Assessment of the Methodologic Quality of Medical and Surgical Clinical Trials in Patients with Arthroplasty

Objective.To assess the methodological quality of randomized controlled trials (RCT) of medical and surgical therapy in patients with arthroplasty.Methods.We conducted a Medline database search for all arthroplasty RCT from 1997 and 2006. The quality of the methods of all eligible RCT was assessed by a trained abstractor. We used a checklist of trial quality characteristics, and the overall trial quality was assessed by 3 scales: Jadad (range 0–5), Delphi list (range 0–9), and numeric rating scale (NRS; range 1–10), based on User’s Guides to the Medical Literature.Results.A total of 196 articles were included in the analysis; most included hip (n = 81) or knee (n = 80) or both hip/knee arthroplasty (n = 19); 66 (34%) assessed pharmacological treatments, 117 (60%) nonpharmacological treatments, and 13 (7%) both. Mean (SEM) overall quality scores of arthroplasty RCT were low: Jadad score 2.36 (1.4), Delphi list 5.33 (1.6), and NRS score 4.30 (2.6). Multivariable analyses revealed that nonpharmacological intervention RCT had lower odds (odds ratio 0.28–0.39; p = 0.008–0.033) and those with no funding had lower odds (OR 0.28–0.50; p = 0.014–0.119) of being in the highest quartiles of the 3 overall quality scores. In contrast, multicenter RCT had 1.8–4.7 times higher odds of being in highest tertiles of quality scores (p = 0.017–0.185).Conclusion.Methodological deficiencies in reporting of hip/knee arthroplasty RCT offer an opportunity for improvement. Type of intervention, number of trial centers, and presence of funding were independently associated with overall trial quality. In future, multicenter RCT (rather than single-center) and modeling protocols of single-center RCT similar in rigor to multicenter RCT may improve the quality of arthroplasty RCT.

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Painful diabetic polyneuropathy and quality of life in Danish type 2 diabetic patients

Scandinavian Journal of Pain ◽

10.1016/j.sjpain.2017.04.026 ◽

2017 ◽

Vol 16 (1) ◽

pp. 173-173 ◽

Cited By ~ 4

Author(s):

Sandra Sif Gylfadottir ◽

Diana Hedevang Christensen ◽

Sia Kromann Nicolaisen ◽

Reimar Wernich Thomsen ◽

Jens Steen Nielsen ◽

...

Keyword(s):

Quality Of Life ◽

Pain Intensity ◽

Rating Scale ◽

Diabetic Polyneuropathy ◽

Numeric Rating Scale ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Type 2 Diabetic

Abstract Background and aims Painful polyneuropathy (PPN) is a disabling complication of diabetes. This study aims to determine its prevalence and relationship with Quality of Life (QoL) in a nationwide prospective cohort of incident recently diagnosed Danish type 2 diabetic patients. Methods We sent a detailed questionnaire on neuropathy, pain and QoL to 6726 patients prospectively enrolled from general practitioners and hospital specialist outpatient clinics into the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) cohort. Patients who reported pain in both feet and a score ≥3 on the Douleur Neuropathique (DN4) questionnaire were considered to have possible PPN. QoL and pain intensity were measured on a numeric rating scale (NRS, 0–10). The Michigan Neuropathy Screening Instrument (MNSI) was used to assess neuropathy. Results A total of 5371 (79.8%) returned a complete questionnaire. 848 (15.8%) recently diagnosed type 2 diabetic patients reported pain in both feet. Of the 619 patients with pain who completed the DN4 questionnaire, 404 (65.2%) had a DN4 score ≥ 3, corresponding to a prevalence in the total population of possible PPN of 10.3%. Mean pain intensity was 5.2 (SD 2.2) and 89% had a MNSI score ≥ 3. Patients with possible PPN had a substantially lower QoL score than those without PPN (median QoL score 6 versus 8 (p < 0.001)), also when correcting for MNSI score. Conclusions Ten percent of newly diagnosed type 2 diabetic patients in Denmark had possible PPN. Patients with PPN had lower QoL than patients without PPN.

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Effectiveness of mebeverine in patients with post-cholecystectomy gastrointestinal spasm: results of prospective observational program “odyssey”

Terapevticheskii arkhiv ◽

10.26442/terarkh201890840-47 ◽

2018 ◽

Vol 90 (8) ◽

pp. 40-47 ◽

Cited By ~ 1

Author(s):

I V Maev ◽

Yu A Kucheravy ◽

V V Tsukanov ◽

E Yu Eremnia ◽

D N Andreev ◽

...

Keyword(s):

Quality Of Life ◽

Abdominal Pain ◽

Surgical Treatment ◽

Rating Scale ◽

Clinical Symptoms ◽

Gastrointestinal Symptoms ◽

Marked Change ◽

Numeric Rating Scale ◽

Observational Assessment

Aim: to assess the effectiveness of mebeverine 200 mg BID in patients with post-cholecystectomy gastrointestinal spasm not requiring surgical treatment. Materials and methods. 218 patients were included in 16 clinical centers in 14 cities in Russia. All patients had post-cholecystectomy gastrointestinal spasms, not requiring surgical treatment and received mebeverine (Duspatalin®) 200 mg BID. The observational assessment period lasted from the moment of their inclusion into the study up to 6 weeks post inlusion. The therapy results were evaluated using visual analog scales (GPA and 11-point numeric rating scale) by patient self-assessment of the dynamics of spasm/discomfort and other post-cholecystectomic gastrointestinal symptoms after 2 and 6 weeks of treatment. Gastrointestinal Quality of Life Index (GIQLI) was used to assess patient quality of life. Results and discussion. All 218 patients completed the 2-week mebeverine treatment course, 101 of them finished the 6-week course (“prolonged population”). Significant positive changes in the relief of abdominal pain and dyspepsia were noted as well as normalization of stool frequency and consistency. A more marked change in values was observed during prolonged (up to 6 weeks) therapy. Both 2-week and 6-week mebeverine courses led to a normalization of patient quality of life. After 6 week therapy, an effect of mebeverine on the quality of life 91% of patients was observed comparable to cholecystectomy itself, speficially related to the quality of life subscore ‘symptoms’. Conclusion. The results of our study demonstrate that mebeverine (Duspatalin®) therapy leads to an effective elimination of clinical symptoms associated with post-cholecystectomy GI-spasm disorders, like abdominal pain, symptoms of dyspepsia and stooldisorders. A more marked change in values was observed during prolonged (up to 6 weeks) therapy.

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Post-caesarean section pain and quality of sleep among mothers who delivered by caesarean section under spinal anesthesia

Malahayati International Journal of Nursing and Health Science ◽

10.33024/minh.v3i2.3473 ◽

2021 ◽

Vol 3 (2) ◽

pp. 110-116

Author(s):

Ririn Harini ◽

Juwitasari Juwitasari ◽

Lilis Setyowati ◽

Rifdah Dita Oktavia

Keyword(s):

Caesarean Section ◽

Sleep Quality ◽

Rating Scale ◽

Healing Process ◽

Numeric Rating Scale ◽

Wound Healing Process ◽

P Value ◽

Poor Sleep ◽

Pain Level

Background: Post caesarean section mothers commonly feel pain in the post-operative area during the wound healing process. Most post-operative mothers feel the pain sensation as a disturbance and lowering their quality of sleep.Purpose: To determine pain level and identify the relationship of pain level and sleep quality among mothers who delivered by caesarean section under spinal anaesthesia.Method: The descriptive non-experimental correlative study design identified 50 mothers from Inpatient Ward Wava Husada Hospital of Kepanjen, Malang, East Java, Indonesia at April 2020. The Post-caesarean section pain level identified by using the Numeric Rating Scale (NRS) and the sleep quality is measured using Pittsburgh Sleep Quality Index (PSQI) questionnaire.Results: 38 mothers (76%) had severe pain level and most of them (43 mothers) had poor sleep quality. The Spearman correlation test showed that there was a relationship between the Post-caesarean section pain level and sleep quality, p value = 0.000 (p <0.05) and r = 0.314.Conclusion: The post-caesarean section pain levels among mothers who delivered by caesarean section under spinal anaesthesia should be identified earlier as we would like to encourage the nursing staff to give further intervention to maintain their sleep quality.

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Clinical Response and Quality of Life in Patients with Severe Atopic Dermatitis Treated with Dupilumab: A Single-Center Real-Life Experience

Journal of Clinical Medicine ◽

10.3390/jcm9030791 ◽

2020 ◽

Vol 9 (3) ◽

pp. 791 ◽

Cited By ~ 6

Author(s):

Silvia Ferrucci ◽

Giovanni Casazza ◽

Luisa Angileri ◽

Simona Tavecchio ◽

Francesca Germiniasi ◽

...

Keyword(s):

Quality Of Life ◽

Atopic Dermatitis ◽

Rating Scale ◽

Real Life ◽

Life Quality ◽

Depression Scale ◽

Interleukin 4 ◽

Severe Atopic Dermatitis ◽

Single Center

Dupilumab is an anti-interleukin-4 receptor monoclonal antibody that was recently approved for the treatment of atopic dermatitis (AD). In this single-center retrospective study, clinical baseline data of 117 severe AD patients treated with dupilumab were collected. At baseline and at weeks 4 and 16, disease severity was assessed through the Eczema Area and Severity Index (EASI) and quality of life through the Dermatology Life Quality Index (DLQI) questionnaire, Patient-Oriented Eczema Measure (POEM), Hospital Anxiety and Depression Scale (HADS), Peak Pruritus Numerical Rating Scale (NRS-itch), and VAS-sleep. Response to dupilumab was defined as an improvement of ≥75% in EASI from baseline (EASI75). At multivariate analysis, AD onset before 18 years [OR, 2.9; 95% CI, 1.2–7.2; p = 0.0207] and absence of hypereosinophilia [OR, 2.24; 95% CI, 1.03–4.86; p = 0.0412] were identified as significant predictive parameters for response to dupilumab in terms of EASI75 at week 4 but not at week 16. Significant reductions in EASI, DLQI, POEM, HADS, NRS-itch, and VAS-sleep were found between week 4 versus baseline (p < 0.0001 for all) and week 16 versus baseline (p < 0.0001 for all). Early AD onset and absence of hypereosinophilia may be suggested as predictive markers of early response to dupilumab. We confirmed the efficacy and safety of this agent along with the improvement of life quality in severe AD patients.

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Effect of Pregabalin on Radiotherapy-Related Neuropathic Pain in Patients With Head and Neck Cancer: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.18.00896 ◽

2019 ◽

Vol 37 (2) ◽

pp. 135-143 ◽

Cited By ~ 8

Author(s):

Jingru Jiang ◽

Yi Li ◽

Qingyu Shen ◽

Xiaoming Rong ◽

Xiaolong Huang ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Event ◽

Neuropathic Pain ◽

Rating Scale ◽

Short Form ◽

Controlled Trial ◽

Numeric Rating Scale ◽

Mood States ◽

Numeric Rating

Purpose Neuropathic pain is an unavoidable treatment-related adverse event among patients with head and neck cancer who are undergoing radiotherapy. We aimed to test the efficacy and safety of pregabalin versus placebo in the treatment of radiotherapy-related neuropathic pain. Patients and Methods This randomized, double-blind, placebo-controlled trial was conducted in four centers in China. Eligible patients with a mean pain intensity score of 4 or more on an 11-point numeric rating scale were randomly assigned to receive either active treatment with a flexible dose of pregabalin or placebo for 16 weeks. The primary efficacy outcome was pain reduction measured on the numeric rating scale. Result There were 128 patients who received treatment as randomly assigned. Pain intensity reduction was 2.44 in the pregabalin arm and 1.58 in the placebo arm at week 16, yielding an adjusted mean difference of 0.87 (95% CI, 0.30 to 1.44; P = .003). In the pregabalin arm, 38 patients (59.4%) achieved at least 30% pain relief versus 21 (32.8%) in the placebo arm ( P = .006). Nineteen patients (29.7%) in the pregabalin group and five (7.8%) in the placebo group achieved 50% or greater pain relief ( P = .003). Total scores on the Profile of Mood States-Short Form, pain severity and functional interference of Brief Pain Inventory-Short Form, as well as the physiology and psychology domain of the WHO Quality of Life-BREF all were reduced significantly at week 16 in patients who received pregabalin compared with those who received placebo. There was no significant difference ( P = .29) in the incidence of experiencing at least one adverse event in the pregabalin arm (n = 35; 54.7%) versus the placebo arm (n = 29; 45.3%). Conclusion Patients treated with pregabalin with radiotherapy-related neuropathic pain had greater pain alleviation, better mood states, and higher quality of life compared with patients in the placebo group, with a good tolerability.

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Extended Duration Regional Analgesia for Total Knee Arthroplasty: A Randomised Controlled Trial Comparing Five Days to Three Days of Continuous Adductor Canal Ropivacaine Infusion

Anaesthesia and Intensive Care ◽

10.1177/0310057x1804600311 ◽

2018 ◽

Vol 46 (3) ◽

pp. 326-331 ◽

Cited By ~ 5

Author(s):

S. C. Sargant ◽

M. J. Lennon ◽

R. J. Khan ◽

D. Fick ◽

H. Robertson ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Rating Scale ◽

Intervention Group ◽

Numeric Rating Scale ◽

Secondary Outcome ◽

Quality Of Recovery ◽

Adductor Canal ◽

Total Knee ◽

Numeric Rating

There is a growing body of evidence in favour of continuous adductor canal block (CACB) for total knee arthroplasty. However, there are no studies describing the optimal duration of the infusion. At our institution the usual practice was to stop the infusion on day three. Our hypothesis was that extending the infusion to five days would improve analgesia and quality of recovery. A prospective, non-blinded, randomised trial was undertaken. Patients received a continuous infusion of 0.2% ropivacaine via an adductor canal catheter for either three or five days. Primary outcome was pain while walking during the 24-hour period up to day five (numeric rating scale from 0 to 10). The minimum clinically important difference was set at 1.5 on the numeric rating scale. Secondary outcome measures included quality of recovery, mobility, pain while walking on postoperative day six, Oxford Knee Scores, and complications. Eighty-six patients were recruited with 43 randomised to each group. Seventy-eight were analysed. Median pain scores reported on day five were significantly better in the intervention group (1 versus 3, P=0.003). Furthermore, quality of recovery (QOR-15) scores were significantly better in the intervention group (133.6 versus 123.4, P=0.017). No statistically significant difference between groups was identified for other secondary outcome measures. CACB prolonged to five days provides superior analgesia and a higher quality of recovery on postoperative days four and five compared to a three-day infusion. This benefit did not extend beyond the period of infusion.

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W1173 A Single-Item Numeric Rating Scale Shows Excellent Correlation with Measures of Crohn's Disease Activity and Health-Related Quality of Life

Gastroenterology ◽

10.1016/s0016-5085(09)63086-9 ◽

2009 ◽

Vol 136 (5) ◽

pp. A-670

Author(s):

Gil Y. Melmed ◽

Andrew Ippoliti ◽

Eric A. Vasiliauskas ◽

Dermot P. McGovern ◽

Marla Dubinsky ◽

...

Keyword(s):

Quality Of Life ◽

Rating Scale ◽

Numeric Rating Scale ◽

Health Related Quality ◽

Excellent Correlation ◽

Single Item ◽

Related Quality ◽

Health Related ◽

Numeric Rating

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Is radiofrequency ablation safe and effective in treating osteoid osteomas? A prospective single-center study with atypical cases

Journal of Orthopaedic Surgery ◽

10.1177/2309499020960555 ◽

2020 ◽

Vol 28 (3) ◽

pp. 230949902096055

Author(s):

Gokhan Yuce ◽

Nedim Aytekin ◽

Serhan Eren ◽

Birgul Genç ◽

Ömer Faruk Ateş ◽

...

Keyword(s):

Radiofrequency Ablation ◽

Osteoid Osteoma ◽

Rating Scale ◽

Clinical Success ◽

Numeric Rating Scale ◽

Radiology Department ◽

Surgical Removal ◽

Single Center ◽

Technical Success ◽

Technical Success Rate

Purpose: Osteoid osteomas are benign and nonprogressive lesions. The clinical presentation of osteoid osteoma is typical with night pain responsive to nonsteroidal anti-inflammatory agents. The typical radiological appearance is lucent nidus and adjacent reactive sclerosis. The most traditional management of osteoid osteoma is surgical removal which is associated with significant morbidity. This article aims to demonstrate our single-center experience of 55 patients with osteoid osteoma treated with percutaneous radiofrequency ablation (RFA). Methods: Fifty-five symptomatic patients who were seen at our orthopedics outpatient clinics, diagnosed with osteoid osteoma, and referred to interventional radiology department between May 2015 and April 2019 were enrolled. The nidus size, pain numeric rating scale score, and intramedullary edema diameter before and after RFA were compared. Clinical and technical success, intervention-related complications, and need for subsequent ablation were recorded. Results: Of the 55 patients, including 12 pediatric cases, 6 had atypical locations such as metatarsal, vertebra, and scapula, while 1 case had osteoid osteoma with multiple nidus. The mean age was 18.5 ± 9.6 years. Preintervention maximum nidus diameter, pain score, and edema diameter were significantly lower in postintervention measurements ( p < 0.001). Technical success rate was 98.1%, and clinical success was 96.36%. Severe complication occurred in one patient with soft tissue burn and osteomyelitis. Conclusion: This is one of the largest series of osteoid osteoma treated with RFA done in a single center with atypical cases. In conclusion, RFA is safe and effective in both pediatric and adult patients with rare complications even in challenging cases with atypical locations.

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Study protocol for a randomised, double-blind, placebo-controlled study evaluating the Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease: the EMERALD trial

BMJ Open ◽

10.1136/bmjopen-2019-029449 ◽

2019 ◽

Vol 9 (11) ◽

pp. e029449 ◽

Cited By ~ 4

Author(s):

Berzenn Urbi ◽

Simon Broadley ◽

Richard Bedlack ◽

Ethan Russo ◽

Arman Sabet

Keyword(s):

Amyotrophic Lateral Sclerosis ◽

Disease Progression ◽

Rating Scale ◽

Numeric Rating Scale ◽

Motor Neurone ◽

Double Blind ◽

Based Medicine ◽

Numeric Rating ◽

Lateral Sclerosis

IntroductionAmyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder with no known cure and with an average life expectancy of 3–5 years post diagnosis. The use of complementary medicine such as medicinal cannabis in search for a potential treatment or cure is common in ALS. Preclinical studies have demonstrated the efficacy of cannabinoids in extending the survival and slowing of disease progression in animal models with ALS. There are anecdotal reports of cannabis slowing disease progression in persons with ALS (pALS) and that cannabis alleviated the symptoms of spasticity and pain. However, a clinical trial in pALS with these objectives has not been conducted.Methods and analysisThe Efficacy of cannabis-based Medicine Extract in slowing the disease pRogression of Amyotrophic Lateral sclerosis or motor neurone Disease trial is a randomised, double-blind, placebo-controlled cannabis trial in pALS conducted at the Gold Coast University Hospital, Australia. The investigational product will be a cannabis-based medicine extract (CBME) supplied by CannTrust Inc., Canada, with a high-cannabidiol-low-tetrahydrocannabinol concentration. A total of 30 pALS with probable or definite ALS diagnosis based on the El Escorial criteria, with a symptom duration of <2 years, age between 25 and 75years and with at least 70% forced vital capacity (FVC) will be treated for 6 months. The primary objective of the study is to evaluate the efficacy of CBME compared with placebo in slowing the disease progression measured by differences in mean ALS Functional Rating Scale-Revised and FVC score between the groups at the end of treatment. The secondary objectives are to evaluate the safety and tolerability of CBME by summarising adverse events, the effects of CBME on spasticity, pain, weight loss and quality of life assessed by the differences in mean Numeric Rating Scale for spasticity and Numeric Rating Scale for pain, percentage of total weight loss and ALS specific quality of life-Revised questionnaire.Ethics and disseminationThe study has been approved by the local Institutional Review Board. The results of this study will be published in a peer-reviewed journal.Trial registration numberNCT03690791

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Comprehensive Assessment of 1-Year Outcomes and Determination of Minimum Clinically Important Difference in Pain, Disability, and Quality of Life After Suboccipital Decompression for Chiari Malformation I in Adults

Neurosurgery ◽

10.1227/neu.0000000000000032 ◽

2013 ◽

Vol 73 (4) ◽

pp. 569-581 ◽

Cited By ~ 16

Author(s):

Scott L. Parker ◽

Saniya S. Godil ◽

Scott L. Zuckerman ◽

Stephen K. Mendenhall ◽

John A. Wells ◽

...

Keyword(s):

Quality Of Life ◽

Rating Scale ◽

Short Form ◽

Minimum Clinically Important Difference ◽

Numeric Rating Scale ◽

Pain Disability ◽

Clinically Important Difference ◽

Patient Reported ◽

Difference Thresholds

Abstract BACKGROUND: To date, there has been no study to comprehensively assess the effectiveness of suboccipital craniectomy (SOC) for Chiari malformation I (CMI) using validated patient-reported outcome measures. OBJECTIVE: To determine the effectiveness and minimum clinically important difference thresholds of SOC for the treatment of adult patients with CMI using patient-reported outcome metrics. METHODS: Fifty patients undergoing first-time SOC and C1 laminectomy for CMI at a single institution were followed up for 1 year. Baseline and 1-year postoperative pain, disability, quality of life, patient satisfaction, and return to work were assessed. Minimum clinically important difference thresholds were calculated with 2 anchors: the Health Transition Index and North American Spine Society satisfaction questionnaire. RESULTS: The severity of headaches improved in 37 patients (74%). Improvement in syrinx size was seen in 12 patients (63%) and myelopathy in 12 patients (60%). All patient-reported outcomes showed significant improvement 1 year postoperatively (P < .05). Of the 38 patients (76%) employed preoperatively, 29 (76%) returned to work postoperatively at a median time of 6 weeks (interquartile range, 4-12 weeks). Minimum clinically important difference thresholds after SOC for CMI were 4.4 points for numeric rating scale for headache, 0.7 points for numeric rating scale for neck pain, 13.8 percentage points for Headache Disability Index, 14.2 percentage points for Neck Disability Index, 7.0 points for Short Form-12 Physical Component Summary, 6.1 points for Short Form-12 Mental Component Summary, 4.5 points for Zung depression, 1.7 points for modified Japanese Orthopaedic Association, and 0.34 quality-adjusted life-years for Euro-Qol-5D. CONCLUSION: Surgical management of CMI in adults via SOC provides significant and sustained improvement in pain, disability, general health, and quality of life as assessed by patient-reported outcomes. This patient-centered assessment suggests that suboccipital decompression for CMI in adults is an effective treatment strategy.

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