AHRQ series on complex intervention systematic reviews-paper 3: adapting frameworks to develop protocols.

Abstract:

BACKGROUND:Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE:Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks. DISCUSSION:This article identifies and describes elements of frameworks and how they can be adapted to inform the protocol and conduct of systematic reviews of complex interventions. Modifications may be needed to adapt the population, intervention, comparators, and outcomes normally used in protocol development to successfully describe complex interventions; in some instances, alternative frameworks may be better suited. Possible approaches to analytic frameworks for complex interventions that illustrate causal and associative linkages are outlined, including time elements, which systematic reviews of complex interventions may need to address. The need for and specifics of the accommodations vary with details of a specific systematic review. This in turn helps determine whether traditional frameworks are sufficient, can be refined, or if alternate frameworks must be adopted.

journal_name

J Clin Epidemiol

authors

Butler M,Epstein RA,Totten A,Whitlock EP,Ansari MT,Damschroder LJ,Balk E,Bass EB,Berkman ND,Hempel S,Iyer S,Schoelles K,Guise JM

doi

10.1016/j.jclinepi.2017.06.013

subject

Has Abstract

pub_date

2017-10-01 00:00:00

pages

19-27

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(17)30632-7

journal_volume

90

pub_type

杂志文章
  • Use of global assessment measures in dementia drug trials.

    abstract::I argue in this paper that the use of a global clinical impression of change as a primary measure in dementia drug trials is appropriate, given that we do not yet understand clearly enough what Alzheimer's disease looks like as it gets better. ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(94)90039-6

    authors: Rockwood K

    更新日期:1994-01-01 00:00:00

  • Methodologic considerations in measuring glycosylated hemoglobin in epidemiologic studies.

    abstract::Multiple linear regression was used to predict an incubated glycosylated hemoglobin value from the unincubated value and blood glucose. Hemoglobin A1 (HbA1) was measured by a disposable microcolumn technique in a large, geographically defined population of diabetic persons in southern Wisconsin. During the study, incu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(88)90116-3

    authors: Moss SE,Klein R,Klein BE,Spennetta TL,Shrago ES

    更新日期:1988-01-01 00:00:00

  • A likelihood-based approach to P-value interpretation provided a novel, plausible, and clinically useful research study metric.

    abstract:OBJECTIVES:Interpretation of clinical research findings using the paradigm of null hypothesis significance testing has a number of limitations. These include arbitrary dichotomization of results, lack of incorporation of study power and prior probability, and the confusing use of conditional probability. This study aim...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2017.08.016

    authors: Adams NG,O'Reilly G

    更新日期:2017-12-01 00:00:00

  • Misclassification in a questionnaire survey of varicose veins.

    abstract::The objective of this study was to assess the determinants and the effect of misclassification in a questionnaire survey of varicose veins. A random sample of 166 individuals aged 50 years in a larger prevalence study (n = 6874) was examined by a surgeon to validate the self-reporting of varicose veins. Varicose veins...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(95)00012-s

    authors: Laurikka J,Läärä E,Sisto T,Tarkka M,Auvinen O,Hakama M

    更新日期:1995-09-01 00:00:00

  • An investigation into factors associated with Helicobacter pylori infection.

    abstract::This study aims to estimate the prevalence of Helicobacter pylori in Glasgow, and to provide a systematic analysis of factors associated with this prevalence. The data used are from a random population sample of 793 men and 838 women aged 25-64 years conducted in 1995. The prevalence is estimated to be 66% (95% confid...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(99)00171-7

    authors: Woodward M,Morrison C,McColl K

    更新日期:2000-02-01 00:00:00

  • Oncology employees valued patient-oriented research over quality of work-life research: a qualitative study.

    abstract:OBJECTIVES:To assess the role of quality of work-life (QWL) research in a clinical research environment. STUDY DESIGN AND SETTING:A phenomenological qualitative research study was conducted. This research was conducted in a large Canadian ambulatory cancer treatment center that serves over 2.3 million people in Ontari...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2006.03.003

    authors: Sale JE

    更新日期:2008-05-01 00:00:00

  • A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.

    abstract:BACKGROUND AND OBJECTIVES:To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. MATERIALS AND METHODS:Using PubMed, we identified empirical studies, anecdotal reports, and opinion ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jclinepi.2005.11.018

    authors: Greene SM,Geiger AM

    更新日期:2006-08-01 00:00:00

  • Systematic review of the epidemiologic and trial evidence of an association between antidepressant medication and breast cancer.

    abstract::Biologic studies have suggested that antidepressant use may increase breast cancer risk. We conducted a systematic review of trials and controlled epidemiologic studies to assess this association. Pooled data from 31 primary efficacy drug company trials of fluoxetine suggested no increased risk but the short duration ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/s0895-4356(02)00568-1

    authors: Lawlor DA,Jüni P,Ebrahim S,Egger M

    更新日期:2003-02-01 00:00:00

  • Subgroup analyses of the major clinical endpoints in the Program on the Surgical Control of the Hyperlipidemias (POSCH): overall mortality, atherosclerotic coronary heart disease (ACHD) mortality, and ACHD mortality or myocardial infarction.

    abstract::The Program on the Surgical Control of the Hyperlipidemias (POSCH) was a secondary atherosclerosis intervention trial employing partial ileal bypass surgery as the intervention modality. For this report, we analyzed 105 subgroups in 35 variables in POSCH, chosen predominantly for their potential relationship to the ri...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/0895-4356(94)00145-g

    authors: Matts JP,Buchwald H,Fitch LL,Campos CT,Varco RL,Campbell GS,Pearce MB,Yellin AE,Smink RD Jr,Sawin HS Jr

    更新日期:1995-03-01 00:00:00

  • Irritable bowel syndrome: are incentives useful for improving survey response rates?

    abstract::Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders. There continues to be a need for community-based research into this condition. Unfortunately, response rates in community-based IBS surveys have typically been very low. In this study, we explore the use of incentives and multiple-res...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(02)00586-3

    authors: Patten SB,Li FX,Cook T,Hilsden RJ,Sutherland LR

    更新日期:2003-03-01 00:00:00

  • Current challenges in clinimetrics.

    abstract::Clinimetrics is a methodologic discipline that focuses on the quality of clinical measurements, for example, diagnostic characteristics and disease outcomes. Different clinimetric properties, such as reproducibility and responsiveness, are important in both the development and the evaluation of measurement instruments...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2003.08.012

    authors: de Vet HC,Terwee CB,Bouter LM

    更新日期:2003-12-01 00:00:00

  • Educational attainment and osteoarthritis: differential associations with radiographic changes and symptom reporting.

    abstract::Educational attainment has been negatively associated with the prevalence, morbidity and mortality of many diseases. With knee osteoarthritis as an example, we used NHANES I data to examine whether the cross-sectional association between formal education and disease is due to known risk factors, and also whether educa...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(92)90006-9

    authors: Hannan MT,Anderson JJ,Pincus T,Felson DT

    更新日期:1992-02-01 00:00:00

  • Real-world evidence was feasible for estimating effectiveness of chemotherapy in breast cancer: a cohort study.

    abstract:OBJECTIVE:Evidence-based guidelines recommend adjuvant chemotherapy in early stage breast cancer whenever treatment benefit is considered sufficient to outweigh the associated risks. However, many groups of patients were either excluded from or underrepresented in the clinical trials that form the evidence base for thi...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2019.01.006

    authors: Gray E,Marti J,Brewster DH,Wyatt JC,Piaget-Rossel R,Hall PS

    更新日期:2019-05-01 00:00:00

  • Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials.

    abstract:OBJECTIVES:The aim of this study was to investigate the use of three treatment-effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results. STUDY DESIGN AND SETTING:A recent equivalence trial showed discordant results with the use of different measures....

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2017.12.010

    authors: Abulizi X,Flandre P

    更新日期:2018-04-01 00:00:00

  • Risk factors for site specific extracranial carotid artery plaque distribution as measured by B-mode ultrasound.

    abstract::The effect of age, sex, diabetes, hypertension, pulse rate and cigarette smoking on extracranial carotid artery plaque thickness evaluated by B-mode ultrasonography was investigated in a cross-sectional study of 698 white men, 730 white women, 77 black men and 76 black women as part of a clinical ultrasound registry. ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(89)90151-0

    authors: Tell GS,Howard G,McKinney WM

    更新日期:1989-01-01 00:00:00

  • Identifying studies for systematic reviews of diagnostic tests was difficult due to the poor sensitivity and precision of methodologic filters and the lack of information in the abstract.

    abstract:BACKGROUND AND OBJECTIVES:Methods to identify studies for systematic reviews of diagnostic accuracy are less well developed than for reviews of intervention studies. This study assessed (1) the sensitivity and precision of five published search strategies and (2) the reliability and accuracy of reviewers screening the ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2004.09.011

    authors: Doust JA,Pietrzak E,Sanders S,Glasziou PP

    更新日期:2005-05-01 00:00:00

  • Development of a short osteoporosis quality of life questionnaire by equating items from two existing instruments.

    abstract::This study aimed to develop a short Osteoporosis-Specific Quality of Life Questionnaire based on the assemblage (equating) of the items of two existing questionnaires (OQLQ and QUALEFFO). For this purpose, each questionnaire was administered by random assignment to a different group of female patients (OQLQ, n = 172; ...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0895-4356(01)00432-2

    authors: Badia X,Prieto L,Roset M,Díez-Pérez A,Herdman M

    更新日期:2002-01-01 00:00:00

  • Conflict of interest as ethical shorthand: understanding the range and nature of "non-financial conflict of interest" in biomedicine.

    abstract:OBJECTIVES:The aim of the study was to identify the range of issues labeled as "non-financial conflicts of interest" in biomedicine, articulate the associated concerns, and analyze the implications of defining these issues as conflicts of interest. STUDY DESIGN AND SETTING:This was a qualitative study, triangulating d...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2019.12.014

    authors: Grundy Q,Mayes C,Holloway K,Mazzarello S,Thombs BD,Bero L

    更新日期:2020-04-01 00:00:00

  • WHO/ISH total risk approach for primary prevention of cardiovascular disease shows greater decrease in costs for women but not the elderly in Jamaica.

    abstract:OBJECTIVES:To investigate cost savings from and implications of replacing the single risk with a total cardiovascular risk approach in primary prevention of cardiovascular disease (CVD). STUDY DESIGN AND SETTING:A cost analysis using data from the 2007-08 Jamaica Health and Lifestyle Survey of 1,432 persons aged 40 ye...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2014.11.027

    authors: Abdulkadri AO,Tulloch-Reid MK,Francis DK,Gordon-Strachan GM,Younger-Coleman NO,Rocke KD,McFarlane SR,Cunningham-Myrie CA,Ferguson TS,Wilks RJ,Anderson SG

    更新日期:2015-09-01 00:00:00

  • A prospective study of factors affecting age at menopause.

    abstract::This paper describes a multivariate analysis of a 3-year prospective study of the covariates of age at menopause among women who were randomly sampled from a general population. This approach avoids three problems that may account for the inconsistent results of prior studies: recall bias in retrospectively collected ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(89)90044-9

    authors: Brambilla DJ,McKinlay SM

    更新日期:1989-01-01 00:00:00

  • The effect of exposure variance and exposure measurement error on study sample size: implications for the design of epidemiologic studies.

    abstract::A small variability of exposure in a population, for example small variance in nutrient intake, limits the power of an epidemiologic study. McKeown-Eyssen and Thomas (J Chron Dis 1985; 38:559-568) have shown that by selecting a population with larger exposure variance vs one with smaller variance, the study sample siz...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/0895-4356(94)90190-2

    authors: White E,Kushi LH,Pepe MS

    更新日期:1994-08-01 00:00:00

  • Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients.

    abstract::Measuring the effectiveness of cognitive rehabilitation programs poses both conceptual and practical challenges. We compared several standardized outcome measures with goal attainment scaling (GAS) to assess their sensitivity to changes in health status in patients undergoing cognitive rehabilitation. GAS is a measure...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(97)00014-0

    authors: Rockwood K,Joyce B,Stolee P

    更新日期:1997-05-01 00:00:00

  • Some methodologic issues in analyzing data from a randomized adolescent tobacco and alcohol use prevention trial.

    abstract::Three issues concerning the design and analysis of randomized behavioral intervention studies are illustrated and discussed within the framework of a tobacco and alcohol prevention trial among migrant Latino adolescents. The first issue arises when subjects are randomized in clusters rather than individually. Because ...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/s0895-4356(03)00012-x

    authors: Slymen DJ,Elder JP,Litrownik AJ,Ayala GX,Campbell NR

    更新日期:2003-04-01 00:00:00

  • High validity of mother-reported use of antiasthmatics among children: a comparison with a population-based prescription database.

    abstract:OBJECTIVES:To examine the validity of (1) maternal questionnaire report of children's use of antiasthmatics using a prescription database as the reference standard and (2) dispensed antiasthmatics as a measure of asthma using maternal report of children's asthma as the reference standard. STUDY DESIGN AND SETTING:A to...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2010.10.014

    authors: Furu K,Karlstad Ø,Skurtveit S,Håberg SE,Nafstad P,London SJ,Nystad W

    更新日期:2011-08-01 00:00:00

  • Postmenopausal estrogen use and invasive versus in situ breast cancer risk.

    abstract::To examine the effect of cancer histopathology on the relationship between estrogen-replacement therapy (ERT) use and breast cancer risk, we performed a case-control study of 109 postmenopausal women 45 years or older with in situ or invasive breast cancer matched to 545 controls. When in situ and invasive tumors were...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(98)00116-4

    authors: Henrich JB,Kornguth PJ,Viscoli CM,Horwitz RI

    更新日期:1998-12-01 00:00:00

  • Translation and psychometric evaluation of a Chinese version of the SF-36 Health Survey in the United States.

    abstract::Outcome measures are rapidly becoming standard tools in the assessment of clinical effectiveness and in the measurement of health status in populations. In this article we document the development of a self-administered Chinese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and report t...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(98)00104-8

    authors: Ren XS,Amick B 3rd,Zhou L,Gandek B

    更新日期:1998-11-01 00:00:00

  • Cohort study of ethnic group and cardiovascular and total mortality over 15 years.

    abstract::Altogether, 3365 men and 3266 women who attended two cardiovascular screenings in 1974-1975 and 1977-1978, have been followed with respect to death for an average of 15 years. The mortality from coronary heart disease was lower in men who reported being of Lappish origin than in men who reported Norse origin at both s...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(97)00021-8

    authors: Tverdal A

    更新日期:1997-06-01 00:00:00

  • Comorbidity independently predicted death in older prostate cancer patients, more of whom died with than from their disease.

    abstract:OBJECTIVE:The purpose of this study was to examine the proportion of men who died from prostate cancer (PrCa) vs. with PrCa and assess the comorbid conditions associated with other-cause deaths. STUDY DESIGN AND SETTING:We identified all male decedents aged >/=65 years in Jefferson County, AL, in 1993-1995. By crossli...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2003.11.009

    authors: Fouad MN,Mayo CP,Funkhouser EM,Irene Hall H,Urban DA,Kiefe CI

    更新日期:2004-07-01 00:00:00

  • What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592.

    abstract::To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We use...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/s0895-4356(01)00477-2

    authors: Cella D,Eton DT,Fairclough DL,Bonomi P,Heyes AE,Silberman C,Wolf MK,Johnson DH

    更新日期:2002-03-01 00:00:00

  • Pain and pain treatment were associated with traffic accident involvement in a cohort of middle-aged workers.

    abstract:BACKGROUND AND OBJECTIVE:To assess the influence of medical conditions on road traffic accidents among a cohort of middle-aged workers and pensioners. STUDY DESIGN AND SETTING:A longitudinal study of 13,548 participants from a cohort study of French workers. Follow-up data covered the 1989-2000 period. Adjusted hazard...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2004.09.008

    authors: Lagarde E,Chastang JF,Lafont S,Coeuret-Pellicer M,Chiron M

    更新日期:2005-05-01 00:00:00