Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 3: Designing Instruments With Patient Input

ObjectivesThe purpose of this article is to describe how we designed patient survey instruments to ensure that patient data about preferences and experience could be included in appropriateness decisions. These actions were part of a project that examined the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain.MethodsWe conducted focus groups, cognitive interviews, a literature review of measures in prior chiropractic and complementary and integrative health research, and a pilot study to develop questionnaires of patient preferences, experiences, values, and beliefs.ResultsQuestionnaires were administered online to 2024 individuals from 125 chiropractic clinics. The survey included 3 long questionnaires and 5 shorter ones. All were administered online. The baseline items had 2 questionnaires that respondents could complete in different sittings. Respondents completed shorter biweekly follow-ups every 2 weeks and a final questionnaire at 3 months. The 2 initial questionnaires had 81 and 140 items, the 5 biweekly follow-up questionnaires had 37 items each, and the endline questionnaire contained 121 items. Participants generally responded positively to the survey items, and 91% of the patients who completed a baseline questionnaire completed the endpoint survey 3 months later. We used “legacy” measures, and we also adapted measures and developed new measures for this study. Preliminary assessment of reliability and validity for a newly developed scale about coping behaviors indicates that the items work well together in a scale.ConclusionsThis article documents the challenges and the efforts involved in designing data collection tools to facilitate the inclusion of patient data into appropriateness decisions.     

Interventions to prevent and reduce the impact of musculoskeletal injuries among nurses: A systematic review

BackgroundMusculoskeletal injuries and musculoskeletal pain are prevalent among nurses compared to many other occupational groups.ObjectiveTo identify interventions that may be effective at reducing the prevalence and impact of musculoskeletal injuries and pain in registered nurses.DesignSystematic review.Data sourcesSeven databases were systematically searched, including MEDLINE, CINAHL, EMBASE, PsycInfo, Academic Search Complete, Health Source Nursing, and the Cochrane Database of Systematic Reviews.Review methodsPeer-reviewed journal articles reporting interventions designed to reduce the occurrence of musculoskeletal injuries and pain among registered nurses, published between January 2004 and June 2016, were eligible for inclusion. Randomised and non-randomised controlled trials, as well as studies implementing before-after designs were included. Studies investigating interventions in samples predominately comprised of nursing aides or non-nursing personnel were excluded. Relevant articles were collected and critically analysed using the Effective Public Health Practice Project methodology. Two reviewers independently extracted data and performed quality appraisals for each study. A narrative synthesis of study findings was performed.ResultsTwenty studies met criteria for inclusion in the review. Types of interventions reported included: patient lift systems (N = 8), patient handling training (N = 3), multi-component interventions (N = 7), cognitive behavioural therapy (N = 1), and unstable shoes (N = 1). Only two studies received a ‘strong’ quality rating according to quality assessment criteria. One of these found no evidence for the effectiveness of patient handling training; the other found preliminary support for unstable shoes reducing self-reported pain and disability among nurses. Overall, evidence for each intervention type was limited.ConclusionsThere is an absence of high quality published studies investigating interventions to protect nurses from musculoskeletal injuries and pain. Further research (including randomised controlled trials) is needed to identify interventions that may reduce the high rates of injury and pain among nurses.     

Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients

SUMMARY

Objective: Documentation of the clinical results obtained utilizing perispinal etanercept off-label for treatment-refractory back and neck pain in a clinical practice setting.

Research design and methods: The medical charts of all patients who were treated with etanercept for back or neck pain at a single private medical clinic in 2003 were reviewed retrospectively. Patients were treated if they had disc-related pain which was chronic, treatment-refractory, present every day for at least 8?h, and of moderate or severe intensity. Patients with active infection, demyelinating disease, uncontrolled diabetes, lymphoma or immunosuppression were excluded from treatment with etanercept. Etanercept 25?mg was administered by subcutaneous injection directly overlying the spine. Visual Analogue Scales (VAS, 0–10?cm) for intensity of pain, sensory disturbance, and weakness prior to and 20?min, 1?day, 1?week, 2?weeks, and 1?month after treatment were completed. Inclusion criteria for analysis required baseline and treatment VAS data.

Main outcome measures: Before and after treatment VAS comparisons for intensity of pain, sensory disturbance, and weakness.

Results: 143 charts out of 204 met the inclusion VAS criteria. The 143 patients had a mean age of 55.8 ± 14, duration of pain of 9.8 ± 11?years, and an initial Oswestry Disability Index of 42.8 ± 18, with 83% having back pain, 61% sciatica, and 33% neck pain. 30% had previous spinal surgery, and 69% had previously received epidural steroid injections (mean 3.0 ± 3). The patients received a mean of 2.3 ± 0.7 doses of perispinal etanercept separated by a mean interval of 13.6 ± 16.3?days. The mean VAS intensity of pain, sensory disturbance, and weakness were significantly reduced after perispinal etanercept at 20?min, 1?day, 1?week, 2?weeks, and 1?month with a p < 0.0001 at each time interval for the first dose in this patient population.

Conclusions: Perispinal etanercept is a new treatment modality which can lead to significant clinical improvement in selected patients with chronic, treatment-refractory disc-related pain. Generalizability of the present study results is limited by the open-label, uncontrolled methodology employed. Based on this and other accumulating recent studies, etanercept may be useful for both acute and chronic disc-related pain. Further study of this new treatment modality utilizing double-blind placebo controlled methodology is indicated.

Note: This treatment method is protected by multiple patents awarded to Edward Tobinick MD, including U.S. patents 6?015?557; 6?177?077; 6?419?944; 6?537?549 and Australian patent 758?523.     

Effect of a corrective exercise program on gait kinetics and muscle activities in older adults with both low back pain and pronated feet: A double-blind,randomized controlled trial

BackgroundLow back pain is among the most common health problems seen in primary care. This study aimed to evaluate the effect of a corrective exercise program on GRF components, back pain, disability score, and muscle activities in back pain patients with pronated feet during walking.Research questionWhat is the effect of corrective exercise program on gait kinetics, back pain, disability score, and muscle activities in back pain patients with pronated feet during walking?MethodsThirty-six older adults with both back pain and pronated feet volunteered to participate in this study. They were randomly divided into two equal groups (experimental and control groups). Kinetic and EMG data were recorded during both pre and posttest. Visual analog pain scale and Roland-Morris disability questionnaire were used to assess back pain and disability values, respectively.ResultsIn the experimental group but not in the control group, walking speed was significantly increased from pre to posttest (p = 0.001). The loading rate and free moment values were similar during both the pre and posttest (p > 0.05). In the experimental group but not in the control group, the disability score, back pain, tibialis anterior activity, and rectus abdominis activity were decreased during the posttest than that in the pretest (p < 0.001).SignificanceHigher walking speed, lower muscle activity and pain, lower disability score along with similar loading rate and free moments in the experimental group compared with the control group after the training protocol demonstrate the improvement of gait efficiency.     

Responder analyses in randomised controlled trials for chronic low back pain: an overview of currently used methods

Purpose

To provide an overview and a critical appraisal of the use of responder analyses in published randomised controlled trials (RCTs) of interventions for chronic low back pain (LBP). The methodology used for the analyses, including the justification, as well as the implications of responder analyses on the conclusions was explored.

Methods

A convenience sample of four systematic reviews evaluating 162 RCTs of interventions for chronic LBP was used to identify individual trials. Randomised trials were screened by two reviewers and included if they performed and reported a responder analysis (i.e. the proportion of participants achieving a pre-defined level of improvement). The cutoff value for responders, the period of follow-up, and the outcome measure used were extracted. Information on how RCT authors justified the methodology of their responder analyses was also appraised.

Results

Twenty-eight articles (17 %) using 20 different definitions of responders were included in this appraisal. Justification for the definition of responders was absent in 80 % of the articles. Pain was the most frequently used domain for the definition of response (50 %), followed by back-specific function (30 %) and a combination of pain and function (20 %). A reduction in pain intensity ≥50 % was the most common threshold used to define responders (IQR 33–60 %).

Conclusions

Few RCTs of interventions for chronic LBP report responder analyses. Where responder analyses are used, the methods are inconsistent. When performing responder analyses authors are encouraged to follow the recommended guidelines, using empirically derived cutoffs, and present results alongside mean differences.     

Predictors for work ability and disability in men and women with low-back or neck problems

In many countries back and neck problems are the most common reason for work incapacity. Numerous studies have looked for reliable predictors of return to work (RTW) or not return to work (NRTW) for those incapacitated, but with few exceptions their predictive and detective ability has been limited. We aimed to perform a comparative study of various commonly used health measures ability to predict RTW or NRTW in a cohort of men and women sick-listed for more than 28 days due to low-back pain (LBP) or neck pain (NP). A cohort of 1,575 men and women sick-listed more than 28 days due to back or neck problems was asked to answer ten different health measures (scales) about various aspects of health status (health related quality of life, pain, back function and depressivity) at four occasions during a 2-year period. A statistical diagnostic test was used to study how well the subjects values on these scales would serve as a predictor for work resumption. There was an improvement from day 28 up until 2 years, reflected by the different scales, more pronounced for LBP than for NP patients and for men with LBP compared with women with LBP. For all separately tested scales EuroQol (EQ-5D) had the highest overall ability to predict RTW or NRTW irrespective of gender, diagnoses or duration of the problems. When RTW or NRTW were predicted in a cohort of sick-listed low-back or neck patients, EQ-5D had outstanding properties in this respect irrespective of gender, diagnosis or elapsed time during this 2-year study.     

Long-term effects of supervised physical training in secondary prevention of low back pain

Background and objectives: In the last few years, several studies have focused on short-term treatment effects of exercise therapy. However, there is a lack of knowledge concerning the long-term treatment effects recorded after several years. Hence, this study was performed to investigate the short- and long-term effects of supervised physical training on functional ability, self-rated pain and disability in secondary prevention of low back pain. Methods: One hundred and eighty-three hospital employees with chronic low back pain were randomly assigned either to back school (comparison group), or three-months supervised physical training including a back school (exercise group). Various measurements of functional ability were performed and subjects completed questionnaires on self-rated pain, disability, and general well-being before treatment, immediately after intervention, and at six-months follow-up. At one-year and at ten-years follow-up participants evaluated treatment effectiveness. Results: Out of 183 employees, 148 completed the program. Participation at follow-ups ranged from 66 to 96%. Supervised physical training significantly improved muscular endurance and isokinetic strength during a six-months follow-up, and effectively decreased self-rated pain and disability during a one-year follow-up. At ten-years follow-up the subjects assessment of the effectiveness of treatment was significantly better in the exercise group. Conclusions: Supervised physical training effectively improved functional capacity and decreased LBP and disability up to one-year follow-up. The subjects positive evaluation of the treatment effect at ten-years follow-up suggests a long-term benefit of training.Supported in part by a grant of the Swiss National Science Foundation (Project NFP 26, No. 4026-27064) and by the BBW (Project SOS-LBD, No. 97.0046).     

Spontaneous resolution of lumbar disk herniation: predictive signs for prognostic evaluation

Spontaneous regression of lumbar disk herniation in patients who did not undergo surgery nor interventional therapy is reported in up to 70% of cases; however, no perspective study has clarified the possible predictive signs of a positive evolution. Aim of our study was to search for plan and contrast enhancement MRI signs able to define disk-herniation resolution. We enrolled 64 patients, affected by 72 lumbar disk herniations as per the classification proposed by the American Society of Neuroradiology (Nomenclature and Classification of Lumbar Disk Pathology 2001). MRI examinations were performed by 1.5-T magnet, using T1w SE sequences on sagittal and axial planes, before and after contrast, and T2w FSE ones on the same planes. The following parameters were considered: age, sex, level and size of disk herniation, its relationship to the spinal canal, clinical onset interval, type of disk herniation, herniated-material signal intensity on T2w sequences and its pattern of contrast enhancement. All the patients, conservatively treated, underwent clinical and MRI follow-up examination after 6 months. At MRI follow-up exams spontaneous regression of disk herniation was observed in 34.72% of cases. Among these, free fragments regressed in 100% of cases, herniations with high signal intensity on T2w sequences in 85.18%, herniations with peripheral contrast-enhancement in 83% of cases. Disk-herniation evolution did not show any relationship with location, size and level. Our study demonstrates that MRI, in addition to its high diagnostic value, offers predictive information about disk-herniation evolution.     

Risk factors of back pain frequency in schoolchildren: a search for explanations to a public health problem

This study examined physical, behavioral and social factors associated with schoolchildren's back pain. Factors associated with back pain were also identified using a stepwise regression method. The study was based on a self-administered questionnaire survey of a random national sample of 2173 Icelandic 11-12 and 15-16-y-old schoolchildren. It found that older subjects tended to report back pain more frequently than younger children. Back pain showed significant associations with different aspects of physical condition such as chronic health conditions, tiredness and physical fitness. A number of behavioral factors including participation in sports, television viewing, eating habits and smoking also had a relationship with back pain. Finally, children with lower social support were more likely to experience back pain. CONCLUSION: Overall, four major factors (age, morning tiredness, eating habits and parental support) emerged as factors associated with back pain in the study subjects. These results highlighted the roles of lifestyle and social factors in the experience of back pain in schoolchildren.