A public and patient consultation process as an aid to design a person-centred randomized clinical trial.

BACKGROUND: Involving patients and members of the public, together with researchers, in decisions about how studies are designed and conducted can create a study that is more person-centred. The aim of this consultation process was to explore ways of designing a study which takes the person into consideration for the randomized clinical study entitled 'Biomechanical Effects of Manual Therapy-A Feasibility Study' using the novel approach of usability testing. DESIGN: Patient and public volunteers were sought with experience of low back pain. Volunteers were invited to participate in usability testing (a physical walkthrough) of the proposed study method. This was followed by a discussion of areas where usability testing could not be used, such as recruitment strategies, continuity of participant care and dissemination of results. Resulting feedback was considered by the research team and alterations to the original study method were incorporated, provided the research questions could be answered and were practical within the resources available. RESULTS: Additional recruitment strategies were proposed. Alterations to the study included reduction in study time burden; completion of study paperwork in a quieter location; continuity of participant care after the study; and methods of dissemination of overall study results to participants. CONCLUSION: The consultation process used the unique method of usability testing, together with a post-usability discussion, and resulted in alterations to the future study which may facilitate making it more person-centred. PATIENT AND PUBLIC CONTRIBUTION: Patients and public developed the future study design but did not participate in manuscript preparation.

Stakeholder involvement in the development of trial material for a clinical trial.

BACKGROUND: Stakeholder involvement includes not just patients and public, but also those delivering treatment for example clinicians and students. Each stakeholder brings unique experiences to the process. The aim of this stakeholder exercise was to explore readability and understanding of the trial material for the future trial to be conducted by the authors: Biomechanical Effects of Manual Therapy-A Feasibility Study. DESIGN: Volunteers from identified stakeholder groups were provided with trial material which included the information sheet, consent form, questionnaires and home management booklet. They provided feedback on content (readability, understanding) and style (font, layout). An additional document was provided with genres of pictures to choose the most appropriate style to be used in the booklet. Readability formulas were used to calculate reading age before and after feedback to objectively measure ease of reading. RESULTS: The public group provided a layperson's perspective to clarify the information sheet for patients, whereas practitioner and intern groups indicated where information could be clarified. The reading age of all documentation decreased following feedback; however, templated sections of the documentation did not. The majority (87%) of volunteers chose coloured classic cartoons for the booklet. CONCLUSION: This process highlighted the importance of involving different stakeholder groups in the development of research materials as each group made a unique contribution. Readability and understanding of the trial material were improved, feeding back into the consent process contributing towards fully informed consent. PATIENT OR PUBLIC CONTRIBUTION: Public helped develop materials for a future trial but not with manuscript preparation.

Attainment rate as a surrogate indicator of the intervertebral neutral zone length in lateral bending: an in vitro proof of concept study.

BACKGROUND: Lumbar segmental instability is often considered to be a cause of chronic low back pain. However, defining its measurement has been largely limited to laboratory studies. These have characterised segmental stability as the intrinsic resistance of spine specimens to initial bending moments by quantifying the dynamic neutral zone. However these measurements have been impossible to obtain in vivo without invasive procedures, preventing the assessment of intervertebral stability in patients. Quantitative fluoroscopy (QF), measures the initial velocity of the attainment of intervertebral rotational motion in patients, which may to some extent be representative of the dynamic neutral zone. This study sought to explore the possible relationship between the dynamic neutral zone and intervertebral rotational attainment rate as measured with (QF) in an in vitro preparation. The purpose was to find out if further work into this concept is worth pursuing. METHOD: This study used passive recumbent QF in a multi-segmental porcine model. This assessed the intrinsic intervertebral responses to a minimal coronal plane bending moment as measured with a digital force guage. Bending moments about each intervertebral joint were calculated and correlated with the rate at which global motion was attained at each intervertebral segment in the first 10° of global motion where the intervertebral joint was rotating. RESULTS: Unlike previous studies of single segment specimens, a neutral zone was found to exist during lateral bending. The initial attainment rates for left and right lateral flexion were comparable to previously published in vivo values for healthy controls. Substantial and highly significant levels of correlation between initial attainment rate and neutral zone were found for left (Rho = 0.75, P = 0.0002) and combined left-right bending (Rho = 0.72, P = 0.0001) and moderate ones for right alone (Rho = 0.55, P = 0.0012). CONCLUSIONS: This study found good correlation between the initial intervertebral attainment rate and the dynamic neutral zone, thereby opening the possibility to detect segmental instability from clinical studies. However the results must be treated with caution. Further studies with multiple specimens and adding sagittal plane motion are warranted.

Ionizing radiation exposure and the development of intervertebral disc degeneration--no case to answer.

In the following perspective article, Mellor and Breen provide a counterpoint to a previous perspective on the potential link between ionizing radiation exposure and intervertebral disc degeneration in humans [1]. The previous perspective asked, is this link a myth or reality? It suggested the potential for such a link. Mellor and Breen offer a drastically alternate view, in essence, that the question itself is flawed. To support their perspective, they explain the different units of radiation measurement and their conversion to risk in humans and how this impacts the previous perspective. They explain the variable sensitivity of different body tissues to radiation and highlight that neither human research nor any of the multiple international regulatory agencies have ever suggested that the intervertebral disc is sensitive to radiation. Finally, they claim that it is impossible to predict with any certainty the effects of low-level radiation on the intervertebral discs.

Measurement of intervertebral motion using quantitative fluoroscopy: report of an international forum and proposal for use in the assessment of degenerative disc disease in the lumbar spine.

Quantitative fluoroscopy (QF) is an emerging technology for measuring intervertebral motion patterns to investigate problem back pain and degenerative disc disease. This International Forum was a networking event of three research groups (UK, US, Hong Kong), over three days in San Francisco in August 2009. Its aim was to reach a consensus on how best to record, analyse, and communicate QF information for research and clinical purposes. The Forum recommended that images should be acquired during regular trunk motion that is controlled for velocity and range, in order to minimise externally imposed variability as well as to correlate intervertebral motion with trunk motion. This should be done in both the recumbent passive and weight bearing active patient configurations. The main recommended outputs from QF were the true ranges of intervertebral rotation and translation, neutral zone laxity and the consistency of shape of the motion patterns. The main clinical research priority should initially be to investigate the possibility of mechanical subgroups of patients with chronic, nonspecific low back pain by comparing their intervertebral motion patterns with those of matched healthy controls.