| Literature DB >> 26576811 |
Tammy C Hoffmann1, Marion F Walker2, Peter Langhorne3, Sally Eames1, Emma Thomas1, Paul Glasziou1.
Abstract
OBJECTIVE: To assess, in a sample of systematic reviews of non-pharmacological interventions, the completeness of intervention reporting, identify the most frequently missing elements, and assess review authors' use of and beliefs about providing intervention information.Entities:
Mesh:
Year: 2015 PMID: 26576811 PMCID: PMC4654305 DOI: 10.1136/bmjopen-2015-009051
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Brief description of the Template for Intervention Description and Replication (TIDieR) items that were used to assess intervention reporting
| Item number* | Item name | Item description |
|---|---|---|
| 2 | Why | Describe any rationale, theory or goal of the elements essential to the intervention |
| 3 | What: materials | Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers; provide information on where the materials can be accessed (eg, online appendix, URL) |
| 4 | What: procedures | Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities |
| 5 | Who provided | For each category of intervention provider (eg, psychologist, nursing assistant), describe their expertise, background and any specific training given |
| 6 | How | Describe the modes of delivery (eg, face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group |
| 7 | Where | Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features |
| 8 | When and how much | Describe the number of times the intervention was delivered and over what period of time, including the number of sessions, their schedule, and their duration, intensity or dose |
| 9 | Tailoring | If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when and how |
| 10 | Modifications | If the intervention was modified during the course of the study, describe the changes (what, why, when and how) |
| 11 | How well: planned | If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them |
| 12* | How well: actual | If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned |
*Item 1 was not scored for this study; item 12 was scored as ‘not applicable’ if item 11 was scored as inadequate.
Categories of interventions of the included systematic reviews, the number of eligible studies and interventions, and excluded studies
| Intervention category | Systematic reviews | Number of eligible studies (interventions) included | Number of excluded studies (main reason) | ||
|---|---|---|---|---|---|
| Cochrane reviews (n) | Non-Cochrane reviews (n) | Cochrane reviews | Non-Cochrane reviews | ||
| Organisation of service | |||||
| Care after hospital discharge | 5 | 1 | 26 (26) | 15 (12) | |
| Hospital care | 2 | 1 | 50 (50) | 4 (4) | 5 (not RCTs) |
| Patient and carer/family support | 1 | 0 | 16 (18) | 0 (0) | |
| Rehabilitation | |||||
| Upper limb | 2 | 11 | 24 (24) | 106 (114) | 10 (not stroke population); 17 (not RCTs) |
| Physical activity | 2 | 5 | 13 (13) | 50 (51) | 13 (not RCTs) |
| Amount, intensity and timing | 1 | 0 | 1 (1) | 0 (0) | |
| Cognition | 5 | 2 | 23 (23) | 7 (9) | 7 (not RCTs) |
| Communication | 1 | 0 | 39 (51) | 0 (0) | |
| Sensorimotor impairment | 2 | 4 | 13 (13) | 51 (48) | 7 (not stroke population) |
| Activities of daily living | 2 | 0 | 18 (21) | 0 (0) | |
| Complications | |||||
| Mood disturbance | 1 | 1 | 2 (2) | 6 (5) | 4 (pharmacological) |
| Loss of cardiorespiratory fitness | 1 | 2 | 32 (32) | 17 (15) | 1 (not RCT) |
| Subluxation | 2 | 0 | 18 (19) | 0 (0) | |
| Poor hygiene | 1 | 0 | 3 (3) | 0 (0) | |
| Fatigue | 1 | 0 | 1 (1) | 0 (0) | 2 (pharmacological) |
| Complementary and alternative therapy for acute management | 1 | 1 | 7 (7) | 8 (8) | |
| Lifestyle modification for secondary prevention | 0 | 2 | 0 (0) | 18 (19) | 3 (pharmacological); 17 (protocols) |
| Total | Cochrane reviews | 286 studies (304 interventions) | |||
| Non-Cochrane reviews | 282 studies (285 interventions) | ||||
RCT, randomised controlled trial.
Figure 1Percentage of systematic reviews, per checklist item, in which intervention descriptions were ‘adequate for all interventions’, ‘adequate for some’ and ‘adequate for none’ of the interventions included in each review.
Figure 2Mean percentage of systematic reviews, per Template for Intervention Description and Replication (TIDieR) checklist item, in which interventions were described ‘adequately for all’ or ‘adequately for some’ of the interventions in the review, for Cochrane and non-Cochrane reviews.
Survey questions to and responses from corresponding authors (n=33)
“No detailed description of the interventions because of word limit and because of clarity. Was out of the focus of the review.” “Some of this information was incorporated…when the meta-analyses were being conducted. Without including this information, the study might not have met inclusion and therefore, would have been excluded.” “Some data contributed to meta-analysis of outcome data” “Only used to determine eligibility for inclusion in review” “Intervention details were not used much in the review but were mostly used to make decisions about inclusion, or sub group allocation” “Was raised…as points of difference in the discussion.” “Other reviews covered the interventions…but not with a stroke- specific population.” | |
| Method of obtaining further information | n (%) |
| Email/fax | 21 (91) |
| Searching for other publications related to original trial/s | 16 (70) |
| Searching for published protocol of original trial/s | 13 (57) |
| Searching clinical trial registries | 9 (39) |
| Face-to-face (eg, semistructured interviews with trialists at conferences) | 4 (13) |
| Telephone | 2 (9) |
| Other (broad intervention approach described in a book, but not specifically about the trial) | 1 (4) |
| Response | n (%) |
| All authors who were contacted responded, | 2 (9) |
| Some authors who were contacted responded, | 10 (46) |
| Some authors responded, but did/could not provide further information (eg, data were so old they were no longer available) | 8 (36) |
| None of the authors who were contacted provided further information | 1 (5) |
| None of the authors responded | 3 (14) |
“Explained what was meant by intervention terms or described tools used for intervention or amount, etc” “Greater detail about components of the intervention, such as intensity, duration, application details, instructions, etc” “Intervention protocols, greater details about intervention type, implementation, intensity, staff training outlines, descriptions…” “Authors sent information/material resources used in the intervention, provided a website with more information, provided greater detail about a component of the intervention, such as intensity or duration” “Internal reports, draft papers, local protocols” | |
| Response from author | n (%) |
| Not needed as interventions were fully described in the original trial | 8 (44) |
| Not necessary as part of a systematic review | 6 (33) |
| Would not have been able to incorporate the information into the review (eg, due to word/page restrictions) | 3 (17) |
| It did not occur to me/the review team to seek additional intervention information | 0 |
| Other (“no time or resources to do this” and “likely to get…negative responses”) | 1 (6) |
“In general, there is a lack of information regarding the intervention in systematic reviews and in papers about clinical trials, which makes implementation of the results in clinical practice almost impossible…” “The word limits…problematic” “Acceptability for publication is a major barrier” “Depending on the research question of the review specific components of the intervention should be reported” “Our reviews have complex interventions…the devil is in the detail so we often chase this up to make sure we are including the right intervention” “Interventionists rarely report sufficient detail to enable replication…or even just detailed reporting of the key elements and may be unwilling to share manuals” “In many studies, usual care is not clearly described and may vary considerably between studies” “Word count is an issue but so often now there is an option to provide “We… use…[other journals] to publish the content and design of the trial” “Guidelines should be developed and their use must be strongly recommended, in which way interventions should be reported in trials and systematic reviews” | |