Current Concepts Review - The Conduct of Orthopaedic Clinical Trials*

Fuson, Robert L.; Sherman, Max H.; Vleet, John Van; Wendt, Theodore

doi:10.2106/00004623-199707000-00019

Cited by 43 publications

(27 citation statements)

References 6 publications

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“…The study was carried out in accordance with the World Medical Association Declaration of Helsinki. 6 With the numbers available, the patients treated with RSWT were not significantly different from the patients treated with placebo with respect to the sex distribution, mean age, mean body weight, affected side and types of job (Table 2).…”

Section: Exclusion Criteriamentioning

confidence: 94%

Chronic Plantar Fasciitis Treated with Two Sessions of Radial Extracorporeal Shock Wave Therapy

Ibrahim¹,

Donatelli²,

Schmitz³

et al. 2010

Foot Ankle Int.

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Section: Exclusion Criteriamentioning

confidence: 94%

Chronic Plantar Fasciitis Treated with Two Sessions of Radial Extracorporeal Shock Wave Therapy

Ibrahim¹,

Donatelli²,

Schmitz³

et al. 2010

Foot Ankle Int.

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“…The ethical board CMO Arnhem-Nijmegen approved the study. The study has been carried out in accordance with the World Medical Association Declaration of Helsinki [13]. …”

Section: Methodsmentioning

confidence: 99%

The Qualification of Outcome after Cervical Spine Surgery by Patients Compared to the Neck Disability Index

Donk¹,

Verbeek

Verhagen

et al. 2016

PLoS ONE

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ObjectiveThe Neck Disability Index (NDI) is a patient self-assessed outcome measurement tool to assess disability, and that is frequently used to evaluate the effects of the treatment of neck-related problems. In individualized medicine it is mandatory that patients can interpret data in order to choose a treatment. A change of NDI or an absolute NDI is generally meaningless to a patient. Therefore, a correlation between the qualification of the clinical situation rated by the patient and the NDI score was evaluated.MethodsPatients who completed an NDI after anterior surgery because of symptomatic single level degenerative cervical disc disease were asked one month after completion of the NDI to qualify their clinical situation of a 5-item Likert scale varying from excellent to bad. Since a clear distinction between the categories was not possible based on the total NDI score, a ROC-curve was built, and the AUC computed in order to estimate best dichotomization in qualification of the clinical situation. The best corresponding cut-off point for the NDI total score was found by studying sensitivity and specificity for all possible cut-off points.Results102 patients were included. The highest AUC was obtained by dichotomizing the qualification into a group with good outcome and less-good outcome. The highest sensitivity and specificity for the dichotomized qualification as good outcome corresponded to a NDI ≤ 7. Sensitivity was 81.08% and specificity was 78.57%.ConclusionThis is the first study that correlated the qualification of the situation by the patients themselves and NDI. An NDI ≤ 7 corresponded to a good outcome according to the patients. This is valuable information to inform patients in their decision for any treatment.

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“…The ethical board CMO Arnhem-Nijmegen approved the study. The study has been carried out in accordance with the World Medical Association Declaration of Helsinki [7].…”

Section: Methodsmentioning

confidence: 99%

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

et al. 2017

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Purpose It is difficult for clinicians to inform patients about the success rate of a treatment as a cervical anterior discectomy procedure. Ideally, a proportion of good outcome as rated by patients is known. Patient-reported outcome measurements are helpful. The purpose is to relate the difference in Neck Disability Index (NDI) after a cervical anterior discectomy procedure for single level cervical degenerative disc disease with the patients' rating of their actual clinical situation after long-term follow-up to define the substantial clinical benefit (SCB). Methods After completion of the NDI, patients who were surgically treated for cervical single level degenerative disease were asked to complete a five-item Likert scale to rate their clinical situation. After dichotomisation of the outcome in good versus less than good, a cut-off value was defined by determining the value of the difference of NDI with the highest specificity and sensitivity. Funding was not obtained.Results SCB for NDI after surgery for cervical single level degenerative disease should be set at ten with area under the curve (AUC) of 0.71 for sensitivity as well specificity. Conclusions The goal for each treatment is a good outcome. While comparing treatments for cervical degenerative disc disease only those with an SCB of ten will be relevant for the patient, as patients who achieved this difference in NDI rated their actual situation at long-term follow-up as good.

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Current Concepts Review - The Conduct of Orthopaedic Clinical Trials*

Cited by 43 publications

References 6 publications

Chronic Plantar Fasciitis Treated with Two Sessions of Radial Extracorporeal Shock Wave Therapy

Chronic Plantar Fasciitis Treated with Two Sessions of Radial Extracorporeal Shock Wave Therapy

The Qualification of Outcome after Cervical Spine Surgery by Patients Compared to the Neck Disability Index

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

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