Second generation direct-acting antiviral (DAAs) Treatment on HCV+ patients: Patient reported outcomes (PROs) and psychiatric symptoms in a real world setting sample

IntroductionAnti-HCV treatments are moving away from interferon-alpha towards DAAs, associated with fewer side effects, better tolerability, and better PROs.AimsTo describe neuropsychiatric symptoms and PROs during DAAs treatment in a group of HCV+ patients.MethodsForty outpatients, scheduled for DAAs treatment, were assessed at enrolment (T0), 4 weeks (T1), at the end of treatment (EOT) and after 12 weeks of follow up (F-UP), by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. Afterwards the sample was divided into two groups as a function of a positive psychiatric history (19) and compared with each other.ResultsTotal sample mean scores between W0 and F-UP were compared and an improving trend was observed in all administered scales. An SF-36 items analysis showed a statistically significant difference in emotional role functioning between W0 vs EOT and EOT vs F-UP, in change in overall health status between W0 vs EOT and W0 vs F-UP.A multivariate logistic regression analysis showed that a positive psychiatric history was not associated with an improvement in vitality of 4.3 (minimal clinically important difference). Comparing the two groups, no significant fluctuations in SF-36 scores were founded and major deviations score increases were recorded in patients with a psychiatric history in all scales.ConclusionsOur real world data shows that new regimens do not seem to be associated with psychiatric side effects and conversely a clinical improvement compared to baseline was found, suggesting an immediate gain in PROs over the treatment period, particularly the psychiatric subgroup.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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New interferon-free therapies on HCV+ chronic hepatitis: Overcoming psychiatric side effects in a real world setting

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.1412 ◽

2016 ◽

Vol 33 (S1) ◽

pp. S392-S393

Author(s):

M. Moneglia ◽

A. Santangelo ◽

A. Ballerini ◽

V. Ricca ◽

A.L. Zignego

Keyword(s):

Chronic Hepatitis ◽

Side Effects ◽

Real World ◽

General Health ◽

Second Generation ◽

Psychiatric Symptoms ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Psychiatric Side Effects

IntroductionInterferon-alpha (IFNα) was the backbone therapy for HCV+ related chronic hepatitis (CH-C). However, it was associated with significant neuropsychiatric side effects and impaired health-related quality of life. Second Generation IFNα-free direct-acting antiviral agents (DAAs) seem to be associated with fewer side effects, better tolerability, high efficacy rates and better patient reported outcomes (PROs) [Younoussi, 2014].AimsTo describe the neuropsychiatric symptoms and PROs during Second Generation DAAs plus ribavirin oral treatment in a group of CH-C real world patients.MethodsNineteen CH-C outpatients, scheduled for IFNα-free treatment, were assessed at enrolment (T0), at 4 (T1) and at 12 (T2) weeks, the end of treatment, by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. A pharmacological therapy, based on clinical evidence, was provided at psychiatric symptoms onset.ResultsDuring the treatment, we didn’t report any worsening in the administred psychometric scales. Furthermore, we observed a general improvement at week 12 (T2), statistically significant only for MRS (P < 0.05). Any statistically significant difference was found for SF-36 mean scores comparing T0, T1 and T2. However, SF-36 cluster analysis showed between T0 and T2 a meaningful and significant rise of global health clusters “General health perceptions” (P < 0.05), “Change in overall health status” (P < 0.001) and a significant impairment in cluster “Emotional role functioning” (P < 0.05).ConclusionsOur real world data are consistent with trial setting results [Younoussi, 2014]. Contrary to previous IFNα-based therapy, new regimens don’t seem to be associated with psychiatric side effects and suggest an immediate gain in general health PROs over the treatment period.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Six-month and 12-month patient outcomes based on inflammatory subphenotypes in sepsis-associated ARDS: secondary analysis of SAILS-ALTOS trial

Thorax ◽

10.1136/thoraxjnl-2020-216613 ◽

2021 ◽

pp. thoraxjnl-2020-216613

Author(s):

Mohamed D Hashem ◽

Ramona O Hopkins ◽

Elizabeth Colantuoni ◽

Victor D Dinglas ◽

Pratik Sinha ◽

...

Keyword(s):

Mental Health ◽

Patient Reported Outcomes ◽

Secondary Analysis ◽

Cognitive Outcomes ◽

Short Term ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Sepsis Trial

BackgroundPrior acute respiratory distress syndrome (ARDS) trials have identified hypoinflammatory and hyperinflammatory subphenotypes, with distinct differences in short-term outcomes. It is unknown if such differences extend beyond 90 days or are associated with physical, mental health or cognitive outcomes.Methods568 patients in the multicentre Statins for Acutely Injured Lungs from Sepsis trial of rosuvastatin versus placebo were included and assigned a subphenotype. Among 6-month and 12-month survivors (N=232 and 219, respectively, representing 243 unique survivors), subphenotype status was evaluated for association with a range of patient-reported outcomes (eg, mental health symptoms, quality of life). Patient subsets also were evaluated with performance-based tests of physical function (eg, 6 min walk test) and cognition.FindingsThe hyperinflammatory versus hypoinflammatory subphenotype had lower overall 12-month cumulative survival (58% vs 72%, p<0.01); however, there was no significant difference in survival beyond 90 days (86% vs 89%, p=0.70). Most survivors had impairment across the range of outcomes, with little difference between subphenotypes at 6-month and 12-month assessments. For instance, at 6 months, in comparing the hypoinflammatory versus hyperinflammatory subphenotypes, respectively, the median (IQR) patient-reported SF-36 mental health domain score was 47 (33–56) vs 44 (35–56) (p=0.99), and the per cent predicted 6 min walk distance was 66% (48%, 80%) vs 66% (49%, 79%) (p=0.76).InterpretationComparing the hyperinflammatory versus hypoinflammatory ARDS subphenotype, there was no significant difference in survival beyond 90 days and no consistent findings of important differences in 6-month or 12-month physical, cognitive and mental health outcomes. These findings, when considered with prior results, suggest that inflammatory subphenotypes largely reflect the acute phase of illness and its short-term impact.

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Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

The British Journal of Psychiatry ◽

10.1192/bjp.187.2.131 ◽

2005 ◽

Vol 187 (2) ◽

pp. 131-136 ◽

Cited By ~ 63

Author(s):

W. Wolfgang Fleischhacker ◽

Jonathan Rabinowitz ◽

Georg Kemmler ◽

Mariëlle Eerdekens ◽

Angelika Mehnert

Keyword(s):

Mental Component Summary ◽

Psychiatric Symptoms ◽

Short Form ◽

Mental Component Summary Score ◽

Well Being ◽

Psychotic Symptoms ◽

Open Label ◽

Sf 36 ◽

Patient Reported ◽

Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

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Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967118774509 ◽

2018 ◽

Vol 6 (5) ◽

pp. 232596711877450 ◽

Cited By ~ 16

Author(s):

Elizabeth J. Scott ◽

Robert Westermann ◽

Nathalie A. Glass ◽

Carolyn Hettrich ◽

Brian R. Wolf ◽

...

Keyword(s):

Anterior Cruciate Ligament ◽

Physical Function ◽

Acl Reconstruction ◽

Cruciate Ligament ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Floor Effects ◽

Anterior Cruciate ◽

Pro Instruments

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains. Purpose: To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Initially, 157 patients completed the PROMIS PF CAT, Short Form–36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol–5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models. Results: At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF ( r = 0.75-0.80, P < .01), KOOS-ADL ( r = 0.63-0.70, P < .01), and KOOS-sport ( r = 0.32-0.69, P < .01); excellent-good correlation with the EQ-5D ( r = 0.60-0.71, P < .01); and good correlation with the KOOS-QOL ( r = 0.52-0.58, P < .01). As expected, there were poor correlations with the MARS ( r = 0.00-0.24, P < .01) and SF-36 GH ( r = 0.16-0.34, P < .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments ( r = 0.42-0.72, P < .01), including the MARS ( r = 0.42, P < .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different. Conclusion: The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction.

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Effect of Psychotropic Medications on Hammertoe Reconstruction Outcomes

Foot & Ankle Orthopaedics ◽

10.1177/2473011420944133 ◽

2020 ◽

Vol 5 (3) ◽

pp. 247301142094413

Author(s):

Samuel D. Maidman ◽

Amalie E. Nash ◽

Amanda Fantry ◽

Shay Tenenbaum ◽

Yahya Daoud ◽

...

Keyword(s):

Short Form ◽

Medication Use ◽

Psychotropic Medications ◽

Activity Level ◽

Mood Stabilizers ◽

Level Of Evidence ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Before And After

Background: Hammertoe deformities can seriously affect activity level and footwear. The use of prescription, mood-altering medications is very common, with some estimates as high as 25% of the population. Mood disorders, especially depression, negatively affect the results of medical and operative treatments. This study assessed the relationship of mood-altering medication use with the outcomes and complications of operative reconstruction of hammertoes. Methods: Data were prospectively collected from 116 patients who underwent hammertoe reconstruction, including demographic information, medical history, the use of mood-altering psychotropic medications (antidepressants, anxiolytics, hypnotics, and mood stabilizers), and postoperative complications. Preoperative patient-reported outcomes were measured using the visual analog scale (VAS) for pain and Short Form Health Survey (SF-36), which were repeated at 1-year follow-up. Results: A total of 36.2% of patients were taking psychotropic medications. Medication and nonmedication groups had similar pain VAS and SF-36 Physical Component Summary (PCS) scores before and after surgery. Compared with nonmedication patients, patients on psychotropic medications had significantly lower SF-36 Mental Component Summary (MCS) scores preoperatively ( P = .001) and postoperatively ( P = .006), but no significant difference in the change in MCS (ΔMCS) from preoperative to postoperative. Psychotropic medication use was associated with superficial wound infections ( P = .048), but not other complications. Conclusions: Patients taking psychotropic medications were equally likely to benefit from forefoot reconstruction as nonmedication patients. Preoperative and postoperative PCS and VAS were not significantly different between medication and nonmedication groups. Although the medication group had lower absolute MCS, they reported the same magnitude of improvement in MCS (ΔMCS) as the nonmedication group. Level of Evidence: Level II, prospective cohort study.

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Particulate Juvenile Articular Cartilage vs Osteochondral Allograft for Patellar Cartilage Defects: A Matched Cohort Analysis

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00510 ◽

2020 ◽

Vol 8 (7_suppl6) ◽

pp. 2325967120S0051

Author(s):

Niv Marom ◽

Francesca Coxe ◽

Dean Wang ◽

Riley Williams ◽

Gabriella Ode

Keyword(s):

Patient Reported Outcomes ◽

Cohort Analysis ◽

Osteochondral Allograft ◽

Cartilage Defects ◽

Matched Cohort ◽

Chondral Defects ◽

Sf 36 ◽

Cartilage Restoration ◽

Significant Difference ◽

Patient Reported

Objectives: Management of full-thickness cartilage defects of the patella remains a significant clinical challenge. Osteochondral allograft transplantation (OCA) is a reliable cartilage restoration procedure for large chondral defects of the knee. OCA reports good long-term outcomes for condylar defects but limited literature on outcomes of patellar defects. Since 2007, particulated juvenile articular cartilage (PJAC) has been used as an alternative method of cartilage restoration. PJAC has demonstrated promising early clinical outcomes, however, no studies have directly compared the clinical and patient reported outcomes of PJAC and OCA for management of full thickness chondral defects of the patella. Methods: Prospective data was collected for patients within our institutional cartilage registry who underwent OCA or PJAC using DeNovo NT (Zimmer-Biomet) for management of grade 4 cartilage defects of the patella. OCA patients were matched to PJAC patients by age, sex and BMI. Patient characteristics and minimum 2-year patient reported outcomes (PROMs) (Knee Outcome Survey-Activities of Daily Living (KOS-ADL) score, International Knee Documentation Committee (IKDC) score, Short Form 36 (SF-36) pain rating, and Marx Activity Rating Scale) and self-reported general overall knee condition were reported. Results: There were 28 patients eligible for analysis (14 OCA, 14 PJAC). Demographics of the two groups are outlined in Table 1. The mean age of the entire cohort was 38.4 +/- 11.4 years with a mean BMI of 24.6 +/- 3.1. One patient in each group had bipolar transplantation (patella and trochlea). OCA patients had more previous surgeries (1.4 vs 0.4) (p<0.01) and significantly larger chondral defects (4.6 cm2 vs. 2.5 cm2) (p<0.01) than PJAC patients. Patient reported outcomes are reported in Figure 1. IKDC, KOS-ADL and SF-36-Pain scores improved by 17, 16 and 14 points for OCA compared to 17, 11, and 23 points for PJAC at last follow-up (average 3.5 years) (p>0.05). Both groups met the published MCID for IKDC (17 pts) and KOS-ADL (10 pts) for osteochondral grafts. There was no significant difference between OCA and PJAC for all postoperative PROMs. The reoperation rate for OCA and PJAC was 36% and 50% respectively (p>0.05). There were 4 graft failures in the PJAC group (29%) and 1 failure in the OCA group (6%) (p>0.05). The failed OCA underwent manipulation and lysis of adhesions for post-operative stiffness at 7 months and arthroscopic synovectomy for synovitis at 8 months after OCA. The four failed PJAC patients underwent revision to OCA (at 8 months), chondroplasty of the graft (at 10 and 26 months), and revision to TKA (at 78 months). Reoperations are further described in Table 2. Conclusion: In a matched cohort analysis, both PJAC and OCA demonstrated significant clinical improvement in patient reported outcomes with no significant difference between the two groups at mean 3.5 years. Larger investigational studies are needed to determine optimal indications for use of PJAC versus OCA for management of focal cartilage defects of the patella. [Table: see text][Table: see text]

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The study of tamoxifen and raloxifene (STAR): First report of patient-reported outcomes (PROs) from the NSABP P-2 Breast Cancer Prevention Study

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.lba561 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. LBA561-LBA561 ◽

Cited By ~ 2

Author(s):

P. A. Ganz ◽

S. R. Land ◽

D. L. Wickerham ◽

M. Lee ◽

M. Ritter ◽

...

Keyword(s):

Breast Cancer ◽

Statistical Power ◽

Phase Iii ◽

Double Blind ◽

Mixed Effects Modeling ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Musculoskeletal Problems ◽

Pre Treatment

LBA561 Background: STAR is a double-blind, randomized phase III prevention trial designed to evaluate the relative efficacy of raloxifene (R) compared to tamoxifen (T) in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. In addition to standard safety monitoring, PROs were measured for quality of life (QOL) and symptoms (SXs). Methods: QOL was measured with the MOS SF-36, the CES-D, and the MOS Sexual Activity Questionnaire. SXs were measured using a modified checklist (SCL) from the NSABP P-1 BCPT. Primary endpoints were the SF-36 physical (PCS) and mental (MCS) component scales. A sample size of 1,670 provided statistical power of at least 0.8 (two-tailed test, alpha = .05). The QOL study was open to accrual at selected sites between 1/4/2000 and 5/31/2001, with questionnaires administered at baseline (pre-treatment), q 6 mos until 60 mos, and at 72 mos. SCL data were collected on all STAR participants. Longitudinal analyses used mixed effects modeling for the PCS, MCS, CES-D, and regression analyses were used to compare the average severity of SCL scores between T and R. Results: 19,747 participants enrolled in STAR and were eligible for the SCL assessment, with median follow-up time (mFU) 4.6 yrs. The QOL study enrolled 1,983 participants, 973 assigned to T and 1,010 assigned to R, mFU 5.4 yrs. QOL participants were comparable to women accrued concurrently at non-participating institutions. SCL and QOL forms compliance was high (with a low of 75% at 4.5 yrs for SCL and 74% for QOL). Mean PCS and MCS scores declined modestly over the 60 mos on study, with no significant difference between T and R. Mean CES-D scores worsened slightly on study, but with no significant difference between T and R. However, statistically significant differences (all p’s < .002) were noted between the T and R for severity of SXs, with R women reporting greater musculoskeletal problems, dyspareunia and weight gain and T women reporting greater vasomotor symptoms, leg cramps, bladder and gynecological problems. Conclusions: There were no significant differences between T and R in PROs for physical & mental health or depresson. While SX severity was generally low in this postmenopausal sample, the pattern of SXs differed between T and R. [Table: see text]

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Short Practical Regimen of Acupuncture for Melasma: A Prospective Cohort Study in a Tertiary Hospital in Thailand

Frontiers in Public Health ◽

10.3389/fpubh.2021.761017 ◽

2021 ◽

Vol 9 ◽

Author(s):

Thanan Supasiri ◽

Nuntida Salakshna ◽

Krit Pongpirul

Keyword(s):

Side Effects ◽

Adverse Events ◽

Severity Index ◽

Tertiary Hospital ◽

Optimal Number ◽

Significant Difference ◽

Patient Reported ◽

Group A ◽

The Mean ◽

Group B

Background: Acupuncture shows benefits for patients with melasma, although no optimal number of sessions have been determined.Methods: The prospective observational study was conducted in melasma patients who were treated with acupuncture procedures two times a week and were evaluated after the 5th and the 10th sessions of acupuncture, with a 1-week follow-up after the last session. Participants Groups A and B received five and 10 acupuncture sessions, respectively. Melasma was assessed by using the melanin index (MI), melasma area and severity index (MASI), patient-reported improvement scores, and acupuncture-related adverse events.Results: Out of 113 participants, 67 received five sessions of acupuncture treatment while 39 received 10 sessions. At 1 week after five sessions of acupuncture in Group A, the mean MI decreased by 28.7 (95% CI −38.5 to −18.8, p < 0.001), whereas the median MASI decreased by 3.4 (95% CI −6.9 to −1.2, p < 0.001) points. At 1 week after ten sessions of acupuncture in Group B, the mean MI decreased by 31.3 (95% CI −45 to −17.6, p < 0.001), whereas the median MASI decreased by 5.4 (95%CI −9.9 to −3, p < 0.001) points. The first five sessions of acupuncture had a higher incremental effect than the last five sessions, although there was no statistically significant difference. Twenty-nine participants reported minor side effects. Group B had a risk ratio (RR) of having adverse events 1.8 times (95% CI 1.0–3.4, p = 0.05) compared with Group A.Conclusion: Short acupuncture regimens of 5–10 sessions in melasma seem to be effective and practical with minor side effects.

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Defining the Minimal Clinically Important Difference in Athletes Undergoing Arthroscopic Correction of Sports-Related Femoroacetabular Impingement: The Percentage of Possible Improvement

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967119894747 ◽

2020 ◽

Vol 8 (1) ◽

pp. 232596711989474 ◽

Cited By ~ 1

Author(s):

Patrick Carton ◽

David Filan

Keyword(s):

Femoroacetabular Impingement ◽

Minimal Clinically Important Difference ◽

Harris Hip Score ◽

Baseline Score ◽

Clinically Important Difference ◽

Sf 36 ◽

Significant Difference ◽

Patient Reported ◽

Ceiling Effects ◽

The Impact

Background: Measures of clinically meaningful improvement in patient-reported outcomes within orthopaedics are becoming a minimum requirement to establish the success of an intervention. Purpose: To (1) define the minimal clinically important difference (MCID) at 2 years postoperatively in competitive athletes undergoing hip arthroscopic surgery for symptomatic, sports-related femoroacetabular impingement utilizing existing anchor- and distribution-based methods and (2) derive a measure of the MCID using the percentage of possible improvement (POPI) method and compare against existing techniques. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: There were 2 objective outcome measures—the modified Harris Hip Score (mHHS) and 36-Item Short Form Health Survey (SF-36)—administered at baseline and 2 years postoperatively. External anchor questions were used to determine the MCID through mean change, mean difference, and receiver operating characteristic (ROC) techniques. Distribution-based calculations consisted of 0.5 SD, effect size, and standard error of measurement techniques. The POPI was calculated alongside each technique as an achieved percentage change of maximum available improvement for each athlete relative to the individual baseline score. The impact of the preoperative baseline score on the MCID was assessed by assigning athletes to groups determined by baseline percentiles. Statistical analysis was performed, with P < .05 considered significant. Results: There were 576 athletes (96% male; mean age, 25.9 ± 5.7 years). The MCID score change (and POPI) for the mHHS and SF-36 ranged from 2.4 to 16.7 (21.6%-63.6%) and from 3.3 to 24.9 (22.1%-57.4%), respectively. The preoperative threshold value for achieving the ROC-determined MCID was 80.5 and 86.5 for the mHHS and 70.1 and 72.4 for the SF-36 for the patient-reported outcome measure (PROM) score– and POPI-calculated MCID, respectively. Through the commonly used mean change method, 40.0% (mHHS) and 42.4% (SF-36) of athletes were unable to achieve the MCID because of high baseline scores and PROM ceiling effects compared with 0% when the POPI technique was used. A highly significant difference for the overall MCID was observed between preoperative baseline percentile groups for the mHHS ( P = .014) and SF-36 ( P = .004) (improvement in points), while there was no significant difference between groups for either the mHHS ( P = .487) or SF-36 ( P = .417) using the POPI technique. Conclusion: The MCID defined by an absolute value of improvement was unable to account for postoperative progress in a large proportion of higher functioning athletes. The POPI technique negated associated ceiling effects, was unrestricted by the baseline score, and may be more appropriate in quantifying clinically important improvement.

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Hypertension referrals from community pharmacy to general practice: multivariate logistic regression analysis of 131 419 patients

British Journal of General Practice ◽

10.3399/bjgp18x697925 ◽

2018 ◽

Vol 68 (673) ◽

pp. e541-e550 ◽

Cited By ~ 10

Author(s):

Ali Albasri ◽

Suman Prinjha ◽

Richard J McManus ◽

James P Sheppard

Keyword(s):

General Practice ◽

Logistic Regression ◽

Side Effects ◽

Antihypertensive Medication ◽

Multivariate Logistic Regression Analysis ◽

Models Of Care ◽

Angiotensin Ii Receptor ◽

Multivariate Logistic Regression ◽

Related Factors ◽

Patient Reported

BackgroundThe burden of hypertension in primary care is high, and alternative models of care, such as pharmacist management, have shown promise. However, data describing outcomes from routine consultations between pharmacists and patients with hypertension are lacking.AimTo identify factors associated with referral of patients from pharmacies to general practice within the first 2 weeks of starting a new antihypertensive medication.Design and settingMultivariate logistic regression conducted on data from community pharmacies in England.MethodData were obtained from the New Medicine Service between 2011 and 2012. Analyses were conducted on 131 419 patients. In all, 15 predictors were included in the model, grouped into three categories: patient-reported factors, demographic factors, and medication-related factors.ResultsMean patient age was 65 years (±13 years), and 85% of patients were of white ethnicity. A total of 5895 (4.5%) patients were referred by a pharmacist to a GP within the first 2 weeks of starting a new antihypertensive medication. Patients reporting side effects (adjusted odds ratio [OR] 11.60, 95% confidence interval [CI] = 10.85 to 12.41) were most likely to be referred. Prescriptions for alpha-blockers were associated with referral (adjusted OR 1.28, 95% CI = 1.12 to 1.47), whereas patients receiving angiotensin-II receptor blockers were less likely to be referred (adjusted OR 0.89, 95% CI = 0.80 to 0.99).ConclusionMost patients were followed up by pharmacists without the need for referral. Patient-reported side effects, medication-related concerns, and the medication class prescribed influenced referral. These data are reassuring, in that additional pharmacist involvement does not increase medical workload appreciably, and support further development of pharmacist-led hypertension interventions.

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