had more benefit than the rest. Only 12 patients of the 74 were checked by the orthopaedic surgeon after delivery of the shoes. In conclusion the authors believe there is a great need for information to be given to the patients about the functions and limitations of orthopaedic shoes and that every patient should be offered a control check-up by the surgeon. Further investigations of the effect of orthopaedic shoes should be carried out to optimise the use of these expensive devices.

关键词：丹麦矫正装置/利用病人依从/统计学和数值数据病人满意度问卷调查鞋老年人老年人 80以上女(雌)性人类男(雄)性中年人

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