Intra-articular hyaluronic acid in knee osteoarthritis: clinical data for a product family (ARTHRUM), with comparative meta-analyses.

INTRODUCTION: Viscosupplementation is widely practiced, to reduce pain in osteoarthritis (OA), using intra articular (IA) injections of hyaluronic acid (HA). In Europe, these products are class III medical devices, for which the Medical Device Regulation (MDR) requires clinical assessment, based on specific studies and/or a bibliographical review of equivalent devices. The purpose of this article is to present a comparative review between a family of devices (ARTHRUM, from LCA Pharmaceuticals, Chartres, France) and an extensive group of presumed equivalent IA HA devices or their controls, whose results have been published in Scientific journals. METHODS: To meet the criteria used in most ARTHRUM studies, the Western Ontario and McMaster Universities' index sub-scores were selected for pain (WOMAC A), stiffness (WOMAC B) and function (WOMAC C). The main criterion was the variation of the WOMAC A score from T0 (date of inclusion) to T6 (6 months). The other WOMAC criteria were assessed at T1, T3, T6 and complemented by OMERACT-OARSI rates of responders to the treatment. Fifty articles were selected, containing treatment details on more than 12,000 patients. These were divided into three groups: ARTHRUM, EQUIVALENTS and CONTROLS. To get quantitative comparisons, meta-analyses were performed for each criterion individually. The 95% confidence interval of each difference from baseline, was used to assess the clinical relevance, with reference to a minimum validated in OA literature. Comparisons between groups and tolerance assessment completed the investigation. RESULTS: For the WOMAC A, B and C scores, the full 95% CI was always above the minimal perceptible clinical improvement (MPCI), in the ARTHRUM and EQUIVALENTS groups, but not for all criteria in the CONTROLS group. In the comparisons, both ARTHRUM and EQUIVALENTS groups were significantly better than the CONTROLS group for each criterion. The effect size (ES) on pain, for the ARTHRUM and EQUIVALENTS groups, varied from 0.28 to 0.56 and from 0.23 to 0.27, respectively. Overall, ARTHRUM was estimated always non-inferior to EQUIVALENTS, and sometimes statistically and clinically superior. CONCLUSIONS: The comparison of ARTHRUM clinical studies, with studies selected through bibliographic research, leads to the conclusion that the clinical efficacy of the ARTHRUM medical devices, to reduce pain and improve the function in knee OA, during a six-month period, is at least as great as those of equivalent products. With good tolerance results (lowest rate of adverse events, and none of them serious), the risk benefit ratio favours using viscosupplementation with ARTHRUM.

Does early childhood education enhance parental school involvement in second grade?: Evidence from Midwest Child-Parent Center Program.

This paper examines the impact on parent involvement in second grade in the Midwest Child-Parent Centers (MCPC), a high-quality preschool-to-third-grade school reform model. A new focus of research on early childhood programs is understanding how early childhood learning gains can be sustained. Two-generation programs that provide diverse family services may be one approach. The MCPC expansion was implemented for a cohort of over 2000 Chicago and Saint Paul students beginning in preschool. Based on a comparison of the program and usual-service comparison groups matched at the school level via propensity scores, ratings were obtained for a subset of the sample by teachers and parents on parent involvement in school in second grade. After accounting for potential attrition bias via multiple imputation and propensity score weighting, results indicated that MCPC participation was associated with significantly higher parent involvement in school at the end of second grade both in the aggregate sample (Effect Size = 0.19 SD) and in Chicago (ES = 0.24). Differences in Saint Paul, however, were small (ES = 0.15) and not statistically significant. Robustness testing using different model specifications revealed similar results. Implications for assessing and sustaining early childhood learning gains are discussed with a focus on recognizing that parental involvement is an integral component of high-quality programs.

Mono-injection intra-articulaire d'acide hyaluronique dans la gonarthrose : Étude multicentrique prospective ouverte (ART-ONE 75) avec comparaison post hoc versus placebo.

INTRODUCTION: La viscosupplémentation du liquide synovial par injection intra-articulaire d'acide hyaluronique est un traitement symptomatique de l'arthrose, largement utilisé dans la gonarthrose (arthrose du genou). À côté des produits conçus pour être administrés par injections multiples (typiquement 3 à 5 injections à intervalles de 1 semaine), un intérêt particulier se porte sur produits en injection unique (mono-injection) qui offrent des avantages spécifiques tels que la réduction du nombre de visites au médecin et du nombre d'interventions invasives avec leurs risques associés. Il subsiste toutefois une question concernant l'efficacité de ces mono-injections, par rapport aux protocoles à injections multiples. MÉTHODES: Une étude post-commercialisation, prospective, multicentrique, ouverte (ART-ONE 75), a été réalisée avec le produit pour injection unique Arthrum 2,5 % (3 mL, 75 mg d'acide hyaluronique) (LCA Pharmaceutical, Chartres, France), sur 214 patients atteints de gonarthrose. Les patients ont été suivis à 30, 60, 120 et 180 jours. Le profil moyen des patients à l'inclusion était un âge de 62,9 ans, 56 % de femmes, un stade radiologique Kellgren-Lawrence de I à III (46 % KL III), un indice de masse corporelle de 27,2 kg/m2 et une antériorité de 4 ans pour la gonarthrose. Une comparaison post hoc a été réalisée par rapport à une injection intra-articulaire unique de placebo (326 patients regroupés à partir de 3 essais randomisés contrôlés), et présentant un profil similaire de patients. RÉSULTATS: Le critère principal était la variation par rapport à la baseline, de l'indice Western Ontario and McMaster Universities, sous-échelle de la douleur (WOMAC A) dont le score (base 0-100), était réduit à 60 jours, de 28,9 (17,4) pour la population en intention de traiter (199 patients), de 28,0 (17,8) pour la population per protocole à l'inclusion (175 patients), et de 27,7 (16.8) pour la population per protocole ayant terminé l'étude (143 patients). Les critères secondaires et accessoires comprenaient le score WOMAC A aux autres dates, le score WOMAC B (raideur), le score WOMAC C (fonction), la qualité de vie et le handicap à chaque date de suivi. Tous les indices étaient significativement améliorés et continuaient à s'améliorer à la fin de l'étude. L'évaluation thérapeutique à 180 jours a montré que plus de 75 % des patients étaient satisfaits de la réduction de la douleur, de l'amélioration de la mobilité et de la réduction de la consommation d'analgésiques et d'anti-inflammatoires non stéroïdiens. Le pourcentage de patients définis comme répondeurs selon les critères de l'OMERACT-OARSI Initiative était > 86 %, à partir de 60 jours. La tolérance globale était bonne, sans aucun évènement indésirable grave. Les résultats de la comparaison post hoc pour le score WOMAC A ont montré une taille d'effet variant de 0,33 (IC 95 % 0,15-0,51), à 60 jours à 0,65 (IC 95 % 0,45-0,85) à 180 jours (p < 0.001), versus placebo injecté (solution saline), qui est cliniquement significative en faveur d'Arthrum 2,5 %. CONCLUSION: La présente étude suggère l'efficacité clinique d'une mono-injection IA de 3 mL de solution viscoélastique contenant 75 mg d'AH natif de haut poids moléculaire (> 2 MDa).

Protein ingestion preserves proteasome activity during intense aseptic inflammation and facilitates skeletal muscle recovery in humans.

The ubiquitin-proteasome system (UPS) is the main cellular proteolytic system responsible for the degradation of normal and abnormal (e.g. oxidised) proteins. Under catabolic conditions characterised by chronic inflammation, the UPS is activated resulting in proteolysis, muscle wasting and impaired muscle function. Milk proteins provide sulphur-containing amino acid and have been proposed to affect muscle inflammation. However, the response of the UPS to aseptic inflammation and protein supplementation is largely unknown. The aim of this study was to investigate how milk protein supplementation affects UPS activity and skeletal muscle function under conditions of aseptic injury induced by intense, eccentric exercise. In a double-blind, cross-over, repeated measures design, eleven men received either placebo (PLA) or milk protein concentrate (PRO, 4×20 g on exercise day and 20 g/d for the following 8 days), following an acute bout of eccentric exercise (twenty sets of fifteen eccentric contractions at 30°/s) on an isokinetic dynamometer. In each trial, muscle biopsies were obtained from the vastus lateralis muscle at baseline, as well as at 2 and 8 d post exercise, whereas blood samples were collected before exercise and at 6 h, 1 d, 2 d and 8 d post exercise. Muscle strength and soreness were assessed before exercise, 6 h post exercise and then daily for 8 consecutive days. PRO preserved chymotrypsin-like activity and attenuated the decrease of strength, facilitating its recovery. PRO also prevented the increase of NF-κB phosphorylation and HSP70 expression throughout recovery. We conclude that milk PRO supplementation following exercise-induced muscle trauma preserves proteasome activity and attenuates strength decline during the pro-inflammatory phase.

Exercise volume load in women with breast cancer: Study protocol for the ABRACE randomized clinical trial.

Background: An increased number of breast cancer patients are challenged by acute and persistent treatment side effects. Oncology guidelines have been establishing physical exercise to counteract several treatment-related toxicities throughout cancer care. However, evidence regarding the optimal dose-response, feasibility, and the minimal resistance exercise volume and/or intensity remains unclear. The ABRACE Study will assess the impact of different resistance training volumes (i.e., single or multiple sets) combined with aerobic exercise on physical and psychological outcomes of breast cancer patients undergoing primary treatment. Methods: This study is a randomized, controlled, three-armed parallel trial. A total of 84 participants, aged ≥18 years, with breast cancer stages I-III, initiating adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed) will be randomized to multiple sets resistance training plus aerobic training group, single set resistance training plus aerobic training group or control group. Neuromuscular and cancer-related fatigue (primary outcomes), muscle strength, muscle thickness, muscle quality by echo intensity, body composition, cardiorespiratory capacity, functional performance, upper-body endurance and quality of life will be measured before and after the 12-week intervention. Our analysis will follow the intention-to-treat approach and per-protocol criteria, with additional sub-group analysis. Discussion: Findings support prescribing exercise during chemotherapy for breast cancer and elucidate the potential role of different resistance training volumes as a management strategy for physical and psychological impairments in women with early-stage breast cancer. Our main hypothesis is for superiority in physical and psychological outcomes for both training groups compared to the control group, with no difference between single or multiple sets groups. Trial registration: Clinical trials NCT03314168.

Meta-analysis of Saccharomyces cerevisiae on enhancement of growth performance, rumen fermentation and haemato-biochemical characteristics of growing goats.

The use of Saccharomyces cerevisiae (SC) feed additives to improve animal performance are on the increase; however, the results of the action of SC supplementation on goats performance indices are conflicting. Thus, the thrust of this meta-analysis was to examine the influence of dietary SC intervention on the growth performance, haemato-biochemical indices and ruminal fermentation characteristics of growing goats fed total mixed ration (TMR). The search conducted in Google Scholar, PubMed and Scopus databases using several keywords yielded 500 studies of which 16 full-text articles were utilised for study. Response variables were aggregated via a random-effects model. The results showed that goats fed SC experienced higher average daily gain (ADG) than the controls (as standardized mean difference, SMD = 2.14; 95% confidence interval, CI: 1.40 to 2.89). In converse, dietary SC intervention had a small impact on dry matter intake (DMI) and feed conversion ratio (FCR). Subgroup analysis demonstrated that SC type (active vs inactive) improved FCR and ADG in growing goats. Results suggested that SC preparation increased blood glucose, white blood cell (WBC), ruminal propionate and total volatile fatty acid levels. There is heterogeneity among the articles used in the study, and aspects of studied covariates explained the variation. In conclusion, this study indicated that dietary yeast can positively influence growth performance, haemato-biochemical indices, and rumen fermentation parameters of growing goats.

Photobiomodulation Associated With Conservative Treatment for Achilles Tendon Rupture: A Double-Blind, Superiority, Randomized Controlled Trial.

Objective: To investigate the effects of photobiomodulation on Achilles tendon rupture (ATR) treated conservatively. Design: Prospective, patient- and assessor-blinded, parallel, randomized controlled trial. Setting: Patients with acute ATR treated conservatively. Participants: Thirty-four male individuals with acute unilateral ATR treated conservatively (N=34), equally divided in 2 groups: photobiomodulation group (PBMG) and sham group, with mean age of 45.5±9.47 and 48.7±8.38 years, respectively. Intervention: All participants underwent through an immobilization period, followed by rehabilitation sessions (2 d/wk for 12 weeks) comprising strengthening, range of motion, and balance/weightbearing exercises. In PBMG, the tendon was irradiated with a photobiomodulation cluster (1 904 nm/50 mW infrared laser, 4 858 nm/50 mW infrared diodes, and 4 658 nm/40 mW red diodes; power density of 105 mW/cm2 per cluster area) during the immobilization period (2 d/wk for 8 weeks) and the sham group received a simulation of the procedure with no irradiation. Outcomes were assessed at the removal of the immobilization 12 and 16 weeks after tendon rupture. Main Outcome Measures: Primary outcome was the Achilles Tendon Rupture Score. Secondary outcomes included Numerical Pain Rating Scale at rest and during effort, plantar flexor strength, and ankle range of motion. Results: Both groups demonstrated an increase in the Achilles Tendon Rupture Score and improvements in range of motion, plantar flexor strength, and pain. There were no significant differences in outcomes between the 2 groups (P>.05) except in pain during walking, which was significantly lower in the PBMG in week 12 (P<.01, effect size=0.56) and week 16 (P<.01, effect size=0.55). Conclusion: Photobiomodulation associated with conservative treatment is not superior to conservative treatment alone for improving function in patients with acute ATR.

Innovation Inspired by COVID: A Virtual Treatment Program for Patients With Mild Cognitive Impairment at Mayo Clinic.

Limited access to mental health and behavioral interventions is a public health issue that predated and is further worsened by coronavirus disease 2019 (COVID-19) social distancing restrictions. The Healthy Action to Benefit Independence and Thinking (HABIT) program is a cognitive rehabilitation and wellness program for patients with a diagnosis of mild cognitive impairment and their partners that involves groups of up to 32 people (16 dyads) at a time. Thus, the public health recommendation to avoid groups at the start of the COVID-19 pandemic immediately impacted our ability to offer this treatment protocol. This brief report provides patient and partner satisfaction data as well as clinical outcomes with a virtual adaptation of the HABIT program developed because of the COVID-19 pandemic. At the time of their participation, patients who attended in-person sessions had an average age of 74.4 years and those who attended virtual sessions had an average age of 75.4 years (P=.60). Both groups had an average of 16.3 years of education (P=.95). Approximately half of the patients in both groups were male (30 of 57 [53%]), most were White (54 of 57 [95%]) and were accompanied to the program by a spouse (50 of 57 [88%]). Overall, patient and partner satisfaction with the HABIT program remained high, ranging from a mean score of 5.8 to 6.6 on a rating scale of 1 to 7 for patients and partners, and clinical outcomes remained consistent with our face-to-face formatting when compared with pre-COVID pandemic sessions. The most notable changes across both formats were improvements in patient anxiety (Cohen's d=0.25 face-to-face; d=0.39 virtual), partner anxiety (d=0.37 face-to-face; d=0.34 virtual), and partner depression (d=0.37 face-to-face; d=0.35 virtual). This preliminary program evaluation suggests that transitioning the HABIT program to virtual formatting provides high-quality care similar to our in-person care models. Ongoing program evaluation is planned as we continue using virtual treatment for safety. Even after COVID-19 pandemic public health restrictions are lifted, these findings will have continued relevance to ongoing demand for telehealth.

Construct validity and responsiveness of commonly used patient reported outcome instruments in decompression for lumbar spinal stenosis.

BACKGROUND: Validity and responsiveness of Oswestry disability index (ODI), Roland Morris disability questionnaires (RMDQ), Short Form-12 Physical Component Score (SF-12 PCS) and Short Form-12 Mental Component Score (SF-12 MCS) in patients undergoing open decompression for lumbar canal stenosis has not been previously reported. METHODS: Outcome assessment was prospectively evaluated using the ODI, RMDQ, SF-12 PCS and SF-12 MCS pre-intervention and at average follow-up of three months post-intervention. Pearson correlation coefficient was used to evaluate the association between change in values of ODI, RMDQ, SF-12 PCS and SF-12 MCS. Distribution based methods (Effect size [ES], standardised response mean [SRM]) and anchor based method (Area under the curve [AUC] of receiver operating curve [ROC]) were used to determine responsiveness. AUC value ≥ 0.70 is considered as adequate level of responsiveness and the outcome instrument with the largest AUC is considered to be the most responsive outcome instrument. RESULTS: This study included 77 participants. Responsiveness was assessed at a mean follow-up of 12 weeks postoperatively. There was significant strong correlation between ODI and RMDQ (r = 0.65, p < 0.0001). The ES of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 1.54, 1.48, 1.85 and 0.51 respectively. The SRM of RMDQ, ODI, SF-12 PCS and SF-12 MCS were 1.22, 1.17, 1.0 and 0.47 respectively. AUC of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 0.83-0.88, 0.82 to 0.86, 0.78 to 0.81 and 0.69 to 0.70 respectively. CONCLUSION: It is recommended to use either ODI or RMDQ as region specific patient reported outcome instrument and SF-12 PCS as a health related quality of life outcome instrument to evaluate outcome after decompressive laminectomy for lumbar canal stenosis.

Pelvic region bone density, soft tissue mass, and injury frequency in female professional ballet dancers and soccer athletes.

We recently observed a high prevalence of low pelvic bone mineral density (BMD) in female professional ballet performers. Because this population is susceptible to musculoskeletal overuse injuries, we aimed to determine which regions of the pelvis may be at greatest risk compared to general population females (GENPOP) as well as professional female soccer players (SOCCER, a comparison to other elite athletes regularly subjected to high degrees of loading). Three groups of age-matched females [(GENPOP; n = 38, 27±1yrs), (BALLET; single company, n = 36, 26±3yrs), (SOCCER; single NWSL® club, n = 34, 25±1yrs)] consented to have their BMD and body composition assessed (DEXA, GE®). In addition to soft tissue and total and regional BMD analyses, a segmental analysis of the pelvis was performed to determine site-specific BMD for the iliac fossa, iliac fossa/iliac crest/ilium combined, pubic bone, ischium, and sacrum. A mixed-model ANOVA followed by a Tukey's post-hoc test was used to compare the groups (Type-I error; α = 0.05). The BALLET group had lower pelvic BMD for all measures (Avg.%Diff. = 15%-27%, p<0.001) compared to the SOCCER group and for the ischium (Avg.%Diff.= 8%; p=0.007) and sacrum (Avg.%Diff. â€‹= â€‹7%; p = 0.028) compared to the GENPOP group. The BALLET group had lower lean mass for all measures compared to the other groups (Avg.%Diff. = 12%-18%; p < 0.01). Professional ballet performers exhibit reduced pelvic region soft tissue and site-specific BMD not previously detected using standard DEXA analyses. These findings highlight which pelvic regions may benefit from preventative strength training and/or nutritional interventions.

The effect of teacher-delivered nutrition education programs on elementary-aged students: An updated systematic review and meta-analysis.

Research shows that schools can make a positive impact on children's nutritional outcomes. However, it is also reported that schools and teaching staff note many barriers, which may restrict nutritional education programming and delivery. This is concerning, considering the view that teachers are the key agents for promoting health and nutrition within schools. The purpose of the updated systematic review and meta-analysis was to ascertain the impact that nutrition education programs have on elementary-aged students' energy intake, fruit, vegetable, sugar consumption and nutritional knowledge. A systematic literature search was conducted using electronic databases (The Cochrane Central Register of Controlled Trials (CENTRAL); A + Education; ERIC; PsycINFO; MEDLINE; ProQuest Central, Journals@Ovid and SAGE Health Sciences Full-Text Collection) from 1990 to 31st October 2018. This process yielded 34 studies for inclusion in this systematic review and meta-analysis. Of these studies, seven studies had a focus on energy intake, five had a focus on sugar consumption, 21 of the studies looked at fruit and vegetable consumption and 13 studies focused on nutritional knowledge. The results suggest that the teaching of nutrition education in elementary schools by qualified teachers can make an important contribution to the knowledge and dietary habits of children. The small and medium effect sizes indicate that prudent, evidence-based decisions need to be made by policy makers and pedagogues as to the teaching strategies employed when delivering nutrition education programs to elementary-aged students. The review is reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (van Sluijs et al., 2007).

Should we use liver grafts repeatedly refused by other transplant teams?

BACKGROUND & AIMS: In France, liver grafts that have been refused at least 5 times can be "rescued" and allocated to a centre which chooses a recipient from its own waiting list, outside the patient-based allocation framework. We explored whether these "rescued" grafts were associated with worse graft/patient survival, as well as assessing their effect on survival benefit. METHODS: Among 7,895 candidates, 5,218 were transplanted between 2009 and 2014 (336 centre-allocated). We compared recipient/graft survival between patient allocation and centre allocation, considering a selection bias and the distribution of centre-allocation recipients among the transplant teams. We used a propensity score approach and a weighted Cox model using the inverse probability of treatment weighting method. We also explored the survival benefit associated with centre-allocation grafts. RESULTS: There was a significantly higher risk of graft loss/death in the centre allocation group compared to the patient allocation group (hazard ratio 1.13; 95% CI 1.05-1.22). However, this difference was no longer significant for teams that performed more than 7% of the centre-allocation transplantations. Moreover, receiving a centre-allocation graft, compared to remaining on the waiting list and possibly later receiving a patient-allocation graft, did not convey a poorer survival benefit (hazard ratio 0.80; 95% CI 0.60-1.08). CONCLUSIONS: In centres which transplanted most of the centre-allocation grafts, using grafts repeatedly refused for top-listed candidates was not detrimental. Given the organ shortage, our findings should encourage policy makers to restrict centre-allocation grafts to targeted centres. LAY SUMMARY: "Centre allocation" (CA) made it possible to save 6 out of 100 available liver grafts that had been refused at least 5 times for use in the top-listed candidates on the national waiting list. In this series, the largest on this topic, we showed that, in centres which transplanted most of the CA grafts, using grafts repeatedly refused for top-listed candidates did not appear to be detrimental. In the context of organ shortage, our results, which could be of interest for any country using this CA strategy, should encourage policy makers to reassess some aspects of graft allocation by restricting CA grafts to targeted centres, fostering the "best" matching between grafts and candidates on the waiting list.

Gene interactions observed with the HDL-c blood lipid, intakes of protein, sugar and biotin in relation to circulating homocysteine concentrations in a group of black South Africans.

BACKGROUND: Elevated homocysteine (Hcy) is associated with several pathologies. Gene-diet interactions related to Hcy might be used to customize dietary advice to reduce disease incidence. To explore this possibility, we investigated interactions between anthropometry, biochemical markers and diet and single-nucleotide polymorphisms (SNPs) in relation to Hcy concentrations. Five SNPs of Hcy-metabolizing enzymes were analyzed in 2010 black South Africans. RESULTS: Hcy was higher with each additional methylenetetrahydrofolate reductase (MTHFR) C677T minor allele copy, but was lower in methionine synthase (MTR) 2756AA homozygotes than heterozygotes. Individuals harboring cystathionine ß synthase (CBS) 833 T/844ins68 had lower Hcy concentrations than others. No interactive effects were observed with any of the anthropometrical markers. MTHFR C677T and CBS T833C/844ins68 homozygote minor allele carriers presented with lower Hcy as high density lipoprotein cholesterol (HDL-c) increased. Hcy concentrations were negatively associated with dietary protein and animal protein intake in the TT and TC genotypes, but positively in the CC genotype of CBS T833C/844ins68. Hcy was markedly higher in TT homozygotes of MTHFR C677T as added sugar intake increased. In CBS T833C/844ins68 major allele carriers, biotin intake was negatively associated with Hcy; but positively in those harboring the homozygous minor allele. CONCLUSIONS: The Hcy-SNP associations are modulated by diet and open up the possibility of invoking dietary interventions to treat hyperhomocysteinemia. Future intervention trials should further explore the observed gene-diet and gene-blood lipid interactions.

Is the modified Harris hip score valid and responsive instrument for outcome assessment in the Indian population with pertrochanteric fractures?

INTRODUCTION: The original Harris hip score (HHS) does not contain ability to perform squatting and sitting cross legged as items in the questionnaire and hence a need was felt to modify the Harris hip score so that it could stay relevant in functional assessment of Indian patients in the rural setting. Validity, responsiveness and ceiling floor effect of the Harris hip score after internal fixation of pertrochanteric fracture has not been previously described. The objective of the study was to investigate construct validity, responsiveness and ceiling floor effects of the modified Harris hip score (mHHS). METHODS: For evaluation of construct validity two hypotheses were formulated: first, there would be no difference in mHHS in cohort of patients treated with short or long proximal femoral nail and second, patients younger than 65 years will have higher mHHS compared to patients older than 65 years postoperatively. Proportion of patients obtaining lowest score of 0 point (floor effect) and those obtaining highest score of 100 points (ceiling effect) was evaluated at one, three and six months postoperatively. It is recommended that the proportion of ceiling and floor effect should be lower than 15% in order to deduce satisfactory internal and content validity of an outcome instrument. Responsiveness was evaluated using distribution based methods (effect size and standardised response mean) and anchor based method (area under the curve using receiver operating curve). Ability to perform cross leg sitting and squatting at six months postoperatively were chosen as two different external anchors. Effect size and standardised response mean values higher than 0.80 and area under the curve value higher than 0.70 are indicators of adequate responsiveness of an outcome instrument. RESULTS: Eighty one consecutive patients with pertrochanteric hip fractures and treated with long and short proximal femoral nail were included in this prospective observational study. Six patients were lost to follow-up due to mortality and complete functional outcome data was available in 75 patients (92.6%). The mean age was 68 years (range: 38-89 years). The mHHS at one, three and six months postoperatively was 39.9 ±â€¯9.5, 61.6 ±â€¯14.7 and 81.0 ±â€¯15.9 respectively. The improvement in mHHS was significant at all time intervals. In accordance with the hypothesis, there was no significant difference in mHHS at one, three and six months postoperatively in patients treated with short or long proximal femoral nail. In accordance with the hypothesis, patients younger than 65 years had significantly better mHHS at one, three and six months postoperatively as compared to patients older than 65 years. There were no floor or ceiling effects at one, three and six months postoperatively. mHHS showed adequate internal responsiveness (Effect size = 4.34; standardised response mean = 4.26) and adequate external responsiveness (Area under curve = 0.77 and 0.89) using different external anchors. CONCLUSION: The mHHS has adequate construct validity, internal validity and responsiveness to evaluate functional outcome of intramedullary nail fixation in pertrochanteric hip fractures in the Indian population.