Additional Information
Book Details
Abstract
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Good publication practice for communicating company sponsored medical research: the GPP2 guidelines
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Improving the reporting of pragmatic trials: an extension of the CONSORT statement
Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers
Comparative effectiveness research in cancer screening programmes
Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting
Consort 2010 statement: extension to cluster randomised trials
IDEAL framework for surgical innovation 1: the idea and development stages
Developing and evaluating complex interventions: the new Medical Research Council guidance
The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement
Economic evaluation alongside randomised controlled trials: design, conduct, analysis, and reporting
IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage
IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages
The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees
Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
Evaluating policy and service interventions: framework to guide selection and interpretation of study end points
Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Book Cover | C | ||
| Title | i | ||
| Copyright | ii | ||
| About the publisher | iii | ||
| About The BMJ | iii | ||
| Contents | iv | ||
| About the author | vi | ||
| Chapter 1 Introduction to Research Methods and Reporting series | vii | ||
| Chapter 2 CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials | 1 | ||
| Incomplete and inaccurate reporting | 1 | ||
| Improving the reporting of RCTs: the CONSORT statement | 2 | ||
| The CONSORT 2010 Statement: explanation and elaboration | 2 | ||
| The CONSORT 2010 Explanation and Elaboration: changes | 2 | ||
| Checklist items | 3 | ||
| Reporting RCTs that did not have a two group parallel design | 21 | ||
| Discussion | 21 | ||
| Chapter 3 SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials | 28 | ||
| Purpose and development of explanation and elaboration paper | 30 | ||
| SPIRIT 2013 Explanation and Elaboration | 31 | ||
| Trial registration—registry | 31 | ||
| Trial registration—data set | 31 | ||
| Roles and responsibilities—contributorship | 32 | ||
| Roles and responsibilities—sponsor contact information | 33 | ||
| Roles and responsibilities—sponsor and funder | 33 | ||
| Roles and responsibilities—committees | 33 | ||
| Section 2: Introduction | 34 | ||
| Background and rationale | 34 | ||
| Background and rationale—choice of comparators | 34 | ||
| Objectives | 35 | ||
| Trial design | 35 | ||
| Section 3a: Methods—participants, interventions, and outcomes | 36 | ||
| Study setting | 36 | ||
| Eligibility criteria | 36 | ||
| Interventions | 37 | ||
| Interventions—modifications | 38 | ||
| Interventions—adherence | 38 | ||
| Interventions—concomitant care | 39 | ||
| Outcomes | 39 | ||
| Participant timeline | 40 | ||
| Sample size | 42 | ||
| Recruitment | 43 | ||
| Section 3b: Methods—assignment of interventions (for controlled trials) | 44 | ||
| Allocation—sequence generation | 44 | ||
| Allocation—concealment mechanism | 44 | ||
| Allocation—implementation | 46 | ||
| Blinding (masking) | 46 | ||
| Blinding (masking)—emergency unblinding | 47 | ||
| Section 3c: Methods—data collection, management, and analysis | 47 | ||
| Data collection methods | 47 | ||
| Data collection methods—retention | 48 | ||
| Data management | 49 | ||
| Statistical methods | 51 | ||
| Statistical methods—outcomes | 51 | ||
| Statistical methods—additional analyses | 51 | ||
| Subgroup analysis | 52 | ||
| Adjusted analysis | 52 | ||
| Data monitoring—formal committee | 54 | ||
| Data monitoring—interim analysis | 55 | ||
| Auditing | 56 | ||
| Research ethics approval | 57 | ||
| Protocol amendments | 57 | ||
| Consent or assent | 57 | ||
| Consent or assent—ancillary studies | 58 | ||
| Confidentiality | 58 | ||
| Declaration of interests | 59 | ||
| Access to data | 59 | ||
| Ancillary and post-trial care | 60 | ||
| Dissemination policy—trial results | 60 | ||
| Dissemination policy—authorship | 61 | ||
| Dissemination policy—reproducible research | 62 | ||
| Informed consent materials | 62 | ||
| Biological specimens | 62 | ||
| Discussion | 63 | ||
| Chapter 4 Good publication practice for communicating company sponsored medical research: the GPP2 guidelines | 72 | ||
| Evolving standards | 72 | ||
| Methods | 72 | ||
| Guidelines and recommendations | 73 | ||
| Roles and responsibilities | 73 | ||
| Written agreement | 73 | ||
| Access to data | 74 | ||
| Reimbursement | 74 | ||
| Publication steering committee | 74 | ||
| Authors | 74 | ||
| Contributorship and acknowledgments | 74 | ||
| Contributorship and contributors | 74 | ||
| Acknowledgments | 75 | ||
| Professional medical writers | 75 | ||
| Working with authors | 75 | ||
| As authors | 75 | ||
| Conflicts of interest | 75 | ||
| Recommendations for specific types of articles and presentations | 76 | ||
| Primary and secondary publications | 76 | ||
| Duplicate publication | 76 | ||
| Presentations | 76 | ||
| Review articles | 76 | ||
| Reporting standards | 76 | ||
| Planning, registering, posting, and documenting | 76 | ||
| Publication planning | 76 | ||
| Before publication | 77 | ||
| Documentation | 77 | ||
| Checklists | 77 | ||
| Chapter 5 CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | 79 | ||
| Introduction | 79 | ||
| Intent of CONSORT 2010 | 79 | ||
| Background to CONSORT | 79 | ||
| Development of CONSORT 2010 | 80 | ||
| Changes in CONSORT 2010 | 80 | ||
| Implications and limitations | 80 | ||
| Chapter 6 Improving the reporting of pragmatic trials: an extension of the CONSORT statement | 84 | ||
| CONSORT initiative | 84 | ||
| Methods | 85 | ||
| Recommendations for reporting pragmatic trials | 85 | ||
| Item 2: introduction; background | 86 | ||
| Item 3: methods; participants | 87 | ||
| Item 4: methods; interventions | 87 | ||
| Item 6: methods; outcomes | 88 | ||
| Item 7: methods; sample size | 88 | ||
| Item 11: methods; blinding (masking) | 88 | ||
| Item 13: results; participant flow | 88 | ||
| Item 21: generalisability (applicability, external validity) | 89 | ||
| Generalisability of the trial findings | 89 | ||
| Discussion | 89 | ||
| Chapter 7 Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers | 92 | ||
| Background | 92 | ||
| Data preparation guidance | 92 | ||
| What is the dataset? | 92 | ||
| Anonymisation | 93 | ||
| Use of dates relevant to individuals | 93 | ||
| File preparation | 93 | ||
| Copyright | 93 | ||
| Prospective data publication | 93 | ||
| Retrospective data publication | 94 | ||
| Preparing for journal submission—statement in submitted manuscript | 94 | ||
| Alternatives to journal publication | 94 | ||
| Limitations of this guidance | 94 | ||
| Chapter 8 Comparative effectiveness research in cancer screening programmes | 96 | ||
| Screening programmes change medicine | 96 | ||
| Comparative effectiveness research | 96 | ||
| Lack of evidence | 96 | ||
| The Norwegian approach | 97 | ||
| Comparative research in public health programmes | 98 | ||
| Chapter 9 Economic evaluation using decision analytical modelling: design, conduct, analysis, and reporting | 99 | ||
| Defining the question | 99 | ||
| Decision trees | 99 | ||
| Markov models | 99 | ||
| Alternative modelling approaches | 100 | ||
| Identifying, synthe sising, and transforming data inputs | 101 | ||
| Quantifying and reporting cost effectiveness | 101 | ||
| Handling variability, uncertainty, and heterogeneity | 101 | ||
| Model evaluation | 102 | ||
| Value of additional research | 102 | ||
| Conclusions | 102 | ||
| Chapter 10 Consort 2010 statement: extension to cluster randomised trials | 104 | ||
| Scope of this paper | 104 | ||
| Updating the CONSORT statement for cluster randomised trials | 105 | ||
| The updating process | 106 | ||
| Advances in methodology since 2004 | 106 | ||
| Advances in reporting requirements since 2004 | 106 | ||
| Quality of reporting of cluster trials | 106 | ||
| Extension of CONSORT 2010 to cluster trials | 106 | ||
| Title and abstract | 109 | ||
| Item 1a | 109 | ||
| Item 1b | 109 | ||
| Introduction | 109 | ||
| Background and objectives | 109 | ||
| Item 2a | 109 | ||
| Item 2b | 110 | ||
| Methods | 110 | ||
| Trial design | 110 | ||
| Item 3a | 110 | ||
| Item 3b | 110 | ||
| Participants | 111 | ||
| Item 4a | 111 | ||
| Interventions | 111 | ||
| Item 5 | 111 | ||
| Outcomes | 111 | ||
| Item 6a | 111 | ||
| Sample size | 111 | ||
| Item 7a | 111 | ||
| Item 7b | 112 | ||
| Randomisation | 112 | ||
| Sequence generation | 112 | ||
| Item 8b | 112 | ||
| Allocation concealment mechanism | 113 | ||
| Item 9 | 113 | ||
| Implementation | 113 | ||
| Item 10 | 113 | ||
| Item 10a | 113 | ||
| Item 10b | 113 | ||
| Item 10c | 114 | ||
| Blinding | 114 | ||
| Item 11a | 114 | ||
| Statistical methods | 114 | ||
| Item 12a | 114 | ||
| Results | 115 | ||
| Participant flow | 115 | ||
| Item 13a | 115 | ||
| Item 13b | 115 | ||
| Baseline data | 115 | ||
| Item 15 | 115 | ||
| Numbers analysed | 116 | ||
| Item 16 | 116 | ||
| Outcomes and estimation | 116 | ||
| Item 17a | 116 | ||
| Discussion | 116 | ||
| Generalisability | 116 | ||
| Item 21 | 116 | ||
| Comment | 117 | ||
| Chapter 11 IDEAL framework for surgical innovation 1: the idea and development stages | 120 | ||
| Introduction | 120 | ||
| Idea (IDEAL stage 1) | 120 | ||
| Development (IDEAL stage 2a) | 121 | ||
| Discussion | 122 | ||
| Summary | 123 | ||
| Chapter 12 Developing and evaluating complex interventions: the new Medical Research Council guidance | 124 | ||
| Revisiting the 2000 MRC framework | 124 | ||
| What are complex interventions? | 124 | ||
| Development, evaluation, and implementation | 124 | ||
| Developing a complex intervention | 125 | ||
| Assessing feasibility | 125 | ||
| Evaluating a complex intervention | 126 | ||
| Assessing effectiveness | 126 | ||
| Measuring outcomes | 126 | ||
| Understanding processes | 126 | ||
| Conclusions | 127 | ||
| Chapter 13 The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration | 128 | ||
| Introduction | 128 | ||
| The QUOROM statement and its evolution into PRISMA | 128 | ||
| Development of PRISMA | 129 | ||
| Scope of PRISMA | 129 | ||
| How to use this paper | 129 | ||
| The PRISMA checklist | 129 | ||
| Title and abstract | 129 | ||
| Methods | 132 | ||
| Results | 137 | ||
| Introduction | 131 | ||
| Outcomes | 138 | ||
| Primary | 138 | ||
| Discussion | 141 | ||
| Funding | 142 | ||
| Additional considerations for systematic reviews of non randomisedintervention studies or for other types of systematic reviews | 143 | ||
| Discussion | 143 | ||
| Chapter 14 Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement | 152 | ||
| Reporting challenges and shortcomings in health economic evaluations | 152 | ||
| Aim and scope | 152 | ||
| Development of the CHEERS statement | 153 | ||
| Checklist items | 153 | ||
| Concluding remarks | 153 | ||
| Chapter 15 Economic evaluation alongside randomisedcontrolled trials: design, conduct, analysis, and reporting | 156 | ||
| What are the objectives of economic evaluation? | 156 | ||
| Design of trial based economic evaluations | 156 | ||
| How are data measured and valued? | 157 | ||
| Use of resources | 157 | ||
| Valuation of resource use | 157 | ||
| Measurement and valuation of outcomes | 157 | ||
| Analysis and reporting of data | 158 | ||
| Discounting | 158 | ||
| Dealing with skewed, missing, and censored data | 158 | ||
| Handling uncertainty | 158 | ||
| Longer term extrapolation | 159 | ||
| Advantages of trial based economic evaluations? | 159 | ||
| Chapter 16 IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage | 161 | ||
| Introduction | 161 | ||
| Randomised controlled trials in the assessment stage | 161 | ||
| Intervention definition | 162 | ||
| Who should deliver the intervention? | 162 | ||
| Impact of treatment preferences | 163 | ||
| Long term study stage | 163 | ||
| Long term evaluation of procedures | 163 | ||
| Surveillance of devices | 164 | ||
| Summary | 164 | ||
| Chapter 17 IDEAL framework for surgical innovation 2:observational studies in the exploration and assessment stages | 166 | ||
| Introduction | 166 | ||
| Reaching the exploration stage (IDEAL stage 2b) | 166 | ||
| Nature and challenges of the exploration stage: preparing for a definitive evaluation | 166 | ||
| Nature and challenges of assessment (IDEAL stage 3) | 167 | ||
| Non-randomised controlled trials | 168 | ||
| Interrupted time series | 169 | ||
| Summary | 169 | ||
| Chapter 18 The Ottawa Statement on the ethical design and conduct of cluster randomised trials: précis for researchers and research ethics committees | 171 | ||
| Introduction | 171 | ||
| Aims | 171 | ||
| Development | 172 | ||
| Implications | 172 | ||
| Justifying the cluster randomised design | 172 | ||
| Research ethics committee review | 172 | ||
| Identifying research participants | 172 | ||
| Obtaining informed consent | 172 | ||
| Gatekeepers | 173 | ||
| Assessing benefits and harms | 173 | ||
| Protecting vulnerable participants | 174 | ||
| Discussion | 174 | ||
| Chapter 19 Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement | 176 | ||
| Terminology | 176 | ||
| Developing the PRISMA statement | 176 | ||
| The PRISMA statement | 177 | ||
| From QUOROM to PRISMA | 177 | ||
| Endorsement | 177 | ||
| The PRISMA explanation and elaboration paper | 177 | ||
| Discussion | 177 | ||
| Chapter 20 Evaluating policy and service interventions: framework to guide selection and interpretation of study end points | 181 | ||
| Assessing targeted service interventions | 181 | ||
| Policy and generic service interventions | 182 | ||
| Narrow versus diffuse effects | 182 | ||
| Selecting end points | 182 | ||
| Cost effectiveness of studies using patient level end points | 183 | ||
| Rare problems and small effect sizes | 183 | ||
| Modelling cost effectiveness | 183 | ||
| Alternatives to measuring effects at patient level | 184 | ||
| Discussion | 184 | ||
| Surrogate outcomes and publication bias | 184 | ||
| Bayesian methods and decision analysis | 184 | ||
| Representational nature of the model | 185 | ||
| Chapter 21 Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project | 186 | ||
| Introduction | 186 | ||
| Special features of quality improvement | 186 | ||
| Differences between SQUIRE and draft guidelines | 188 | ||
| The development process | 188 | ||
| Informal feedback | 188 | ||
| Deciding when to use the guidelines | 189 | ||
| Forcing articles into a rigid format | 189 | ||
| Creating longer articles | 189 | ||
| Conjoint use with other publication guidelines | 189 | ||
| Formal commentaries | 189 | ||
| Health disparities | 189 | ||
| IMRaD structure | 189 | ||
| Dumbing down improvement reports | 189 | ||
| Consensus meeting of editors and research scholars | 190 | ||
| Delphi process | 190 | ||
| Limitations and questions | 190 | ||
| Applying SQUIRE | 190 | ||
| Current and future directions | 190 | ||
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