scholarly journals Are the Effects of Homeopathy Attributable to a Statistical Artefact? A Reanalysis of an Observational Study

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Rainer Lüdtke ◽  
Stefan N. Willich ◽  
Thomas Ostermann

Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM).Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects.Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua’s modifiedt-test.Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06–0.19,P<0.001) in the mental and 0.25 (0.22–0.28,P<0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses.Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.

2015 ◽  
Vol 16 (6) ◽  
pp. 621-625 ◽  
Author(s):  
Anja Kutscher ◽  
Ulf Nestler ◽  
Matthias K. Bernhard ◽  
Andreas Merkenschlager ◽  
Ulrich Thome ◽  
...  

OBJECT Congenital hydrocephalus has a major impact on the lives of patients and their relatives, as well as their long-term neurological development and social integration. The aim of this study was to assess the self-reported health-related quality of life (HRQOL) of patients after reaching adulthood. METHODS A total of 31 patients who required CSF shunt treatment for congenital hydrocephalus within the 1st year of life (between 1963 and 1987) agreed to undergo a structured SF-36 self-assessment. An age-matched German standard cohort was used as control. Additional parameters of surgical, social, and global neurological outcome were analyzed. The mean patient age was 35 years (range 26–51 years, 13 females and 18 males). Hydrocephalus etiologies were posthemorrhagic hydrocephalus (n = 9), postinfectious hydrocephalus (n = 5), aqueductal stenosis (n = 10), myelomeningocele (n = 2), and unknown cause (n = 5). RESULTS The mean modified Rankin Scale score was 1.6 (range 0–4). Hydrocephalic patients achieved lower scores for the SF-36 items physical functioning (70.5 vs 93.5, p < 0.05), physical role functioning (74.2 vs 88.3, p < 0.05), and general health perceptions (64.5 vs 72.3, p < 0.05). Emotional, social role functioning, and mental health items did not differ between the groups. Assessment of vitality and pain resulted in a trend to worse values. Whereas the Physical Component Summary score was lower (46.1 vs 54.3, p < 0.05), the Mental Component Summary score was not significantly different (50.2 vs 48.7, p = 0.3). There was neither a statistically significant difference between subgroups of different etiologies nor an association with the number of subsequent hydrocephalus-related surgeries. CONCLUSIONS Adult HRQOL for patients with congenital hydrocephalus appears to be similar to that for healthy con with regard to mental health and social functioning aspects. Physical impairment is a predominant factor of compro quality of life.


2014 ◽  
Vol 120 (2) ◽  
pp. 528-537 ◽  
Author(s):  
Roberto Jose Diaz ◽  
Nicole Maggacis ◽  
Shudong Zhang ◽  
Michael D. Cusimano

Object Skull base chordomas can be managed by surgical intervention and adjuvant radiotherapy. As survival for this disease increases, identification of determinants of quality of life becomes an important focus for guiding comprehensive patient care. In this study the authors sought to measure functional outcome and quality of life in patients with skull base chordomas and to identify determinants of quality of life in these patients. Methods The authors carried out an internet-based cross-sectional survey, collecting detailed data for 83 individual patients. Demographic and clinical variables were evaluated. Functional outcomes were determined by Karnofsky Performance Scale (KPS) and Glasgow Outcome Scale Extended (GOSE), quality of life was measured using the 36-Item Short Form Health Survey (SF-36), and depression was assessed using Patient Health Questions–9 (PHQ-9) instrument. Caregiver burden was assessed using the Zarit Burden Interview (ZBI). Univariate and multivariate analysis was performed to identify determinants of the physical and mental components of the SF-36. Results Patients with skull base chordomas who have undergone surgery and/or radiation treatment had a median KPS score of 90 (range 10–100, IQR 10) and a median GOSE score of 8 (range 2–8, IQR 3). The mean SF-36 Physical Component Summary score (± SD) was 43.6 ± 11.8, the mean Mental Component Summary score was 44.2 ±12.6, and both were significantly lower than norms for the general US population (p < 0.001). The median PHQ-9 score was 5 (range 0–27, IQR 8). A PHQ-9 score of 10 or greater, indicating moderate to severe depression, was observed in 29% of patients. The median ZBI score was 12 (range 0–27, IQR 11), indicating a low burden. Neurological deficit, use of pain medication, and requirement for corticosteroids were found to be associated with worse SF-36 Physical Component Summary score, while higher levels of depression (higher PHQ-9 score) correlated with worse SF-36 Mental Component Summary score. Conclusions Patients with skull base chordomas have a lower quality of life than the general US population. The most significant determinants of quality of life in the posttreatment phase in this patient population were neurological deficits (sensory deficit and bowel/bladder dysfunction), pain medication use, corticosteroid use, and levels of depression as scored by PHQ-9.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047812
Author(s):  
Takuya Aoki ◽  
Shunichi Fukuhara ◽  
Yasuki Fujinuma ◽  
Yosuke Yamamoto

ObjectivesLongitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical outcomes among patients with multimorbidity. This study aimed to examine the effects of different multimorbidity patterns on the decline in HRQoL.DesignNationwide prospective cohort study.SettingJapanese adult residents.ParticipantsResidents aged ≥50 years selected by the quota sampling method.Primary outcome measureClinically relevant decline in HRQoL was defined as a 0.50 SD (5-point) decrease in the 36-Item Short Form Health Survey (SF-36) component summary scores for 1 year.ResultsIn total, 1211 participants completed the follow-up survey. Among the multimorbidity patterns identified using confirmatory factor analysis, multivariable logistic regression analyses revealed that high cardiovascular/renal/metabolic and malignant/digestive/urologic pattern scores were significantly associated with the clinically relevant decline in SF-36 physical component summary score (adjusted OR (aOR)=1.25, 95% CI: 1.08 to 1.44 and aOR=1.28, 95% CI: 1.04 to 1.58, respectively). High cardiovascular/renal/metabolic pattern score was also significantly associated with the clinically relevant decline in SF-36 role/social component summary score (aOR=1.23, 95% CI: 1.06 to 1.42).ConclusionsOur study revealed that multimorbidity patterns have different effects on the clinically relevant decline in HRQoL for 1 year. These findings can be useful in identifying populations at high risk and with poor clinical outcomes among patients with chronic diseases and multimorbidity for efficient resource allocation.


Hand Surgery ◽  
2006 ◽  
Vol 11 (03) ◽  
pp. 103-107 ◽  
Author(s):  
Izuru Kitajima ◽  
Kazureru Doi ◽  
Yasunori Hattori ◽  
Semih Takka ◽  
Emmanuel Estrella

To evaluate the subjective satisfaction of brachial plexus injury (BPI) patients after surgery based on the medical outcomes study 36-item short form health survey (SF-36) and to correlate their SF-36 scores with upper extremity functions. Four items were assessed statistically for 30 patients: SF-36 scores after BPI surgery were compared with Japanese standard scores; the correlation between SF-36 scores and objective joint functions; difference in SF-36 scores between each type of BPI; and influence of each joint function on the SF-36 scores. The SF-36 subscale: PF — physical functioning, RP — role-physical, BP — bodily pain, and the summary score PCS — physical component summary, were significantly inferior to the Japanese standard scores. SF-36 is more sensitive to shoulder joint function than to elbow and finger joint functions. Little correlation was found between SF-36 scores and objective evaluations of joint functions. Greater effort is needed to improve the quality of life (QOL) of BPI patients. This study showed that SF-36 is not sensitive enough to evaluate regional conditions. A region- or site-specific questionnaire is required to evaluate upper extremity surgery.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Suzanne H Lo ◽  
Anne M Chang ◽  
Janita P Chau ◽  
Glenn E Gardner

Introduction: Health-related quality of life is a significant outcome of stroke survivors’ recovery. The 49-item English version of the Stroke Specific Quality of Life Scale (SSQOL) (Williams et al., 2009) is a stroke-specific assessment of stroke survivors’ health-related quality of life in 12 domains. However there has been no Chinese version of the scale for Chinese stroke survivors in Hong Kong. Aim: To examine the reliability and validity of the Chinese version of Stroke Specific Quality of Life Scale (SSQOL-C) in stroke survivors. Methods: SSQOL was translated into Chinese and blind back-translated by independent bilingual baccalaureate nursing students. Content validity was reviewed by an expert panel which consisted of one nurse academic, one nurse manager, three advanced practice nurses, and two registered nurses. A cross-sectional study was conducted to validate the translated version. A convenience sample of 135 adult stroke survivors were recruited from three community centres and a stroke support group in Hong Kong. Internal consistency analysis was performed. Pearson’s correlation coefficients were calculated between SSQOL-C, SF-36, and Frenchay Activities Index (FAI) to determine the convergent validity. Results: Content validity index of SSQOL-C was 0.99. SSQOL-C had high internal consistency with Cronbach’s alpha of 0.94 for the total scale, and between 0.65 and 0.90 for the 12 domains. The total SSQOL-C scores showed significant positive correlations with SF-36 physical health (r=0.58, p<0.01) and mental health (r=0.54, p<0.01) component scores, and FAI score (r=0.59, p<0.01). SSQOL-C physical subtotal scores showed significant positive correlations with SF-36 physical health (r=0.55, p<0.01) and mental health (r=0.43, p<0.01) component scores, and FAI score (r=0.54, p<0.01). SSQOL-C psychosocial subtotal scores showed significant positive correlations with SF-36 physical health (r=0.52, p<0.01) and mental health (r=0.56, p<0.01) component scores, and FAI score (r=0.56, p<0.01). Conclusion: The results showed SSQOL-C had good content and convergent validity, and reliability in Chinese stroke survivors. Further evaluation of factor structure of SSQOL-C will be conducted to determine its validity.


Author(s):  
Rosanna Tavella ◽  
Natalie Cutri ◽  
John F Beltrame

BACKGROUND. Patients with chest pain and no evidence of obstructive coronary artery disease on angiography (NoCAD) are frequently considered not to have significant pathology and their symptoms trivialized. This study compared the health status of patients with NoCAD, obstructive coronary artery disease (CAD) and healthy subjects. METHOD. Patients undergoing angiography within the preceding 12 months for the investigation of chest pain were categorized as NoCAD or CAD on the basis of the angiographic findings and completed a health-related quality of life instrument, the Short Form-36 (SF-36). These were compared with a ‘healthy control’ group that were randomly selected from the electronic white pages and recruited if they had no self-reported history of cardiovascular disease. Cross sectional comparisons between the three groups were age adjusted and performed using liner regression. RESULTS. As shown in the table below, the healthy controls were significantly younger and therefore comparison of SF36 scores were age adjusted. All SF-36 sub-scales (except for bodily pain) and summary scores (see table ), were significantly lower in the CAD and NoCAD groups compared to the healthy controls. There were no differences in SF-36 scores between NoCAD and CAD. CONCLUSION. Compared with a healthy population, patients with stable CAD and NoCAD have significantly poorer quality of life asF-36. Future management strategies need to address the health outcomes in these patients. Healthy Controls (n = 3168) NoCAD (n = 320) CAD (n = 828) Age 52 ± 15 57 ± 12 * 62 ± 11 # SF-36: Physical Summary Score 49 ± 10 41 ± 11 * 41 ± 11 # SF-36: Mental Summary Score 51 ± 10 46 ± 11 * 46 ± 11 # * p <0.01 for healthy controls vs NoCAD, # p <0.01 for healthy controls vs CAD


2011 ◽  
Vol 31 (2) ◽  
pp. 138-147 ◽  
Author(s):  
Wieneke M. Michels ◽  
Sandra Van Dijk ◽  
Marion Verduijn ◽  
Saskia Le Cessie ◽  
Elisabeth W. Boeschoten ◽  
...  

ObjectiveDespite a lack of strong evidence, automated peritoneal dialysis (APD) is often prescribed on account of an expected better quality of life (QoL) than that expected with continuous ambulatory peritoneal dialysis (CAPD). Our aim was to analyze differences in QoL in patients starting dialysis on APD or on CAPD with a follow-up of 3 years.MethodsAdult patients in the prospective NECOSAD cohort who started dialysis on APD or CAPD were included 3 months after the start of dialysis. The Medical Outcomes Survey Short Form 36 [SF-36 (Medical Outcomes Trust and QualityMetric, Lincoln, RI, USA)] and Kidney Disease and Quality of Life Short Form [KDQOL-SF (KDQOL Working Group, Santa Monica, CA, USA)] questionnaires were used to measure QoL. Differences in QoL over time were calculated using linear mixed models. Patients were followed until transplantation, death, or a first switch to any other dialysis modality.ResultsThe clinical and social characteristics of the 64 APD and 486 CAPD patients were slightly different at baseline. In the crude analysis, the pattern of the mental summary score differed between the modalities ( p = 0.03, adjusted p = 0.06), because of a different pattern for role function emotional ( p = 0.03, adjusted p = 0.05). The pattern of the physical summary score was not different between the groups. Scores on dialysis staff encouragement had a different pattern over time ( p = 0.01), because of an in-equality in scores 3 months after the start of dialysis, which disappeared after 18 months on dialysis. Over time, patients on APD scored higher on sexual function. After adjustment for age, sex, glomerular filtration rate, comorbidity, and primary kidney disease, that difference disappeared. This study showed no major differences in QoL on the KDQOL-SF and the SF-36 between the two modalities.


2011 ◽  
Vol 17 (10) ◽  
pp. 1238-1249 ◽  
Author(s):  
Oscar Fernández ◽  
Karine Baumstarck-Barrau ◽  
Marie-Claude Simeoni ◽  
Pascal Auquier ◽  

Background: Multiple sclerosis (MS) can have psychological and socioeconomic consequences that affect patients’ health-related quality of life (HRQoL) as much as physical disability. Objective: To determine the clinical and sociodemographic factors affecting HRQoL in a large international study using the MS International QoL (MusiQoL) questionnaire. Methods: Patients aged >18 years with a diagnosis of MS for >6 months or clinically isolated syndrome (CIS) were enrolled. Sociodemographic and clinical data were recorded, and patients completed the MusiQoL and 36-item short form (SF-36) health survey questionnaires. Results: In total, 1992 patients from 15 countries were enrolled (mean [standard deviation] age: 42.3 [12.5] years; 70.5% women; 70.4% with relapsing–remitting MS). Multivariate multiple regression analyses identified lower educational level, higher Expanded Disability Status Scale (EDSS) score, cognitive impairment, being single and shorter time since last relapse as significant predictors of lower MusiQoL global index scores ( p < 0.05). Older age, female sex, higher EDSS score, shorter time since last relapse and receiving current MS treatment were significant predictors of lower SF-36 physical component summary scores ( p < 0.05). The SF-36 mental component summary score was linked to occupational status, inpatient/outpatient status, time since last relapse, and whether the patient was receiving MS treatment ( p < 0.05). Conclusion: Sociodemographic and clinical factors are linked to HRQoL in patients with MS. Interventions that affect these factors might be expected to influence HRQoL.


2013 ◽  
Vol 39 (3) ◽  
pp. 349-356 ◽  
Author(s):  
Juliessa Florian ◽  
Adalberto Rubin ◽  
Rita Mattiello ◽  
Fabricio Farias da Fontoura ◽  
Jose de Jesus Peixoto Camargo ◽  
...  

OBJECTIVE: To investigate the impact of a pulmonary rehabilitation program on the functional capacity and on the quality of life of patients on waiting lists for lung transplantation. METHODS: Patients on lung transplant waiting lists were referred to a pulmonary rehabilitation program consisting of 36 sessions. Before and after the program, participating patients were evaluated with the six-minute walk test and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). The pulmonary rehabilitation program involved muscle strengthening exercises, aerobic training, clinical evaluation, psychiatric evaluation, nutritional counseling, social assistance, and educational lectures. RESULTS: Of the 112 patients initially referred to the program, 58 completed it. The mean age of the participants was 46 ± 14 years, and females accounted for 52%. Of those 58 patients, 37 (47%) had pulmonary fibrosis, 13 (22%) had pulmonary emphysema, and 18 (31%) had other types of advanced lung disease. The six-minute walk distance was significantly greater after the program than before (439 ± 114 m vs. 367 ± 136 m, p = 0.001), the mean increase being 72 m. There were significant point increases in the scores on the following SF-36 domains: physical functioning, up 22 (p = 0.001), role-physical, up 10 (p = 0.045); vitality, up 10 (p < 0.001); social functioning, up 15 (p = 0.001); and mental health, up 8 (p = 0.001). CONCLUSIONS: Pulmonary rehabilitation had a positive impact on exercise capacity and quality of life in patients on lung transplant waiting lists.


2021 ◽  
Vol 10 (5) ◽  
pp. 321-327
Author(s):  
Nike Walter ◽  
Markus Rupp ◽  
Katja Hierl ◽  
Christian Pfeifer ◽  
Maximilian Kerschbaum ◽  
...  

Aims We aimed to evaluate the long-term impact of fracture-related infection (FRI) on patients’ physical health and psychological wellbeing. For this purpose, quality of life after successful surgical treatment of FRIs of long bones was assessed. Methods A total of 37 patients treated between November 2009 and March 2019, with achieved eradication of infection and stable bone consolidation after long bone FRI, were included. Quality of life was evaluated with the EuroQol five-dimension questionnaire (EQ-5D) and German Short-Form 36 (SF-36) outcome instruments as well as with an International Classification of Diseases of the World Health Organization (ICD)-10 based symptom rating (ISR) and compared to normative data. Results With a mean follow-up of 4.19 years (SD 2.7) after the last surgery, the mean SF-36 score was 40.1 (SD 14.6) regarding the physical health component and 48.7 (SD 5.1) regarding the mental health component, compared to German normative values of 48.4 (SD 9.2) (p < 0.001) and 50.9 (SD 8.8) (p = 0.143). The mean EQ-5D index reached 0.76 (SD 0.27) with a mean EQ-5D visual analogue scale (VAS) rating of 65.7 (SD 22.7) compared to reference scores of 0.88 (p < 0.001) and 72.9 (p < 0.001). Mean scores of the ISR did not reveal significant psychological symptom burden, while an individual analysis showed moderate to severe impairments in 21.6% (n = 8) of the patients. Conclusion Even a mean 4.2 years (SD 2.7) after surgically successful treatment of FRI of long bones, patients report significantly lower quality of life in comparison to normative data. Future clinical studies on FRIs should focus on patient-related outcome measures enabling best possible shared treatment decision-making. Prevention methods and interdisciplinary approaches should be implemented to improve the overall quality of life of FRI patients. Cite this article: Bone Joint Res 2021;10(5):321–327.


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